On June 15, Pfizer announced that research found that Paxlovid, a COVID-19 tablet, did not significantly reduce the risk of hospitalisation or death in people with a typical risk of acquiring serious infections.

The findings could mean that the antiviral is only used in high-risk patient groups when it has been proven to be effective.

Pfizer announced that enrollment in the study of standard-risk patients would be halted after Paxlovid revealed a "non-significant" 51 percent risk reduction.

The results will be incorporated into a full FDA approval application for the medicine in high-risk patients.Pfizer stated that the findings would have no impact on their sales forecast for the year 2022.

The FDA approved Paxlovid in December for the treatment of people who are at high risk of severe COVID sickness.

The Biden administration said in April that it would purchase 20 million courses of the medicine from Pfizer and set up a plan to distribute them to states, community health centres, and other physicians.

According to a new Israeli study, Paxlovid reduced hospitalizations for older patients but not for younger patients.

Pfizer announced a new Paxlovid study on clinicaltrials.gov this month, which would assess the drug's safety and tolerability in a small group of pregnant women in their second or third trimester. A trial in children with Paxlovid is also being studied, and a trial in adults with impaired immune systems will begin soon.

Pfizer released preliminary findings from the research in December, suggesting that Paxlovid failed to relieve symptoms in so-called "standard risk" patients and did not reduce the risk of hospitalisation or death in a statistically meaningful way. 
&nbsp;

WATCH WION LIVE HERE

<iframe allow="accelerometer; autoplay; encrypted-media; gyroscope; picture-in-picture" allowfullscreen="" frameborder="0" height="350" src="https://www.wionews.com/live-tv/embed?autoplay=1&amp;mute=1" width="100%"></iframe>

You can now write for wionews.com and be a part of the community. Share your stories and opinions with us <a href="https://www.wionews.com/content-contribution-registration-form">here</a>.

On June 15, Pfizer announced that research found that Paxlovid, a COVID-19 tablet, did not significantly reduce the risk of hospitalisation or death in people with a typical risk of acquiring serious infections.

On June 15, Pfizer announced that research found that Paxlovid, a COVID-19 tablet, did not significantly reduce the risk of hospitalisation or death in people with a typical risk of acquiring serious infections. The findings could mean that the antiviral is only used in high-risk patient groups when it has been proven to be effective. Pfizer announced that enrollment in the study of standard-risk patients would be halted after Paxlovid revealed a "non-significant" 51 percent risk reduction. The results will be incorporated into a full FDA approval application for the medicine in high-risk patients.Pfizer stated that the findings would have no impact on their sales forecast for the year 2022. The FDA approved Paxlovid in December for the treatment of people who are at high risk of severe COVID sickness. The Biden administration said in April that it would purchase 20 million courses of the medicine from Pfizer and set up a plan to distribute them to states, community health centres, and other physicians. According to a new Israeli study, Paxlovid reduced hospitalizations for older patients but not for younger patients. Pfizer announced a new Paxlovid study on clinicaltrials.gov this month, which would assess the drug's safety and tolerability in a small group of pregnant women in their second or third trimester. A trial in children with Paxlovid is also being studied, and a trial in adults with impaired immune systems will begin soon. Pfizer released preliminary findings from the research in December, suggesting that Paxlovid failed to relieve symptoms in so-called "standard risk" patients and did not reduce the risk of hospitalisation or death in a statistically meaningful way. WATCH WION LIVE HERE You can now write for wionews.com and be a part of the community. Share your stories and opinions with us here.

Pfizer says the Covid pill is not beneficial for standard-risk patients

Staff reviewers of US Food and Drug Administration (FDA) said on Sunday that Pfizer-BioNTech's COVID vaccines were safe and effective for children from ages 6 months to 4 years. &nbsp;

The FDA reviewers said in briefing documents published on Sunday evening that their evaluation did not reveal any new safety concerns related to the use of the vaccine in young children.

The FDA analysis of data from Pfizer's trial was published ahead of a June 15 meeting of its outside advisers. Recommendations from these external advisers will determine the FDA's decision on the vaccines.

"Available data support the effectiveness of the Pfizer-BioNTech COVID-19 Vaccine 3-dose primary series in preventing COVID-19 in the age group of 6 months through 4 years," FDA staff said in the review.

An early analysis of data from Pfizer-BioNTech's vaccine based on 10 symptomatic COVID-19 cases identified when the Omicron coronavirus variant was dominant suggested a vaccine efficacy of 80.3% in the under-5 age group.

COVID vaccines for children under the age of 6 are not yet approved in most countries. Due to low demand for vaccines in for kids aged 5 to 11, it is also not known how many parents would get their young ones vaccinated.

(With inputs from agencies)

You can now write for wionews.com and be a part of the community. Share your stories and opinions with us <a href="https://www.wionews.com/content-contribution-registration-form">here</a>.

WATCH WION LIVE HERE

<div class="ui-state-default" contenteditable="false">
<div class="twitter-block" draggable="false"><iframe allow="accelerometer; autoplay; encrypted-media; gyroscope; picture-in-picture" allowfullscreen="" frameborder="0" height="350" src="https://www.wionews.com/live-tv/embed?autoplay=1&amp;mute=1" width="100%"></iframe></div>
<a class="close-mark close-div" href="#" id="jqclosemark">×</a></div>

&nbsp;

Staff reviewers of US Food and Drug Administration (FDA) said on Sunday that Pfizer-BioNTech's COVID vaccines were safe and effective for children from ages 6 months to 4 years.

Staff reviewers of US Food and Drug Administration (FDA) said on Sunday that Pfizer-BioNTech's COVID vaccines were safe and effective for children from ages 6 months to 4 years. The FDA reviewers said in briefing documents published on Sunday evening that their evaluation did not reveal any new safety concerns related to the use of the vaccine in young children. The FDA analysis of data from Pfizer's trial was published ahead of a June 15 meeting of its outside advisers. Recommendations from these external advisers will determine the FDA's decision on the vaccines. "Available data support the effectiveness of the Pfizer-BioNTech COVID-19 Vaccine 3-dose primary series in preventing COVID-19 in the age group of 6 months through 4 years," FDA staff said in the review. An early analysis of data from Pfizer-BioNTech's vaccine based on 10 symptomatic COVID-19 cases identified when the Omicron coronavirus variant was dominant suggested a vaccine efficacy of 80.3% in the under-5 age group. COVID vaccines for children under the age of 6 are not yet approved in most countries. Due to low demand for vaccines in for kids aged 5 to 11, it is also not known how many parents would get their young ones vaccinated. (With inputs from agencies) You can now write for wionews.com and be a part of the community. Share your stories and opinions with us here. WATCH WION LIVE HERE ×

Pfizer COVID vaccines are safe for small children, says FDA staff

American multinational pharmaceutical Pzifer completed its emergency use application to the United States Food and Drug Administration (FDA) to administer its COVID-19 vaccine to children under the age of 5 on Wednesday.

Pfizer said that its vaccine called ‘Pfizer-BioNTech COVID-19 vaccine’ is 80% effective against symptomatic COVID-19 for younger children.

"Pfizer and BioNTech completed a rolling application to the U.S. Food and Drug Administration (FDA) for emergency use authorization (EUA) of the 3-µg [microgram] dose of the Pfizer-BioNTech COVID-19 Vaccine for children 6 months through 4 years of age (also referred to as 6 months to under 5 years of age) on June 1, 2022," the company said in a statement.

Children under 5 are the last to get vaccines, but it also requires safety measures in place as it is a very sensitive target age group.

"We recognize parents are anxious to have their young children vaccinated against COVID-19 and while the FDA cannot predict how long its evaluation of the data and information will take, we will review any EUA request we receive as quickly as possible using a science-based approach," the FDA said.

According to a Kaiser Family Foundation poll, a lot of parents are hesitant to vaccinate children as young as 5, with 27 per cent saying they will "definitely not" get their children in this age group vaccinated. Only 18 per cent plan to vaccinate their kids right away, while 38 per cent say that they would like to wait and see before they decide.

[ With inputs from agencies] 
&nbsp;

WATCH WION LIVE HERE

<iframe allow="accelerometer; autoplay; encrypted-media; gyroscope; picture-in-picture" allowfullscreen="" frameborder="0" height="350" src="https://www.wionews.com/live-tv/embed?autoplay=1&amp;mute=1" width="100%"></iframe>

You can now write for wionews.com and be a part of the community. Share your stories and opinions with us <a href="https://www.wionews.com/content-contribution-registration-form">here</a>.

American multinational pharmaceutical Pzifer completed its emergency use application to the United States Food and Drug Administration (FDA) to administer its COVID-19 vaccine to children under the age of 5 on Wednesday.

American multinational pharmaceutical Pzifer completed its emergency use application to the United States Food and Drug Administration (FDA) to administer its COVID-19 vaccine to children under the age of 5 on Wednesday. Pfizer said that its vaccine called ‘Pfizer-BioNTech COVID-19 vaccine’ is 80% effective against symptomatic COVID-19 for younger children. "Pfizer and BioNTech completed a rolling application to the U.S. Food and Drug Administration (FDA) for emergency use authorization (EUA) of the 3-µg [microgram] dose of the Pfizer-BioNTech COVID-19 Vaccine for children 6 months through 4 years of age (also referred to as 6 months to under 5 years of age) on June 1, 2022," the company said in a statement. Children under 5 are the last to get vaccines, but it also requires safety measures in place as it is a very sensitive target age group. "We recognize parents are anxious to have their young children vaccinated against COVID-19 and while the FDA cannot predict how long its evaluation of the data and information will take, we will review any EUA request we receive as quickly as possible using a science-based approach," the FDA said. According to a Kaiser Family Foundation poll, a lot of parents are hesitant to vaccinate children as young as 5, with 27 per cent saying they will "definitely not" get their children in this age group vaccinated. Only 18 per cent plan to vaccinate their kids right away, while 38 per cent say that they would like to wait and see before they decide. [ With inputs from agencies] WATCH WION LIVE HERE You can now write for wionews.com and be a part of the community. Share your stories and opinions with us here.

Pfizer applies to FDA for covid vaccine approval for children under five

In a bid to make its medical products more accessible, US pharma giant Pfizer Inc. has decided to sell nearly two dozen patent-protected medicines and vaccines at not-for-profit prices to 45 low-income countries, the Wall Street Journal has reported.

Pfizer will begin shipping the medicines first to Ghana, Malawi, Rwanda, Senegal and Uganda before the end of this year, Chief Executive&nbsp;Albert Bourla told the US newspaper on Wednesday.

The company said that it is working with governments to improve their health-system infrastructure and resolve regulatory and procurement obstacles that often delay the arrival of drugs.

Among the 23 drugs that are being sent for almost a fraction of the cost are for cancer, heart conditions and autoimmune diseases.

The report suggests that the move to sell its medicines at a cheaper cost will help Pfizer build a potentially large new market for prescription drugs and vaccines and also earn goodwill with employees for philanthropic efforts.

It comes at a time when US pharma giants such as Pfizer, and Moderna have been facing criticism over pricing and for keeping monopoly control over vaccines and new Paxlovid pill.

Pfizer has made nearly $26bn in revenues in the first three months of 2022, the bulk from its COVID-19 vaccine and new pill to treat the virus, The Guardian reported.

The New York-based firm&nbsp;posted total sales&nbsp;of $25.7bn in the first quarter, up 77 per cent from a year earlier.

Pfizer has also voiced its opposition to sharing its intellectual property for medicines, saying that others would struggle to produce its mRNA vaccine – one of only two on the market. It said that “it is not as simple as sharing the ‘recipe’”.

(With inputs from agencies)

WATCH WION LIVE HERE

<iframe allow="accelerometer; autoplay; encrypted-media; gyroscope; picture-in-picture" allowfullscreen="" frameborder="0" height="350" src="https://www.wionews.com/live-tv/embed?autoplay=1&amp;mute=1" width="100%"></iframe>

You can now write for wionews.com and be a part of the community. Share your stories and opinions with us <a href="https://www.wionews.com/content-contribution-registration-form">here</a>.

In a bid to make its medical products more accessible, US pharma giant Pfizer Inc. has decided to sell nearly two dozen patent-protected medicines and vaccines at not-for-profit prices to 45 low-income countries, the Wall Street Journal has reported.

In a bid to make its medical products more accessible, US pharma giant Pfizer Inc. has decided to sell nearly two dozen patent-protected medicines and vaccines at not-for-profit prices to 45 low-income countries, the Wall Street Journal has reported. Pfizer will begin shipping the medicines first to Ghana, Malawi, Rwanda, Senegal and Uganda before the end of this year, Chief Executive Albert Bourla told the US newspaper on Wednesday. The company said that it is working with governments to improve their health-system infrastructure and resolve regulatory and procurement obstacles that often delay the arrival of drugs. Among the 23 drugs that are being sent for almost a fraction of the cost are for cancer, heart conditions and autoimmune diseases. The report suggests that the move to sell its medicines at a cheaper cost will help Pfizer build a potentially large new market for prescription drugs and vaccines and also earn goodwill with employees for philanthropic efforts. It comes at a time when US pharma giants such as Pfizer, and Moderna have been facing criticism over pricing and for keeping monopoly control over vaccines and new Paxlovid pill. Pfizer has made nearly $26bn in revenues in the first three months of 2022, the bulk from its COVID-19 vaccine and new pill to treat the virus, The Guardian reported. The New York-based firm posted total sales of $25.7bn in the first quarter, up 77 per cent from a year earlier. Pfizer has also voiced its opposition to sharing its intellectual property for medicines, saying that others would struggle to produce its mRNA vaccine – one of only two on the market. It said that “it is not as simple as sharing the ‘recipe’”. (With inputs from agencies) WATCH WION LIVE HERE You can now write for wionews.com and be a part of the community. Share your stories and opinions with us here.

Amid criticism of Covid profiteering, Pfizer to sell vaccines, drugs at lower prices to poor nations

Pfizer has said that the three-dose vaccine created by them has shown 80 per cent effectiveness against the Omicron COVID-19 infection among children aged between six months and five years.

This is good news for parents as cases continue to rise once again around the world and according to the timeline presented by Pfizer, the vaccine is expected to be authorised by July this year. The company said in its statement that the vaccine has produced extremely positive results in the tests till now and if authorised, the vaccine will comprise of three shots of three micrograms each.

“We are pleased that our formulation for the youngest children, which we carefully selected to be one-tenth of the dose strength for adults, was well tolerated and produced a strong immune response,” said Albert Bourla, Pfizer's chairman and chief executive officer in the statement.

The development meant that Pfizer are closer to getting an emergency use authorisation for the vaccine and according to ABC News, the FDA will be reviewing their application on June 21 and 22.

If authorised, the company will be able to release the vaccine in the market by July and according to experts, the high efficacy against symptomatic COVID-19 infection can be great news for patients.

However, Pfizer has made it clear that the results are preliminary and they will be conducting more tests in the future. They also warned that there can be some side effects from the vaccines in all age groups and they are looking to test it on a larger sample to verify all of their results.

Pfizer has said that the three-dose vaccine created by them has shown 80 per cent effectiveness against the Omicron COVID-19 infection among children aged between six months and five years.

Pfizer has said that the three-dose vaccine created by them has shown 80 per cent effectiveness against the Omicron COVID-19 infection among children aged between six months and five years. This is good news for parents as cases continue to rise once again around the world and according to the timeline presented by Pfizer, the vaccine is expected to be authorised by July this year. The company said in its statement that the vaccine has produced extremely positive results in the tests till now and if authorised, the vaccine will comprise of three shots of three micrograms each. “We are pleased that our formulation for the youngest children, which we carefully selected to be one-tenth of the dose strength for adults, was well tolerated and produced a strong immune response,” said Albert Bourla, Pfizer's chairman and chief executive officer in the statement. The development meant that Pfizer are closer to getting an emergency use authorisation for the vaccine and according to ABC News, the FDA will be reviewing their application on June 21 and 22. If authorised, the company will be able to release the vaccine in the market by July and according to experts, the high efficacy against symptomatic COVID-19 infection can be great news for patients. However, Pfizer has made it clear that the results are preliminary and they will be conducting more tests in the future. They also warned that there can be some side effects from the vaccines in all age groups and they are looking to test it on a larger sample to verify all of their results.

Pfizer 3-dose COVID-19 vaccine 80 per cent effective in kids aged under five

The United States has approved Pfizer's booster shots for the 5-11 age group against COVID-19. The decision comes at a time when COVID-19 cases are increasing in the US.

The US approves Pfizer booster shots for the 5-11 age group against COVID-19

US drugmaker Pfizer reported a net income of $7.86 billion due to the COVID-19 vaccine and the Paxlovid pill.

The vaccine helped the drugmaker to report $13 billion in sales in the quarter as the Paxlovid pill brought in $1.5 billion helping to boost the company's revenue by 77 per cent. The profits of the company grew 61 per cent.

The adjusted earnings of the company stood at $1.62 per share in the first quarter which surpassed $1.49 projected by industry experts. The company's revenue was $25.66 billion which was above Wall Street's expectation of $24.1 billion.

<a href="https://www.wionews.com/world/eu-authorises-moderna-vaccine-for-young-kids-recommends-pfizers-booster-458691">Also Read:&nbsp;EU authorises Moderna vaccine for young kids; recommends Pfizer's booster</a>

Pfizer had launched its vaccine for adults in late 2020 in the US and later expanded it to include children.

The pharmaceutical giant had said last month that a third dose of the COVID-19 vaccine protection against the Omicron variant in children was meant for age group of 5 to 11.

Watch:&nbsp;Biden calls Pfizer COVID-19 pill a 'gamechanger'

<div class="videoWrapper trancodeVideo"><iframe allowfullscreen="" autoplay="1" class="includeVideo" frameborder="0" height="350" src="https://www.wionews.com/videos/us-president-joe-biden-calls-pfizer-covid-19-pill-a-game-changer-442327/embed" style="width:100%;max-width:560px;" width="560"></iframe></div>

The vaccine maker had added that it will apply for US emergency use authorization for the booster dose for the age group.

WATCH WION LIVE HERE

<iframe allow="accelerometer; autoplay; encrypted-media; gyroscope; picture-in-picture" allowfullscreen="" frameborder="0" height="350" src="https://www.wionews.com/live-tv/embed?autoplay=1&amp;mute=1" width="100%"></iframe>

US drugmaker Pfizer reported a net income of $7.86 billion due to the COVID-19 vaccine and the Paxlovid pill. The vaccine helped the drugmaker to report $13 billion in sales in the quarter as the Paxlovid pill brought in $1.

US drugmaker Pfizer reported a net income of $7.86 billion due to the COVID-19 vaccine and the Paxlovid pill. The vaccine helped the drugmaker to report $13 billion in sales in the quarter as the Paxlovid pill brought in $1.5 billion helping to boost the company's revenue by 77 per cent. The profits of the company grew 61 per cent. The adjusted earnings of the company stood at $1.62 per share in the first quarter which surpassed $1.49 projected by industry experts. The company's revenue was $25.66 billion which was above Wall Street's expectation of $24.1 billion. Also Read: EU authorises Moderna vaccine for young kids; recommends Pfizer's booster Pfizer had launched its vaccine for adults in late 2020 in the US and later expanded it to include children. The pharmaceutical giant had said last month that a third dose of the COVID-19 vaccine protection against the Omicron variant in children was meant for age group of 5 to 11. Watch: Biden calls Pfizer COVID-19 pill a 'gamechanger' The vaccine maker had added that it will apply for US emergency use authorization for the booster dose for the age group. WATCH WION LIVE HERE

Pfizer reports record profits amid growth in vaccine, Paxlovid pill

The World Health Organization (WHO) on Friday "strongly recommended" Pfizer’s COVID-19 antiviral pill Paxlovid for patients who have milder forms of the disease but are still at a high risk of hospitalisation, reports AFP.

The global health agency, however, expressed concern over the possibility of Paxlovid being inaccessible to low and middle-income countries as has been the case for Covid vaccines

Here are some key things you need to know about Pfizer's antiviral pill

1) Paxlovid is a combination of nirmatrelvir and ritonavir tablets and is administered orally.

2) WHO's recommendation is based on data from two randomized controlled trials showing that the risk of hospital admission is reduced by 85 per cent following the intake of the pill in a high-risk group.

3) The UN agency has recommended its use in Covid patients who at lower risk of hospitalisation.

4) While the brand name drug, sold by Pfizer, will be included in the WHO prequalification list, the health agency said that generic products are not yet available from quality-assured sources. Generic products are the copy of brand name drugs and are available at a much lower price, making accessibility easier in low- and middle-income countries.

5) According to the WHO, a licensing agreement between Pfizer and Medicines Patent Pool limits the number of countries that can benefit from the generic production of the medicine.

Limitations and inequities

The WHO stressed the limitations of such antiviral treatments. "The medicine can only be administered while the disease is at its early stages," they said.

This means that the patients must quickly test positive and be prescribed the pill by a doctor — all of which can pose obstacles for low- and middle-income countries, the WHO said.

Patients must start taking their Paxlovid pills within five days of the onset of symptoms — the course then lasts five days.

Also read |&nbsp;<a href="https://www.wionews.com/world/spanish-woman-infected-with-covid-twice-in-record-20-days-472698" hreflang="en">Spanish woman infected with Covid twice in record 20 days</a>

Remdesivir can be taken within seven days of symptoms setting in, but it is administered intravenously over three days.

Questions about cost

The WHO called on Pfizer to "make its pricing and deals more transparent" for Paxlovid.

Also read |&nbsp;<a href="https://www.wionews.com/india/new-omicron-ba2121-sub-variant-detected-in-delhi-driving-spike-in-covid-infections-report-472863" hreflang="en">New Omicron sub-variant detected in Delhi, causing surge in Covid cases</a>

Lisa Hedman, the WHO's senior advisor on access to medicines, said that radio station NPR reported a full course of Paxlovid costs $530 in the United States. Another source unconfirmed by WHO gave the price of $250 in an upper-middle income country

(With inputs from agencies)

The World Health Organization (WHO) on Friday "strongly recommended" Pfizer’s COVID-19 antiviral pill Paxlovid for patients who have milder forms of the disease but are still at a high risk of hospitalisation, reports AFP.

The World Health Organization (WHO) on Friday "strongly recommended" Pfizer’s COVID-19 antiviral pill Paxlovid for patients who have milder forms of the disease but are still at a high risk of hospitalisation, reports AFP. The global health agency, however, expressed concern over the possibility of Paxlovid being inaccessible to low and middle-income countries as has been the case for Covid vaccines Here are some key things you need to know about Pfizer's antiviral pill 1) Paxlovid is a combination of nirmatrelvir and ritonavir tablets and is administered orally. 2) WHO's recommendation is based on data from two randomized controlled trials showing that the risk of hospital admission is reduced by 85 per cent following the intake of the pill in a high-risk group. 3) The UN agency has recommended its use in Covid patients who at lower risk of hospitalisation. 4) While the brand name drug, sold by Pfizer, will be included in the WHO prequalification list, the health agency said that generic products are not yet available from quality-assured sources. Generic products are the copy of brand name drugs and are available at a much lower price, making accessibility easier in low- and middle-income countries. 5) According to the WHO, a licensing agreement between Pfizer and Medicines Patent Pool limits the number of countries that can benefit from the generic production of the medicine. Limitations and inequities The WHO stressed the limitations of such antiviral treatments. "The medicine can only be administered while the disease is at its early stages," they said. This means that the patients must quickly test positive and be prescribed the pill by a doctor — all of which can pose obstacles for low- and middle-income countries, the WHO said. Patients must start taking their Paxlovid pills within five days of the onset of symptoms — the course then lasts five days. Also read | Spanish woman infected with Covid twice in record 20 days Remdesivir can be taken within seven days of symptoms setting in, but it is administered intravenously over three days. Questions about cost The WHO called on Pfizer to "make its pricing and deals more transparent" for Paxlovid. Also read | New Omicron sub-variant detected in Delhi, causing surge in Covid cases Lisa Hedman, the WHO's senior advisor on access to medicines, said that radio station NPR reported a full course of Paxlovid costs $530 in the United States. Another source unconfirmed by WHO gave the price of $250 in an upper-middle income country (With inputs from agencies)

Pfizer's anti-Covid pill gets WHO approval. Here's what you should know about Paxlovid

A COVID-19 vaccine developed specifically for the Omicron variant has been approved for clinical trials on Saturday (April 16).

A Sinopharm and Sinovac subsidiary called China National Biotec Group (CNBG) has developed the vaccine.

During the trial, researchers found the effectiveness of the third dose of the SARS-CoV-2-mRNA vaccine wanes quickly in the period in which Omicron is pre-dominant.

<div class="videoWrapper trancodeVideo"><iframe allowfullscreen="" autoplay="1" class="includeVideo" frameborder="0" height="350" src="https://www.wionews.com/videos/shanghai-remains-mired-in-covid-19-lockdown-cases-rise-in-chinas-financial-hub-471395/embed" style="width:100%;max-width:560px;" width="560"></iframe></div>

The existing Sinopharm vaccine's fourth dose did not lift the antibody levels against Omicron.&nbsp;It was administered six months after a third booster dose to a regular two-dose regimen.

Following the third dose, the fourth dose restored antibody levels to around the peaks.

CNBG will conduct further trials on candidates as boosters in those who have already received two vaccine doses.

Also read |&nbsp;<a href="https://www.wionews.com/world/ba2-covid-variant-driving-new-infections-in-some-parts-of-us-471264" hreflang="en">BA.2 Covid variant driving new infections in some parts of US</a>

Researchers believe that new vaccines will offer a better alternative as future alternatives. Several studies are being conducted to combat 'stealth' Omicron which has become dominant across the world.

Antibodies elicited by vaccines that are based on older variants show weaker activity to neutralise the highly transmissible variant.

Scientists are also upgrading injections against emerging variants as well.

Also read |&nbsp;<a href="https://www.wionews.com/world/australia-authorities-on-alert-as-first-case-of-covid-xe-variant-emerges-471174" hreflang="en">Australia: Authorities on alert as first case of Covid XE variant emerges</a>

"We are beyond the time when you can eradicate SARS-CoV-2," said the director-general of the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) Thomas Cueni.

Meanwhile, Pfizer has said it is striving to make a COVID-19 vaccine for all variants before the end of 2022.

"I hope, clearly by autumn... that we could have a vaccine," said the company's chairman Albert Bourla.

"It is a possibility that we have it by then. It is not a certainty," he added.

The US pharmaceutical giant is also working on producing a vaccine that provides strong protection against coronavirus for a whole year.

(With inputs from agencies)

A COVID-19 vaccine developed specifically for the Omicron variant has been approved for clinical trials on Saturday (April 16). A Sinopharm and Sinovac subsidiary called China National Biotec Group (CNBG) has developed the vaccine.

A COVID-19 vaccine developed specifically for the Omicron variant has been approved for clinical trials on Saturday (April 16). A Sinopharm and Sinovac subsidiary called China National Biotec Group (CNBG) has developed the vaccine. During the trial, researchers found the effectiveness of the third dose of the SARS-CoV-2-mRNA vaccine wanes quickly in the period in which Omicron is pre-dominant. The existing Sinopharm vaccine's fourth dose did not lift the antibody levels against Omicron. It was administered six months after a third booster dose to a regular two-dose regimen. Following the third dose, the fourth dose restored antibody levels to around the peaks. CNBG will conduct further trials on candidates as boosters in those who have already received two vaccine doses. Also read | BA.2 Covid variant driving new infections in some parts of US Researchers believe that new vaccines will offer a better alternative as future alternatives. Several studies are being conducted to combat 'stealth' Omicron which has become dominant across the world. Antibodies elicited by vaccines that are based on older variants show weaker activity to neutralise the highly transmissible variant. Scientists are also upgrading injections against emerging variants as well. Also read | Australia: Authorities on alert as first case of Covid XE variant emerges "We are beyond the time when you can eradicate SARS-CoV-2," said the director-general of the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) Thomas Cueni. Meanwhile, Pfizer has said it is striving to make a COVID-19 vaccine for all variants before the end of 2022. "I hope, clearly by autumn... that we could have a vaccine," said the company's chairman Albert Bourla. "It is a possibility that we have it by then. It is not a certainty," he added. The US pharmaceutical giant is also working on producing a vaccine that provides strong protection against coronavirus for a whole year. (With inputs from agencies)

Sinopharm, Sinovac vaccine candidates for Omicron variant get clearance for clinical trial

According to a US Fed Report, the government paid $1 Billion to American media to promote COVID-19 vaccines. Pfizer vaccine data reveals side effects.

US Fed Report: Government paid $1 Billion to American media to promote COVID-19 vaccines

The European medicines agency said that it has authorised Moderna's coronavirus vaccine for children aged six to 11. This comes in addition to recommending booster shots of Pfizer's vaccine for people aged 12 and over.

EU regulator's vaccines chief Dr Marco Cavaleri, at a press briefing said that the Moderna vaccine for children will be a half-dose of what is given to adults.&nbsp;

He further said that the research showed how young children had an immune response compared to older populations “as measured by the level of neutralising antibodies” against the virus.&nbsp;

Earlier, Moderna's Covid "Spikevax" vaccine received full approval from the US Food and Drug Administration (FDA). It had previously been authorised for emergency use in the US.

<a href="https://www.wionews.com/world/just-watch-taiwan-is-going-to-be-next-trump-warns-as-russia-ukraine-war-rages-on-458579">Also read |&nbsp;‘Just watch, Taiwan is going to be next’: Trump warns as Russia-Ukraine war rages on</a>

Janet Woodcock, the acting FDA commissioner, said in a statement that "the public can be assured that Spikevax meets the FDA's high standards for safety, effectiveness and manufacturing quality required of any vaccine approved for use in the United States."

"The FDA's approval of Spikevax is a significant step in the fight against the COVID-19 pandemic, marking the second vaccine approved to prevent COVID-19," Woodcock said.

The Moderna vaccine was approved for emergency use in December 2020.

Moderna has full FDA approval for only the first two doses, emergency use authorisation remains in effect for the booster dose.

(With inputs from agencies)

The European medicines agency said that it has authorised Moderna's coronavirus vaccine for children aged six to 11. This comes in addition to recommending booster shots of Pfizer's vaccine for people aged 12 and over.

The European medicines agency said that it has authorised Moderna's coronavirus vaccine for children aged six to 11. This comes in addition to recommending booster shots of Pfizer's vaccine for people aged 12 and over. EU regulator's vaccines chief Dr Marco Cavaleri, at a press briefing said that the Moderna vaccine for children will be a half-dose of what is given to adults. He further said that the research showed how young children had an immune response compared to older populations “as measured by the level of neutralising antibodies” against the virus. Earlier, Moderna's Covid "Spikevax" vaccine received full approval from the US Food and Drug Administration (FDA). It had previously been authorised for emergency use in the US. Also read | ‘Just watch, Taiwan is going to be next’: Trump warns as Russia-Ukraine war rages on Janet Woodcock, the acting FDA commissioner, said in a statement that "the public can be assured that Spikevax meets the FDA's high standards for safety, effectiveness and manufacturing quality required of any vaccine approved for use in the United States." "The FDA's approval of Spikevax is a significant step in the fight against the COVID-19 pandemic, marking the second vaccine approved to prevent COVID-19," Woodcock said. The Moderna vaccine was approved for emergency use in December 2020. Moderna has full FDA approval for only the first two doses, emergency use authorisation remains in effect for the booster dose. (With inputs from agencies)

EU authorises Moderna vaccine for young kids; recommends Pfizer's booster

India’s Covid inoculation programme is largely driven by Indian made vaccines.

Even though Russia’s Sputnik and Johnson &amp; Johnson's single-dose vaccine were given a go-ahead by the Indian drug regulatory authority, it was Indian made Covaxin and Covishield that was widely used under the government-run vaccine programme.

But it begs the question as to why Moderna and Pfizer vaccines were not available in India.

For the first time, India’s health minister has revealed the reasons that forced India to rely heavily on indigenous vaccines.

When India was reporting more than 100,000 Covid cases in November 2021, it was negotiating with Moderna and Pfizer to secure their vaccines.

However, the negotiation&nbsp;fell through and India went ahead with its own inoculation plan.

It was never revealed before as to why the discussions didn’t work out, even as the Indian government faced mounting criticism.

But during the book launch of ‘A Nation to Protect’ in New Delhi, health minister Mansukh Mandaviya revealed why the Indian government didn’t procure the vaccines manufactured by Pfizer and Moderna. &nbsp;

When Sudhir Chaudhary, Editor In Chief&nbsp;of WION, asked about the reasons, Mandaviya said that Moderna and Pfizer had placed a condition before the Indian government that it would only their vaccines if an indemnity clause is signed.

It means that if there is any side effect or if someone dies after taking the vaccine, then the company will not be held accountable and prosecuted under Indian law.

This caused problems for India.

The health minister said that it didn’t seem wise for the Indian government to accept their demands, and instead went ahead with the indigenous vaccines.

Watch |&nbsp;WION speaks to Indian Health Minister Mansukh Mandaviya: 'New India will run by its own rules'

<div class="videoWrapper trancodeVideo"><iframe allowfullscreen="" autoplay="1" class="includeVideo" frameborder="0" height="350" src="https://www.wionews.com/videos/wion-speaks-to-indian-health-minister-mansukh-mandaviya-new-india-will-run-by-its-own-rules-454527/embed" style="width:100%;max-width:560px;" width="560"></iframe></div>

India’s Covid inoculation programme is largely driven by Indian made vaccines. Even though Russia’s Sputnik and Johnson & Johnson's single-dose vaccine were given a go-ahead by the Indian drug regulatory authority, it was Indian made Covaxin and Covishield that was widely used under the government-run vaccine programme.

India’s Covid inoculation programme is largely driven by Indian made vaccines. Even though Russia’s Sputnik and Johnson & Johnson's single-dose vaccine were given a go-ahead by the Indian drug regulatory authority, it was Indian made Covaxin and Covishield that was widely used under the government-run vaccine programme. But it begs the question as to why Moderna and Pfizer vaccines were not available in India. For the first time, India’s health minister has revealed the reasons that forced India to rely heavily on indigenous vaccines. When India was reporting more than 100,000 Covid cases in November 2021, it was negotiating with Moderna and Pfizer to secure their vaccines. However, the negotiation fell through and India went ahead with its own inoculation plan. It was never revealed before as to why the discussions didn’t work out, even as the Indian government faced mounting criticism. But during the book launch of ‘A Nation to Protect’ in New Delhi, health minister Mansukh Mandaviya revealed why the Indian government didn’t procure the vaccines manufactured by Pfizer and Moderna. When Sudhir Chaudhary, Editor In Chief of WION, asked about the reasons, Mandaviya said that Moderna and Pfizer had placed a condition before the Indian government that it would only their vaccines if an indemnity clause is signed. It means that if there is any side effect or if someone dies after taking the vaccine, then the company will not be held accountable and prosecuted under Indian law. This caused problems for India. The health minister said that it didn’t seem wise for the Indian government to accept their demands, and instead went ahead with the indigenous vaccines. Watch | WION speaks to Indian Health Minister Mansukh Mandaviya: 'New India will run by its own rules'

Why were Pfizer and Moderna vaccines not available in India? Health minister responds

US health regulators delayed the review of Pfizer Inc's COVID-19 vaccine for children under 5 years of age because its two-dose regimen did not work well against the Omicron variant, the Wall Street Journal reported on Friday.

Last week, the US Food and Drug Administration (FDA) said it needed more data on the vaccine, delaying its decision for using the vaccine in children 6 months through 4 years of age for at least two months.

An early look at data showed the vaccine to be effective against the Delta variant during testing while that was the dominant strain, but some vaccinated children developed COVID-19 after Omicron emerged, the report said, citing people familiar with the FDA's decision.

However, since the overall COVID-19 cases were low, the small number of Omicron cases made the vaccine appear less effective in an early statistical analysis, the report added.

The FDA did not respond to a Reuters request for comment.

Pfizer and BioNTech had submitted data on the first two doses of a planned three-dose regimen earlier this month at the request of the FDA. Pfizer did not disclose efficacy data.

The submission was surprising because in December, the companies said early trial results of the two low doses of the vaccine fell short of expectations, and the clinical trial was amended to test a three-dose version.

US health regulators delayed the review of Pfizer Inc's COVID-19 vaccine for children under 5 years of age because its two-dose regimen did not work well against the Omicron variant, the Wall Street Journal reported on Friday.

US health regulators delayed the review of Pfizer Inc's COVID-19 vaccine for children under 5 years of age because its two-dose regimen did not work well against the Omicron variant, the Wall Street Journal reported on Friday. Last week, the US Food and Drug Administration (FDA) said it needed more data on the vaccine, delaying its decision for using the vaccine in children 6 months through 4 years of age for at least two months. An early look at data showed the vaccine to be effective against the Delta variant during testing while that was the dominant strain, but some vaccinated children developed COVID-19 after Omicron emerged, the report said, citing people familiar with the FDA's decision. However, since the overall COVID-19 cases were low, the small number of Omicron cases made the vaccine appear less effective in an early statistical analysis, the report added. The FDA did not respond to a Reuters request for comment. Pfizer and BioNTech had submitted data on the first two doses of a planned three-dose regimen earlier this month at the request of the FDA. Pfizer did not disclose efficacy data. The submission was surprising because in December, the companies said early trial results of the two low doses of the vaccine fell short of expectations, and the clinical trial was amended to test a three-dose version.

Low Omicron efficacy behind delay of Pfizer COVID vaccine for kids under 5: WSJ

A new study by the US Centers of Disease Control and Prevention (CDC) has said that the efficacy of third doses of the Pfizer and Moderna mRNA vaccines wanes substantially by the fourth month after administration.

CDC examined data on 93,000 hospitalisations and 241,000 emergency department and urgent care visits across 10 states during the Delta and Omicron waves. In the study, about 10 per cent of people were boosted and over 50 per cent of people hospitalised were over 65 years old.&nbsp;

<div class="videoWrapper trancodeVideo"><iframe allowfullscreen="" autoplay="1" class="includeVideo" frameborder="0" height="350" src="https://www.wionews.com/videos/nycs-municipal-workers-face-termination-over-covid-19-vaccine-status-452560/embed" style="width:100%;max-width:560px;" width="560"></iframe></div>

During Omicron, vaccine effectiveness against hospitalisation was 91 per cent during the first two months after a third dose and remained high, at 78 per cent, four or more months after a third dose.

Study participants were recruited from the companies' late-stage COVID-19 vaccine study, and those who had received the second dose of the company's COVID-19 vaccine at least six months before entering the co-administration study.

Also read |&nbsp;<a href="https://www.wionews.com/science/future-of-covid-vaccines-scientists-develop-a-vaccine-that-can-be-inhaled-wont-need-needles-452473" hreflang="en">Future of Covid vaccines: Scientists develop a vaccine that can be inhaled, won't need needles</a>

The study reveals that a third dose of mRNA vaccine continues to offer high levels of protection against severe disease, even months after administration, underscoring the importance of staying up to date when eligible after receiving a primary series.

"The finding that protection conferred by mRNA vaccines waned in the months after receipt of a third vaccine dose reinforces the importance of further consideration of additional doses to sustain or improve protection," the authors concluded.

Speaking at a White House Covid briefing, President Joe Biden's top medical advisor Anthony Fauci said it was likely that fourth doses would more likely be needed for subsets of people who mount weaker immune responses, such as the elderly and immunocompromised.

Pfizer Inc Chief Executive Albert Bourla said that an annual COVID-19 vaccine would be preferable to more frequent booster shots in fighting the coronavirus pandemic.

Pfizer/BioNtech's COVID-19 vaccine has shown to be effective against severe disease and death caused by the heavily-mutated Omicron variant but less effective in preventing transmission.

With cases soaring, some countries have expanded COVID-19 vaccine booster programs or shortened the gap between shots as governments scramble to shore up protection.

(With inputs from agencies)

A new study by the US Centers of Disease Control and Prevention (CDC) has said that the efficacy of third doses of the Pfizer and Moderna mRNA vaccines wanes substantially by the fourth month after administration.

A new study by the US Centers of Disease Control and Prevention (CDC) has said that the efficacy of third doses of the Pfizer and Moderna mRNA vaccines wanes substantially by the fourth month after administration. CDC examined data on 93,000 hospitalisations and 241,000 emergency department and urgent care visits across 10 states during the Delta and Omicron waves. In the study, about 10 per cent of people were boosted and over 50 per cent of people hospitalised were over 65 years old. During Omicron, vaccine effectiveness against hospitalisation was 91 per cent during the first two months after a third dose and remained high, at 78 per cent, four or more months after a third dose. Study participants were recruited from the companies' late-stage COVID-19 vaccine study, and those who had received the second dose of the company's COVID-19 vaccine at least six months before entering the co-administration study. Also read | Future of Covid vaccines: Scientists develop a vaccine that can be inhaled, won't need needles The study reveals that a third dose of mRNA vaccine continues to offer high levels of protection against severe disease, even months after administration, underscoring the importance of staying up to date when eligible after receiving a primary series. "The finding that protection conferred by mRNA vaccines waned in the months after receipt of a third vaccine dose reinforces the importance of further consideration of additional doses to sustain or improve protection," the authors concluded. Speaking at a White House Covid briefing, President Joe Biden's top medical advisor Anthony Fauci said it was likely that fourth doses would more likely be needed for subsets of people who mount weaker immune responses, such as the elderly and immunocompromised. Pfizer Inc Chief Executive Albert Bourla said that an annual COVID-19 vaccine would be preferable to more frequent booster shots in fighting the coronavirus pandemic. Pfizer/BioNtech's COVID-19 vaccine has shown to be effective against severe disease and death caused by the heavily-mutated Omicron variant but less effective in preventing transmission. With cases soaring, some countries have expanded COVID-19 vaccine booster programs or shortened the gap between shots as governments scramble to shore up protection. (With inputs from agencies)

Efficacy of Pfizer and Moderna vaccines wane after third dose: Study

In 2021, Pfizer's annual profits were more than double what they were in 2020. The company brought in $22 billion in profits in 2020. Vaccine sales accounted for 36.8 billion of the $81.3 billion in annual revenues.

"2021 was a watershed year for Pfizer," said Chief Executive Albert Bourla in a statement. "Our successes in leading the fight against COVID-19 have not only made a positive difference in the world; I believe they have fundamentally changed our company forever."

Also read |&nbsp;<a href="https://www.wionews.com/world/modernas-spikevax-coronavirus-vaccine-gets-full-fda-approval-in-us-449362" hreflang="en">Moderna's 'Spikevax' coronavirus vaccine gets full FDA approval in US</a>

However, the bumper sales prompted accusations of "pandemic profiteering" from campaigners. Pfizer's revenue of $81bn is more than the GDP of most countries, according to Global Justice Now, which accuses the company of "ripping off public health systems."

Worldwide, the vaccines produced by Pfizer Covid, US rival Moderna, and Britain's AstraZeneca have saved millions of lives.

Pharmaceutical companies have, however, been accused of not sharing their vaccine recipes, which would allow drugmakers in poorer countries to produce cheaper versions of their products.

Also read |&nbsp;<a href="https://www.wionews.com/world/more-than-3000-personnel-face-getting-discharged-as-us-army-tightens-vaccine-mandate-rules-449993" hreflang="en">More than 3000 personnel face getting discharged as US Army tightens vaccine mandate rules</a>

Global Justice Now pointed out that BioNTech invented Pfizer's COVID-19 vaccine, which was funded by a €100 million (£84 million) loan from the European Investment Bank and a €375 million German government grant.

According to Tim Bierley, a pharma campaigner for the group, mRNA vaccines should have revolutionised the global Covid response, but Pfizer is withholding this essential medical innovation from the world, ripping public health systems off for an "eye-watering mark-up."

As Pfizer reported a more than doubling of annual profits on strong vaccine sales, the giant pharma company has also forecasted more than $50 billion in sales for COVID-19 vaccine and therapeutic by 2022.

Watch |&nbsp;DCGI grants emergency use permission to single-dose Sputnik Light Covid-19 vaccine

<div class="videoWrapper trancodeVideo"><iframe allowfullscreen="" autoplay="1" class="includeVideo" frameborder="0" height="350" src="https://www.wionews.com/videos/dcgi-grants-emergency-use-permission-to-single-dose-sputnik-light-covid-19-vaccine-451172/embed" style="width:100%;max-width:560px;" width="560"></iframe></div>

Pfizer, which along with BioNTech won approval for the first vaccine to combat the deadly virus, sees slightly lower revenue from the vaccine in 2022 compared to the previous year, but huge growth from the company's COVID-19 pill Paxlovid.

The results are the latest proof of how the Coronavirus has transformed Pfizer. It predicted just $15 billion in vaccine sales for COVID-19 a year ago, but ended up selling more than twice that amount after increasing its forecast repeatedly.

(With inputs from agency)

In 2021, Pfizer's annual profits were more than double what they were in 2020. The company brought in $22 billion in profits in 2020. Vaccine sales accounted for 36.

In 2021, Pfizer's annual profits were more than double what they were in 2020. The company brought in $22 billion in profits in 2020. Vaccine sales accounted for 36.8 billion of the $81.3 billion in annual revenues. "2021 was a watershed year for Pfizer," said Chief Executive Albert Bourla in a statement. "Our successes in leading the fight against COVID-19 have not only made a positive difference in the world; I believe they have fundamentally changed our company forever." Also read | Moderna's 'Spikevax' coronavirus vaccine gets full FDA approval in US However, the bumper sales prompted accusations of "pandemic profiteering" from campaigners. Pfizer's revenue of $81bn is more than the GDP of most countries, according to Global Justice Now, which accuses the company of "ripping off public health systems." Worldwide, the vaccines produced by Pfizer Covid, US rival Moderna, and Britain's AstraZeneca have saved millions of lives. Pharmaceutical companies have, however, been accused of not sharing their vaccine recipes, which would allow drugmakers in poorer countries to produce cheaper versions of their products. Also read | More than 3000 personnel face getting discharged as US Army tightens vaccine mandate rules Global Justice Now pointed out that BioNTech invented Pfizer's COVID-19 vaccine, which was funded by a €100 million (£84 million) loan from the European Investment Bank and a €375 million German government grant. According to Tim Bierley, a pharma campaigner for the group, mRNA vaccines should have revolutionised the global Covid response, but Pfizer is withholding this essential medical innovation from the world, ripping public health systems off for an "eye-watering mark-up." As Pfizer reported a more than doubling of annual profits on strong vaccine sales, the giant pharma company has also forecasted more than $50 billion in sales for COVID-19 vaccine and therapeutic by 2022. Watch | DCGI grants emergency use permission to single-dose Sputnik Light Covid-19 vaccine Pfizer, which along with BioNTech won approval for the first vaccine to combat the deadly virus, sees slightly lower revenue from the vaccine in 2022 compared to the previous year, but huge growth from the company's COVID-19 pill Paxlovid. The results are the latest proof of how the Coronavirus has transformed Pfizer. It predicted just $15 billion in vaccine sales for COVID-19 a year ago, but ended up selling more than twice that amount after increasing its forecast repeatedly. (With inputs from agency)

Vaccine maker Pfizer faces accusations of 'pandemic profiteering' as profits double

Pfizer and BioNTech announced on Tuesday that they have begun a study comparing their Omicron-based Covid-19 vaccine against the original vaccine.

If regulators decide to wait for the results of such a study, it might be months before an Omicron-specific vaccination becomes accessible.

Initial data from the research, which will enrol 1,420 volunteers, is expected in the first half of 2022, according to Pfizer.&nbsp;

It is unclear, however, what information authorities, such as the Food and Drug Administration, would require before approving an Omicron-specific vaccination, or what criteria the Centers for Disease Control and Prevention will use to prescribe one.

<a href="https://www.wionews.com/india-news/covid-19-is-omicron-sub-variant-ba2-a-threat-in-india-more-than-400-cases-found-in-england-446950">Also read | COVID-19: Is Omicron 'sub-variant' BA.2 a threat in India? More than 400 cases found in England</a> 
 
While recent data revealed that boosters against the original Covid strain continued to protect against severe outcomes with Omicron, the business was operating cautiously, according to Kathrin Jansen, the company's head of vaccine research.&nbsp;

"We recognise the need to be prepared in the event this protection wanes over time and to potentially help address Omicron and new variants in the future," she said.

According to Ugur Sahin, CEO of the German biotech business BioNTech, the original vaccine's protection against mild and moderate COVID appeared to fade more quickly against Omicron.

A total of 1,420 people between the ages of 18 and 55 will participate in the study.

The study did not include anyone over the age of 55, according to a Pfizer spokesman, because the purpose of the study was to assess the immunological response of participants dosed rather than to estimate vaccination efficacy.

Three groups of volunteers have been formed. 
 
<a href="https://www.wionews.com/world/us-uk-along-with-12-countries-criticise-whos-report-on-covid-origin-374383">Also read |&nbsp;US, UK, along with 12 countries, criticise WHO's report on COVID origin</a>

The first group of patients will receive one or two doses of the Omicron vaccination after receiving two doses of the current Pfizer-BioNTech vaccine 90-180 days prior to enrollment.&nbsp;

The second group will get either another dose of the existing vaccine or an Omicron-specific vaccine after receiving three doses of the current vaccine 90-180 days prior to the research.

The third and final group will receive three doses of the Omicron-specific vaccination if they have never had a Covid vaccine before.

In December 2020, the Pfizer-BioNTech vaccination became the first COVID injection to be approved in the West.&nbsp;

(With inputs from agencies)

Pfizer and BioNTech announced on Tuesday that they have begun a study comparing their Omicron-based Covid-19 vaccine against the original vaccine. If regulators decide to wait for the results of such a study, it might be months before an Omicron-specific vaccination becomes accessible.

Pfizer and BioNTech announced on Tuesday that they have begun a study comparing their Omicron-based Covid-19 vaccine against the original vaccine. If regulators decide to wait for the results of such a study, it might be months before an Omicron-specific vaccination becomes accessible. Initial data from the research, which will enrol 1,420 volunteers, is expected in the first half of 2022, according to Pfizer. It is unclear, however, what information authorities, such as the Food and Drug Administration, would require before approving an Omicron-specific vaccination, or what criteria the Centers for Disease Control and Prevention will use to prescribe one. Also read | COVID-19: Is Omicron 'sub-variant' BA.2 a threat in India? More than 400 cases found in England While recent data revealed that boosters against the original Covid strain continued to protect against severe outcomes with Omicron, the business was operating cautiously, according to Kathrin Jansen, the company's head of vaccine research. "We recognise the need to be prepared in the event this protection wanes over time and to potentially help address Omicron and new variants in the future," she said. According to Ugur Sahin, CEO of the German biotech business BioNTech, the original vaccine's protection against mild and moderate COVID appeared to fade more quickly against Omicron. A total of 1,420 people between the ages of 18 and 55 will participate in the study. The study did not include anyone over the age of 55, according to a Pfizer spokesman, because the purpose of the study was to assess the immunological response of participants dosed rather than to estimate vaccination efficacy. Three groups of volunteers have been formed. Also read | US, UK, along with 12 countries, criticise WHO's report on COVID origin The first group of patients will receive one or two doses of the Omicron vaccination after receiving two doses of the current Pfizer-BioNTech vaccine 90-180 days prior to enrollment. The second group will get either another dose of the existing vaccine or an Omicron-specific vaccine after receiving three doses of the current vaccine 90-180 days prior to the research. The third and final group will receive three doses of the Omicron-specific vaccination if they have never had a Covid vaccine before. In December 2020, the Pfizer-BioNTech vaccination became the first COVID injection to be approved in the West. (With inputs from agencies)

COVID-19: Pfizer and BioNTech begin clinical trial of Omicron-based vaccine

A latest preliminary study has revealed that Russia's Covid vaccine, Sputnik V, shows higher Omicron-antibody levels than the Pfizer Covid vaccine. The joint Russian-Italian study was conducted by scientists from the Spallanzani Institute in Italy and Gamaleya Institute in Moscow, which also happens to be the developer of the Sputnik V vaccine.

"Today the necessity of third booster vaccination is obvious," the preliminary study.&nbsp;

The study involved 51 people vaccinated with Sputnik V and 17 people who were vaccinated with two shots of the Pfizer vaccine.

As a part of the study, the researchers compared the blood serum of people who had received the different vaccines. They elaborated that the samples which were taken 3-6 months after the second dose of a vaccine have shown that the levels of antibodies in people who have taken two doses of Sputnik V were more resistant to Omicron than those vaccinated with Pfizer.

<a href="https://www.wionews.com/world/who-urges-countries-to-lift-travel-bans-and-not-ask-for-vaccination-proof-for-entry-446291">Also read |&nbsp;WHO urges countries to lift travel bans and not ask for vaccination proof for entry</a>

Head of RDIF Kirill Dmitriev, in a statement, said, "Partnership of different platforms is the key...boosting with Sputnik Light will help strengthen efficacy of other vaccines in light of combined Delta and Omicron challenge."

The study will soon seek certification by peer review.&nbsp;

Study's findings revealed that Omicron-specific neutralising antibodies were detected in the blood serum of 74.2 per cent of the people vaccinated with Sputnik while for Pfizer it was 56.9 per cent.

The Omicron variant of coronavirus has driven a surge of cases all across the world. While most countries have imposed travel restrictions, WHO has urged nations to lift travel bans and mandatory vaccination for entry into countries.

WHO chief Tedros Adhanom Ghebreyesus had earlier warned global leaders that the Covid pandemic “is nowhere near over” adding that the Omicron variant is causing hospitalisations and deaths the world over.

(With inputs from agencies)

A latest preliminary study has revealed that Russia's Covid vaccine, Sputnik V, shows higher Omicron-antibody levels than the Pfizer Covid vaccine. The joint Russian-Italian study was conducted by scientists from the Spallanzani Institute in Italy and Gamaleya Institute in Moscow, which also happens to be the developer of the Sputnik V vaccine.

A latest preliminary study has revealed that Russia's Covid vaccine, Sputnik V, shows higher Omicron-antibody levels than the Pfizer Covid vaccine. The joint Russian-Italian study was conducted by scientists from the Spallanzani Institute in Italy and Gamaleya Institute in Moscow, which also happens to be the developer of the Sputnik V vaccine. "Today the necessity of third booster vaccination is obvious," the preliminary study. The study involved 51 people vaccinated with Sputnik V and 17 people who were vaccinated with two shots of the Pfizer vaccine. As a part of the study, the researchers compared the blood serum of people who had received the different vaccines. They elaborated that the samples which were taken 3-6 months after the second dose of a vaccine have shown that the levels of antibodies in people who have taken two doses of Sputnik V were more resistant to Omicron than those vaccinated with Pfizer. Also read | WHO urges countries to lift travel bans and not ask for vaccination proof for entry Head of RDIF Kirill Dmitriev, in a statement, said, "Partnership of different platforms is the key...boosting with Sputnik Light will help strengthen efficacy of other vaccines in light of combined Delta and Omicron challenge." The study will soon seek certification by peer review. Study's findings revealed that Omicron-specific neutralising antibodies were detected in the blood serum of 74.2 per cent of the people vaccinated with Sputnik while for Pfizer it was 56.9 per cent. The Omicron variant of coronavirus has driven a surge of cases all across the world. While most countries have imposed travel restrictions, WHO has urged nations to lift travel bans and mandatory vaccination for entry into countries. WHO chief Tedros Adhanom Ghebreyesus had earlier warned global leaders that the Covid pandemic “is nowhere near over” adding that the Omicron variant is causing hospitalisations and deaths the world over. (With inputs from agencies)

Sputnik V shows higher Omicron-antibody levels than Pfizer: Study

Amid a rise in the coronavirus (COVID-19) cases globally after the emergence of the Omicron variant, experts and medical scientists are working to investigate the immune escape potential.&nbsp;

As governments across the world are pushing ahead with booster shots to protect amid the emergence of new variants, latest Israeli study regarding Pfizer and Moderna vaccines impact on Omicron gives valuable inputs.&nbsp;

The authors of an Israeli trial said on Monday&nbsp;that the fourth doses of the Pfizer and Moderna vaccines against Covid are only "partially" effective for the Omicron variant of the virus.&nbsp;

ALSO READ |&nbsp;<a href="https://www.wionews.com/india-news/indias-main-cities-record-sharp-fall-in-covid-infections-445558">India’s main cities record sharp fall in Covid infections</a>

A trial was conducted by a team from Sheba Medical Center near Tel Aviv in December on fourth doses of coronavirus vaccines, inoculating 154 hospital personnel with Pfizer jabs and 120 other volunteers with Moderna doses.&nbsp;

As per a statement released by the hospital, the initial results showed that "the vaccines are safe and have shown to produce substantial antibodies, but are only partially effective in defending against the Omicron variant."&nbsp;

Professor Gili Regev-Yochay, who leads the study, said that while there was an increase in antibodies after administering the fourth dose, it nonetheless "only offers a partial defenser against the virus" for those infected with the Omicron variant.&nbsp;

ALSO READ |&nbsp;<a href="https://www.wionews.com/world/china-office-locked-with-workers-trapped-inside-after-omicron-case-detected-445537">China: Office locked with workers trapped inside after Omicron case detected</a>

"The vaccine, which was very effective against the previous strains, is less effective against the Omicron strain," Regev-Yochay said as quoted by The Times Of Israel.&nbsp;

"We see an increase in antibodies, higher than after the third dose. However, we see many infected with Omicron who received the fourth dose. Granted, a bit less than in the control group, but still a lot of infections," she added.

"The bottom line is that the vaccine is excellent against the Alpha and Delta [variants], for Omicron it’s not good enough," she said.

Meanwhile, the World Health Organization (WHO) urged countries to delay booster programs as people around the world are yet to get their&nbsp;initial vaccine jabs.&nbsp;

COVID-19 situation in Israel

In Israel, official figures showed that a total of more than 1.7 million infections have been recorded since the start of the pandemic, including more than 8,300 deaths.&nbsp;

Israel was among the first countries to launch mass immunisation campaigns for its population. It then began offering booster shots last summer. More than 537,000 Israelis have received a fourth dose of vaccine, according to the health ministry's latest figures.&nbsp;

<div class="ui-state-default" contenteditable="false">
<div class="twitter-block" draggable="false">
<div class="videoWrapper trancodeVideo"><iframe allowfullscreen="" autoplay="1" class="includeVideo" frameborder="0" height="350" src="https://www.wionews.com/videos/twindemic-europe-faces-severe-flu-amid-ongoing-covid-19-pandemic-445624/embed" style="width:100%;max-width:560px;" width="560"></iframe></div>
</div>
<a class="close-mark close-div" href="#" id="jqclosemark">×</a></div>

&nbsp;

Amid a rise in the coronavirus (COVID-19) cases globally after the emergence of the Omicron variant, experts and medical scientists are working to investigate the immune escape potential.

Amid a rise in the coronavirus (COVID-19) cases globally after the emergence of the Omicron variant, experts and medical scientists are working to investigate the immune escape potential. As governments across the world are pushing ahead with booster shots to protect amid the emergence of new variants, latest Israeli study regarding Pfizer and Moderna vaccines impact on Omicron gives valuable inputs. The authors of an Israeli trial said on Monday that the fourth doses of the Pfizer and Moderna vaccines against Covid are only "partially" effective for the Omicron variant of the virus. ALSO READ | India’s main cities record sharp fall in Covid infections A trial was conducted by a team from Sheba Medical Center near Tel Aviv in December on fourth doses of coronavirus vaccines, inoculating 154 hospital personnel with Pfizer jabs and 120 other volunteers with Moderna doses. As per a statement released by the hospital, the initial results showed that "the vaccines are safe and have shown to produce substantial antibodies, but are only partially effective in defending against the Omicron variant." Professor Gili Regev-Yochay, who leads the study, said that while there was an increase in antibodies after administering the fourth dose, it nonetheless "only offers a partial defenser against the virus" for those infected with the Omicron variant. ALSO READ | China: Office locked with workers trapped inside after Omicron case detected "The vaccine, which was very effective against the previous strains, is less effective against the Omicron strain," Regev-Yochay said as quoted by The Times Of Israel. "We see an increase in antibodies, higher than after the third dose. However, we see many infected with Omicron who received the fourth dose. Granted, a bit less than in the control group, but still a lot of infections," she added. "The bottom line is that the vaccine is excellent against the Alpha and Delta [variants], for Omicron it’s not good enough," she said. Meanwhile, the World Health Organization (WHO) urged countries to delay booster programs as people around the world are yet to get their initial vaccine jabs. COVID-19 situation in Israel In Israel, official figures showed that a total of more than 1.7 million infections have been recorded since the start of the pandemic, including more than 8,300 deaths. Israel was among the first countries to launch mass immunisation campaigns for its population. It then began offering booster shots last summer. More than 537,000 Israelis have received a fourth dose of vaccine, according to the health ministry's latest figures. ×

COVID-19: Fourth dose of vaccine 'not good enough' against Omicron variant, reveals Israeli study

A new revelation by the US Centers for Disease Control and Prevention (CDC) states that two doses of the Pfizer Covid vaccine can help in protecting a 'rare but often serious' condition in children. Experts believe that this condition causes organ inflammation a few weeks after Covid infection. This comes in after a study which concluded that the vaccine was 91 per cent effective in preventing Multisystem inflammatory syndrome in children aged 12- to 18-years.

The syndrome leads to inflammation in children in organs such as the heart, lungs, kidneys and brain.

The study involved 283 hospitalised patients aged 12–18 years. They were in 24 different children's hospitals in 20 states between July and early December. As per the study, children aged 5–11 years are at the highest risk for this inflammatory syndrome.&nbsp;

<a href="https://www.wionews.com/world/omicron-update-cdc-suggests-pfizer-booster-shot-for-kids-aged-12-and-above-442658">Also read |&nbsp;Omicron update: CDC suggests Pfizer booster shot for kids aged 12 and above</a>

Meanwhile, both FDA and CDC have suggested Pfizer booster shots for kids aged 12 and above.&nbsp;

The booster shot will be given at least five months after the two doses have been given. The decision was taken after a CDC advisory panel voted 13-1 in favour of booster dose.&nbsp;

The vaccine made by Pfizer and its partner BioNTech is the only US option for children of any age. According to the CDC, about 13.5 million 12- to 17-year-olds, just over half that age group, have received two Pfizer shots.

Global Covid cases experiencing a surge due to the Omicron variant. The health authorities have warned that its extremely high transmissibility could overwhelm many health systems.

(With inputs from agencies)

A new revelation by the US Centers for Disease Control and Prevention (CDC) states that two doses of the Pfizer Covid vaccine can help in protecting a 'rare but often serious' condition in children.

A new revelation by the US Centers for Disease Control and Prevention (CDC) states that two doses of the Pfizer Covid vaccine can help in protecting a 'rare but often serious' condition in children. Experts believe that this condition causes organ inflammation a few weeks after Covid infection. This comes in after a study which concluded that the vaccine was 91 per cent effective in preventing Multisystem inflammatory syndrome in children aged 12- to 18-years. The syndrome leads to inflammation in children in organs such as the heart, lungs, kidneys and brain. The study involved 283 hospitalised patients aged 12–18 years. They were in 24 different children's hospitals in 20 states between July and early December. As per the study, children aged 5–11 years are at the highest risk for this inflammatory syndrome. Also read | Omicron update: CDC suggests Pfizer booster shot for kids aged 12 and above Meanwhile, both FDA and CDC have suggested Pfizer booster shots for kids aged 12 and above. The booster shot will be given at least five months after the two doses have been given. The decision was taken after a CDC advisory panel voted 13-1 in favour of booster dose. The vaccine made by Pfizer and its partner BioNTech is the only US option for children of any age. According to the CDC, about 13.5 million 12- to 17-year-olds, just over half that age group, have received two Pfizer shots. Global Covid cases experiencing a surge due to the Omicron variant. The health authorities have warned that its extremely high transmissibility could overwhelm many health systems. (With inputs from agencies)

Pfizer vaccine protects children against this 'rare' Covid complication

After FDA, Centers for Disease Control Director Dr Rochelle Walensky has suggested the use of Pfizer booster doses for teenagers from 12 through 15 years of age. "It is critical that we protect our children and teens from COVID-19 infection and the complications of severe disease," CDC Director said in a statement.&nbsp;

"This booster dose will provide optimised protection against COVID-19 and the Omicron variant. I encourage all parents to keep their children up to date with CDC’s COVID-19 vaccine recommendations," she further added.&nbsp;

The booster shot will be given at least five months after the two doses have been given. The decision was taken after a CDC advisory panel voted 13-1 in favour of booster dose.&nbsp;

<a href="https://www.wionews.com/world/omicron-update-fda-amends-emergency-use-of-pfizer-booster-dose-for-more-teens-442035">Also read |&nbsp;Omicron update: FDA amends emergency use of Pfizer booster dose for more teens</a>

The vaccine made by Pfizer and its partner BioNTech is the only US option for children of any age. According to the CDC, about 13.5 million 12- to 17-year-olds, just over half that age group, have received two Pfizer shots.

The FDA approved the same booster shot for teens earlier this week. According to Acting FDA Commissioner Janet Woodcock,

“Throughout the pandemic, as the virus that causes COVID-19 has continuously evolved, the need for the FDA to quickly adapt has meant using the best available science to make informed decisions with the health and safety of the American public in mind.”&nbsp;

Global Covid cases experiencing a surge due to the Omicron variant. The health authorities have warned that its extremely high transmissibility could overwhelm many health systems all across the globe.

(With inputs from agencies)

After FDA, Centers for Disease Control Director Dr Rochelle Walensky has suggested the use of Pfizer booster doses for teenagers from 12 through 15 years of age.

After FDA, Centers for Disease Control Director Dr Rochelle Walensky has suggested the use of Pfizer booster doses for teenagers from 12 through 15 years of age. "It is critical that we protect our children and teens from COVID-19 infection and the complications of severe disease," CDC Director said in a statement. "This booster dose will provide optimised protection against COVID-19 and the Omicron variant. I encourage all parents to keep their children up to date with CDC’s COVID-19 vaccine recommendations," she further added. The booster shot will be given at least five months after the two doses have been given. The decision was taken after a CDC advisory panel voted 13-1 in favour of booster dose. Also read | Omicron update: FDA amends emergency use of Pfizer booster dose for more teens The vaccine made by Pfizer and its partner BioNTech is the only US option for children of any age. According to the CDC, about 13.5 million 12- to 17-year-olds, just over half that age group, have received two Pfizer shots. The FDA approved the same booster shot for teens earlier this week. According to Acting FDA Commissioner Janet Woodcock, “Throughout the pandemic, as the virus that causes COVID-19 has continuously evolved, the need for the FDA to quickly adapt has meant using the best available science to make informed decisions with the health and safety of the American public in mind.” Global Covid cases experiencing a surge due to the Omicron variant. The health authorities have warned that its extremely high transmissibility could overwhelm many health systems all across the globe. (With inputs from agencies)

Omicron update: CDC suggests Pfizer booster shot for kids aged 12 and above

The US Food and Drug Administration has authorised the use of a third dose of the Pfizer-BioNTech's COVID-19 vaccine for children ages 12 to 15, and reduced the wait time between initial vaccination and an extra dose from six months to five months for all ages.

US FDA authorises Pfizer COVID-19 vaccine booster for children ages 12 to 15

The US Food and Drug Administration has amended the use of Pfizer booster doses for teenagers from 12 through 15 years of age.

It has also reduced the time between the completion of primary vaccination of the Pfizer-BioNTech COVID-19 vaccine and a booster dose to at least five months.

The federal agency has also allowed the third dose for immunocompromised children 5 through 11 years of age.

Also read |&nbsp;<a href="https://www.wionews.com/world/record-levels-of-coronavirus-revealed-in-wastewater-samples-across-united-states-442013">Record levels of coronavirus revealed in wastewater samples across US</a>

According to Acting FDA Commissioner Janet Woodcock, “Throughout the pandemic, as the virus that causes COVID-19 has continuously evolved, the need for the FDA to quickly adapt has meant using the best available science to make informed decisions with the health and safety of the American public in mind.”&nbsp;

“With the current wave of the omicron variant, it’s critical that we continue to take effect, life-saving preventative measures such as primary vaccination and boosters, mask-wearing and social distancing to in order to effectively fight COVID-19,” she added.

Also read |&nbsp;<a href="https://www.wionews.com/world/over-2700-flights-cancelled-in-united-states-due-to-omicron-related-disruptions-441784" hreflang="en">Over 2,700 flights cancelled in United States due to Omicron-related disruptions</a>

The FDA said it reviewed published data and real-world evidence on the safety of booster doses provided by the Israeli Ministry of Health including data from over 6,300 individuals 12-to-15 years of age who received a Pfizer shot.

The vaccine made by Pfizer and its partner BioNTech is the only US&nbsp;option for children of any age. About 13.5 million 12- to 17-year-olds,&nbsp;just over half that age group,&nbsp;have received two Pfizer shots, according to the CDC.

Global COVID-19 cases are surging due to the Omicron variant and health authorities have warned that its extremely high transmissibility could overwhelm many health systems.

Laboratory tests have shown that two doses of the Pfizer-BioNTech and Moderna vaccines generate low immune responses against Omicron, while boosters appear to be protective against the highly-mutated variant.

(With inputs from agencies)

The US Food and Drug Administration has amended the use of Pfizer booster doses for teenagers from 12 through 15 years of age. It has also reduced the time between the completion of primary vaccination of the Pfizer-BioNTech COVID-19 vaccine and a booster dose to at least five months.

The US Food and Drug Administration has amended the use of Pfizer booster doses for teenagers from 12 through 15 years of age. It has also reduced the time between the completion of primary vaccination of the Pfizer-BioNTech COVID-19 vaccine and a booster dose to at least five months. The federal agency has also allowed the third dose for immunocompromised children 5 through 11 years of age. Also read | Record levels of coronavirus revealed in wastewater samples across US According to Acting FDA Commissioner Janet Woodcock, “Throughout the pandemic, as the virus that causes COVID-19 has continuously evolved, the need for the FDA to quickly adapt has meant using the best available science to make informed decisions with the health and safety of the American public in mind.” “With the current wave of the omicron variant, it’s critical that we continue to take effect, life-saving preventative measures such as primary vaccination and boosters, mask-wearing and social distancing to in order to effectively fight COVID-19,” she added. Also read | Over 2,700 flights cancelled in United States due to Omicron-related disruptions The FDA said it reviewed published data and real-world evidence on the safety of booster doses provided by the Israeli Ministry of Health including data from over 6,300 individuals 12-to-15 years of age who received a Pfizer shot. The vaccine made by Pfizer and its partner BioNTech is the only US option for children of any age. About 13.5 million 12- to 17-year-olds, just over half that age group, have received two Pfizer shots, according to the CDC. Global COVID-19 cases are surging due to the Omicron variant and health authorities have warned that its extremely high transmissibility could overwhelm many health systems. Laboratory tests have shown that two doses of the Pfizer-BioNTech and Moderna vaccines generate low immune responses against Omicron, while boosters appear to be protective against the highly-mutated variant. (With inputs from agencies)

Omicron update: FDA amends emergency use of Pfizer booster dose for more teens

The Food and Drug Administration is planning to broaden eligibility for coronavirus vaccine booster doses Monday, allowing 12- to 15-year-olds to receive third doses of Pfizer-BioNTech’s vaccine, according to people familiar with the agency’s deliberations.

Regulators also plan to allow both adolescents and adults to seek an extra shot of Pfizer’s vaccine five months after receiving a second dose, instead of the current period of six months. A booster shot is also expected to be authorized for younger children, ages 5 to 11, with immune deficiencies.

The Centers for Disease Control and Prevention’s vaccine advisory committee is planning to meet by the middle of next week to vote on whether to recommend the changes. If the committee agrees with the FDA’s authorizations, Dr. Rochelle Walensky, the CDC director, is expected to promptly endorse the revisions.

The move to expand boosters comes as the highly contagious omicron variant is infecting a record number of Americans with the coronavirus, putting more pressure on hospitals already deluged by COVID-19 patients from the delta variant.

More than 70% of people in the United States 12 years and older are fully vaccinated, according to the CDC. Children can better withstand coronavirus infections but in rare instances still can get very sick and even die. At least 1.8 million adolescents between 12 and 15 years old have tested positive for the virus, according to the CDC.

The FDA had hoped to announce its decision as early as Thursday, the people familiar with the deliberations said, but agreed to wait until Monday because Walensky said she wanted to hear recommendations from her agency’s outside advisory group before signing off on the changes. That group, which has met throughout the pandemic to consider FDA decisions around vaccines, might not meet until Wednesday.

The two agencies share responsibility for setting the nation’s vaccine policy and have worked to present a unified front in their reviews of booster shots. But the FDA has been more willing to act without the advice of its outside advisory committee, with some top officials arguing that the agency needs to respond as quickly as possible in the face of the ongoing public health crisis.

Federal regulators based their decision at least in part on data from Israel that showed no serious safety concerns in thousands of 12- to 15-year-olds who received a third dose of the Pfizer vaccine. There were no reports of myocarditis, a rare side effect seen mostly in younger men that has been linked to the Pfizer and Moderna vaccines. The condition involves inflammation of the heart muscle.

The FDA wants to allow a booster dose as early as five months after the second Pfizer dose in part because Israeli data suggests that the shorter interval is effective, according to people familiar with the government’s deliberations.

One recent South African study showed that the effectiveness of Pfizer’s vaccine against severe illness and hospitalization was about 70% after two doses.

Pfizer and BioNTech, its German partner, have both said their studies show that a third dose is needed to protect against omicron. Dr. Albert Bourla, the CEO of Pfizer, said earlier this month that while two doses may still prevent severe disease from omicron, a third strengthens protection.

Dr. Ugur Sahin, the CEO of BioNTech, said three doses “could still offer a sufficient level of protection from disease of any severity” caused by the variant.

Although the FDA convened its outside advisory committee repeatedly earlier this year, it has not asked the committee for recommendations before its most recent decisions to expand boosters.

Walensky earlier this month endorsed offering Pfizer-BioNTech booster shots to 16- and 17-year-olds without convening her agency’s expert committee. But she was unwilling to do that for younger adolescents, people familiar with the government’s deliberations said.

Some outside experts have argued that by bypassing the outside committees, the CDC and FDA were wrongly limiting public discussion about the evidence to justify expanding the use of boosters.

The Food and Drug Administration is planning to broaden eligibility for coronavirus vaccine booster doses Monday, allowing 12- to 15-year-olds to receive third doses of Pfizer-BioNTech’s vaccine, according to people familiar with the agency’s deliberations.

The Food and Drug Administration is planning to broaden eligibility for coronavirus vaccine booster doses Monday, allowing 12- to 15-year-olds to receive third doses of Pfizer-BioNTech’s vaccine, according to people familiar with the agency’s deliberations. Regulators also plan to allow both adolescents and adults to seek an extra shot of Pfizer’s vaccine five months after receiving a second dose, instead of the current period of six months. A booster shot is also expected to be authorized for younger children, ages 5 to 11, with immune deficiencies. The Centers for Disease Control and Prevention’s vaccine advisory committee is planning to meet by the middle of next week to vote on whether to recommend the changes. If the committee agrees with the FDA’s authorizations, Dr. Rochelle Walensky, the CDC director, is expected to promptly endorse the revisions. The move to expand boosters comes as the highly contagious omicron variant is infecting a record number of Americans with the coronavirus, putting more pressure on hospitals already deluged by COVID-19 patients from the delta variant. More than 70% of people in the United States 12 years and older are fully vaccinated, according to the CDC. Children can better withstand coronavirus infections but in rare instances still can get very sick and even die. At least 1.8 million adolescents between 12 and 15 years old have tested positive for the virus, according to the CDC. The FDA had hoped to announce its decision as early as Thursday, the people familiar with the deliberations said, but agreed to wait until Monday because Walensky said she wanted to hear recommendations from her agency’s outside advisory group before signing off on the changes. That group, which has met throughout the pandemic to consider FDA decisions around vaccines, might not meet until Wednesday. The two agencies share responsibility for setting the nation’s vaccine policy and have worked to present a unified front in their reviews of booster shots. But the FDA has been more willing to act without the advice of its outside advisory committee, with some top officials arguing that the agency needs to respond as quickly as possible in the face of the ongoing public health crisis. Federal regulators based their decision at least in part on data from Israel that showed no serious safety concerns in thousands of 12- to 15-year-olds who received a third dose of the Pfizer vaccine. There were no reports of myocarditis, a rare side effect seen mostly in younger men that has been linked to the Pfizer and Moderna vaccines. The condition involves inflammation of the heart muscle. The FDA wants to allow a booster dose as early as five months after the second Pfizer dose in part because Israeli data suggests that the shorter interval is effective, according to people familiar with the government’s deliberations. One recent South African study showed that the effectiveness of Pfizer’s vaccine against severe illness and hospitalization was about 70% after two doses. Pfizer and BioNTech, its German partner, have both said their studies show that a third dose is needed to protect against omicron. Dr. Albert Bourla, the CEO of Pfizer, said earlier this month that while two doses may still prevent severe disease from omicron, a third strengthens protection. Dr. Ugur Sahin, the CEO of BioNTech, said three doses “could still offer a sufficient level of protection from disease of any severity” caused by the variant. Although the FDA convened its outside advisory committee repeatedly earlier this year, it has not asked the committee for recommendations before its most recent decisions to expand boosters. Walensky earlier this month endorsed offering Pfizer-BioNTech booster shots to 16- and 17-year-olds without convening her agency’s expert committee. But she was unwilling to do that for younger adolescents, people familiar with the government’s deliberations said. Some outside experts have argued that by bypassing the outside committees, the CDC and FDA were wrongly limiting public discussion about the evidence to justify expanding the use of boosters.

FDA plans to allow 12- to 15-year-olds to receive Pfizer boosters

Israel on Thursday received first shipment of Pfizer's anti-Covid pill. Prime Minister Nafatali Bennett hailed it as critical to combat the Omicron threat.

"Thanks to our rapid action, the drugs have arrived in Israel quickly and will assist us in getting past the peak of the coming Omicron wave," Bennett said.

Pfizer's Paxlovid pill has already got a go-ahead from US Food and Drug Administration (USFDA) last week.

In trials, the treatment has been shown to reduce Covid hospitalisations and deaths by 88 percent among at-risk people.&nbsp;

The pills landed in Israel as coronavirus infections are surging.

Health authorities reported nearly 4,000 new cases Wednesday, a high not seen since September.&nbsp;

Also Read | <a href="https://www.wionews.com/world/uk-falls-short-of-self-testing-kits-amid-coronavirus-wave-441245">UK falls short of self-testing kits amid coronavirus wave</a>

The oral treatments block the virus' ability to replicate and should withstand variants, experts say.

Until now, the main treatments for Covid have been synthetic antibodies or Gilead's antiviral remdesivir, which are administered by infusion.

The United States has paid $5.3 billion for 10 million courses of Pfizer's new treatment, as well as $2.2 billion for treatment from rival Merck, whose pill appears to be less effective.

The European Union's drug regulator has also allowed member states to use Pfizer's Covid medications ahead of formal approval as an emergency measure.

(With inputs from agencies)

Israel on Thursday received first shipment of Pfizer's anti-Covid pill. Prime Minister Nafatali Bennett hailed it as critical to combat the Omicron threat. "Thanks to our rapid action, the drugs have arrived in Israel quickly and will assist us in getting past the peak of the coming Omicron wave," Bennett said.

Israel on Thursday received first shipment of Pfizer's anti-Covid pill. Prime Minister Nafatali Bennett hailed it as critical to combat the Omicron threat. "Thanks to our rapid action, the drugs have arrived in Israel quickly and will assist us in getting past the peak of the coming Omicron wave," Bennett said. Pfizer's Paxlovid pill has already got a go-ahead from US Food and Drug Administration (USFDA) last week. In trials, the treatment has been shown to reduce Covid hospitalisations and deaths by 88 percent among at-risk people. The pills landed in Israel as coronavirus infections are surging. Health authorities reported nearly 4,000 new cases Wednesday, a high not seen since September. Also Read | UK falls short of self-testing kits amid coronavirus wave The oral treatments block the virus' ability to replicate and should withstand variants, experts say. Until now, the main treatments for Covid have been synthetic antibodies or Gilead's antiviral remdesivir, which are administered by infusion. The United States has paid $5.3 billion for 10 million courses of Pfizer's new treatment, as well as $2.2 billion for treatment from rival Merck, whose pill appears to be less effective. The European Union's drug regulator has also allowed member states to use Pfizer's Covid medications ahead of formal approval as an emergency measure. (With inputs from agencies)

First shipment of Pfizer's anti-Covid drug arrives in Israel

In a recent revelation, experts have said that antiviral pills against Covid, may not be safe for everyone. After doctors and pharmacists closely analysed the pills, they concluded that these pills can be life-threatening when taken with other medications, reports NBC.&nbsp;

The Food and Drug Administration (FDA), recently gave heads up to two pills - Pfizer's Paxlovid and Merck's Molnupiravair.&nbsp; 
Paxlovid's treatment is a combination of two pills taken over five days.

It has been authorised for mild to moderate Covid in people as young as 12 years, who have underlying conditions that increase the risk of hospitalisation and death from the coronavirus.&nbsp;

The Paxlovid cocktail consists of two tablets of the antiviral nirmatrelvir and one tablet of ritonavir. However, FDA does not recommend Paxlovid for people with severe kidney and&nbsp;liver disease. This is because one of the two drugs in the antiviral cocktail could lead to severe consequences with widely used medications. These medications range from statins, blood thinners to several antidepressants.

In a report by The Hill, a spokesperson said, "The potential for drug-drug interactions (DDI) for Paxlovid was examined in a series of in vitro studies, as well as clinical DDI studies."

He further added, "The product's emergency use authorisation fact sheets include information on drug interactions and contraindications. Healthcare providers should consider the potential for drug interactions prior to and during Paxlovid therapy and review concomitant medications during Paxlovid therapy."

In the case of Merck's Molnupiravair, the FDA has already restricted its use to adults, only in scenarios in which other authorised treatments, including monoclonal antibodies, are not “clinically appropriate.”&nbsp;

Emily Zadvorny, a clinical pharmacist who is the executive director of the Colorado Pharmacists Society, in a statement to NBC, said, "Pharmacists are highly trained experts in medication safety and monitoring and are an excellent source of information and advice about interactions between medications and also supplements and herbal products. They will help determine if a significant interaction exists and devise solutions to mitigate the interaction if possible.”

Pfizer's treatment has previously been authorised in the European Union. The US has already paid for 10 million courses.

The authorisation comes as cases are surging across the US, driven by Omicron, the most infectious variant seen so far.

(With inputs from agencies)

In a recent revelation, experts have said that antiviral pills against Covid, may not be safe for everyone. After doctors and pharmacists closely analysed the pills, they concluded that these pills can be life-threatening when taken with other medications, reports NBC.

In a recent revelation, experts have said that antiviral pills against Covid, may not be safe for everyone. After doctors and pharmacists closely analysed the pills, they concluded that these pills can be life-threatening when taken with other medications, reports NBC. The Food and Drug Administration (FDA), recently gave heads up to two pills - Pfizer's Paxlovid and Merck's Molnupiravair. Paxlovid's treatment is a combination of two pills taken over five days. It has been authorised for mild to moderate Covid in people as young as 12 years, who have underlying conditions that increase the risk of hospitalisation and death from the coronavirus. The Paxlovid cocktail consists of two tablets of the antiviral nirmatrelvir and one tablet of ritonavir. However, FDA does not recommend Paxlovid for people with severe kidney and liver disease. This is because one of the two drugs in the antiviral cocktail could lead to severe consequences with widely used medications. These medications range from statins, blood thinners to several antidepressants. In a report by The Hill, a spokesperson said, "The potential for drug-drug interactions (DDI) for Paxlovid was examined in a series of in vitro studies, as well as clinical DDI studies." He further added, "The product's emergency use authorisation fact sheets include information on drug interactions and contraindications. Healthcare providers should consider the potential for drug interactions prior to and during Paxlovid therapy and review concomitant medications during Paxlovid therapy." In the case of Merck's Molnupiravair, the FDA has already restricted its use to adults, only in scenarios in which other authorised treatments, including monoclonal antibodies, are not “clinically appropriate.” Emily Zadvorny, a clinical pharmacist who is the executive director of the Colorado Pharmacists Society, in a statement to NBC, said, "Pharmacists are highly trained experts in medication safety and monitoring and are an excellent source of information and advice about interactions between medications and also supplements and herbal products. They will help determine if a significant interaction exists and devise solutions to mitigate the interaction if possible.” Pfizer's treatment has previously been authorised in the European Union. The US has already paid for 10 million courses. The authorisation comes as cases are surging across the US, driven by Omicron, the most infectious variant seen so far. (With inputs from agencies)

Pfizer's pill against Covid can be dangerous when taken with other medications

US Food and Drug Administration on Wednesday gave a go-ahead to Pfizer's Covid pill for its use among high-risk people aged 12 and above.

"Today's authorization introduces the first treatment for Covid-19 that is in the form of a pill that is taken orally -- a major step forward in the fight against this global pandemic," said FDA scientist Patrizia Cavazzoni.

Paxlovid, Pfizer's treatment is a combination of two pills taken over five days. The treatment was shown to be safe and reduced the risk of hospitalizations and deaths among at-risk people by 88 percent. The clinical trial included 2,200 people.

In an unusual move, the FDA did not convene its customary panel of independent experts to review in depth data surrounding Pfizer's pill ahead of authorization.

Also Raed | <a href="https://www.wionews.com/world/boosters-cannot-be-seen-as-a-ticket-to-go-ahead-says-who-chief-tedros-amid-omicron-threat-439113">Boosters cannot be seen as a ticket to go ahead, says WHO chief Tedros amid Omicron threat</a>

Pfizer's treatment has previously been authorized in the European Union.

The US has already paid for 10 million courses.

The authorization comes as cases are surging across the United States, driven by Omicron, the most infectious variant seen to date.

The highly-mutated variant is better able to bypass immunity conferred by prior infection, and health authorities are urging the public to get boosted with mRNA vaccines in order to restore a higher degree of protection.

Unlike vaccines, the Covid pill does not target the ever-evolving spike protein of the coronavirus, which it uses to invade cells. It should in theory be more variant proof, and Pfizer has said preliminary studies have backed up that hypothesis.

Authorization is still awaited for another Covid pill, developed by Merck, which is also taken over five days and has been shown to reduce the same outcomes by 30 percent among high-risk people.

(With inputs from agencies)

US Food and Drug Administration on Wednesday gave a go-ahead to Pfizer's Covid pill for its use among high-risk people aged 12 and above. "Today's authorization introduces the first treatment for Covid-19 that is in the form of a pill that is taken orally -- a major step forward in the fight against this global pandemic," said FDA scientist Patrizia Cavazzoni.

US Food and Drug Administration on Wednesday gave a go-ahead to Pfizer's Covid pill for its use among high-risk people aged 12 and above. "Today's authorization introduces the first treatment for Covid-19 that is in the form of a pill that is taken orally -- a major step forward in the fight against this global pandemic," said FDA scientist Patrizia Cavazzoni. Paxlovid, Pfizer's treatment is a combination of two pills taken over five days. The treatment was shown to be safe and reduced the risk of hospitalizations and deaths among at-risk people by 88 percent. The clinical trial included 2,200 people. In an unusual move, the FDA did not convene its customary panel of independent experts to review in depth data surrounding Pfizer's pill ahead of authorization. Also Raed | Boosters cannot be seen as a ticket to go ahead, says WHO chief Tedros amid Omicron threat Pfizer's treatment has previously been authorized in the European Union. The US has already paid for 10 million courses. The authorization comes as cases are surging across the United States, driven by Omicron, the most infectious variant seen to date. The highly-mutated variant is better able to bypass immunity conferred by prior infection, and health authorities are urging the public to get boosted with mRNA vaccines in order to restore a higher degree of protection. Unlike vaccines, the Covid pill does not target the ever-evolving spike protein of the coronavirus, which it uses to invade cells. It should in theory be more variant proof, and Pfizer has said preliminary studies have backed up that hypothesis. Authorization is still awaited for another Covid pill, developed by Merck, which is also taken over five days and has been shown to reduce the same outcomes by 30 percent among high-risk people. (With inputs from agencies)

USFDA gives go-ahead to Pfizer's Covid pill

The US has authorized Pfizer's anti-COVID pill. It has been authorized for people aged 12 and above who are at risk. Now the steps come as the country witnesses a surge in COVID cases.

US authorizes Pfizer's anti-COVID pill

Bernie Sanders claims investors of Pfizer & Moderna made $10 billion as news about Omicron spread. Through secret contracts & vaccine patents - vaccine makers want to control the prices of boosters. Palki Sharma tells you how they could profit from boosters and variants.

Gravitas: How Vaccine Makers could profit from boosters and variants

The United States has authorised Pfizer's anti-covid pill for people aged 12 or above who are at high risk, it's called Paxlovid; the pill comprises of two types of tablets.

US approves Pfizer's anti-covid pill for 12 years of age and above

United States authorizes Pfizer's anti-COVID pill,

The European Commission said on Sunday that European Union countries will get additional 20 million doses of Pfizer-BioNTech Covid vaccine to fight Omicron virus that is fast spreading. The vaccines will be made available in first three months of year 2022.

Europe is currently bracing for a new Covid-19 wave driven by Omicron variant which is highly transmissible and mutated. The festive season of Christmas is fast approaching.

Many countries are ramping up their vaccination drives and reimposing travel restrictions and other curbs to try to put a break on infections weeks after the variant was first detected in South Africa.

Member states will get an additional five million doses of the Pfizer-BioNTech jab in January, five million in February and 10 million in March, the Commission said in a statement.

Also Read | <a href="https://www.wionews.com/world/uk-health-minister-says-it-may-be-too-late-to-react-to-omicron-as-covid-19-cases-continue-to-rise-438158">UK health minister says it may be 'too late to react' to Omicron as COVID-19 cases continue to rise</a>

"These doses come on top of the already scheduled 195 million doses from Pfizer-BioNTech, bringing the total number of deliveries in the first quarter to 215 million."

Full vaccination and boosters are "now even more urgent than ever" given the "expected rapid increase in infections due to the Omicron variant".

The EU is due to receive 650 million doses of Pfizer-BioNTech jabs in total in 2022.

Also Read | <a href="https://www.wionews.com/world/now-germany-imposes-restrictions-on-uk-travellers-to-check-omicron-spread-438104">Now, Germany imposes restrictions on UK travellers to check Omicron spread</a>

Omicron is expected to become the dominant strain by mid January in the EU, where 67 percent of the population is fully vaccinated.

(With inputs from agencies)

The European Commission said on Sunday that European Union countries will get additional 20 million doses of Pfizer-BioNTech Covid vaccine to fight Omicron virus that is fast spreading.

The European Commission said on Sunday that European Union countries will get additional 20 million doses of Pfizer-BioNTech Covid vaccine to fight Omicron virus that is fast spreading. The vaccines will be made available in first three months of year 2022. Europe is currently bracing for a new Covid-19 wave driven by Omicron variant which is highly transmissible and mutated. The festive season of Christmas is fast approaching. Many countries are ramping up their vaccination drives and reimposing travel restrictions and other curbs to try to put a break on infections weeks after the variant was first detected in South Africa. Member states will get an additional five million doses of the Pfizer-BioNTech jab in January, five million in February and 10 million in March, the Commission said in a statement. Also Read | UK health minister says it may be 'too late to react' to Omicron as COVID-19 cases continue to rise "These doses come on top of the already scheduled 195 million doses from Pfizer-BioNTech, bringing the total number of deliveries in the first quarter to 215 million." Full vaccination and boosters are "now even more urgent than ever" given the "expected rapid increase in infections due to the Omicron variant". The EU is due to receive 650 million doses of Pfizer-BioNTech jabs in total in 2022. Also Read | Now, Germany imposes restrictions on UK travellers to check Omicron spread Omicron is expected to become the dominant strain by mid January in the EU, where 67 percent of the population is fully vaccinated. (With inputs from agencies)

To fight Omicron, EU to get 20 million extra vaccines

pfizer

Pfizer, News on Pfizer, stories on Pfizer, articles on Pfizer, Pfizer stories at Wion, Pfizer news, Pfizer latest news