Britain has became the first country in the world to approve the Pfizer-BioNTech COVID-19 vaccine for widespread use and said that it will be made available for rollout across the UK from early next week.

BioNTech news conference on COVID-19 vaccine that got approval by UK

Watch: UK vaccine regulator briefs on rollout after Pfizer vaccine gets approval

Britain on Wednesday became the first country to approve Pfizer-BioNTech's Covid-19 vaccine for general use and said it would be introduced next week.

"The government has today accepted the recommendation from the independent Medicines and Healthcare products Regulatory Agency (MHRA) to approve Pfizer-BioNTech's Covid-19 vaccine for use," the department of health said in a statement.

"The vaccine will be made available across the UK from next week," the statement said, with priority groups including care home residents, health and care staff.

To this end, Pfizer said Britain's emergency use authorisation marks a historic moment in the fight against COVID-19.

"This authorisation is a goal we have been working toward since we first declared that science will win, and we applaud the MHRA for their ability to conduct a careful assessment and take timely action to help protect the people of the U.K.,” said CEO Albert Bourla.

"As we anticipate further authorisations and approvals, we are focussed on moving with the same level of urgency to safely supply a high-quality vaccine around the world."

Britain will start vaccinating people against COVID-19 with the Pfizer vaccine next week.

<a href="https://www.wionews.com/world/covid-vaccines-may-be-targetted-by-criminals-warns-interpol-346905">ALSO READ |&nbsp;Covid vaccines may be targetted by criminals, warns Interpol</a>

"From early next week we will start a programme of vaccinating people against COVID-19 here in this country," health minister Matt Hancock&nbsp;told Sky News, calling it "fantastic news".

(with inputs)

Britain on Wednesday became the first country to approve Pfizer-BioNTech's Covid-19 vaccine for general use and said it would be introduced next week. "The government has today accepted the recommendation from the independent Medicines and Healthcare products Regulatory Agency (MHRA) to approve Pfizer-BioNTech's Covid-19 vaccine for use," the department of health said in a statement.

Britain on Wednesday became the first country to approve Pfizer-BioNTech's Covid-19 vaccine for general use and said it would be introduced next week. "The government has today accepted the recommendation from the independent Medicines and Healthcare products Regulatory Agency (MHRA) to approve Pfizer-BioNTech's Covid-19 vaccine for use," the department of health said in a statement. "The vaccine will be made available across the UK from next week," the statement said, with priority groups including care home residents, health and care staff. To this end, Pfizer said Britain's emergency use authorisation marks a historic moment in the fight against COVID-19. "This authorisation is a goal we have been working toward since we first declared that science will win, and we applaud the MHRA for their ability to conduct a careful assessment and take timely action to help protect the people of the U.K.,” said CEO Albert Bourla. "As we anticipate further authorisations and approvals, we are focussed on moving with the same level of urgency to safely supply a high-quality vaccine around the world." Britain will start vaccinating people against COVID-19 with the Pfizer vaccine next week. ALSO READ | Covid vaccines may be targetted by criminals, warns Interpol "From early next week we will start a programme of vaccinating people against COVID-19 here in this country," health minister Matt Hancock told Sky News, calling it "fantastic news". (with inputs)

UK becomes first country to approve Pfizer-BioNTech Covid vaccine for general use

Just as the UK became the first country to approve a Covid-19 vaccine for general use, Interpol on Wednesday had a grim warning. The Interpol global police co-ordination agency warned that organised criminal networks could be targeting COVID-19 vaccines, and could look to sell fake shots.

Interpol said that it had issued a global alert to law enforcement across 194 member countries. It has warned them to prepare for organised crime networks to target coronavirus vaccines, both physically and online.

Also Read | <a href="https://www.wionews.com/world/uk-becomes-first-country-to-approve-pfizer-biontech-covid-vaccine-for-general-use-346858">UK becomes first country to approve Pfizer-BioNTech Covid vaccine for general use</a>

"As governments are preparing to roll out vaccines, criminal organisations are planning to infiltrate or disrupt supply chains. Criminal networks will also be targeting unsuspecting members of the public via fake websites and false cures, which could pose a significant risk to their health, even their lives," said Interpol secretary general Juergen Stock.

(With Reuters&nbsp;inputs)

Just as the UK became the first country to approve a Covid-19 vaccine for general use, Interpol on Wednesday had a grim warning. The Interpol global police co-ordination agency warned that organised criminal networks could be targeting COVID-19 vaccines, and could look to sell fake shots.

Just as the UK became the first country to approve a Covid-19 vaccine for general use, Interpol on Wednesday had a grim warning. The Interpol global police co-ordination agency warned that organised criminal networks could be targeting COVID-19 vaccines, and could look to sell fake shots. Interpol said that it had issued a global alert to law enforcement across 194 member countries. It has warned them to prepare for organised crime networks to target coronavirus vaccines, both physically and online. Also Read | UK becomes first country to approve Pfizer-BioNTech Covid vaccine for general use "As governments are preparing to roll out vaccines, criminal organisations are planning to infiltrate or disrupt supply chains. Criminal networks will also be targeting unsuspecting members of the public via fake websites and false cures, which could pose a significant risk to their health, even their lives," said Interpol secretary general Juergen Stock. (With Reuters inputs)

Covid vaccines may be targetted by criminals, warns Interpol

UK approves Pfizer-BioNTech vaccine for use, first in the world

United Kingdom has became the first country in the world to approve the Pfizer-BioNTech COVID-19 vaccine for widespread use and said that it will be made available across the Britain from early next week.

Breaking News: UK approves Pfizer-BioNTech COVID-19 vaccine for mass rollout

Indian Prime Minister Narendra Modi interacted with various vaccine developers like the Gennova Biopharma and Biological E Ltd and Dr. Reddy's laboratories Ltd. This comes after the PM visited three Biotechnology firms.

News Alert: Indian PM Modi holds virtual meet with 3 biotechnology firms

UK has asked it's independent regulator to assess Astrazeneca vaccine for possible rollout. WION brings you a report.

UK regulatory to study Aztrazeneca vaccine

Indian Prime Minister Narendra Modi embarked a pretty comprehensive tri city tour of the COVID facilities in the country that are involved in the manufacturing & development of the COVID-19 vaccine.

PM Modi visits India's top 3 vaccine hubs

Indian Prime Minister Narendra Modi visited the Zydus Biotech Park in Ahmedabad and got first hand information on ZycoV-D, a Covid19 vaccine candidate.

Indian PM Modi meets scientists at Zydus Cadila Plant in Ahmedabad

As a direct outcome of the India-Luxembourg virtual summit, a company from the European country is partnering with the government of the western state of Gujarat to produce portable vaccine refrigeration equipment.

Luxembourg's Prime Minister Xavier Bettel had made the suggestion to Indian PM Modi during the virtual meet on 19th November. PM Modi had "enthusiastically" taken the offer and asked officials to move quickly.

A govt source said, "We are&nbsp;making it happen. The distinguishing factor is quick response. We have pushed and got it moving within a week after the summit"

The company, B Systems is ordering machines for India operations, and production is expected by end-March in India. Its team will travel next week or early the following week.&nbsp;

The COVID vaccine is expected to need cold temperature, and for that portable refrigeration will be required.&nbsp;

Oxford vaccine requires ordinary refrigeration temperatures, while other vaccines like the one from Pfizer need to be kept at much lower temperatures. Russia's Sputnik V requires a temperature of around 2 to 8 degrees.

The Indian Embassy in Brussels is facilitating the entire process, with 2 virtual meets between the mission and the company taking place already.&nbsp;

The November virtual summit was the first stand-alone Summit meeting between India and Luxembourg in the past two decades.&nbsp;

As a direct outcome of the India-Luxembourg virtual summit, a company from the European country is partnering with the government of the western state of Gujarat to produce portable vaccine refrigeration equipment.

As a direct outcome of the India-Luxembourg virtual summit, a company from the European country is partnering with the government of the western state of Gujarat to produce portable vaccine refrigeration equipment. Luxembourg's Prime Minister Xavier Bettel had made the suggestion to Indian PM Modi during the virtual meet on 19th November. PM Modi had "enthusiastically" taken the offer and asked officials to move quickly. A govt source said, "We are making it happen. The distinguishing factor is quick response. We have pushed and got it moving within a week after the summit" The company, B Systems is ordering machines for India operations, and production is expected by end-March in India. Its team will travel next week or early the following week. The COVID vaccine is expected to need cold temperature, and for that portable refrigeration will be required. Oxford vaccine requires ordinary refrigeration temperatures, while other vaccines like the one from Pfizer need to be kept at much lower temperatures. Russia's Sputnik V requires a temperature of around 2 to 8 degrees. The Indian Embassy in Brussels is facilitating the entire process, with 2 virtual meets between the mission and the company taking place already. The November virtual summit was the first stand-alone Summit meeting between India and Luxembourg in the past two decades.

Luxembourg-India tie-up to produce COVID vaccine refrigeration equipment by mid-March

India's Prime Minister Narendra Modi has embarked on a visit to review the vaccine development in the country. PM Modi will be visiting 3 top vaccine production hubs in three different cities all in a span of a day.

News Alert: Indian PM Modi to visit top 3 drug makers to review vaccine development

The world is desperately waiting for the Corona vaccine, but citizens in Sweden are extremely sceptical. The reason is the bitter experience of the last mass vaccination drive. WION brings you a report.

Survey: 56% Swedes unsure about Corona vaccine

WASHINGTON — When President Donald Trump talks about efforts to deliver the coronavirus vaccine to millions of Americans eager to return to their normal lives, he often says he is “counting on the military” to get it done.

Trump has given the impression that troops would be packing up vials, transporting them from factories to pharmacies and perhaps even administering shots. And, at times, military officers working on the sprawling interagency program to move those vaccine doses from drug companies into doctors’ offices have indicated the same thing.

In reality, the role of the military has been less public and more pervasive than this characterization suggests.

When companies have lacked the physical spaces needed to conduct their drug trials, the Defense Department has acquired trailers and permits to create pop-up medical sites in parking lots. When a required piece of plastic or glass was in short supply, the military leveraged a law passed during the Korean War to force manufacturers to move them to the front of the line. Should a hurricane hit somewhere, blocking trucks, the military has transportation ready.

But the distribution of vaccines will be left largely to their producers and commercial transportation companies. Black Hawk helicopters will not be landing next to neighborhood drugstores to drop off doses. No troops will be administering shots.

“It is extremely unlikely that anyone from the government will touch a vaccine, whether that’s loading a truck, unloading a truck, moving dry ice or actually injecting the vaccine before Americans getting it,” said Paul Mango, the deputy chief of staff for policy at the Department of Health and Human Services and the main spokesman for Operation Warp Speed, the multiagency federal consortium for fast-tracking a vaccine.

However, he added, “every logistical detail you could think of, needles, syringes, swabs, bandages, dry ice,” could be procured through the government contracting process, and often faster than through the private sector.

Scores of Defense Department employees are laced through the government offices involved in the effort, making up a large portion of the federal personnel devoted to the effort. Those numbers have led some current and former officials at the Centers for Disease Control and Prevention to privately grumble that the military’s role in Operation Warp Speed was too large for a task that is, at its core, a public health campaign.

“Frankly, it has been breathtaking to watch,” said Paul Ostrowski, the director of supply, production and distribution for Operation Warp Speed. He is a retired Army lieutenant general who was selected to manage logistics for the program by Gen. Gustave F. Perna, the chief operating officer for Operation Warp Speed.

Wrangling volunteers for four expedited vaccine trials — a chore in any circumstance — became even more challenging during a pandemic, when asking hundreds of thousands of subjects to sit in hospital waiting rooms and other health care centers was often not feasible. The Pentagon has helped three companies — AstraZeneca, Moderna and Janssen — set up pop-up sites to conduct trials at 63 locations nationwide.

Needed for each site: double-wide trailers equipped with wheelchair ramps and septic systems. Also, some will need to be hurricane-proof.

These are the types of things that the military can quickly obtain through its contracting system, as well as any permits needed to set it all up. “We have the ability to set up large-scale housing capabilities throughout the entire world at a moment’s notice,” Ostrowski said.

Military officials can call up companies, he said, “And say, ‘I need X number of trailers, and I need them immediately.’” The personnel on his team “work closely with all the city officials to make sure we have all the certificates and that all the codes are being addressed,” he said.

The two pharmaceutical companies leading the vaccine race, Pfizer and Moderna, have estimated that they will have 45 million doses, or enough to vaccinate 22.5 million Americans, by early next year. Because they began manufacturing vaccines that were awaiting federal approval, they should be ready to begin shipping them within days of securing it.

But some companies were hampered by a lack of excess manufacturing capacity in the United States and a shortage of many of the goods needed to make and package vaccines. For raw materials, the military has been able to leverage its contracting muscle, as well as the Defense Production Act, a Korean War-era law that permits the federal government to impose some control over the private sector.

“Everyone is clamoring for that substance or this product,” Ostrowski said. “That’s what we do, we understand capturing supply chains.”

Operation Warp Speed has issued six Defense Production Act orders to companies to put themselves at the front of the line for certain supplies, like large vats needed to produce a vaccine. In October, the government awarded $31 million to manufacturer Cytiva to expand production of the vats.

“There are only a certain number of producers of those in the world,” Ostrowski said. “We were able to make sure they knew where the priority was.”

Military officials also came up with the clever idea — if it works — to coordinate the delivery of vaccines to drugstores, medical centers and other immunization sites by sending kits full of needles, syringes and alcohol wipes. Vaccine makers will be alerted when the kits arrive at an immunization site so they know to ship doses. Once the first dose is given, the manufacturer will be notified so it can send the second dose with a patient’s name attached several weeks later.

But when it comes to the herculean task of vaccine distribution, the job will largely fall to the manufacturers to get the vaccines from loading docks to pharmacies and medical offices.

While governors may use their National Guard units in their vaccine programs, the military is least likely to play a role in moving doses of the vaccine — and certainly troops are not expected to help administer shots, even though Trump has suggested that they will.

“I was surprised when Trump talked about the Department of Defense disseminating any vaccine,” said Dr. Marcus Plescia, the chief medical officer for the Association of State and Territorial Health Officials, which has been deeply involved in the planning process for the vaccines. “There is not any role for the military there. And if there were, we would be up in arms about it because we are advocates for the states.”

Concerns about conspiracy theories surrounding the vaccines are even more reason to keep the military out of sight, Plescia said. “There has been a lot of concern around vaccine hesitancy, and having a bunch of troops around would not be very helpful,” he said. “Even having the National Guard participate could have a down side.”

As one of the largest suppliers of liquid-injectable medicine in the country, Pfizer already has a large network of commercial shippers that helps move its drugs from its manufacturing facility in Michigan to providers around the country. This will be all the more important with the company’s coronavirus vaccine, which needs to be kept at a subfreezing temperature.

The military has spent hours conducting tabletop exercises to help think through how the program could go awry and how it might need to step in to help.

“The government has offered any and all support and is prepared to help clear any obstacle,” said Amy Rose, a spokeswoman for Pfizer. Of the six companies developing a vaccine, the pharmaceutical giant was the only one to reject federal funding.

Pentagon planners have looked at a range of risks to distributing a vaccine, from large-scale protests that could disrupt traffic to poor weather conditions. The military says it can use its airplanes and helicopters to deliver vaccines to remote locations, but only if no other means of transportation are feasible.

The military will also monitor vaccine distribution through an operations center. “They will know where every vaccine dose is,” Mango said on a call with reporters. “If a vaccine dose is at risk of expiring, they will guide the movement of that to someplace else.”

Ostrowski said this specific assignment was worth delaying his retirement. “This is very important to our nation and our world,” he said. “I could think of no better challenge and something more noble than being able to do this.”

WASHINGTON — When President Donald Trump talks about efforts to deliver the coronavirus vaccine to millions of Americans eager to return to their normal lives, he often says he is “counting on the military” to get it done.

WASHINGTON — When President Donald Trump talks about efforts to deliver the coronavirus vaccine to millions of Americans eager to return to their normal lives, he often says he is “counting on the military” to get it done. Trump has given the impression that troops would be packing up vials, transporting them from factories to pharmacies and perhaps even administering shots. And, at times, military officers working on the sprawling interagency program to move those vaccine doses from drug companies into doctors’ offices have indicated the same thing. In reality, the role of the military has been less public and more pervasive than this characterization suggests. When companies have lacked the physical spaces needed to conduct their drug trials, the Defense Department has acquired trailers and permits to create pop-up medical sites in parking lots. When a required piece of plastic or glass was in short supply, the military leveraged a law passed during the Korean War to force manufacturers to move them to the front of the line. Should a hurricane hit somewhere, blocking trucks, the military has transportation ready. But the distribution of vaccines will be left largely to their producers and commercial transportation companies. Black Hawk helicopters will not be landing next to neighborhood drugstores to drop off doses. No troops will be administering shots. “It is extremely unlikely that anyone from the government will touch a vaccine, whether that’s loading a truck, unloading a truck, moving dry ice or actually injecting the vaccine before Americans getting it,” said Paul Mango, the deputy chief of staff for policy at the Department of Health and Human Services and the main spokesman for Operation Warp Speed, the multiagency federal consortium for fast-tracking a vaccine. However, he added, “every logistical detail you could think of, needles, syringes, swabs, bandages, dry ice,” could be procured through the government contracting process, and often faster than through the private sector. Scores of Defense Department employees are laced through the government offices involved in the effort, making up a large portion of the federal personnel devoted to the effort. Those numbers have led some current and former officials at the Centers for Disease Control and Prevention to privately grumble that the military’s role in Operation Warp Speed was too large for a task that is, at its core, a public health campaign. “Frankly, it has been breathtaking to watch,” said Paul Ostrowski, the director of supply, production and distribution for Operation Warp Speed. He is a retired Army lieutenant general who was selected to manage logistics for the program by Gen. Gustave F. Perna, the chief operating officer for Operation Warp Speed. Wrangling volunteers for four expedited vaccine trials — a chore in any circumstance — became even more challenging during a pandemic, when asking hundreds of thousands of subjects to sit in hospital waiting rooms and other health care centers was often not feasible. The Pentagon has helped three companies — AstraZeneca, Moderna and Janssen — set up pop-up sites to conduct trials at 63 locations nationwide. Needed for each site: double-wide trailers equipped with wheelchair ramps and septic systems. Also, some will need to be hurricane-proof. These are the types of things that the military can quickly obtain through its contracting system, as well as any permits needed to set it all up. “We have the ability to set up large-scale housing capabilities throughout the entire world at a moment’s notice,” Ostrowski said. Military officials can call up companies, he said, “And say, ‘I need X number of trailers, and I need them immediately.’” The personnel on his team “work closely with all the city officials to make sure we have all the certificates and that all the codes are being addressed,” he said. The two pharmaceutical companies leading the vaccine race, Pfizer and Moderna, have estimated that they will have 45 million doses, or enough to vaccinate 22.5 million Americans, by early next year. Because they began manufacturing vaccines that were awaiting federal approval, they should be ready to begin shipping them within days of securing it. But some companies were hampered by a lack of excess manufacturing capacity in the United States and a shortage of many of the goods needed to make and package vaccines. For raw materials, the military has been able to leverage its contracting muscle, as well as the Defense Production Act, a Korean War-era law that permits the federal government to impose some control over the private sector. “Everyone is clamoring for that substance or this product,” Ostrowski said. “That’s what we do, we understand capturing supply chains.” Operation Warp Speed has issued six Defense Production Act orders to companies to put themselves at the front of the line for certain supplies, like large vats needed to produce a vaccine. In October, the government awarded $31 million to manufacturer Cytiva to expand production of the vats. “There are only a certain number of producers of those in the world,” Ostrowski said. “We were able to make sure they knew where the priority was.” Military officials also came up with the clever idea — if it works — to coordinate the delivery of vaccines to drugstores, medical centers and other immunization sites by sending kits full of needles, syringes and alcohol wipes. Vaccine makers will be alerted when the kits arrive at an immunization site so they know to ship doses. Once the first dose is given, the manufacturer will be notified so it can send the second dose with a patient’s name attached several weeks later. But when it comes to the herculean task of vaccine distribution, the job will largely fall to the manufacturers to get the vaccines from loading docks to pharmacies and medical offices. While governors may use their National Guard units in their vaccine programs, the military is least likely to play a role in moving doses of the vaccine — and certainly troops are not expected to help administer shots, even though Trump has suggested that they will. “I was surprised when Trump talked about the Department of Defense disseminating any vaccine,” said Dr. Marcus Plescia, the chief medical officer for the Association of State and Territorial Health Officials, which has been deeply involved in the planning process for the vaccines. “There is not any role for the military there. And if there were, we would be up in arms about it because we are advocates for the states.” Concerns about conspiracy theories surrounding the vaccines are even more reason to keep the military out of sight, Plescia said. “There has been a lot of concern around vaccine hesitancy, and having a bunch of troops around would not be very helpful,” he said. “Even having the National Guard participate could have a down side.” As one of the largest suppliers of liquid-injectable medicine in the country, Pfizer already has a large network of commercial shippers that helps move its drugs from its manufacturing facility in Michigan to providers around the country. This will be all the more important with the company’s coronavirus vaccine, which needs to be kept at a subfreezing temperature. The military has spent hours conducting tabletop exercises to help think through how the program could go awry and how it might need to step in to help. “The government has offered any and all support and is prepared to help clear any obstacle,” said Amy Rose, a spokeswoman for Pfizer. Of the six companies developing a vaccine, the pharmaceutical giant was the only one to reject federal funding. Pentagon planners have looked at a range of risks to distributing a vaccine, from large-scale protests that could disrupt traffic to poor weather conditions. The military says it can use its airplanes and helicopters to deliver vaccines to remote locations, but only if no other means of transportation are feasible. The military will also monitor vaccine distribution through an operations center. “They will know where every vaccine dose is,” Mango said on a call with reporters. “If a vaccine dose is at risk of expiring, they will guide the movement of that to someplace else.” Ostrowski said this specific assignment was worth delaying his retirement. “This is very important to our nation and our world,” he said. “I could think of no better challenge and something more noble than being able to do this.”

Military’s role in vaccine will be strictly behind the scenes, despite Trump’s claims

South Korea's intelligence agency said it foiled the North's attempts to hack into its companies developing coronavirus vaccines.

North Korea has so far not confirmed any coronavirus infection.

Ha Tae-keung, a member of the parliamentary intelligence committee, said after being briefed by the National Intelligence Service (NIS) that the agency did not specify how many and which drugmakers were targetted but said there was no damage from the hacking attempts.

The revelation came after Microsoft said early this month that hackers working for the Russian and North Korean governments tried to break into the networks of seven pharmaceutical companies and vaccine researchers in Canada, France, India, South Korea and the United States.

The closed-door briefings by the NIS which shares intelligence and analyses with other key neighbours provide rare public access to information about the reclusive North.

Ha and another member Kim Byung-kee said North Korean leader Kim Jong Un had taken some "unreasonable" action due to a COVID-19 "paranoia."

That included banning fishing and salt production because the seawater might have been contaminated with the virus, and stranding some 110,000 tons of rice from China in the northeastern Chinese port of Dalian.

 
&nbsp;

South Korea's intelligence agency said it foiled the North's attempts to hack into its companies developing coronavirus vaccines. North Korea has so far not confirmed any coronavirus infection.

South Korea's intelligence agency said it foiled the North's attempts to hack into its companies developing coronavirus vaccines. North Korea has so far not confirmed any coronavirus infection. Ha Tae-keung, a member of the parliamentary intelligence committee, said after being briefed by the National Intelligence Service (NIS) that the agency did not specify how many and which drugmakers were targetted but said there was no damage from the hacking attempts. The revelation came after Microsoft said early this month that hackers working for the Russian and North Korean governments tried to break into the networks of seven pharmaceutical companies and vaccine researchers in Canada, France, India, South Korea and the United States. The closed-door briefings by the NIS which shares intelligence and analyses with other key neighbours provide rare public access to information about the reclusive North. Ha and another member Kim Byung-kee said North Korean leader Kim Jong Un had taken some "unreasonable" action due to a COVID-19 "paranoia." That included banning fishing and salt production because the seawater might have been contaminated with the virus, and stranding some 110,000 tons of rice from China in the northeastern Chinese port of Dalian.

South Korea says it foiled the North's attempt to hack COVID-19 vaccine makers

The announcement this week that a cheap, easy-to-make coronavirus vaccine appeared to be up to 90% effective was greeted with jubilation. “Get yourself a vaccaccino,” a British tabloid celebrated, noting that the vaccine, developed by AstraZeneca and the University of Oxford, costs less than a cup of coffee.

But since unveiling the preliminary results, AstraZeneca has acknowledged a key mistake in the vaccine dosage received by some study participants, adding to questions about whether the vaccine’s apparently spectacular efficacy will hold up under additional testing.

Scientists and industry experts said the error and a series of other irregularities and omissions in the way AstraZeneca initially disclosed the data have eroded their confidence in the reliability of the results.

Officials in the United States have noted that the results were not clear. It was the head of the flagship federal vaccine initiative — not the company — who first disclosed that the vaccine’s most promising results did not reflect data from older people.

The upshot, the experts said, is that the odds of regulators in the United States and elsewhere quickly authorizing the emergency use of the AstraZeneca vaccine are declining, an unexpected setback in the global campaign to corral the devastating pandemic.

“I think that they have really damaged confidence in their whole development program,” said Geoffrey Porges, an analyst for the investment bank SVB Leerink.

Michele Meixell, a spokesperson for AstraZeneca, said the trials “were conducted to the highest standards.”

In an interview Wednesday, Menelas Pangalos, the AstraZeneca executive in charge of much of the company’s research and development, defended the company’s handling of the testing and its public disclosures. He said the error in the dosage was made by a contractor, and that, once it was discovered, regulators were immediately notified and signed off on the plan to continue testing the vaccine in different doses.

Asked why AstraZeneca shared some information with Wall Street analysts and some other officials and experts but not with the public, he responded, “I think the best way of reflecting the results is in a peer-reviewed scientific journal, not in a newspaper.”

AstraZeneca was the third company this month to report encouraging early results on a coronavirus vaccine candidate. At first glance Monday morning, the results looked promising. Depending on the strength at which the doses were given, the vaccine appeared to be either 90% or 62% effective. The average efficacy, the developers said, was 70%.

Almost immediately, though, there were doubts about the data.

The regimen that appeared to be 90% effective was based on participants receiving a half dose of the vaccine followed a month later by a full dose; the less effective version involved a pair of full doses. AstraZeneca disclosed in its initial announcement that fewer than 2,800 participants received the smaller dosing regimen, compared with nearly 8,900 participants who received two full doses.

The biggest questions were, why was there such a large variation in the effectiveness of the vaccine at different doses, and why did a smaller dose appear to produce much better results? AstraZeneca and Oxford researchers said they did not know.

Crucial information was also missing. The company said that the early analysis was based on 131 symptomatic COVID-19 cases that had turned up in study participants. But it did not break down how many cases were found in each group of participants — those who received the half-strength initial dose, the regular-strength initial dose and the placebo.

“The press release raised more questions than it answered,” said John Moore, a professor of microbiology and immunology at Weill Cornell Medical College.

Adding to the confusion, AstraZeneca pooled the results from two differently designed clinical trials in Britain and Brazil, a break from standard practice in reporting the results of drug and vaccine trials.

“I just can’t figure out where all the information is coming from and how it’s combining together,” said Natalie Dean, a biostatistician and an expert in vaccine trial design at the University of Florida. She wrote on Twitter that AstraZeneca and Oxford “get a poor grade for transparency and rigor when it comes to the vaccine trial results they have reported.”

With AstraZeneca’s shares declining Monday, company executives held several private conference calls with industry analysts in which they disclosed details that were not in the public announcement, including how the COVID-19 cases broke down across different groups. Such disclosures to analysts are not uncommon in the industry, but they often generate criticism about why the details were not shared with the public.

Bigger problems soon surfaced.

Pangalos told Reuters on Monday that the company had not intended for any participants to receive the half dose. British researchers running the trial there had meant to give the full dose initially to volunteers, but a miscalculation meant they were mistakenly given only a half dose. Pangalos described the error as “serendipity,” allowing researchers to stumble onto a more promising dosing regimen.

To many outside experts, that undercut the credibility of the results because the closely calibrated clinical trials had not been designed to test how well a half-strength initial dose worked.

The company’s initial announcement didn’t mention the accidental nature of the discovery.

“The reality is, it could end up being quite a useful mistake,” Pangalos said in the interview with The New York Times on Wednesday. “It wasn’t putting anyone in danger. It was a dosing error. Everyone was moving very fast. We corrected the mistake and continued on with the study, with no changes to the study, and agreed with the regulator to include those patients in the analysis of the study as well.”

He added, “What is there to disclose? It actually doesn’t matter whether it was done on purpose or not.”

In the statement attributed to Oxford, Meixell, the AstraZeneca spokeswoman, said the error stemmed from an issue, which has since been fixed, with how some of the vaccine doses were manufactured.

Then, on Tuesday, Moncef Slaoui, the head of Operation Warp Speed, the U.S. initiative to fast-track coronavirus vaccines, noted another limitation in AstraZeneca’s data. On a call with reporters, he suggested that the participants who received the half-strength initial dose had been 55 years old or younger.

Pangalos confirmed that Wednesday, saying the participants received the half-strength dose over a matter of weeks before the error was discovered.

The fact that the initial half-strength dose wasn’t tested in older participants, who are especially vulnerable to COVID-19, could undermine AstraZeneca’s case to regulators that the vaccine should be authorized for emergency use.

Stephanie Caccomo, a spokeswoman for the Food and Drug Administration, declined to comment on whether the dosing error would hurt the vaccine’s chances of being authorized. The FDA has said it expects vaccines to be at least 50% effective in preventing or reducing the severity of the disease, a bar that the vaccine appears to have cleared even in the group that got the two full doses.

AstraZeneca’s shares have fallen about 5% this week, while broader stock indexes have climbed to record highs. Investors seem to be disappointed with the murky results, especially compared with the much clearer data released by two of AstraZeneca’s chief rivals in the race for a coronavirus vaccine.

Pfizer and Moderna said this month that their vaccines, which use a technology known as “messenger RNA,” appear to be about 95% effective. Both offerings seem nearly certain to win emergency authorization from the FDA in the coming weeks.

The AstraZeneca vaccine, which uses a different approach involving a chimpanzee virus to provoke an immune response to the coronavirus, had all the hallmarks of a blockbuster.

It was inexpensive — only a few dollars per dose — and easy to mass-produce. Unlike Pfizer and Moderna’s vaccines, AstraZeneca’s could be stored for months in normal refrigerators. The company has estimated it will be able to produce some 3 billion doses next year, enough to vaccinate nearly one-fifth of the global population.

Compared to most of the other leading COVID-19 vaccine developers, AstraZeneca is inexperienced when it comes to vaccines. And even before the chaotic release of results, the company was under scrutiny for its handling of the testing process.

In September, AstraZeneca paused clinical trials worldwide after a participant fell ill — but the company didn’t promptly announce the decision publicly. AstraZeneca also came under fire for providing details about the nature of the illness on a private conference call with investors hosted by the investment bank J.P. Morgan, rather than disseminating the information to the public. Both of those developments were first reported by STAT, which covers health and science news.

Ever since the Oxford-AstraZeneca team emerged as front-runners in the race to develop a vaccine this spring, Prime Minister Boris Johnson of Britain has embraced the effort. The government preordered 100 million doses and cast the research as one of the country’s most important contributions to fighting the pandemic.

Basking in the results on Monday, Johnson said the vaccine “has the makings of a wonderful British scientific achievement.”

In the United States, which has ordered at least 300 million doses of AstraZeneca’s vaccine, the regulatory path forward is unclear. AstraZeneca was circumspect on Monday about its plans for seeking regulatory approval. The company said it would seek guidance from the Food and Drug Administration on whether it should formally submit its findings to apply for emergency authorization.

AstraZeneca has not been testing the promising half-strength initial dose in its ongoing U.S. trial. The company said it would work with the agency to add it as quickly as possible to that trial.

Pangalos said the company is planning a global trial to compare the two dosing regimens. The number of participants it will enroll hasn’t yet been determined, but it will be in the thousands.

“The only way they’re going to find out is by specifically and deliberately testing this serendipitous observation,” Moore said. “The onus is on them to prove the speculation.”

The announcement this week that a cheap, easy-to-make coronavirus vaccine appeared to be up to 90% effective was greeted with jubilation. “Get yourself a vaccaccino,” a British tabloid celebrated, noting that the vaccine, developed by AstraZeneca and the University of Oxford, costs less than a cup of coffee.

The announcement this week that a cheap, easy-to-make coronavirus vaccine appeared to be up to 90% effective was greeted with jubilation. “Get yourself a vaccaccino,” a British tabloid celebrated, noting that the vaccine, developed by AstraZeneca and the University of Oxford, costs less than a cup of coffee. But since unveiling the preliminary results, AstraZeneca has acknowledged a key mistake in the vaccine dosage received by some study participants, adding to questions about whether the vaccine’s apparently spectacular efficacy will hold up under additional testing. Scientists and industry experts said the error and a series of other irregularities and omissions in the way AstraZeneca initially disclosed the data have eroded their confidence in the reliability of the results. Officials in the United States have noted that the results were not clear. It was the head of the flagship federal vaccine initiative — not the company — who first disclosed that the vaccine’s most promising results did not reflect data from older people. The upshot, the experts said, is that the odds of regulators in the United States and elsewhere quickly authorizing the emergency use of the AstraZeneca vaccine are declining, an unexpected setback in the global campaign to corral the devastating pandemic. “I think that they have really damaged confidence in their whole development program,” said Geoffrey Porges, an analyst for the investment bank SVB Leerink. Michele Meixell, a spokesperson for AstraZeneca, said the trials “were conducted to the highest standards.” In an interview Wednesday, Menelas Pangalos, the AstraZeneca executive in charge of much of the company’s research and development, defended the company’s handling of the testing and its public disclosures. He said the error in the dosage was made by a contractor, and that, once it was discovered, regulators were immediately notified and signed off on the plan to continue testing the vaccine in different doses. Asked why AstraZeneca shared some information with Wall Street analysts and some other officials and experts but not with the public, he responded, “I think the best way of reflecting the results is in a peer-reviewed scientific journal, not in a newspaper.” AstraZeneca was the third company this month to report encouraging early results on a coronavirus vaccine candidate. At first glance Monday morning, the results looked promising. Depending on the strength at which the doses were given, the vaccine appeared to be either 90% or 62% effective. The average efficacy, the developers said, was 70%. Almost immediately, though, there were doubts about the data. The regimen that appeared to be 90% effective was based on participants receiving a half dose of the vaccine followed a month later by a full dose; the less effective version involved a pair of full doses. AstraZeneca disclosed in its initial announcement that fewer than 2,800 participants received the smaller dosing regimen, compared with nearly 8,900 participants who received two full doses. The biggest questions were, why was there such a large variation in the effectiveness of the vaccine at different doses, and why did a smaller dose appear to produce much better results? AstraZeneca and Oxford researchers said they did not know. Crucial information was also missing. The company said that the early analysis was based on 131 symptomatic COVID-19 cases that had turned up in study participants. But it did not break down how many cases were found in each group of participants — those who received the half-strength initial dose, the regular-strength initial dose and the placebo. “The press release raised more questions than it answered,” said John Moore, a professor of microbiology and immunology at Weill Cornell Medical College. Adding to the confusion, AstraZeneca pooled the results from two differently designed clinical trials in Britain and Brazil, a break from standard practice in reporting the results of drug and vaccine trials. “I just can’t figure out where all the information is coming from and how it’s combining together,” said Natalie Dean, a biostatistician and an expert in vaccine trial design at the University of Florida. She wrote on Twitter that AstraZeneca and Oxford “get a poor grade for transparency and rigor when it comes to the vaccine trial results they have reported.” With AstraZeneca’s shares declining Monday, company executives held several private conference calls with industry analysts in which they disclosed details that were not in the public announcement, including how the COVID-19 cases broke down across different groups. Such disclosures to analysts are not uncommon in the industry, but they often generate criticism about why the details were not shared with the public. Bigger problems soon surfaced. Pangalos told Reuters on Monday that the company had not intended for any participants to receive the half dose. British researchers running the trial there had meant to give the full dose initially to volunteers, but a miscalculation meant they were mistakenly given only a half dose. Pangalos described the error as “serendipity,” allowing researchers to stumble onto a more promising dosing regimen. To many outside experts, that undercut the credibility of the results because the closely calibrated clinical trials had not been designed to test how well a half-strength initial dose worked. The company’s initial announcement didn’t mention the accidental nature of the discovery. “The reality is, it could end up being quite a useful mistake,” Pangalos said in the interview with The New York Times on Wednesday. “It wasn’t putting anyone in danger. It was a dosing error. Everyone was moving very fast. We corrected the mistake and continued on with the study, with no changes to the study, and agreed with the regulator to include those patients in the analysis of the study as well.” He added, “What is there to disclose? It actually doesn’t matter whether it was done on purpose or not.” In the statement attributed to Oxford, Meixell, the AstraZeneca spokeswoman, said the error stemmed from an issue, which has since been fixed, with how some of the vaccine doses were manufactured. Then, on Tuesday, Moncef Slaoui, the head of Operation Warp Speed, the U.S. initiative to fast-track coronavirus vaccines, noted another limitation in AstraZeneca’s data. On a call with reporters, he suggested that the participants who received the half-strength initial dose had been 55 years old or younger. Pangalos confirmed that Wednesday, saying the participants received the half-strength dose over a matter of weeks before the error was discovered. The fact that the initial half-strength dose wasn’t tested in older participants, who are especially vulnerable to COVID-19, could undermine AstraZeneca’s case to regulators that the vaccine should be authorized for emergency use. Stephanie Caccomo, a spokeswoman for the Food and Drug Administration, declined to comment on whether the dosing error would hurt the vaccine’s chances of being authorized. The FDA has said it expects vaccines to be at least 50% effective in preventing or reducing the severity of the disease, a bar that the vaccine appears to have cleared even in the group that got the two full doses. AstraZeneca’s shares have fallen about 5% this week, while broader stock indexes have climbed to record highs. Investors seem to be disappointed with the murky results, especially compared with the much clearer data released by two of AstraZeneca’s chief rivals in the race for a coronavirus vaccine. Pfizer and Moderna said this month that their vaccines, which use a technology known as “messenger RNA,” appear to be about 95% effective. Both offerings seem nearly certain to win emergency authorization from the FDA in the coming weeks. The AstraZeneca vaccine, which uses a different approach involving a chimpanzee virus to provoke an immune response to the coronavirus, had all the hallmarks of a blockbuster. It was inexpensive — only a few dollars per dose — and easy to mass-produce. Unlike Pfizer and Moderna’s vaccines, AstraZeneca’s could be stored for months in normal refrigerators. The company has estimated it will be able to produce some 3 billion doses next year, enough to vaccinate nearly one-fifth of the global population. Compared to most of the other leading COVID-19 vaccine developers, AstraZeneca is inexperienced when it comes to vaccines. And even before the chaotic release of results, the company was under scrutiny for its handling of the testing process. In September, AstraZeneca paused clinical trials worldwide after a participant fell ill — but the company didn’t promptly announce the decision publicly. AstraZeneca also came under fire for providing details about the nature of the illness on a private conference call with investors hosted by the investment bank J.P. Morgan, rather than disseminating the information to the public. Both of those developments were first reported by STAT, which covers health and science news. Ever since the Oxford-AstraZeneca team emerged as front-runners in the race to develop a vaccine this spring, Prime Minister Boris Johnson of Britain has embraced the effort. The government preordered 100 million doses and cast the research as one of the country’s most important contributions to fighting the pandemic. Basking in the results on Monday, Johnson said the vaccine “has the makings of a wonderful British scientific achievement.” In the United States, which has ordered at least 300 million doses of AstraZeneca’s vaccine, the regulatory path forward is unclear. AstraZeneca was circumspect on Monday about its plans for seeking regulatory approval. The company said it would seek guidance from the Food and Drug Administration on whether it should formally submit its findings to apply for emergency authorization. AstraZeneca has not been testing the promising half-strength initial dose in its ongoing U.S. trial. The company said it would work with the agency to add it as quickly as possible to that trial. Pangalos said the company is planning a global trial to compare the two dosing regimens. The number of participants it will enroll hasn’t yet been determined, but it will be in the thousands. “The only way they’re going to find out is by specifically and deliberately testing this serendipitous observation,” Moore said. “The onus is on them to prove the speculation.”

After admitting mistake, AstraZeneca faces difficult questions about its vaccine

The makers of the Oxford vaccine want to sell their shot at cost price to developing countries. How are other vaccine makers planning to price their vaccines? WION's Molly Gambhir has the details.

Gravitas: Will the Oxford shot be the cheapest available vaccine?

As countries compete in the vaccine race, they are all leaning on India for the vaccine supplies. India holds the key to vaccine manufacturing - and unlike some countries, India is not prioritising profit over the health of billions. WION's Molly Gambhir has the details.

Gravitas: Wuhan Vaccine: The World turns to India

As expectations grow that the first Covid-19 jabs will be administered in a matter of weeks, German glassmaker Schott is quietly doing what it has been for months: churning out vials that will hold the vaccine.

The 130-year-old company, whose founder Otto Schott invented the high-quality borosilicate glass favoured by the pharma industry, has been working round the clock to meet unprecedented demand.

Already it has delivered millions of the little bottles to vaccine makers involved in Covid-19 trials, who have already started filling them so they can be shipped out the minute regulators give the okay.

While non-disclosure agreements prevent Schott from detailing its customer list, head of communications Christina Rettig said they include "the ones you hear about in the media".

In fact, Schott is supplying vials for three-quarters of the more than 100 coronavirus vaccine trials worldwide.

Closest to the finish line are US firm Moderna and a joint effort by US giant Pfizer and Germany's BioNTech -- which coincidentally has its headquarters in the same western German city of Mainz as Schott.

Large-scale data has shown both vaccines to be around 95 percent effective and US and European authorities have signalled that inoculations could start in mid-December.

With the world on the brink of a mass immunisation effort to end the pandemic, Schott and its competitors say they are ready to rise to the challenge.

The company issued a statement in July with Germany's Gerresheimer and Italy's Stevanato Group, fellow leaders in pharmaceutical packaging, to say they were coordinating closely with pharma customers and could ensure sufficient supply.

Schott alone aims to produce enough vials to store two billion doses of a coronavirus vaccine by the end of 2021, Rettig told AFP at the company's offices in Mainz.

- Ramping up -

In a lucky break, the industry was already seeing rising demand from China and other countries for top-level Type 1 borosilicate glass products, meaning Schott and other major players were building up capacity well before the pandemic struck.

Schott launched a $1.0-billion (840-million-euro) investment programme in 2019 to expand its pharmaceutical business. By the time the Covid-19 vial requests started pouring in, new manufacturing equipment was already up and running.&nbsp;&nbsp;

"That puts us in a very good position to ramp up production quickly," Rettig said.

And because regulators have long been familiar with the tried-and-tested vials, which have to meet strict international norms, they won't hold up the vaccine authorisation process.

To keep production moving, workers are churning out vials 24 hours a day, a typical pace in the sector, and outsiders are banned from the premises to minimise the risk of coronavirus infections.

Schott itself had an early encounter with the virus at its Mitterteich plant in Bavaria, where it manufactures glass tubes that can be turned into vials.

The town became one of Germany's first coronavirus hotspots in March after a beer festival, and Rettig said several Schott workers from the Czech Republic ended up "not seeing friends and family for weeks" as borders slammed shut.

- 'Gold standard' -

Borosilicate glass was invented around 1890 by Otto Schott, a chemist from a family of glassmakers. Together with scientists Ernst Abbe and Carl Zeiss, he set up a lab that would lay the foundation for modern glass technology.

What makes borosilicate glass special is that it can handle temperatures from -80 to 500 degrees Celsius, which is handy considering the Pfizer/BioNTech vaccine needs to be stored at a frigid -70 degrees.

It is also chemically inert, meaning there is no chemical interaction between the container and the liquid inside it, preventing any interference that could potentially harm the vaccine.

Borosilicate glass is considered "the gold standard" for packaging drugs, Rettig said.

The Schott company, wholly owned by the Carl Zeiss Foundation, now has over 16,000 employees in more than 30 countries and reported revenues of 2.2 billion euros ($2.6 billion) in 2018-2019.

Its other products range from specialist cabin lighting in aeroplanes to ceramic cooktops, as well as microscope slides being used in rapid Covid-19 antibody testing, and medical lights that help doctors examine respiratory tracts.

While vial makers aren't quite grabbing the headlines as much as vaccine developers, Rettig said Schott employees "are proud to contribute to the fight against the coronavirus".

As expectations grow that the first Covid-19 jabs will be administered in a matter of weeks, German glassmaker Schott is quietly doing what it has been for months: churning out vials that will hold the vaccine.

As expectations grow that the first Covid-19 jabs will be administered in a matter of weeks, German glassmaker Schott is quietly doing what it has been for months: churning out vials that will hold the vaccine. The 130-year-old company, whose founder Otto Schott invented the high-quality borosilicate glass favoured by the pharma industry, has been working round the clock to meet unprecedented demand. Already it has delivered millions of the little bottles to vaccine makers involved in Covid-19 trials, who have already started filling them so they can be shipped out the minute regulators give the okay. While non-disclosure agreements prevent Schott from detailing its customer list, head of communications Christina Rettig said they include "the ones you hear about in the media". In fact, Schott is supplying vials for three-quarters of the more than 100 coronavirus vaccine trials worldwide. Closest to the finish line are US firm Moderna and a joint effort by US giant Pfizer and Germany's BioNTech -- which coincidentally has its headquarters in the same western German city of Mainz as Schott. Large-scale data has shown both vaccines to be around 95 percent effective and US and European authorities have signalled that inoculations could start in mid-December. With the world on the brink of a mass immunisation effort to end the pandemic, Schott and its competitors say they are ready to rise to the challenge. The company issued a statement in July with Germany's Gerresheimer and Italy's Stevanato Group, fellow leaders in pharmaceutical packaging, to say they were coordinating closely with pharma customers and could ensure sufficient supply. Schott alone aims to produce enough vials to store two billion doses of a coronavirus vaccine by the end of 2021, Rettig told AFP at the company's offices in Mainz. - Ramping up - In a lucky break, the industry was already seeing rising demand from China and other countries for top-level Type 1 borosilicate glass products, meaning Schott and other major players were building up capacity well before the pandemic struck. Schott launched a $1.0-billion (840-million-euro) investment programme in 2019 to expand its pharmaceutical business. By the time the Covid-19 vial requests started pouring in, new manufacturing equipment was already up and running. "That puts us in a very good position to ramp up production quickly," Rettig said. And because regulators have long been familiar with the tried-and-tested vials, which have to meet strict international norms, they won't hold up the vaccine authorisation process. To keep production moving, workers are churning out vials 24 hours a day, a typical pace in the sector, and outsiders are banned from the premises to minimise the risk of coronavirus infections. Schott itself had an early encounter with the virus at its Mitterteich plant in Bavaria, where it manufactures glass tubes that can be turned into vials. The town became one of Germany's first coronavirus hotspots in March after a beer festival, and Rettig said several Schott workers from the Czech Republic ended up "not seeing friends and family for weeks" as borders slammed shut. - 'Gold standard' - Borosilicate glass was invented around 1890 by Otto Schott, a chemist from a family of glassmakers. Together with scientists Ernst Abbe and Carl Zeiss, he set up a lab that would lay the foundation for modern glass technology. What makes borosilicate glass special is that it can handle temperatures from -80 to 500 degrees Celsius, which is handy considering the Pfizer/BioNTech vaccine needs to be stored at a frigid -70 degrees. It is also chemically inert, meaning there is no chemical interaction between the container and the liquid inside it, preventing any interference that could potentially harm the vaccine. Borosilicate glass is considered "the gold standard" for packaging drugs, Rettig said. The Schott company, wholly owned by the Carl Zeiss Foundation, now has over 16,000 employees in more than 30 countries and reported revenues of 2.2 billion euros ($2.6 billion) in 2018-2019. Its other products range from specialist cabin lighting in aeroplanes to ceramic cooktops, as well as microscope slides being used in rapid Covid-19 antibody testing, and medical lights that help doctors examine respiratory tracts. While vial makers aren't quite grabbing the headlines as much as vaccine developers, Rettig said Schott employees "are proud to contribute to the fight against the coronavirus".

German vials in spotlight as Covid-19 vaccine nears

Which vaccine candidates are frontrunners? When will you be able to take a shot? Do the vaccines work for everyone? How long does the immunity last? Will the vaccines have any long-term side effects? WION's Molly Gambhir answers some frequently asked questions on vaccines.

Gravitas: Vaccine FAQs: Your every question answered

Britain President Boris Johnson has announced new measures which bring back regional approach to tackle COVID-19. Fresh measure has to be taken to open business where infection rate is low. Boris Johnson has said that government will not force anyone to get vaccinated.

Britain Government will not force anyone to get vaccinated

A top official of the US government's vaccine development effort has said on Sunday that the United States hopes to begin a sweeping program of Covid vaccinations in early December. 
 
Also Read |&nbsp;<a href="https://www.wionews.com/world/nasal-spray-that-aims-to-fight-covid-19-other-respiratory-illness-gets-million-dollar-funding-344698">Nasal spray that aims to fight Covid-19, other respiratory illness gets million-dollar funding</a>

Some 70% of the US population of 330 million would need to be inoculated to achieve "herd" immunity from the virus, a goal the country could achieve by May, according to Dr Moncef Slaoui, chief scientific adviser for "Operation Warp Speed."

Slaoui said the US Food and Drug Administration (FDA) would likely grant approval in mid-December for distribution of the vaccine produced by Pfizer Inc and German partner BioNTech, launching the largest inoculation campaign in U.S. history. 
 
'Our plan is to be able to ship vaccines to the immunization sites within 24 hours of approval' by the US Food and Drug Administration,' Moncef Slaoui said.

"So I expect maybe on Day Two of the approval, on the 11th or the 12th of December."

Citing reports, AFP said that FDA vaccine advisors will meet between December 8 and 10 to discuss approval of vaccines. Pfizer and Moderna have said that their vaccines against COVID-19 are at least 95 per cent effective.

Pfizer and its partner BioNTech confirmed on Friday (December 20) that they had applied to US health regulators for emergency use authorisation (EUA) of its COVID-19 vaccine, becoming the first to do so in the US as the pandemic rages around the world. The companies have said that they are prepared to ship vaccines as soon as they get a go-ahead from the government.

The USA is the worst affected country in the world. It has had more than 12,000,000 coronavirus cases so far. The death tally is fast approaching 300 thousand. Nearly 5 million people are still affected due to coronavirus.

(With inputs from agencies)

A top official of the US government's vaccine development effort has said on Sunday that the United States hopes to begin a sweeping program of Covid vaccinations in early December.

A top official of the US government's vaccine development effort has said on Sunday that the United States hopes to begin a sweeping program of Covid vaccinations in early December. Also Read | Nasal spray that aims to fight Covid-19, other respiratory illness gets million-dollar funding Some 70% of the US population of 330 million would need to be inoculated to achieve "herd" immunity from the virus, a goal the country could achieve by May, according to Dr Moncef Slaoui, chief scientific adviser for "Operation Warp Speed." Slaoui said the US Food and Drug Administration (FDA) would likely grant approval in mid-December for distribution of the vaccine produced by Pfizer Inc and German partner BioNTech, launching the largest inoculation campaign in U.S. history. 'Our plan is to be able to ship vaccines to the immunization sites within 24 hours of approval' by the US Food and Drug Administration,' Moncef Slaoui said. "So I expect maybe on Day Two of the approval, on the 11th or the 12th of December." Citing reports, AFP said that FDA vaccine advisors will meet between December 8 and 10 to discuss approval of vaccines. Pfizer and Moderna have said that their vaccines against COVID-19 are at least 95 per cent effective. Pfizer and its partner BioNTech confirmed on Friday (December 20) that they had applied to US health regulators for emergency use authorisation (EUA) of its COVID-19 vaccine, becoming the first to do so in the US as the pandemic rages around the world. The companies have said that they are prepared to ship vaccines as soon as they get a go-ahead from the government. The USA is the worst affected country in the world. It has had more than 12,000,000 coronavirus cases so far. The death tally is fast approaching 300 thousand. Nearly 5 million people are still affected due to coronavirus. (With inputs from agencies)

Covid vaccine could reach first Americans by December 11: Top health official

Moderna will charge governments between $25 and $37 per dose of its COVID-19 vaccine candidate, depending on the amount ordered, Chief Executive Stephane Bancel told German weekly Welt am Sonntag (WamS).

"Our vaccine therefore costs about the same as a flu shot, which is between $10 and $50," he was quoted as saying.

On Monday, an EU official involved in the talks said the European Commission wanted to reach a deal with Moderna for the supply of millions of doses of its vaccine candidate for a price below $25 per dose.

"Nothing is signed yet, but we`re close to a deal with the EU Commission. We want to deliver to Europe and are in constructive talks," Bancel told WamS, adding it was just a "matter of days" until a contract would be ready.

Moderna has said its experimental vaccine is 94.5% effective in preventing COVID-19, based on interim data from a late-stage clinical trial, becoming the second developer to report results that far exceeded expectations after Pfizer and its partner BioNTech.

The EU has been in talks with Moderna for its experimental COVID-19 vaccine at least since July.

Moderna will charge governments between $25 and $37 per dose of its COVID-19 vaccine candidate, depending on the amount ordered, Chief Executive Stephane Bancel told German weekly Welt am Sonntag (WamS).

Moderna will charge governments between $25 and $37 per dose of its COVID-19 vaccine candidate, depending on the amount ordered, Chief Executive Stephane Bancel told German weekly Welt am Sonntag (WamS). "Our vaccine therefore costs about the same as a flu shot, which is between $10 and $50," he was quoted as saying. On Monday, an EU official involved in the talks said the European Commission wanted to reach a deal with Moderna for the supply of millions of doses of its vaccine candidate for a price below $25 per dose. "Nothing is signed yet, but we`re close to a deal with the EU Commission. We want to deliver to Europe and are in constructive talks," Bancel told WamS, adding it was just a "matter of days" until a contract would be ready. Moderna has said its experimental vaccine is 94.5% effective in preventing COVID-19, based on interim data from a late-stage clinical trial, becoming the second developer to report results that far exceeded expectations after Pfizer and its partner BioNTech. The EU has been in talks with Moderna for its experimental COVID-19 vaccine at least since July.

Moderna to charge $25-$37 for COVID-19 vaccine

Head of US government's coronavirus vaccine effort said on Sunday that the country hopes to begin a sweeping vaccination in early December. If such an effort takes place, it will mark first mass vaccination against coronavirus and will also be a decisive step against the global Covid-19 pandemic. The coronavirus pandemic has killed more than a million people worldwide. The number of active cases worldwide is more than 15 million at present.

"Our plan is to be able to ship vaccines to the immunization sites within 24 hours of approval" by the US Food and Drug Administration, Moncef Slaoui told CNN.&nbsp;

"So I expect maybe on Day Two of the approval, on the 11th or the 12th of December."

Citing reports, AFP said that FDA vaccine advisors will meet between December 8 and 10 to discuss approval of vaccines. Pfizer and Moderna have said that their vaccines against COVID-19 are at least 95 per cent effective.

Also Read | <a href="https://www.wionews.com/world/nasal-spray-that-aims-to-fight-covid-19-other-respiratory-illness-gets-million-dollar-funding-344698">Nasal spray that aims to fight Covid-19, other respiratory illness gets million-dollar funding</a>

Pfizer and its partner BioNTech confirmed on Friday (December 20) that they had applied to US health regulators for emergency use authorisation (EUA) of its COVID-19 vaccine, becoming the first to do so in the US as the pandemic rages around the world. The companies have said that they are prepared to ship vaccines as soon as they get a go-ahead from the government.

USA is the worst affected country in the world. It has had more than 12,000,000 coronavirus cases so far. The death tally is fast approaching 300 thousand. Nearly 5 million people are still affected due to coronavirus.

(With agency&nbsp;inputs)

Head of US government's coronavirus vaccine effort said on Sunday that the country hopes to begin a sweeping vaccination in early December. If such an effort takes place, it will mark first mass vaccination against coronavirus and will also be a decisive step against the global Covid-19 pandemic.

Head of US government's coronavirus vaccine effort said on Sunday that the country hopes to begin a sweeping vaccination in early December. If such an effort takes place, it will mark first mass vaccination against coronavirus and will also be a decisive step against the global Covid-19 pandemic. The coronavirus pandemic has killed more than a million people worldwide. The number of active cases worldwide is more than 15 million at present. "Our plan is to be able to ship vaccines to the immunization sites within 24 hours of approval" by the US Food and Drug Administration, Moncef Slaoui told CNN. "So I expect maybe on Day Two of the approval, on the 11th or the 12th of December." Citing reports, AFP said that FDA vaccine advisors will meet between December 8 and 10 to discuss approval of vaccines. Pfizer and Moderna have said that their vaccines against COVID-19 are at least 95 per cent effective. Also Read | Nasal spray that aims to fight Covid-19, other respiratory illness gets million-dollar funding Pfizer and its partner BioNTech confirmed on Friday (December 20) that they had applied to US health regulators for emergency use authorisation (EUA) of its COVID-19 vaccine, becoming the first to do so in the US as the pandemic rages around the world. The companies have said that they are prepared to ship vaccines as soon as they get a go-ahead from the government. USA is the worst affected country in the world. It has had more than 12,000,000 coronavirus cases so far. The death tally is fast approaching 300 thousand. Nearly 5 million people are still affected due to coronavirus. (With agency inputs)

Covid-19 vaccination may start in early December in US: Top official

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