India is racing ahead with work on its coronavirus vaccine as countries around the world sought to conquer the pandemic and rescue their economies. 
 
<a href="https://www.wionews.com/india-news/these-three-indian-companies-are-ready-to-produce-covid-19-vaccine-342884">Also read: These three Indian companies are ready to produce Covid-19 vaccine</a> 
 
Companies like Zydus Cadila, Serum Institute and Bharat Biotech are at the forefront of research on covid vaccines and are likely to be among the leading manufacturers as and when their commercial application is permitted. 
 
Also read |&nbsp;<a href="https://www.wionews.com/india-news/confident-that-covid-19-vaccine-will-be-ready-in-3-4-months-indias-health-minister-344051">Confident that Covid-19 vaccine will be ready in 3-4 months: India's health minister</a>

Serum Institute of India's CEO Adar Poonawalla on Thursday said the Oxford COVID-19 vaccine should be available for healthcare workers and elderly people by around February 2021 and by April for the general public and will be priced at a maximum of ₹ 1,000 for two necessary doses for the public, depending on the final trial results and regulatory approvals.

Probably by 2024, every Indian will get vaccinated, he said at a media event.

"It will probably take two or three years for every Indian to get inoculated, not just because of the supply constraints but because you need the budget, the vaccine, logistics, infrastructure and then, people should be willing to take the vaccine. So these are the factors that lead up to being able to vaccinate 80-90 per cent of the population.

"It will be 2024 for everybody, if willing to take a two-dose vaccine, to be vaccinated," Mr Poonawalla said.

Asked at what price the public will get it, he said it will be around USD 5-6 per dose with an MRP of around ₹ 1,000 for the two necessary doses.

"The government of India will be getting it at a far cheaper price at around USD 3-4, because it will be buying in a large volume and get access to the price that is similar to what COVAX has got. We are still pricing it far cheaper and more affordable than other vaccines we have in the market today," Mr Poonawalla said.

Asked about the efficacy of the vaccine, he said the Oxford-Astrazeneca vaccine is so far proving to work very well even in elderly people, which was a concern earlier.

"It has induced a good T-cell response, which is an indicator for your long-term immunity and antibody response but then again, time will only tell if these vaccines are going to protect you in the long term. Nobody can answer that for any of the vaccines today," Mr Poonawalla said.

Responding to a question on the safety aspect, he said there has been no major complaints, reactions or adverse events, adding, "We would need to wait and see. The efficacy and immunogenicity results from the Indian trials will come out in about a month-and-a-half."

(With inputs from agencies)

India is racing ahead with work on its coronavirus vaccine as countries around the world sought to conquer the pandemic and rescue their economies. Also read: These three Indian companies are ready to produce Covid-19 vaccine Companies like Zydus Cadila, Serum Institute and Bharat Biotech are at the forefront of research on covid vaccines and are likely to be among the leading manufacturers as and when their commercial application is permitted.

India is racing ahead with work on its coronavirus vaccine as countries around the world sought to conquer the pandemic and rescue their economies. Also read: These three Indian companies are ready to produce Covid-19 vaccine Companies like Zydus Cadila, Serum Institute and Bharat Biotech are at the forefront of research on covid vaccines and are likely to be among the leading manufacturers as and when their commercial application is permitted. Also read | Confident that Covid-19 vaccine will be ready in 3-4 months: India's health minister Serum Institute of India's CEO Adar Poonawalla on Thursday said the Oxford COVID-19 vaccine should be available for healthcare workers and elderly people by around February 2021 and by April for the general public and will be priced at a maximum of ₹ 1,000 for two necessary doses for the public, depending on the final trial results and regulatory approvals. Probably by 2024, every Indian will get vaccinated, he said at a media event. "It will probably take two or three years for every Indian to get inoculated, not just because of the supply constraints but because you need the budget, the vaccine, logistics, infrastructure and then, people should be willing to take the vaccine. So these are the factors that lead up to being able to vaccinate 80-90 per cent of the population. "It will be 2024 for everybody, if willing to take a two-dose vaccine, to be vaccinated," Mr Poonawalla said. Asked at what price the public will get it, he said it will be around USD 5-6 per dose with an MRP of around ₹ 1,000 for the two necessary doses. "The government of India will be getting it at a far cheaper price at around USD 3-4, because it will be buying in a large volume and get access to the price that is similar to what COVAX has got. We are still pricing it far cheaper and more affordable than other vaccines we have in the market today," Mr Poonawalla said. Asked about the efficacy of the vaccine, he said the Oxford-Astrazeneca vaccine is so far proving to work very well even in elderly people, which was a concern earlier. "It has induced a good T-cell response, which is an indicator for your long-term immunity and antibody response but then again, time will only tell if these vaccines are going to protect you in the long term. Nobody can answer that for any of the vaccines today," Mr Poonawalla said. Responding to a question on the safety aspect, he said there has been no major complaints, reactions or adverse events, adding, "We would need to wait and see. The efficacy and immunogenicity results from the Indian trials will come out in about a month-and-a-half." (With inputs from agencies)

Oxford COVID-19 vaccine to be available for Indians by April 2021: Serum Institute Chief 

From Pfizer to Moderna, while vaccine makers are announcing efficacy rates of their shots - What do they mean for you? What's the next step? When will the vaccine finally reach you? WION's Molly Gambhir has the answers

Gravitas: Vaccine tracker

The United States' top infectious disease scientist on Monday hailed early trial results from Moderna's Covid-19 vaccine as "stunningly impressive," and said the findings were an emphatic validation of experimental mRNA technology that some had doubted.

In an interview with AFP, Anthony Fauci said he would have settled for injections that protected 70-75 percent of people from falling sick.

"The idea that we have a 94.5 percent effective vaccine is stunningly impressive. It is really a spectacular result that I don't think anybody had anticipated would be this good," he said.

Fauci leads the National Institutes of Allergies and Infectious Diseases (NIAID), which began co-developing the vaccine with the US biotech company in January, shortly after China shared the genetic sequence of the new coronavirus.

It is based on a relatively new technology that uses a synthetic version of a molecule called "messenger RNA" to hack into human cells, and effectively turn them into vaccine-making factories.

No vaccine based on this platform has ever been approved.

"There were many people who had reservations about using something that had not been tried and true over the years; in fact, some people even criticized us for that," said Fauci.

On Monday, Moderna and NIAID announced their preliminary results based on 95 of the 30,000 volunteers they had recruited who fell ill with Covid-19.

Of the 95, 90 had been in the trial's placebo group, and five in the group that received the drug, called mRNA-1273, translating to an efficacy rate of 94.5 percent.

Fauci recalled that some had questioned whether the vaccine would prevent severe forms of Covid-19, not just mild or moderate cases -- and this too had been resoundingly answered.

"There were 11 severe events, none in the vaccine group -- 11 in the placebo group, so that settles the question of whether it prevents severe disease, which it definitely does."

- 'The data speak for themselves' -

It follows a similarly impressive result from American pharmaceutical firm Pfizer and its German partner BioNTech last week, who reported an efficacy of 90 percent for their vaccine.

Asked whether it was too early to say if mRNA technology had now been proven, Fauci -- who is usually known for his cautious statements -- said the jury was definitely in.

"I think when you have two vaccines like this, that have proven to be greater than 90 percent effective, I think that mRNA is here, it's established itself, it doesn't need to prove anything anymore.

"The data speak for themselves; it isn't me, it isn't my opinion -- look at the data," he said.

Traditional virus vaccines use actual viruses that have to be grown in chicken eggs or fetal cell lines and are weakened so they don't harm people -- a process that can take many months.&nbsp;

By contrast, the Covid-19 mRNA vaccines deliver the genetic information needed to create a protein that lies on the surface of the virus -- called the spike protein -- directly to cells in the human body, which then grow it.

This primes the immune system to make antibodies to the actual virus, and has the major advantage of shortening vaccine development time to a matter of weeks, once scientists have the genetic sequence of the protein they want to create.

Fauci was keen to highlight the critical work of NIAID, which he said was responsible for developing a precise way to orient the spike protein molecule such that it elicited the strongest immune response.

But there are still some unanswered questions, including how long the immunity lasts.&nbsp;

Fauci said he was "certain" it would endure to some extent, as immune system cells called "memory B cells" remained on standby to generate new antibodies to the virus.

But for how long was unclear. "We don't know whether it's going to be a year, two years, three years, five years, we don't know," he said.

The vaccine could receive emergency approval in the US within a matter of weeks.

Looking forward, Fauci said he was worried about anti-vaccine sentiment in the United States, the country that has been the worst-hit by the pandemic.&nbsp;

"You've got to overcome that and convince people to get vaccinated, because a vaccine with a high degree of efficacy is of no use if nobody gets vaccinated."&nbsp;

The United States' top infectious disease scientist on Monday hailed early trial results from Moderna's Covid-19 vaccine as "stunningly impressive," and said the findings were an emphatic validation of experimental mRNA technology that some had doubted.

The United States' top infectious disease scientist on Monday hailed early trial results from Moderna's Covid-19 vaccine as "stunningly impressive," and said the findings were an emphatic validation of experimental mRNA technology that some had doubted. In an interview with AFP, Anthony Fauci said he would have settled for injections that protected 70-75 percent of people from falling sick. "The idea that we have a 94.5 percent effective vaccine is stunningly impressive. It is really a spectacular result that I don't think anybody had anticipated would be this good," he said. Fauci leads the National Institutes of Allergies and Infectious Diseases (NIAID), which began co-developing the vaccine with the US biotech company in January, shortly after China shared the genetic sequence of the new coronavirus. It is based on a relatively new technology that uses a synthetic version of a molecule called "messenger RNA" to hack into human cells, and effectively turn them into vaccine-making factories. No vaccine based on this platform has ever been approved. "There were many people who had reservations about using something that had not been tried and true over the years; in fact, some people even criticized us for that," said Fauci. On Monday, Moderna and NIAID announced their preliminary results based on 95 of the 30,000 volunteers they had recruited who fell ill with Covid-19. Of the 95, 90 had been in the trial's placebo group, and five in the group that received the drug, called mRNA-1273, translating to an efficacy rate of 94.5 percent. Fauci recalled that some had questioned whether the vaccine would prevent severe forms of Covid-19, not just mild or moderate cases -- and this too had been resoundingly answered. "There were 11 severe events, none in the vaccine group -- 11 in the placebo group, so that settles the question of whether it prevents severe disease, which it definitely does." - 'The data speak for themselves' - It follows a similarly impressive result from American pharmaceutical firm Pfizer and its German partner BioNTech last week, who reported an efficacy of 90 percent for their vaccine. Asked whether it was too early to say if mRNA technology had now been proven, Fauci -- who is usually known for his cautious statements -- said the jury was definitely in. "I think when you have two vaccines like this, that have proven to be greater than 90 percent effective, I think that mRNA is here, it's established itself, it doesn't need to prove anything anymore. "The data speak for themselves; it isn't me, it isn't my opinion -- look at the data," he said. Traditional virus vaccines use actual viruses that have to be grown in chicken eggs or fetal cell lines and are weakened so they don't harm people -- a process that can take many months. By contrast, the Covid-19 mRNA vaccines deliver the genetic information needed to create a protein that lies on the surface of the virus -- called the spike protein -- directly to cells in the human body, which then grow it. This primes the immune system to make antibodies to the actual virus, and has the major advantage of shortening vaccine development time to a matter of weeks, once scientists have the genetic sequence of the protein they want to create. Fauci was keen to highlight the critical work of NIAID, which he said was responsible for developing a precise way to orient the spike protein molecule such that it elicited the strongest immune response. But there are still some unanswered questions, including how long the immunity lasts. Fauci said he was "certain" it would endure to some extent, as immune system cells called "memory B cells" remained on standby to generate new antibodies to the virus. But for how long was unclear. "We don't know whether it's going to be a year, two years, three years, five years, we don't know," he said. The vaccine could receive emergency approval in the US within a matter of weeks. Looking forward, Fauci said he was worried about anti-vaccine sentiment in the United States, the country that has been the worst-hit by the pandemic. "You've got to overcome that and convince people to get vaccinated, because a vaccine with a high degree of efficacy is of no use if nobody gets vaccinated."

Moderna vaccine results 'stunningly impressive,' Fauci says

The Belgian government intends to make any coronavirus vaccine available to around 70 per cent of the population, some eight million people, and free of charge.

Brussels expects the first vaccines to come on stream from early next year. The jab will not be compulsory.

Belgium, population 11.5 million, has registered almost 540,000 cases of coronavirus and more than 14,000 deaths to date. Its death rate per million residents is one of the worst in Europe.

As an EU member state Belgium is engaged in bloc-wide procedures for bulk purchases of anti-Covid-19 vaccines once they emerge in the coming months.

Earlier Monday, Brussels indicated it was signing a contract with German pharmaceutical company CureVac for another potential Covid-19 vaccine, bringing to five the number of vaccines in the bloc's portfolio and a sixth on the way from US firm Moderna.

Belgium itself has so far signed up to receive 7.7 million doses from AstraZeneca (administered in two doses) and a further 5.5 million from Johnson &amp; Johnson, national news agency Belga reported.

Distribution of any vaccine in EU states will only go ahead, however, once they are seen as safe and effective and that requires the green light from regulator the European Medicines Agency.

The Belgian government intends to make any coronavirus vaccine available to around 70 per cent of the population, some eight million people, and free of charge. Brussels expects the first vaccines to come on stream from early next year.

The Belgian government intends to make any coronavirus vaccine available to around 70 per cent of the population, some eight million people, and free of charge. Brussels expects the first vaccines to come on stream from early next year. The jab will not be compulsory. Belgium, population 11.5 million, has registered almost 540,000 cases of coronavirus and more than 14,000 deaths to date. Its death rate per million residents is one of the worst in Europe. As an EU member state Belgium is engaged in bloc-wide procedures for bulk purchases of anti-Covid-19 vaccines once they emerge in the coming months. Earlier Monday, Brussels indicated it was signing a contract with German pharmaceutical company CureVac for another potential Covid-19 vaccine, bringing to five the number of vaccines in the bloc's portfolio and a sixth on the way from US firm Moderna. Belgium itself has so far signed up to receive 7.7 million doses from AstraZeneca (administered in two doses) and a further 5.5 million from Johnson & Johnson, national news agency Belga reported. Distribution of any vaccine in EU states will only go ahead, however, once they are seen as safe and effective and that requires the green light from regulator the European Medicines Agency.

Coronavirus vaccine to be free in Belgium

Johnson &amp; Johnson launched a new large-scale late-stage trial on Monday to test a two-dose regimen of its experimental COVID-19 vaccine and evaluate potential incremental benefits for the duration of protection with a second dose.

The U.S. drugmaker plans to enrol up to 30,000 participants for the study and run it in parallel with a one-dose trial with as many as 60,000 volunteers that began in September.

The UK arm of the study is aiming to recruit 6,000 participants and the rest will join from other countries with a high incidence of COVID-19 cases such as the United States, Belgium, Colombia, France, Germany, the Philippines, South Africa and Spain, it said.

They will be given a first dose of either a placebo or the experimental shot, currently called Ad26COV2, followed by a second dose or placebo 57 days later, said Saul Faust, a professor of paediatric immunology and infectious diseases who is co-leading the trial at University Hospital Southampton.

The trial follows positive interim results from the company`s ongoing early to mid stage clinical study that showed a single dose of its vaccine candidate induced a robust immune response and was generally well-tolerated.

"The study will assess efficacy of the investigational vaccine after both the first and second dose to evaluate protection against the virus and potential incremental benefits for duration of protection with a second dose," J&amp;J said in a statement.

Rival drugmakers Pfizer and BioNtech said last week that their potential COVID-19 shot showed more than 90% efficacy in interim data from a late-stage trial, boosting hopes that vaccines against the pandemic disease may be ready for use soon.

While the Pfizer-BioNtech vaccine uses a new technology known as messenger RNA, J&amp;J`s uses a cold virus to deliver genetic material from the coronavirus into the body to prompt an immune response.

The platform, called AdVac, is also used in an Ebola vaccine that was approved earlier this year.

"It`s really important that we pursue trials of many different vaccines from many different manufacturers and be able then to ensure the supply both to the UK and global population," Faust told reporters at a briefing.

Recruitment into the study will complete in March 2021 and the trial will last for 12 months.

Johnson & Johnson launched a new large-scale late-stage trial on Monday to test a two-dose regimen of its experimental COVID-19 vaccine and evaluate potential incremental benefits for the duration of protection with a second dose.

Johnson & Johnson launched a new large-scale late-stage trial on Monday to test a two-dose regimen of its experimental COVID-19 vaccine and evaluate potential incremental benefits for the duration of protection with a second dose. The U.S. drugmaker plans to enrol up to 30,000 participants for the study and run it in parallel with a one-dose trial with as many as 60,000 volunteers that began in September. The UK arm of the study is aiming to recruit 6,000 participants and the rest will join from other countries with a high incidence of COVID-19 cases such as the United States, Belgium, Colombia, France, Germany, the Philippines, South Africa and Spain, it said. They will be given a first dose of either a placebo or the experimental shot, currently called Ad26COV2, followed by a second dose or placebo 57 days later, said Saul Faust, a professor of paediatric immunology and infectious diseases who is co-leading the trial at University Hospital Southampton. The trial follows positive interim results from the company`s ongoing early to mid stage clinical study that showed a single dose of its vaccine candidate induced a robust immune response and was generally well-tolerated. "The study will assess efficacy of the investigational vaccine after both the first and second dose to evaluate protection against the virus and potential incremental benefits for duration of protection with a second dose," J&J said in a statement. Rival drugmakers Pfizer and BioNtech said last week that their potential COVID-19 shot showed more than 90% efficacy in interim data from a late-stage trial, boosting hopes that vaccines against the pandemic disease may be ready for use soon. While the Pfizer-BioNtech vaccine uses a new technology known as messenger RNA, J&J`s uses a cold virus to deliver genetic material from the coronavirus into the body to prompt an immune response. The platform, called AdVac, is also used in an Ebola vaccine that was approved earlier this year. "It`s really important that we pursue trials of many different vaccines from many different manufacturers and be able then to ensure the supply both to the UK and global population," Faust told reporters at a briefing. Recruitment into the study will complete in March 2021 and the trial will last for 12 months.

Johnson & Johnson starts two-dose trial of its COVID-19 vaccine candidate

Britain will be the first country to run final stage trials of an experimental coronavirus vaccine being developed by the pharmaceutical company Janssen.

Scientists will begin recruiting some 6,000 people across the UK on Monday for the 12-month trial. The research will start first in Britain but aims to recruit a total of 30,000 people in six countries around the world.

Janssen is a subsidiary of Johnson &amp; Johnson.

The vaccine shot uses a harmless cold virus to deliver the spike protein of the coronavirus into the body, which scientists hope will prompt an immune response.

Half of the people in the new UK study will be given a placebo vaccine of saline.

Researchers are hoping to recruit people from groups disproportionately affected by COVID-19, including older people and those of ethnic minorities.

The Jannsen vaccine is among the six experimental coronavirus vaccines that Britain has ordered as part of a planned 350 million-dose stockpile.

Britain will be the first country to run final stage trials of an experimental coronavirus vaccine being developed by the pharmaceutical company Janssen. Scientists will begin recruiting some 6,000 people across the UK on Monday for the 12-month trial.

Britain will be the first country to run final stage trials of an experimental coronavirus vaccine being developed by the pharmaceutical company Janssen. Scientists will begin recruiting some 6,000 people across the UK on Monday for the 12-month trial. The research will start first in Britain but aims to recruit a total of 30,000 people in six countries around the world. Janssen is a subsidiary of Johnson & Johnson. The vaccine shot uses a harmless cold virus to deliver the spike protein of the coronavirus into the body, which scientists hope will prompt an immune response. Half of the people in the new UK study will be given a placebo vaccine of saline. Researchers are hoping to recruit people from groups disproportionately affected by COVID-19, including older people and those of ethnic minorities. The Jannsen vaccine is among the six experimental coronavirus vaccines that Britain has ordered as part of a planned 350 million-dose stockpile.

UK to run final stage trials of Janssen Covid vaccine

With the prospect that a coronavirus vaccine will become available for emergency use as soon as next month, states and cities are warning that distributing the shots to an anxious public could be hindered by inadequate technology, severe funding shortfalls and a lack of trained personnel.

While the Trump administration has showered billions of dollars on the companies developing the vaccines, it has left the logistics of inoculating and tracking as many as 20 million people by year’s end — and many tens of millions more next year — largely to local governments without providing enough money, officials in several localities and public health experts involved in the preparations said in interviews.

Public health departments, already strained by a pandemic that has overrun hospitals and drained budgets, are racing to expand online systems to track and share information about who has been vaccinated; to recruit and train hundreds of thousands of doctors, nurses and pharmacists to give people the shot and collect data about everyone who gets it; to find safe locations for mass vaccination events; and to convince the public of the importance of getting immunized.

The federal Centers for Disease Control and Prevention have sent $200 million to the states for the effort, with another $140 million promised in December, but state and local officials said that was billions of dollars short of what would be needed to carry out their complex plans.

“We absolutely do not have enough to pull this off successfully,” said Dr. Thomas E. Dobbs III, the state health officer of Mississippi. “This is going to be a phenomenal logistical feat, to vaccinate everybody in the country. We absolutely have zero margin for failure. We really have to get this right.”

Health departments have asked Congress for at least $8.4 billion more for “a timely, comprehensive, and equitable vaccine distribution campaign”; the CDC director, Dr. Robert Redfield, has said that at least $6 billion is needed. But negotiations for further funding are caught up in the stalemate between House Democrats and the Trump administration over the coronavirus stimulus bill.

“There’s a lot of anxiety,” said Rebecca Coyle, executive director of the American Immunization Registry Association, which has been helping states prepare. “I don’t think we are ready today.”

Congress has allocated $10 billion to Operation Warp Speed, the federal effort subsidizing vaccine companies’ clinical trials and manufacturing costs. Dr. Mandy Cohen, the secretary of health and human services in North Carolina, said her state had received just $6 million for distributing and promoting the shot. She expects $3 million more by the end of the year and called the money “a down payment” for what is likely to be $30 million worth of work over the first year of vaccine distribution.

Dr. Nirav Shah, director of the Maine Center for Disease Control and Prevention, said that more than anything, insufficient funding would slow the rate of vaccination, particularly among disadvantaged populations that are harder to reach.

“The speed at which we vaccinate the population in Maine is directly dependent on the funding,” he said. “We will still get the job done, but it will take longer if I can’t train the people to give it.”

There are myriad other costs too — including, Shah noted, paying for secure convoys to transport the vaccine once it gets to states.

“We can’t just throw it into Bob’s pickup truck and drive it down the road,” he said.

One official working on distribution plans at the CDC, who did not have authorization to speak publicly, said the slow drip of money had made it difficult for states to carry out plans and to hire for vaccine-related jobs.

“It’s unfortunate and inefficient to do it this way,” the official said.

Preliminary plans that almost every state has shared with the CDC offer a glimpse of urgent preparations for a mass vaccination campaign larger than the United States has never seen. Although the vaccine will be available to only a very small slice of Americans at first, probably starting with health care workers, access could expand rapidly over the first half of 2021.

Michigan is enlisting pharmacies to tell their customers with chronic conditions — like diabetes, asthma and high blood pressure — about the vaccine, as they will be prioritized to get it. Tennessee is recruiting more than 1,000 volunteer doctors and nurses to help administer the vaccine initially. Nebraska is making plans to promote it on gas station video screens and in robocalls. New Hampshire — the only state without an online immunization registry — is scrambling to build one to track which residents have received the shot and to report the information to the CDC.

The first vaccine that is likely to be authorized by the Food and Drug Administration, made by Pfizer, comes with especially daunting logistical challenges, including the fact that every recipient will need a booster shot three weeks after the initial dose. Keeping track of which people need the follow-up dose, and getting them to return for it, are among the steepest hurdles that public health officials face. So is a requirement that providers report, for every dose administered, demographic and other data to their state within 24 hours; states, in turn, will quickly report it to the CDC.

A new federal platform, called the Immunization Gateway, aims to connect state vaccine registries so they can share information with one another — for example, if someone gets an initial coronavirus vaccine in New York and then goes to Florida for the winter, a doctor there can look up that person’s first dose information in order to give the correct second dose. But most registries have not yet connected to the platform. Between that and another new federal platform to track vaccines, public health officials are haunted by the spectacular crash of HealthCare.gov, the federal online insurance marketplace set up under the Affordable Care Act, when it went live in 2013 after being finished in a rush.

“A month before the vaccine is about to become available is not the time to think about making systems across 3,000 health departments in 50 states interoperable,” said Lori Freeman, chief executive of the National Association of County and City Health Officials. “It just doesn’t work.”

Addressing Americans’ wariness toward the vaccine — recent polls show that between a third and half of Americans would be reluctant to get it — is also hard, some state officials said, given that none has been approved yet and comprehensive safety data from the ongoing clinical trials has not been released.

“We don’t really have the safety studies available to quote from,” said Dr. Jennifer Dillaha, the medical director for immunizations with the Arkansas Department of Health. “What we’re trying to do is develop relationships with people and organizations that can help us with messaging when the time comes.”

Other unknowns include how many doses of vaccine each state will initially receive, which groups will the CDC will recommend to get it first and even whether states need to worry about building the ultracold storage capacity needed for the Pfizer vaccine.

The CDC has told states and localities not to buy ultracold freezers for now, since the Pfizer vaccine will be shipped in coolers with dry ice that can keep it viable for up to 15 days with re-icing; it can then last five additional days in a conventional freezer. But many academic medical centers and other hospitals that can afford it are acquiring colder freezers anyway, setting up a have and have-not scenario.

Record-keeping requirements will also be an overwhelming task, officials said. The CDC wants to track, in real time, the age, sex, race and ethnicity of everyone who is vaccinated — states usually provide such data quarterly, at best — so it can analyze how well the vaccination campaign is going among different demographic groups day by day and make adjustments if certain populations or regions have low vaccination rates.

The CDC, which holds frequent planning calls with state and local health officials, is also still working on persuading states to hand over the personal data of their citizens. In its data use agreement with the states, the agency has requested each vaccine recipient’s name, date of birth, address, race, ethnicity and certain medical history.

“States have never had to report that to the federal government,” said J.T. Lane, the chief population health and innovation officer of the Association of State and Territorial Health Officials, adding that his organization was seeking clarity on exactly how the information would be used.

In particular, the organization’s members worry that the information could be used by Immigrations and Customs Enforcement to track undocumented immigrants.

As soon as the FDA approves a vaccine, the CDC’s Advisory Committee on Immunization Practices will meet to issue recommendations, already in the works, on how it should be distributed. It will almost certainly say that health care workers should be the group with the highest priority for vaccination, followed by essential service workers, people with high-risk medical conditions and those older than 65.

But states will be allowed flexibility within those guidelines; Maryland, for example, plans to include its prison and jail populations in its “Phase 1” priority group. State officials also have to figure out whom to focus on within priority populations if they get less vaccine than they need.

During the CDC advisory committee’s meeting last month, some members said they wanted to ensure that information about any safety problems would be made public quickly. The Department of Health and Human Services has said its goal is to start shipping a vaccine within a day of FDA authorization. Until now, the FDA and the CDC have maintained one data system for patients or providers to report bad reactions to vaccines. They plan to supplement that system with a smartphone-based tool that checks in with individuals who have been vaccinated to see whether they have had any health problems.

The CDC advisory group has also stressed the importance of a campaign to persuade the public to take the vaccine, noting that messages were likely to be more effective if they came from community leaders than from the federal government. North Carolina says its campaign will use “photos, video, and personal testimony of celebrities, leaders of historically marginalized populations, and other trusted messengers receiving vaccine as early adopters.”

To ease the burden on health departments, the federal government is contracting with CVS and Walgreens pharmacies to vaccinate residents of nursing homes and other long-term-care centers around the country. But it could be difficult to reach those in isolated regions, and some might opt out of the program. Last week, the administration announced it would contract with pharmacies across the nation to provide the vaccine generally, as they do with flu shots, once supplies of it increase next year.

Christine Finley, the immunization program manager at the Vermont Department of Health, said her focus right now was enrolling hospitals to provide the first doses to health care workers and preparing a communications strategy. She hopes enthusiasm for the vaccine will grow once it gets through the approval process.

“A doctor the other day told me he thinks people may be much more hesitant about a theoretical vaccine than when we begin to see safety and efficacy data on a real one,” she said. “There are so many questions we’ve received, and so much interest, with the disease rate soaring — people saying, ‘We need a vaccine, now.’”

With the prospect that a coronavirus vaccine will become available for emergency use as soon as next month, states and cities are warning that distributing the shots to an anxious public could be hindered by inadequate technology, severe funding shortfalls and a lack of trained personnel.

With the prospect that a coronavirus vaccine will become available for emergency use as soon as next month, states and cities are warning that distributing the shots to an anxious public could be hindered by inadequate technology, severe funding shortfalls and a lack of trained personnel. While the Trump administration has showered billions of dollars on the companies developing the vaccines, it has left the logistics of inoculating and tracking as many as 20 million people by year’s end — and many tens of millions more next year — largely to local governments without providing enough money, officials in several localities and public health experts involved in the preparations said in interviews. Public health departments, already strained by a pandemic that has overrun hospitals and drained budgets, are racing to expand online systems to track and share information about who has been vaccinated; to recruit and train hundreds of thousands of doctors, nurses and pharmacists to give people the shot and collect data about everyone who gets it; to find safe locations for mass vaccination events; and to convince the public of the importance of getting immunized. The federal Centers for Disease Control and Prevention have sent $200 million to the states for the effort, with another $140 million promised in December, but state and local officials said that was billions of dollars short of what would be needed to carry out their complex plans. “We absolutely do not have enough to pull this off successfully,” said Dr. Thomas E. Dobbs III, the state health officer of Mississippi. “This is going to be a phenomenal logistical feat, to vaccinate everybody in the country. We absolutely have zero margin for failure. We really have to get this right.” Health departments have asked Congress for at least $8.4 billion more for “a timely, comprehensive, and equitable vaccine distribution campaign”; the CDC director, Dr. Robert Redfield, has said that at least $6 billion is needed. But negotiations for further funding are caught up in the stalemate between House Democrats and the Trump administration over the coronavirus stimulus bill. “There’s a lot of anxiety,” said Rebecca Coyle, executive director of the American Immunization Registry Association, which has been helping states prepare. “I don’t think we are ready today.” Congress has allocated $10 billion to Operation Warp Speed, the federal effort subsidizing vaccine companies’ clinical trials and manufacturing costs. Dr. Mandy Cohen, the secretary of health and human services in North Carolina, said her state had received just $6 million for distributing and promoting the shot. She expects $3 million more by the end of the year and called the money “a down payment” for what is likely to be $30 million worth of work over the first year of vaccine distribution. Dr. Nirav Shah, director of the Maine Center for Disease Control and Prevention, said that more than anything, insufficient funding would slow the rate of vaccination, particularly among disadvantaged populations that are harder to reach. “The speed at which we vaccinate the population in Maine is directly dependent on the funding,” he said. “We will still get the job done, but it will take longer if I can’t train the people to give it.” There are myriad other costs too — including, Shah noted, paying for secure convoys to transport the vaccine once it gets to states. “We can’t just throw it into Bob’s pickup truck and drive it down the road,” he said. One official working on distribution plans at the CDC, who did not have authorization to speak publicly, said the slow drip of money had made it difficult for states to carry out plans and to hire for vaccine-related jobs. “It’s unfortunate and inefficient to do it this way,” the official said. Preliminary plans that almost every state has shared with the CDC offer a glimpse of urgent preparations for a mass vaccination campaign larger than the United States has never seen. Although the vaccine will be available to only a very small slice of Americans at first, probably starting with health care workers, access could expand rapidly over the first half of 2021. Michigan is enlisting pharmacies to tell their customers with chronic conditions — like diabetes, asthma and high blood pressure — about the vaccine, as they will be prioritized to get it. Tennessee is recruiting more than 1,000 volunteer doctors and nurses to help administer the vaccine initially. Nebraska is making plans to promote it on gas station video screens and in robocalls. New Hampshire — the only state without an online immunization registry — is scrambling to build one to track which residents have received the shot and to report the information to the CDC. The first vaccine that is likely to be authorized by the Food and Drug Administration, made by Pfizer, comes with especially daunting logistical challenges, including the fact that every recipient will need a booster shot three weeks after the initial dose. Keeping track of which people need the follow-up dose, and getting them to return for it, are among the steepest hurdles that public health officials face. So is a requirement that providers report, for every dose administered, demographic and other data to their state within 24 hours; states, in turn, will quickly report it to the CDC. A new federal platform, called the Immunization Gateway, aims to connect state vaccine registries so they can share information with one another — for example, if someone gets an initial coronavirus vaccine in New York and then goes to Florida for the winter, a doctor there can look up that person’s first dose information in order to give the correct second dose. But most registries have not yet connected to the platform. Between that and another new federal platform to track vaccines, public health officials are haunted by the spectacular crash of HealthCare.gov, the federal online insurance marketplace set up under the Affordable Care Act, when it went live in 2013 after being finished in a rush. “A month before the vaccine is about to become available is not the time to think about making systems across 3,000 health departments in 50 states interoperable,” said Lori Freeman, chief executive of the National Association of County and City Health Officials. “It just doesn’t work.” Addressing Americans’ wariness toward the vaccine — recent polls show that between a third and half of Americans would be reluctant to get it — is also hard, some state officials said, given that none has been approved yet and comprehensive safety data from the ongoing clinical trials has not been released. “We don’t really have the safety studies available to quote from,” said Dr. Jennifer Dillaha, the medical director for immunizations with the Arkansas Department of Health. “What we’re trying to do is develop relationships with people and organizations that can help us with messaging when the time comes.” Other unknowns include how many doses of vaccine each state will initially receive, which groups will the CDC will recommend to get it first and even whether states need to worry about building the ultracold storage capacity needed for the Pfizer vaccine. The CDC has told states and localities not to buy ultracold freezers for now, since the Pfizer vaccine will be shipped in coolers with dry ice that can keep it viable for up to 15 days with re-icing; it can then last five additional days in a conventional freezer. But many academic medical centers and other hospitals that can afford it are acquiring colder freezers anyway, setting up a have and have-not scenario. Record-keeping requirements will also be an overwhelming task, officials said. The CDC wants to track, in real time, the age, sex, race and ethnicity of everyone who is vaccinated — states usually provide such data quarterly, at best — so it can analyze how well the vaccination campaign is going among different demographic groups day by day and make adjustments if certain populations or regions have low vaccination rates. The CDC, which holds frequent planning calls with state and local health officials, is also still working on persuading states to hand over the personal data of their citizens. In its data use agreement with the states, the agency has requested each vaccine recipient’s name, date of birth, address, race, ethnicity and certain medical history. “States have never had to report that to the federal government,” said J.T. Lane, the chief population health and innovation officer of the Association of State and Territorial Health Officials, adding that his organization was seeking clarity on exactly how the information would be used. In particular, the organization’s members worry that the information could be used by Immigrations and Customs Enforcement to track undocumented immigrants. As soon as the FDA approves a vaccine, the CDC’s Advisory Committee on Immunization Practices will meet to issue recommendations, already in the works, on how it should be distributed. It will almost certainly say that health care workers should be the group with the highest priority for vaccination, followed by essential service workers, people with high-risk medical conditions and those older than 65. But states will be allowed flexibility within those guidelines; Maryland, for example, plans to include its prison and jail populations in its “Phase 1” priority group. State officials also have to figure out whom to focus on within priority populations if they get less vaccine than they need. During the CDC advisory committee’s meeting last month, some members said they wanted to ensure that information about any safety problems would be made public quickly. The Department of Health and Human Services has said its goal is to start shipping a vaccine within a day of FDA authorization. Until now, the FDA and the CDC have maintained one data system for patients or providers to report bad reactions to vaccines. They plan to supplement that system with a smartphone-based tool that checks in with individuals who have been vaccinated to see whether they have had any health problems. The CDC advisory group has also stressed the importance of a campaign to persuade the public to take the vaccine, noting that messages were likely to be more effective if they came from community leaders than from the federal government. North Carolina says its campaign will use “photos, video, and personal testimony of celebrities, leaders of historically marginalized populations, and other trusted messengers receiving vaccine as early adopters.” To ease the burden on health departments, the federal government is contracting with CVS and Walgreens pharmacies to vaccinate residents of nursing homes and other long-term-care centers around the country. But it could be difficult to reach those in isolated regions, and some might opt out of the program. Last week, the administration announced it would contract with pharmacies across the nation to provide the vaccine generally, as they do with flu shots, once supplies of it increase next year. Christine Finley, the immunization program manager at the Vermont Department of Health, said her focus right now was enrolling hospitals to provide the first doses to health care workers and preparing a communications strategy. She hopes enthusiasm for the vaccine will grow once it gets through the approval process. “A doctor the other day told me he thinks people may be much more hesitant about a theoretical vaccine than when we begin to see safety and efficacy data on a real one,” she said. “There are so many questions we’ve received, and so much interest, with the disease rate soaring — people saying, ‘We need a vaccine, now.’”

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After Pfizer's claim that the COVID-19 vaccine is more than 90% effective based on initial trial results, a few volunteers said that they suffered side effects comparable to a flu jab, with one comparing them to "a severe hangover".

Around 43,500 people in six countries have taken part in the phase three trial run by the pharmaceutical giant and its partner BioNTech.

One of the volunteers of the trial, Texas lobbyist Glenn Deshields compared side effects of the shot as being similar to "a severe hangover" whereas another one, 45-year old Carrie said that she went through fever, body aches and headache after the second shot.&nbsp;

Carrie also said that signing up for the trial was a “civic duty” and said Monday’s positive news left her feeling “very proud”.She said that 'There are so many people who have had it and suffered.'She had received her first shot back in September and her second last month.

Pfizer and German partner BioNTech said they had found no serious safety concerns yet and expected to seek U.S. emergency use authorization this month, raising the chance of a regulatory decision as soon as December.

If granted, the companies estimate they can roll out up to 50 million doses this year, enough to protect 25 million people, and then produce up to 1.3 billion doses in 2021.

The Pfizer and BioNTech vaccine uses messenger RNA (mRNA) technology, which relies on synthetic genes that can be generated and manufactured in weeks and produced at scale more rapidly than conventional vaccines. The technology is designed to trigger an immune response without using pathogens, such as actual virus particles.

(With inputs from agencies)

After Pfizer's claim that the COVID-19 vaccine is more than 90% effective based on initial trial results, a few volunteers said that they suffered side effects comparable to a flu jab, with one comparing them to "a severe hangover".

After Pfizer's claim that the COVID-19 vaccine is more than 90% effective based on initial trial results, a few volunteers said that they suffered side effects comparable to a flu jab, with one comparing them to "a severe hangover". Around 43,500 people in six countries have taken part in the phase three trial run by the pharmaceutical giant and its partner BioNTech. One of the volunteers of the trial, Texas lobbyist Glenn Deshields compared side effects of the shot as being similar to "a severe hangover" whereas another one, 45-year old Carrie said that she went through fever, body aches and headache after the second shot. Carrie also said that signing up for the trial was a “civic duty” and said Monday’s positive news left her feeling “very proud”.She said that 'There are so many people who have had it and suffered.'She had received her first shot back in September and her second last month. Pfizer and German partner BioNTech said they had found no serious safety concerns yet and expected to seek U.S. emergency use authorization this month, raising the chance of a regulatory decision as soon as December. If granted, the companies estimate they can roll out up to 50 million doses this year, enough to protect 25 million people, and then produce up to 1.3 billion doses in 2021. The Pfizer and BioNTech vaccine uses messenger RNA (mRNA) technology, which relies on synthetic genes that can be generated and manufactured in weeks and produced at scale more rapidly than conventional vaccines. The technology is designed to trigger an immune response without using pathogens, such as actual virus particles. (With inputs from agencies)

Volunteers face 'severe hangover', headache and pain after getting Pfizer vaccine shot

The entire world is scrambling to formulate a potion for the coronavirus-ravaged human race -- a Covid-19 vaccine. And scientists have been successful too.

But the vaccines have unfortunately exhibited a few side-effects -- proving to be a setback for humanity and its survival in the face of the raging coronavirus pandemic.

Drugmakers and research centres around the world, however, continue to work on COVID-19 vaccines, with large global trials of several of the candidates involving tens of thousands of participants well underway.

Here's a status check of the global race to deliver vaccines to help end the coronavirus pandemic:

PFIZER INC

US drugmaker Pfizer Inc has become the first company to release preliminary data showing that their shot worked in late-stage clinical trials.

In a major victory in the war against a virus that has killed over a million people and battered the world's economy, Pfizer Inc said its experimental COVID-19 vaccine is more than 90% effective based on initial trial results.

The interim analysis, conducted after 94 participants in the trial developed COVID-19, examined how many had received the vaccine versus a placebo. Pfizer did not provide that detail, but over 90% effective implies that no more than 8 of the 94 had received the vaccine, administered in two shots about three weeks apart.

The efficacy rate, which could drop once full results are available, is well above the 50% effectiveness required by the US Food and Drug Administration for a coronavirus vaccine.

But this appeared a contentious as one of the volunteers of the trial, Texas lobbyist Glenn Deshields compared side effects of the shot as being similar to "a severe hangover" whereas another one, 45-year old Carrie said that she went through fever, body aches and headache after the second shot.

<a href="https://www.wionews.com/world/volunteers-face-severe-hangover-headache-and-pain-after-getting-pfizer-vaccine-shot-342518">READ FULL STORY&nbsp;</a>

Pfizer and German partner BioNTech, however, said they had found no serious safety concerns yet and expected to seek US&nbsp;emergency use authorisation this month, raising the chance of a regulatory decision as soon as December.

Shortly after Pfizer’s announcement, Russia said its Sputnik V vaccine was also more than 90% effective, based on data collated from inoculations of the public.

RUSSIA'S SPUTNIK V

Russia’s Sputnik V vaccine was found to be 92 per cent effective at protecting people from COVID-19 according to interim trial results, the country’s sovereign wealth fund said on November 11.

But this came at a cost.

Russia registered the vaccine for public use in August, the first country to do so, ahead of the start of the large-scale trial in September.

But soon after, Russian health minister Mikhail Murashko said that one in seven volunteers complained of side effects, including weakness and muscle pain after receiving the Sputnik V coronavirus vaccine.&nbsp;

Results of the phase 1/2 trials of the vaccine published in The Lancet showed no serious adverse effects and a stable immune response in 100 per cent of participants.

Despite this, Russian health authorities announced advanced trials of Sputnik V among 40,000 volunteers two weeks after it received government approval. Officials also said that vaccination of risk groups, such as doctors and teachers, will be carried out in parallel to the studies.

More than 55,000 volunteers had applied to take part in post-registration clinical trials of the Sputnik V vaccine -- the results of which were announced two days back.

Post-registration trials of Russia’s Sputnik V coronavirus vaccine revealed no new side effects, Director of the Gamaleya Scientific Research Institute of Epidemiology and Microbiology Alexander Gintsburg told the Rossiya-24 TV channel.

"These expanded trials have proved that about 15-17% of those vaccinated develop side effects, which means that 80% don’t have any issues after vaccination," Gintsburg added.

According to him, potential side effects include a small temperature rise for up to two days, redness at the injection site, headache and muscle discomfort.

According to the Russian Health Ministry, experience shows that such vaccines are capable of creating long-term immunity that lasts for up to two years.

ASTRAZENECA

AstraZeneca got the FDA’s all-clear to restart the US study of its COVID-19 vaccine almost three weeks back.

Although the agency couldn’t rule out a link between AstraZeneca’s vaccine and side effects observed in one patient, it did not find the vaccine was responsible for them.

At least two participants in AstraZeneca’s phase III trial had experienced transverse myelitis, an inflammatory syndrome that affects the spinal cord.

On September 11, AstraZeneca published a report saying “there was insufficient evidence to say for certain that the illnesses were or were not related to the vaccine.”

The British pharma company halted testing globally last month after the first case of transverse myelitis was reported.

The company has now resumed phase 3 trials in the UK, Brazil, South Africa and India, but not yet in the US.

AstraZeneca had also employed a blood-cancer medicine Calquence to help patients hospitalised with respiratory symptoms of Covid-19. But the group of patients taking the drug in addition to standard care didn’t show fewer deaths or respiratory failures, the drugmaker said in a statement.

Meanwhile, Serum Institute of India, the world's largest vaccine producer, has said it has made 40 million doses of AstraZeneca's potential Covid-19 vaccine, and will soon begin making Novavax's rival shot, as they both seek regulatory approval.

JOHNSON &amp; JOHNSON

Then came Johnson &amp; Johnson -- which paused its phase III vaccine trial after a volunteer experienced unexplained illness after receiving the shot.

The company didn’t disclose what the illness was. It’s also unclear whether the sick participant was in the actual vaccine group or in the placebo group.

"Adverse events—illnesses, accidents, etc.—even those that are serious, are an expected part of any clinical study, especially large studies," Johnson &amp; Johnson said in a statement.

CHINA'S SINOVAC

Brazil's health regulator halted clinical trials of the potential coronavirus vaccine CoronaVac, citing an “adverse, serious event.”

The decision posted on Anvisa's website this month elicited immediate surprise from parties involved in producing the vaccine.

The potential vaccine is being developed by Chinese biopharmaceutical firm Sinovac and in Brazil would be mostly produced by Sao Paulo's state-run Butantan Institute.

On November 12, Anvisa allowed the resumption of late-stage Brazilian clinical trials for Sinovac vaccine.

It was reported there had been no need to stop the study as the death had no relation to the vaccine.

Brazil has one of the world’s worst COVID-19 outbreaks, with more than 5.7 million confirmed cases and 163,000 deaths. And President Jair Bolsonaro has come under fire for his constant dismissal of the virus and its dangers.

(with inputs)

The entire world is scrambling to formulate a potion for the coronavirus-ravaged human race -- a Covid-19 vaccine. And scientists have been successful too. But the vaccines have unfortunately exhibited a few side-effects -- proving to be a setback for humanity and its survival in the face of the raging coronavirus pandemic.

The entire world is scrambling to formulate a potion for the coronavirus-ravaged human race -- a Covid-19 vaccine. And scientists have been successful too. But the vaccines have unfortunately exhibited a few side-effects -- proving to be a setback for humanity and its survival in the face of the raging coronavirus pandemic. Drugmakers and research centres around the world, however, continue to work on COVID-19 vaccines, with large global trials of several of the candidates involving tens of thousands of participants well underway. Here's a status check of the global race to deliver vaccines to help end the coronavirus pandemic: PFIZER INC US drugmaker Pfizer Inc has become the first company to release preliminary data showing that their shot worked in late-stage clinical trials. In a major victory in the war against a virus that has killed over a million people and battered the world's economy, Pfizer Inc said its experimental COVID-19 vaccine is more than 90% effective based on initial trial results. The interim analysis, conducted after 94 participants in the trial developed COVID-19, examined how many had received the vaccine versus a placebo. Pfizer did not provide that detail, but over 90% effective implies that no more than 8 of the 94 had received the vaccine, administered in two shots about three weeks apart. The efficacy rate, which could drop once full results are available, is well above the 50% effectiveness required by the US Food and Drug Administration for a coronavirus vaccine. But this appeared a contentious as one of the volunteers of the trial, Texas lobbyist Glenn Deshields compared side effects of the shot as being similar to "a severe hangover" whereas another one, 45-year old Carrie said that she went through fever, body aches and headache after the second shot. READ FULL STORY Pfizer and German partner BioNTech, however, said they had found no serious safety concerns yet and expected to seek US emergency use authorisation this month, raising the chance of a regulatory decision as soon as December. Shortly after Pfizer’s announcement, Russia said its Sputnik V vaccine was also more than 90% effective, based on data collated from inoculations of the public. RUSSIA'S SPUTNIK V Russia’s Sputnik V vaccine was found to be 92 per cent effective at protecting people from COVID-19 according to interim trial results, the country’s sovereign wealth fund said on November 11. But this came at a cost. Russia registered the vaccine for public use in August, the first country to do so, ahead of the start of the large-scale trial in September. But soon after, Russian health minister Mikhail Murashko said that one in seven volunteers complained of side effects, including weakness and muscle pain after receiving the Sputnik V coronavirus vaccine. Results of the phase 1/2 trials of the vaccine published in The Lancet showed no serious adverse effects and a stable immune response in 100 per cent of participants. Despite this, Russian health authorities announced advanced trials of Sputnik V among 40,000 volunteers two weeks after it received government approval. Officials also said that vaccination of risk groups, such as doctors and teachers, will be carried out in parallel to the studies. More than 55,000 volunteers had applied to take part in post-registration clinical trials of the Sputnik V vaccine -- the results of which were announced two days back. Post-registration trials of Russia’s Sputnik V coronavirus vaccine revealed no new side effects, Director of the Gamaleya Scientific Research Institute of Epidemiology and Microbiology Alexander Gintsburg told the Rossiya-24 TV channel. "These expanded trials have proved that about 15-17% of those vaccinated develop side effects, which means that 80% don’t have any issues after vaccination," Gintsburg added. According to him, potential side effects include a small temperature rise for up to two days, redness at the injection site, headache and muscle discomfort. According to the Russian Health Ministry, experience shows that such vaccines are capable of creating long-term immunity that lasts for up to two years. ASTRAZENECA AstraZeneca got the FDA’s all-clear to restart the US study of its COVID-19 vaccine almost three weeks back. Although the agency couldn’t rule out a link between AstraZeneca’s vaccine and side effects observed in one patient, it did not find the vaccine was responsible for them. At least two participants in AstraZeneca’s phase III trial had experienced transverse myelitis, an inflammatory syndrome that affects the spinal cord. On September 11, AstraZeneca published a report saying “there was insufficient evidence to say for certain that the illnesses were or were not related to the vaccine.” The British pharma company halted testing globally last month after the first case of transverse myelitis was reported. The company has now resumed phase 3 trials in the UK, Brazil, South Africa and India, but not yet in the US. AstraZeneca had also employed a blood-cancer medicine Calquence to help patients hospitalised with respiratory symptoms of Covid-19. But the group of patients taking the drug in addition to standard care didn’t show fewer deaths or respiratory failures, the drugmaker said in a statement. Meanwhile, Serum Institute of India, the world's largest vaccine producer, has said it has made 40 million doses of AstraZeneca's potential Covid-19 vaccine, and will soon begin making Novavax's rival shot, as they both seek regulatory approval. JOHNSON & JOHNSON Then came Johnson & Johnson -- which paused its phase III vaccine trial after a volunteer experienced unexplained illness after receiving the shot. The company didn’t disclose what the illness was. It’s also unclear whether the sick participant was in the actual vaccine group or in the placebo group. "Adverse events—illnesses, accidents, etc.—even those that are serious, are an expected part of any clinical study, especially large studies," Johnson & Johnson said in a statement. CHINA'S SINOVAC Brazil's health regulator halted clinical trials of the potential coronavirus vaccine CoronaVac, citing an “adverse, serious event.” The decision posted on Anvisa's website this month elicited immediate surprise from parties involved in producing the vaccine. The potential vaccine is being developed by Chinese biopharmaceutical firm Sinovac and in Brazil would be mostly produced by Sao Paulo's state-run Butantan Institute. On November 12, Anvisa allowed the resumption of late-stage Brazilian clinical trials for Sinovac vaccine. It was reported there had been no need to stop the study as the death had no relation to the vaccine. Brazil has one of the world’s worst COVID-19 outbreaks, with more than 5.7 million confirmed cases and 163,000 deaths. And President Jair Bolsonaro has come under fire for his constant dismissal of the virus and its dangers. (with inputs)

Where are we in the COVID-19 vaccine race? Here's a status check of trials and side-effects

India is racing ahead with work on its coronavirus vaccine as countries around the world sought to conquer the pandemic and rescue their economies. 
 
<a href="https://www.wionews.com/world/volunteers-face-severe-hangover-headache-and-pain-after-getting-pfizer-vaccine-shot-342518">Also read | Volunteers face 'severe hangover', headache and pain after getting Pfizer vaccine shot</a>

Companies like Zydus Cadila, Serum Institute and Bharat Biotech are at the forefront of research on covid vaccines and are likely to be among the leading manufacturers as and when their commercial application is permitted.

Ahmedabad-based pharmaceutical major Zydus Cadila's COVID-19 candidate vaccine ZyCov-D is likely to enter Phase III final stage of clinical trials by December. If all goes well, the vaccine should be ready for launch by March, next year. Further, Zydus is working on a second vaccine for COVID-19 and its pre-clinical data will be ready by January.

Hyderabad based Bharat Biotech is also reached to the third phase of clinical trials for 'Covaxin', in collaboration with the Indian Council of Medical Research (ICMR). Phase 3 trials of Covaxin will take place at 25 centres across India with a total of 26,000 participants. India's drug regulator, the Drug Controller General of India (DCGI), granted approval for the third phase after successful completion of the first two phases of trials.&nbsp;

Serum Insitute of India, the world's largest maker of vaccines, has also said that it has already produced 40 million doses of AstraZeneca's potential COVID-19 vaccine.

The vaccine is named Covishield by the institute and is jointly developed by pharma giant AstraZeneca and the University of Oxford. It is originally named ChAdOx1 nCoV-19 and is one of the top contenders in the race to develop vaccines to treat Covid-19.&nbsp;

Covishield has been developed at SII Pune laboratory with a master seed from Oxford University/AstraZeneca.

Serum refused to confirm whether the 40 million doses of vaccine will be supplied globally or only distributed in India, news agency Reuters reported.&nbsp;

The vaccine maker also said doses of Novavax vaccine, another top candidate, will be produced soon, adding that the bulk of the drug has been received from the US Company.&nbsp;

(With inputs from agencies)

India is racing ahead with work on its coronavirus vaccine as countries around the world sought to conquer the pandemic and rescue their economies. Also read | Volunteers face 'severe hangover', headache and pain after getting Pfizer vaccine shot Companies like Zydus Cadila, Serum Institute and Bharat Biotech are at the forefront of research on covid vaccines and are likely to be among the leading manufacturers as and when their commercial application is permitted.

India is racing ahead with work on its coronavirus vaccine as countries around the world sought to conquer the pandemic and rescue their economies. Also read | Volunteers face 'severe hangover', headache and pain after getting Pfizer vaccine shot Companies like Zydus Cadila, Serum Institute and Bharat Biotech are at the forefront of research on covid vaccines and are likely to be among the leading manufacturers as and when their commercial application is permitted. Ahmedabad-based pharmaceutical major Zydus Cadila's COVID-19 candidate vaccine ZyCov-D is likely to enter Phase III final stage of clinical trials by December. If all goes well, the vaccine should be ready for launch by March, next year. Further, Zydus is working on a second vaccine for COVID-19 and its pre-clinical data will be ready by January. Hyderabad based Bharat Biotech is also reached to the third phase of clinical trials for 'Covaxin', in collaboration with the Indian Council of Medical Research (ICMR). Phase 3 trials of Covaxin will take place at 25 centres across India with a total of 26,000 participants. India's drug regulator, the Drug Controller General of India (DCGI), granted approval for the third phase after successful completion of the first two phases of trials. Serum Insitute of India, the world's largest maker of vaccines, has also said that it has already produced 40 million doses of AstraZeneca's potential COVID-19 vaccine. The vaccine is named Covishield by the institute and is jointly developed by pharma giant AstraZeneca and the University of Oxford. It is originally named ChAdOx1 nCoV-19 and is one of the top contenders in the race to develop vaccines to treat Covid-19. Covishield has been developed at SII Pune laboratory with a master seed from Oxford University/AstraZeneca. Serum refused to confirm whether the 40 million doses of vaccine will be supplied globally or only distributed in India, news agency Reuters reported. The vaccine maker also said doses of Novavax vaccine, another top candidate, will be produced soon, adding that the bulk of the drug has been received from the US Company. (With inputs from agencies)

These three Indian companies are ready to produce Covid-19 vaccine

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Morning news brief: Armenia-Azerbaijan's truce, update on Covid vaccine, and more

Brazil's health regulator has suspended clinical trials of a Chinese-developed Covid-19 vaccine after an "adverse incident" involving a volunteer recipient.

On Monday, the regulator, Anvisa, said in a statement that it had "ruled to interrupt the clinical trial of the CoronaVac vaccine after a serious adverse incident" on October 29.

It said -- without giving details on what happened -- such incidents included death, potentially fatal side effects, serious disability, hospitalisation, birth defects and other "clinically significant events."

The setback for CoronaVac, developed by Chinese pharmaceutical firm Sinovac Biotech, came on the same day US pharmaceutical giant Pfizer said its own vaccine candidate had shown 90 per cent effectiveness.

Both the Pfizer and Sinovac vaccines are in Phase III trials, the final stage of testing before regulatory approval. And both are being tested in Brazil.

CoronaVac has been caught up in a messy political battle in Brazil, where its most visible backer has been Sao Paulo Governor Joao Doria, a top opponent of far-right President Jair Bolsonaro.

President Jair Bolsonaro has meanwhile labeled it the vaccine from "that other country," and pushed instead for a rival vaccine developed by Oxford University and pharmaceutical firm AstraZeneca.

Earlier on November 2, more than 300 Brazilians gathered on São Paulo's main commercial thoroughfare to protest state Governor João Doria's support for mandatory COVID-19 immunisation and testing the potential vaccine.

In São Paulo, the Sinovac vaccine was being tested as part of phase III clinical trials with support from the Doria government.

Brazil’s federal health ministry announced last month it would buy 46 million doses of the vaccine, contingent on regulatory approval, in a deal supported by state governors. But a day later, Bolsonaro said that Brazil would not buy the vaccine.

Bolsonaro has bashed China intermittently since the campaign trail in 2018, over the Asian countries growing investments and influence in Brazil.

The protestors in São Paulo rallied in support of Bolsonaro. Many of the tightly packed protestors did not wear masks.

Brazil has the third-worst outbreak of coronavirus globally, with over 5.5 million cases, after the United States and India

Brazil's health regulator has suspended clinical trials of a Chinese-developed Covid-19 vaccine after an "adverse incident" involving a volunteer recipient. On Monday, the regulator, Anvisa, said in a statement that it had "ruled to interrupt the clinical trial of the CoronaVac vaccine after a serious adverse incident" on October 29.

Brazil's health regulator has suspended clinical trials of a Chinese-developed Covid-19 vaccine after an "adverse incident" involving a volunteer recipient. On Monday, the regulator, Anvisa, said in a statement that it had "ruled to interrupt the clinical trial of the CoronaVac vaccine after a serious adverse incident" on October 29. It said -- without giving details on what happened -- such incidents included death, potentially fatal side effects, serious disability, hospitalisation, birth defects and other "clinically significant events." The setback for CoronaVac, developed by Chinese pharmaceutical firm Sinovac Biotech, came on the same day US pharmaceutical giant Pfizer said its own vaccine candidate had shown 90 per cent effectiveness. Both the Pfizer and Sinovac vaccines are in Phase III trials, the final stage of testing before regulatory approval. And both are being tested in Brazil. CoronaVac has been caught up in a messy political battle in Brazil, where its most visible backer has been Sao Paulo Governor Joao Doria, a top opponent of far-right President Jair Bolsonaro. President Jair Bolsonaro has meanwhile labeled it the vaccine from "that other country," and pushed instead for a rival vaccine developed by Oxford University and pharmaceutical firm AstraZeneca. Earlier on November 2, more than 300 Brazilians gathered on São Paulo's main commercial thoroughfare to protest state Governor João Doria's support for mandatory COVID-19 immunisation and testing the potential vaccine. In São Paulo, the Sinovac vaccine was being tested as part of phase III clinical trials with support from the Doria government. Brazil’s federal health ministry announced last month it would buy 46 million doses of the vaccine, contingent on regulatory approval, in a deal supported by state governors. But a day later, Bolsonaro said that Brazil would not buy the vaccine. Bolsonaro has bashed China intermittently since the campaign trail in 2018, over the Asian countries growing investments and influence in Brazil. The protestors in São Paulo rallied in support of Bolsonaro. Many of the tightly packed protestors did not wear masks. Brazil has the third-worst outbreak of coronavirus globally, with over 5.5 million cases, after the United States and India

Brazil halts trials of Chinese Covid-19 vaccine

Positive data on BioNTech and US partner Pfizer Inc's COVID-19 vaccine came as a happy surprise for not only the world, but also the married couple behind the German biotech firm.

Physicians Ugur Sahin and Oezlem Tuereci, who bonded over their love of medical research, are the people&nbsp;behind the Covid-19 vaccine that could change the world.&nbsp;

Pfizer and BioNTech are the first drugmakers to show successful data from a large-scale clinical trial of a coronavirus vaccine. The companies said they have so far found no serious safety concerns and expect to seek US emergency use authorisation later this month.

Reuters describes BioNTech Chief Executive Ugur Sahin&nbsp;as the son of a Turkish immigrant working at a Ford factory in Cologne. He now figures among the 100 richest Germans, together with his wife and fellow board member Oezlem Tuereci&nbsp;according to weekly Welt am Sonntag.

The market value of Nasdaq-listed BioNTech, which the pair co-founded, had ballooned to $21 billion as of Friday's close from $4.6 billion a year ago, with the firm set to play a major role in mass immunisation against the coronavirus.

Sahin has, however, maintained his humility, as he typically walks into business meetings wearing jeans and carrying his signature bicycle helmet and backpack with him.

Doggedly pursuing his childhood dream of studying medicine and becoming a physician, Sahin worked at teaching hospitals in Cologne and the southwestern city of Homburg, where he met Tuereci during his early academic career.

Medical research and oncology became a shared passion of the couple.

Tuereci, the daughter of a Turkish physician who had migrated to Germany, said in a media interview that even on the day of their wedding, both made time for lab work.

Together they honed in on the immune system as a potential ally in the fight against cancer and tried to address the unique genetic makeup of each tumour.

Life as entrepreneurs started in 2001 when they set up Ganymed Pharmaceuticals to develop cancer-fighting antibodies, but Sahin - by then a professor at Mainz university - never gave up academic research and teaching.

They won funding from MIG AG as well as from Thomas and Andreas Struengmann, who sold their generic drugs business Hexal to Novartis in 2005.

That venture was sold to Japan's Astellas in 2016 for up to $1.4 billion. By then, the team behind Ganymed was already busy building BioNTech, founded in 2008, to pursue a much broader range of cancer immunotherapy tools. That included mRNA, a versatile messenger substance to send genetic instructions into cells.

HOW IT HAPPENED

Sahin came from humble roots to build two billion-dollar companies but still rides to work on his mountain bike.

People who have worked with Sahin for years said his tendency toward understatement belies a relentless ambition to transform medicine, exemplified by the leap of faith to a COVID-19 vaccine.

The BioNTech story took a twist when Sahin in January came across a scientific paper on a new coronavirus outbreak in the Chinese city of Wuhan and it struck him how small the step was from anti-cancer mRNA drugs to mRNA-based viral vaccines.

BioNTech quickly assigned about 500 staff to project "light speed" to work on several possible compounds, winning pharma giant Pfizer and Chinese drugmaker Fosun as partners in March.

(with inputs from Reuters)

Positive data on BioNTech and US partner Pfizer Inc's COVID-19 vaccine came as a happy surprise for not only the world, but also the married couple behind the German biotech firm.

Positive data on BioNTech and US partner Pfizer Inc's COVID-19 vaccine came as a happy surprise for not only the world, but also the married couple behind the German biotech firm. Physicians Ugur Sahin and Oezlem Tuereci, who bonded over their love of medical research, are the people behind the Covid-19 vaccine that could change the world. Pfizer and BioNTech are the first drugmakers to show successful data from a large-scale clinical trial of a coronavirus vaccine. The companies said they have so far found no serious safety concerns and expect to seek US emergency use authorisation later this month. Reuters describes BioNTech Chief Executive Ugur Sahin as the son of a Turkish immigrant working at a Ford factory in Cologne. He now figures among the 100 richest Germans, together with his wife and fellow board member Oezlem Tuereci according to weekly Welt am Sonntag. The market value of Nasdaq-listed BioNTech, which the pair co-founded, had ballooned to $21 billion as of Friday's close from $4.6 billion a year ago, with the firm set to play a major role in mass immunisation against the coronavirus. Sahin has, however, maintained his humility, as he typically walks into business meetings wearing jeans and carrying his signature bicycle helmet and backpack with him. Doggedly pursuing his childhood dream of studying medicine and becoming a physician, Sahin worked at teaching hospitals in Cologne and the southwestern city of Homburg, where he met Tuereci during his early academic career. Medical research and oncology became a shared passion of the couple. Tuereci, the daughter of a Turkish physician who had migrated to Germany, said in a media interview that even on the day of their wedding, both made time for lab work. Together they honed in on the immune system as a potential ally in the fight against cancer and tried to address the unique genetic makeup of each tumour. Life as entrepreneurs started in 2001 when they set up Ganymed Pharmaceuticals to develop cancer-fighting antibodies, but Sahin - by then a professor at Mainz university - never gave up academic research and teaching. They won funding from MIG AG as well as from Thomas and Andreas Struengmann, who sold their generic drugs business Hexal to Novartis in 2005. That venture was sold to Japan's Astellas in 2016 for up to $1.4 billion. By then, the team behind Ganymed was already busy building BioNTech, founded in 2008, to pursue a much broader range of cancer immunotherapy tools. That included mRNA, a versatile messenger substance to send genetic instructions into cells. HOW IT HAPPENED Sahin came from humble roots to build two billion-dollar companies but still rides to work on his mountain bike. People who have worked with Sahin for years said his tendency toward understatement belies a relentless ambition to transform medicine, exemplified by the leap of faith to a COVID-19 vaccine. The BioNTech story took a twist when Sahin in January came across a scientific paper on a new coronavirus outbreak in the Chinese city of Wuhan and it struck him how small the step was from anti-cancer mRNA drugs to mRNA-based viral vaccines. BioNTech quickly assigned about 500 staff to project "light speed" to work on several possible compounds, winning pharma giant Pfizer and Chinese drugmaker Fosun as partners in March. (with inputs from Reuters)

Of the 'dream team': The married couple behind Pfizer's Covid vaccine

Moderna Inc has said it is preparing to launch its experimental coronavirus vaccine. It on Thursday said it is on track to report early data from a late-stage trial of its experimental COVID-19 vaccine next month, offering the clearest timeline yet for when the world will know whether it is effective.

The company has received $1.1 billion in customer deposits for the shots during the third quarter.

“We are actively preparing for the launch of mRNA-1273 and we have signed a number of supply agreements with governments around the world," Moderna CEO Stephane Bancel said in a press release.&nbsp;

The company, one of the front-runners in the global race to produce vaccines to protect against COVID-19, said an independent data monitoring committee is expected to conduct an interim review of its ongoing 30,000-person trial in November. Its shares rose 3%.

The company said it is preparing to distribute the vaccine, known as mRNA-1273, and expects to be able to produce 20 million doses by the end of the year, and between 500 million and 1 billion in 2021.

Moderna Inc earlier told Reuters it would seek emergency FDA authorisation to use its vaccine in high-risk groups if an interim assessment of its trial showed its vaccine was at least 70% effective.

The Moderna vaccine uses synthetic messenger RNA (mRNA) to mimic the surface of the coronavirus and teach the immune system to recognize and neutralize it. The technology, which has yet to produce an approved vaccine, is also used in the COVID-19 vaccine being developed by Pfizer Inc PFE.N and German partner BioNTech SE 22AUy.F.

Moderna said it expects two-month follow-up safety data, as required by the US Food and Drug Administration, in the second half of November, after which it will file for an emergency use authorization. Recent FDA guidelines called on COVID-19 vaccine developers to watch trial subjects for two months after they receive a final dose for any side effects that may crop up.

The Cambridge, Massachusetts-based company has signed supply deals with the U.S. government and several other countries, and is also in talks with the World Health Organisation-led group, COVAX, about vaccine distribution and a tiered pricing proposal.

Moderna said its deal with the US government for 100 million doses values the vaccine at $25 per dose, based on the grants it received and performance payments. The U.S. government has an option to buy an additional 400 million doses.

The company, whose supply agreements include deals with Japan, Canada and Israel, said it is in talks with the European Union and others.

Other vaccine in final stages of human testing include those from Pfizer, AstraZeneca Plc AZN.L and Johnson &amp; Johnson JNJ.N.

Pfizer said this week that there had not yet been enough infections in its 44,000-volunteer trial to trigger the first analysis of whether its vaccine works.

(with inputs)

Moderna Inc has said it is preparing to launch its experimental coronavirus vaccine. It on Thursday said it is on track to report early data from a late-stage trial of its experimental COVID-19 vaccine next month, offering the clearest timeline yet for when the world will know whether it is effective.

Moderna Inc has said it is preparing to launch its experimental coronavirus vaccine. It on Thursday said it is on track to report early data from a late-stage trial of its experimental COVID-19 vaccine next month, offering the clearest timeline yet for when the world will know whether it is effective. The company has received $1.1 billion in customer deposits for the shots during the third quarter. “We are actively preparing for the launch of mRNA-1273 and we have signed a number of supply agreements with governments around the world," Moderna CEO Stephane Bancel said in a press release. The company, one of the front-runners in the global race to produce vaccines to protect against COVID-19, said an independent data monitoring committee is expected to conduct an interim review of its ongoing 30,000-person trial in November. Its shares rose 3%. The company said it is preparing to distribute the vaccine, known as mRNA-1273, and expects to be able to produce 20 million doses by the end of the year, and between 500 million and 1 billion in 2021. Moderna Inc earlier told Reuters it would seek emergency FDA authorisation to use its vaccine in high-risk groups if an interim assessment of its trial showed its vaccine was at least 70% effective. The Moderna vaccine uses synthetic messenger RNA (mRNA) to mimic the surface of the coronavirus and teach the immune system to recognize and neutralize it. The technology, which has yet to produce an approved vaccine, is also used in the COVID-19 vaccine being developed by Pfizer Inc PFE.N and German partner BioNTech SE 22AUy.F. Moderna said it expects two-month follow-up safety data, as required by the US Food and Drug Administration, in the second half of November, after which it will file for an emergency use authorization. Recent FDA guidelines called on COVID-19 vaccine developers to watch trial subjects for two months after they receive a final dose for any side effects that may crop up. The Cambridge, Massachusetts-based company has signed supply deals with the U.S. government and several other countries, and is also in talks with the World Health Organisation-led group, COVAX, about vaccine distribution and a tiered pricing proposal. Moderna said its deal with the US government for 100 million doses values the vaccine at $25 per dose, based on the grants it received and performance payments. The U.S. government has an option to buy an additional 400 million doses. The company, whose supply agreements include deals with Japan, Canada and Israel, said it is in talks with the European Union and others. Other vaccine in final stages of human testing include those from Pfizer, AstraZeneca Plc AZN.L and Johnson & Johnson JNJ.N. Pfizer said this week that there had not yet been enough infections in its 44,000-volunteer trial to trigger the first analysis of whether its vaccine works. (with inputs)

Moderna says preparing for Covid-19 vaccine launch

India has increased its engagement with Myanmar and Bangladesh on Covid-19 vaccine with in-person and virtual high-level meetings with officials of the two countries.&nbsp;

Earlier this month an Indian delegation visited Bangladesh from 17th to 19th October with Ministry of External Affairs saying that both sides had "fruitful discussions" on the "current stage of vaccine development in India and modalities of clinical trials in Bangladesh".

Also read |&nbsp;<a href="https://www.wionews.com/india-news/indias-vaccine-production-delivery-capacity-to-help-all-humanity-in-fighting-covid-19-mea-338838">India's vaccine production, delivery capacity to help all humanity in fighting COVID-19: MEA</a>

With Myanmar, a virtual interaction happened with key stakeholders from both sides present in the meeting. The MEA said, "As the situation with respect to vaccine development evolves, the sides will discuss and decide on modalities of cooperation."

Remember India's foreign secretary Harsh Shringla had visited both the countries and cooperation amidst the Covid-19 crisis and Covid-19 vaccine was the key focus of the meet. During his Myanmar visit earlier this month along with Army Chief General Manoj Mukund Naravane, India gifted 3000 vials of Anti Covid Remdesivir to State Counsellor Aung San Suu Kyi as a "symbol" of India‘s commitment to helping Myanmar mitigate the impact of the pandemic.

Remember at the United Nations General Assembly, Indian Prime Minister Narendra Modi announced India’s vaccine production and delivery capacity will be used to "help all humanity" in fighting the COVID-19 pandemic.

While India has sent medicines like HCQ, paracetamol to more than 150 countries, it is also been organising training to build capacity. In fact, for the neighbourhood, India has organised two training modules in which about 90 health experts and scientists have participated.

India has increased its engagement with Myanmar and Bangladesh on Covid-19 vaccine with in-person and virtual high-level meetings with officials of the two countries.

India has increased its engagement with Myanmar and Bangladesh on Covid-19 vaccine with in-person and virtual high-level meetings with officials of the two countries. Earlier this month an Indian delegation visited Bangladesh from 17th to 19th October with Ministry of External Affairs saying that both sides had "fruitful discussions" on the "current stage of vaccine development in India and modalities of clinical trials in Bangladesh". Also read | India's vaccine production, delivery capacity to help all humanity in fighting COVID-19: MEA With Myanmar, a virtual interaction happened with key stakeholders from both sides present in the meeting. The MEA said, "As the situation with respect to vaccine development evolves, the sides will discuss and decide on modalities of cooperation." Remember India's foreign secretary Harsh Shringla had visited both the countries and cooperation amidst the Covid-19 crisis and Covid-19 vaccine was the key focus of the meet. During his Myanmar visit earlier this month along with Army Chief General Manoj Mukund Naravane, India gifted 3000 vials of Anti Covid Remdesivir to State Counsellor Aung San Suu Kyi as a "symbol" of India‘s commitment to helping Myanmar mitigate the impact of the pandemic. Remember at the United Nations General Assembly, Indian Prime Minister Narendra Modi announced India’s vaccine production and delivery capacity will be used to "help all humanity" in fighting the COVID-19 pandemic. While India has sent medicines like HCQ, paracetamol to more than 150 countries, it is also been organising training to build capacity. In fact, for the neighbourhood, India has organised two training modules in which about 90 health experts and scientists have participated.

India increases engagement with Myanmar, Bangladesh on Covid-19 vaccine

Two major clinical trials for experimental Covid-19 vaccines got back on track in the United States Friday -- providing a glimmer of hope as the number of cases skyrocket across the country.

COVID-19 has now killed more than 223,000 Americans, and the health crisis is a top issue in the presidential election pitting incumbent Donald Trump against Joe Biden.

AstraZeneca announced that the trial of its vaccine candidate, developed with the Britain's University of Oxford, has resumed in the US, the only country where it remained suspended following a participant's illness six weeks ago.

"The Food and Drug Administration (FDA) today authorized the restart in the US, following the resumption of trials in other countries in recent weeks," the drugmaker said.

The trial was suspended worldwide on September 6 but resumed shortly thereafter in Britain, and in the following weeks in South Africa, Brazil and Japan, with authorities determining the illness was not apparently linked to the vaccine.

"The FDA reviewed all safety data from trials globally and concluded it was safe to resume the trial," AstraZeneca said.

The company added it was hoping to have results later this year, "depending on the rate of infection within the communities where the clinical trials are being conducted."

The AstraZeneca/Oxford vaccine project is one of the most promising and advanced in the world to combat the global pandemic, which has now claimed the lives of 1.1 million people.

It is one of 10 vaccine candidates being tested on tens of thousands of people in so-called phase 3 trials.

In the United States, the two top candidates vying to get a green light from the FDA are those made by Pfizer and Moderna. Both expect to request approval next month.

Many countries are counting on using the AstraZeneca/Oxford vaccine to inoculate their populations.

The drugmaker pre-sold hundreds of millions of doses on several continents and signed partnership deals with other producers to ensure the doses could be made locally.

"No evidence" vaccine to blame

Shortly after AstraZeneca's announcement, Johnson &amp; Johnson said it was preparing to resume recruitment for its parallel trial, which was suspended last week after a volunteer fell ill.

"After a thorough evaluation of a serious medical event experienced by one study participant, no clear cause has been identified," the group said in a statement.

"The company has found no evidence that the vaccine candidate caused the event."

Just before Friday's announcements, a top US official involved with Operation Warp Speed, the government's vaccine initiative, said he expected the J&amp;J trial to resume quickly.

Paul Mango, from the US Department of Health and Human Services, also said he expected the country to have enough doses on hand to vaccinate the "most vulnerable" Americans before year's end.

"By the end of January, we believe we'll be able to vaccinate all seniors," Mango said, adding that by March or April, "we believe we'll be able to vaccinate any American who desires a vaccination."

Two major clinical trials for experimental Covid-19 vaccines got back on track in the United States Friday -- providing a glimmer of hope as the number of cases skyrocket across the country.

Two major clinical trials for experimental Covid-19 vaccines got back on track in the United States Friday -- providing a glimmer of hope as the number of cases skyrocket across the country. COVID-19 has now killed more than 223,000 Americans, and the health crisis is a top issue in the presidential election pitting incumbent Donald Trump against Joe Biden. AstraZeneca announced that the trial of its vaccine candidate, developed with the Britain's University of Oxford, has resumed in the US, the only country where it remained suspended following a participant's illness six weeks ago. "The Food and Drug Administration (FDA) today authorized the restart in the US, following the resumption of trials in other countries in recent weeks," the drugmaker said. The trial was suspended worldwide on September 6 but resumed shortly thereafter in Britain, and in the following weeks in South Africa, Brazil and Japan, with authorities determining the illness was not apparently linked to the vaccine. "The FDA reviewed all safety data from trials globally and concluded it was safe to resume the trial," AstraZeneca said. The company added it was hoping to have results later this year, "depending on the rate of infection within the communities where the clinical trials are being conducted." The AstraZeneca/Oxford vaccine project is one of the most promising and advanced in the world to combat the global pandemic, which has now claimed the lives of 1.1 million people. It is one of 10 vaccine candidates being tested on tens of thousands of people in so-called phase 3 trials. In the United States, the two top candidates vying to get a green light from the FDA are those made by Pfizer and Moderna. Both expect to request approval next month. Many countries are counting on using the AstraZeneca/Oxford vaccine to inoculate their populations. The drugmaker pre-sold hundreds of millions of doses on several continents and signed partnership deals with other producers to ensure the doses could be made locally. "No evidence" vaccine to blame Shortly after AstraZeneca's announcement, Johnson & Johnson said it was preparing to resume recruitment for its parallel trial, which was suspended last week after a volunteer fell ill. "After a thorough evaluation of a serious medical event experienced by one study participant, no clear cause has been identified," the group said in a statement. "The company has found no evidence that the vaccine candidate caused the event." Just before Friday's announcements, a top US official involved with Operation Warp Speed, the government's vaccine initiative, said he expected the J&J trial to resume quickly. Paul Mango, from the US Department of Health and Human Services, also said he expected the country to have enough doses on hand to vaccinate the "most vulnerable" Americans before year's end. "By the end of January, we believe we'll be able to vaccinate all seniors," Mango said, adding that by March or April, "we believe we'll be able to vaccinate any American who desires a vaccination."

AstraZeneca, Johnson & Johnson Covid vaccine trials back on track in US 

AstraZeneca Plc has resumed the U.S. trial of its experimental COVID-19 vaccine after approval by regulators, and Johnson & Johnson is preparing to resume its trial on Monday or Tuesday, the companies said on Friday.

Phase-3 trial of Oxford-AstraZeneca Covid-19 vaccine to begin in few days

Union Finance Minister Nirmala Sitharaman Thursday released the BJPs manifesto for the Bihar assembly polls which promised free COVID-19 vaccine once it has been cleared by the ICMR.

It also sought to reach out to the youth with the promise of 19 lakh jobs in the next five years and farmers with the assurance of bringing lentils under the MSP regime.

"The NDA government in Bihar has set an example before the country in the fight against corona. It's our resolve that once the vaccine against the coronavirus has been cleared by the ICMR, we will make it available to the people of Bihar free of cost," said the manifesto. The promise figured at the top of the BJP's election document.

Carrying the tagline 'BJP hai to bharosa hai', the party drew heavily upon the trust enjoyed by Prime Minister Narendra Modi among the masses by virtue of pro-people measures like the Jan Dhan scheme and the Ujjwala Yojana.

"Bihar is a politically sensitive state. Here people cannot be fobbed off with empty promises. Claims made by parties are likely to be weighed against their past track record. This is where the BJP scores," Sitharaman told a press conference where she released the manifesto.

"We have the confidence that we can deliver on our promises. In the last six years, all the programmes announced by the prime minister have been implemented, be it electrification of villages, gas cylinders for poor women or financial inclusion of all citizens by getting accounts opened in their name in banks," she asserted.

Speaking about the coronavirus vaccine, the minister said India has reached a point where it is on the verge of producing three vaccines after different stages of trial.

"When we reach the stage where scientists give clearance for large-scale production of the vaccine, we will make it available to the people of Bihar free of cost," she said.

The highlights of the party's vision document, displayed through a power point presentation, include recruitment of three lakh teachers in primary, secondary and higher educational institutions.

The party also proposed to develop the state, which has so far remained largely untouched by the boom in information technology, into an IT hub holding out the promise of five lakh jobs in the sector.

The manifesto also said a large number of people will be provided employment in the health sector which is in for a major facelift through projects like the AIIMS at Darbhanga.

Other attractive promises include self-reliance for one crore women through micro finance, pucca houses for 30 lakh people, and a boost to fisheries making Bihar number one in the sector.

It also promised a fresh impetus to the dairy sector with setting up of 15 milk processing units.

A boost to production of maize, fruits, vegetables, betel leaves, honey and makhana etc. Has been promised, and to facilitate these a conglomerate of 1,000 farm producer organisations has also been proposed.

Yet another promise made in the manifesto which is likely to find resonance among students is introducing Hindi as a medium of instruction for medical, engineering and other technical courses.

"Our promises are backed by credibility. Compare the situation in Bihar between 1990 and 2005 (when the RJD was in power) with the changes that occurred after we took over. You will get a clear picture," Sitharaman said.

"During the NDA rule, the state's growth rate in the industrial sector has been 17 per cent. In contrast, we are unable to find the figures for the preceding 15 years, apparently because industries were never on the radar of the previous government," she remarked with a smirk.

Union Finance Minister Nirmala Sitharaman Thursday released the BJPs manifesto for the Bihar assembly polls which promised free COVID-19 vaccine once it has been cleared by the ICMR.

Union Finance Minister Nirmala Sitharaman Thursday released the BJPs manifesto for the Bihar assembly polls which promised free COVID-19 vaccine once it has been cleared by the ICMR. It also sought to reach out to the youth with the promise of 19 lakh jobs in the next five years and farmers with the assurance of bringing lentils under the MSP regime. "The NDA government in Bihar has set an example before the country in the fight against corona. It's our resolve that once the vaccine against the coronavirus has been cleared by the ICMR, we will make it available to the people of Bihar free of cost," said the manifesto. The promise figured at the top of the BJP's election document. Carrying the tagline 'BJP hai to bharosa hai', the party drew heavily upon the trust enjoyed by Prime Minister Narendra Modi among the masses by virtue of pro-people measures like the Jan Dhan scheme and the Ujjwala Yojana. "Bihar is a politically sensitive state. Here people cannot be fobbed off with empty promises. Claims made by parties are likely to be weighed against their past track record. This is where the BJP scores," Sitharaman told a press conference where she released the manifesto. "We have the confidence that we can deliver on our promises. In the last six years, all the programmes announced by the prime minister have been implemented, be it electrification of villages, gas cylinders for poor women or financial inclusion of all citizens by getting accounts opened in their name in banks," she asserted. Speaking about the coronavirus vaccine, the minister said India has reached a point where it is on the verge of producing three vaccines after different stages of trial. "When we reach the stage where scientists give clearance for large-scale production of the vaccine, we will make it available to the people of Bihar free of cost," she said. The highlights of the party's vision document, displayed through a power point presentation, include recruitment of three lakh teachers in primary, secondary and higher educational institutions. The party also proposed to develop the state, which has so far remained largely untouched by the boom in information technology, into an IT hub holding out the promise of five lakh jobs in the sector. The manifesto also said a large number of people will be provided employment in the health sector which is in for a major facelift through projects like the AIIMS at Darbhanga. Other attractive promises include self-reliance for one crore women through micro finance, pucca houses for 30 lakh people, and a boost to fisheries making Bihar number one in the sector. It also promised a fresh impetus to the dairy sector with setting up of 15 milk processing units. A boost to production of maize, fruits, vegetables, betel leaves, honey and makhana etc. Has been promised, and to facilitate these a conglomerate of 1,000 farm producer organisations has also been proposed. Yet another promise made in the manifesto which is likely to find resonance among students is introducing Hindi as a medium of instruction for medical, engineering and other technical courses. "Our promises are backed by credibility. Compare the situation in Bihar between 1990 and 2005 (when the RJD was in power) with the changes that occurred after we took over. You will get a clear picture," Sitharaman said. "During the NDA rule, the state's growth rate in the industrial sector has been 17 per cent. In contrast, we are unable to find the figures for the preceding 15 years, apparently because industries were never on the radar of the previous government," she remarked with a smirk.

BJP's Bihar poll manifesto promises free COVID vaccine, 19L jobs

The United Nations is planning to stockpile one billion syringes around the world by the end of 2021 -- to be used for the delivery of any future coronavirus vaccine.

UNICEF, the UN Children's Fund, Monday said it aims to get 520 million syringes in its warehouses by the end of this year, to guarantee an initial supply in countries ahead of the vaccine.

UNICEF said it was also buying five million safety boxes for used syringes.

The syringes will be used by Covax, the international coronavirus vaccine procurement, production and distribution pool created by the World Health Organization (WHO).

Covax is run by the Gavi vaccine alliance, which will reimburse UNICEF for the syringes.

A public-private partnership, Gavi helps vaccinate half the world's children against some of the deadliest diseases on the planet.

Syringes have a five-year shelf life and tend to be shipped by sea, rather than vaccines, which are heat-sensitive and transported more quickly by air freight.

The billion syringes come on top of the 620 million that UNICEF would purchase for other vaccination programmes against diseases such as measles and typhoid.

The WHO says 42 vaccine candidates are currently being tested on humans, of which 10 have reached the mass testing third and final stage.

A further 156 are being worked on in laboratories in preparation for human testing.

Typically, only around 10 per cent of vaccine candidates make it through the trials.

The number of confirmed coronavirus cases worldwide passed 40 million on Monday, according to an AFP tally based on official sources. More than 1.1 million deaths have been recorded across the globe.

The United Nations is planning to stockpile one billion syringes around the world by the end of 2021 -- to be used for the delivery of any future coronavirus vaccine.

The United Nations is planning to stockpile one billion syringes around the world by the end of 2021 -- to be used for the delivery of any future coronavirus vaccine. UNICEF, the UN Children's Fund, Monday said it aims to get 520 million syringes in its warehouses by the end of this year, to guarantee an initial supply in countries ahead of the vaccine. UNICEF said it was also buying five million safety boxes for used syringes. The syringes will be used by Covax, the international coronavirus vaccine procurement, production and distribution pool created by the World Health Organization (WHO). Covax is run by the Gavi vaccine alliance, which will reimburse UNICEF for the syringes. A public-private partnership, Gavi helps vaccinate half the world's children against some of the deadliest diseases on the planet. Syringes have a five-year shelf life and tend to be shipped by sea, rather than vaccines, which are heat-sensitive and transported more quickly by air freight. The billion syringes come on top of the 620 million that UNICEF would purchase for other vaccination programmes against diseases such as measles and typhoid. The WHO says 42 vaccine candidates are currently being tested on humans, of which 10 have reached the mass testing third and final stage. A further 156 are being worked on in laboratories in preparation for human testing. Typically, only around 10 per cent of vaccine candidates make it through the trials. The number of confirmed coronavirus cases worldwide passed 40 million on Monday, according to an AFP tally based on official sources. More than 1.1 million deaths have been recorded across the globe.

UN to stockpile billion syringes to be used for delivery of Covid vaccine

Serum Institute of India and Bharat Biotech are expected to pursue late stage clinical trials of intranasal COVID-19 vaccines in the coming months once they receive regulatory approval, India`s health minister said on Sunday.

Dr Harsh Vardhan said the late stage trial generally involves thousands of participants, sometimes 30,000 to 40,000.

Of the vaccines currently in Phase 3 trials, all are administered by injection, according to the World Health Organization (WHO).

On Saturday, India`s Dr Reddy`s Laboratories Ltd and the Russian Direct Investment Fund (RDIF) said they have received renewed approval to conduct late-stage clinical trials in India of the Russian COVID-19 vaccine.

India`s coronavirus infections rose by another 61,871 over the past 24 hours, data released on Sunday showed, although the health ministry said it is seeing a trend of steadily declining active cases.

The Indian Council of Medical Research (ICMR) said it will revisit its protocol for COVID-19 treatment after the WHO found some of the commonly used drugs, including remdesivir, had little or no impact on a patient`s chances of surviving, local media reported earlier on Sunday.

Serum Institute of India and Bharat Biotech are expected to pursue late stage clinical trials of intranasal COVID-19 vaccines in the coming months once they receive regulatory approval, India`s health minister said on Sunday.

Serum Institute of India and Bharat Biotech are expected to pursue late stage clinical trials of intranasal COVID-19 vaccines in the coming months once they receive regulatory approval, India`s health minister said on Sunday. Dr Harsh Vardhan said the late stage trial generally involves thousands of participants, sometimes 30,000 to 40,000. Of the vaccines currently in Phase 3 trials, all are administered by injection, according to the World Health Organization (WHO). On Saturday, India`s Dr Reddy`s Laboratories Ltd and the Russian Direct Investment Fund (RDIF) said they have received renewed approval to conduct late-stage clinical trials in India of the Russian COVID-19 vaccine. India`s coronavirus infections rose by another 61,871 over the past 24 hours, data released on Sunday showed, although the health ministry said it is seeing a trend of steadily declining active cases. The Indian Council of Medical Research (ICMR) said it will revisit its protocol for COVID-19 treatment after the WHO found some of the commonly used drugs, including remdesivir, had little or no impact on a patient`s chances of surviving, local media reported earlier on Sunday.

Serum Institute, Bharat Biotech to begin trial of intranasal COVID-19 vaccine soon

A row broke out on Friday over a World Health Organisation (WHO) clinical trial which concluded that the anti-viral drug remdesivir had little or no impact on a patient's chances of surviving COVID-19.

Notably, a concoction of remdesivir with a few other drugs was used to treat US President Donald Trump's coronavirus infection.

Gilead Sciences Inc., the US company that developed the drug, said the findings appeared inconsistent with evidence from other studies validating the clinical benefit of the drug.

"We are concerned the data from this open-label global trial has not undergone the rigorous review required to allow for constructive scientific discussion," Gilead said in a statement.

But Richard Peto, an independent statistician hired by the WHO to scrutinise the results of its Solidarity trial, dismissed Gilead's criticism.

"It's a reliable result, don't let anybody tell you otherwise, because they'll try to," Peto said adding, "this is real world evidence."

Earlier in the day, the UN health agency said remdesivir appeared to have little or no effect on keeping people alive or on the length of hospital stays among patients with the respiratory disease.

Its trial was conducted on 11,266 adult patients in over 30 countries and its findings may shift the focus of treatments away from antivirals such as remdesivir to new monoclonal antibodies which the WHO has said could be added to its studies.

Gilead, which quickly repurposed what it had developed as an Ebola drug when the COVID-19 pandemic began, said that other, smaller remdesivir trials showed the treatment cut COVID-19 recovery time by five days and helped reduce the risk of death in some patients who were getting oxygen.

Peto, an Oxford University professor emeritus, said the smaller trial's perceived benefit in keeping people alive could have been mere "chance".

"And you've got to randomise in large numbers," Peto said. "There isn't sufficient emphasis based on the need for large numbers if you want really reliable results."

For the remdesivir arm of the WHO's Solidarity trial, 2,743 patients were given remdesivir, compared to 2,708 in the control group. Gilead's study had 1,062 participants.

"The real disappointment is that remdesivir has also failed in a larger number of cases and in the 'real world setting'," Clemens Wendtner, Chief Physician of Infectiology and Tropical Medicine at Munich's Schwabing Clinic, said.

The WHO's trial also found that other medicines repurposed since the pandemic began -- malaria drug hydroxychloroquine, anti-HIV drug combination lopinavir/ritonavir and interferon -- offered little or no benefit to COVID-19 patients.

The hydroxychloroquine and anti-HIV studies were abandoned earlier this year, and interferon was dropped on Thursday.

Guidance on how countries should deploy remdesivir will come in two or three weeks after a data review, WHO officials said.

Remdesivir was given emergency use authorisation from the US Food and Drug Administration on May 1.

The European Union has also given remdesivir emergency authorisation and agreed to a 1 billion euro ($1.2 billion) remdesivir deal on Tuesday, weeks after Gilead was informed by the WHO about the results of the Solidarity trial.

The European Medicines Agency said it would review the trial data "to see if any changes are needed to the way these medicines are used."

(with inputs from agencies)

A row broke out on Friday over a World Health Organisation (WHO) clinical trial which concluded that the anti-viral drug remdesivir had little or no impact on a patient's chances of surviving COVID-19.

A row broke out on Friday over a World Health Organisation (WHO) clinical trial which concluded that the anti-viral drug remdesivir had little or no impact on a patient's chances of surviving COVID-19. Notably, a concoction of remdesivir with a few other drugs was used to treat US President Donald Trump's coronavirus infection. Gilead Sciences Inc., the US company that developed the drug, said the findings appeared inconsistent with evidence from other studies validating the clinical benefit of the drug. "We are concerned the data from this open-label global trial has not undergone the rigorous review required to allow for constructive scientific discussion," Gilead said in a statement. But Richard Peto, an independent statistician hired by the WHO to scrutinise the results of its Solidarity trial, dismissed Gilead's criticism. "It's a reliable result, don't let anybody tell you otherwise, because they'll try to," Peto said adding, "this is real world evidence." Earlier in the day, the UN health agency said remdesivir appeared to have little or no effect on keeping people alive or on the length of hospital stays among patients with the respiratory disease. Its trial was conducted on 11,266 adult patients in over 30 countries and its findings may shift the focus of treatments away from antivirals such as remdesivir to new monoclonal antibodies which the WHO has said could be added to its studies. Gilead, which quickly repurposed what it had developed as an Ebola drug when the COVID-19 pandemic began, said that other, smaller remdesivir trials showed the treatment cut COVID-19 recovery time by five days and helped reduce the risk of death in some patients who were getting oxygen. Peto, an Oxford University professor emeritus, said the smaller trial's perceived benefit in keeping people alive could have been mere "chance". "And you've got to randomise in large numbers," Peto said. "There isn't sufficient emphasis based on the need for large numbers if you want really reliable results." For the remdesivir arm of the WHO's Solidarity trial, 2,743 patients were given remdesivir, compared to 2,708 in the control group. Gilead's study had 1,062 participants. "The real disappointment is that remdesivir has also failed in a larger number of cases and in the 'real world setting'," Clemens Wendtner, Chief Physician of Infectiology and Tropical Medicine at Munich's Schwabing Clinic, said. The WHO's trial also found that other medicines repurposed since the pandemic began -- malaria drug hydroxychloroquine, anti-HIV drug combination lopinavir/ritonavir and interferon -- offered little or no benefit to COVID-19 patients. The hydroxychloroquine and anti-HIV studies were abandoned earlier this year, and interferon was dropped on Thursday. Guidance on how countries should deploy remdesivir will come in two or three weeks after a data review, WHO officials said. Remdesivir was given emergency use authorisation from the US Food and Drug Administration on May 1. The European Union has also given remdesivir emergency authorisation and agreed to a 1 billion euro ($1.2 billion) remdesivir deal on Tuesday, weeks after Gilead was informed by the WHO about the results of the Solidarity trial. The European Medicines Agency said it would review the trial data "to see if any changes are needed to the way these medicines are used." (with inputs from agencies)

Row breaks out over WHO trial casting doubt on remdesivir as COVID-19 drug

US pharmaceutical giant Pfizer is planning to file for emergency use authorisation for its Covid-19 vaccine in late November -- two weeks after the November 3 US presidential election.

The company said it hopes to move ahead with the vaccine after safety data is available in the third week of November, immediately lifting the company's shares two percent in the US.

"So let me be clear, assuming positive data, Pfizer will apply for Emergency Authorization Use in the US soon after the safety milestone is achieved in the third week of November,"&nbsp;the company's chairman and CEO Albert Bourla said in an open letter.

The announcement means the United States could have two vaccines ready by the end of the year, with Massachussetts biotech firm Moderna aiming for November 25 to seek authorization.&nbsp;

The United States' Food and Drug Administration (FDA)&nbsp;asked vaccine developers last week to spend two months monitoring for serious side effects after the second dose is given to trial participants.

The FDA will require the vaccine to prove effective and safe, while Pfizer will have to demonstrate it is capable of producing large scale production.&nbsp;

Pfizer and Modern, both funded by the US government, launched Phase 3 of their clinical trials at the end of July, and both have started production of doses.

They aim to be in a position to deliver tens of millions of doses to the US by the end of the year.

Bourla said the Pfizer trial, involving 30,000 participants, might produce results on the vaccine's efficacy within the next two weeks.&nbsp;

Pfizer, which is partnering with German company BioNTech on the research, gained more than two percent in online trading ahead of the opening of US markets.&nbsp;

US pharmaceutical giant Pfizer is planning to file for emergency use authorisation for its Covid-19 vaccine in late November -- two weeks after the November 3 US presidential election.

US pharmaceutical giant Pfizer is planning to file for emergency use authorisation for its Covid-19 vaccine in late November -- two weeks after the November 3 US presidential election. The company said it hopes to move ahead with the vaccine after safety data is available in the third week of November, immediately lifting the company's shares two percent in the US. "So let me be clear, assuming positive data, Pfizer will apply for Emergency Authorization Use in the US soon after the safety milestone is achieved in the third week of November," the company's chairman and CEO Albert Bourla said in an open letter. The announcement means the United States could have two vaccines ready by the end of the year, with Massachussetts biotech firm Moderna aiming for November 25 to seek authorization. The United States' Food and Drug Administration (FDA) asked vaccine developers last week to spend two months monitoring for serious side effects after the second dose is given to trial participants. The FDA will require the vaccine to prove effective and safe, while Pfizer will have to demonstrate it is capable of producing large scale production. Pfizer and Modern, both funded by the US government, launched Phase 3 of their clinical trials at the end of July, and both have started production of doses. They aim to be in a position to deliver tens of millions of doses to the US by the end of the year. Bourla said the Pfizer trial, involving 30,000 participants, might produce results on the vaccine's efficacy within the next two weeks. Pfizer, which is partnering with German company BioNTech on the research, gained more than two percent in online trading ahead of the opening of US markets.

Pfizer plans to seek authorisation for Covid vaccine in November

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