Pfizer submits FDA software for emergency approval of Covid therapy capsule

Albert Bourla, CEO of Pfizer, speaks to a press conference after a visit to monitor the production of the Pfizer-BioNtech COVID-19 vaccine at the US pharmaceutical company Pfizer’s factory in Puurs, Belgium, on April 23, 2021.

John Thys | Swimming pool | Reuters

Pfizer filed an application with the Food and Drug Administration on Tuesday for emergency approval of its Covid-19 treatment pill, saying it reduces hospital stays and deaths by 89% when given with a popular HIV drug.

The pill, if approved by the FDA, could help revolutionize the fight against Covid by allowing high-risk people infected with the virus to take an oral antiviral drug at home instead of going to the hospital. Such treatment could help ease the burden on hospital systems during the pandemic.

In a clinical study of people aged 18 and over who were at increased risk of developing severe Covid, the pill reduced hospital stays and deaths by 89% when taken within three days of symptoms appearing. according to Pfizer.

The pill, known as paxlovid, blocks the activity of an enzyme that the virus needs to replicate. Paxlovid is used in combination with a low-dose ritonavir, an HIV drug, to slow the patient’s metabolism down so that the drug can stay active in the body at a higher concentration for longer to fight the virus.

Pfizer said the Covid treatment was shown to be safe, adding that study participants taking paxlovid reported fewer adverse events than the placebo, and most of them were “mild intensity”.

If approved, paxlovid is given in two 150 mg tablets with one 100 mg tablet of ritonavir twice a day.

“We are working hard to get this potential treatment into patients’ hands as soon as possible and look forward to working with the US FDA to review our application as well as other regulatory agencies around the world,” said Pfizer Das said CEO Albert Bourla in a statement on Tuesday.

Bourla had previously said that Pfizer planned to file its data with the FDA before Thanksgiving.

Early Tuesday, Pfizer announced that it would allow generic drug companies to ship their antiviral pill to 95 low and middle income countries.

Merck is also developing an antiviral pill, molnupiravir, to fight Covid. The company found in an interim analysis that the pill reduced the risk of hospitalization and death in adults with mild to moderate Covid by 50%.

Merck, which co-developed the drug with Ridgeback Biotherapeutics, filed an application with the FDA for approval of the pill last month.

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FDA panel unanimously recommends Moderna Covid booster pictures for at-risk adults

A key advisory committee to the Food and Drug Administration unanimously recommended Thursday that booster shots be taken from ModernCovid-19 vaccine for people 65 and older and other Americans at risk. The vote was a critical step before the US can begin giving third vaccinations to some of the more than 69 million people who originally received this vaccine.

The non-binding decision of the Advisory Committee on Vaccines and Allied Biological Products of the FDA would extend the guidelines for Moderna with the third recordings of the FDA PfizerBioNTech Vaccination. These recordings were authorized less than a month ago to a wide range of Americans, including the elderly, adults with pre-existing medical conditions, and those who work or live in high-risk environments such as healthcare and grocery stores.

Although the agency has not always followed the advice of its committee, it often does. A final FDA decision on Moderna boosters could be made within days. A CDC Vaccines Advisory Committee is then expected to vote on the FDA’s proposal next week. If it recommends approval and the CDC endorses it, eligible Americans who completed their vaccinations at least six months ago could begin booster vaccinations immediately.

Booster vaccination has been a controversial issue for scientists – inside and outside of government – especially since many people in the US and other parts of the world have not yet received a single dose of a vaccine. The World Health Organization is urging wealthy countries to wait before distributing boosters, and some scientists say they are not convinced that most Americans need boosters right now.

When the FDA committee met last month, they opposed a proposal to distribute booster vaccines from Pfizer and BioNTech to the general public. Some committee members said at the time they were concerned that there wasn’t enough data to make a recommendation, while others argued that third shots should be restricted to specific groups.

After Moderna’s unanimous vote on Thursday, committee member Dr. Patrick Moore said the data the company submitted for approval of a booster was “not well explained,” adding that he was more on “gut instinct”.

“The data itself is not strong, but it is certainly going in a direction that supports this vote,” he said.

Some members said the boosters should prevent what they call breakthrough infections, which they believe are critical to protecting healthcare facilities from being overloaded, while other members said the third vaccinations should ensure high-risk patients don’t have serious illnesses. Some committee members also suggested that young people might not need boosters as the first few shots in these groups still persist.

Dr. Another member, Paul Offit, stressed that most people who received the first two doses of Moderna’s vaccine are still well protected and hopes the recommendation doesn’t send the “wrong message” to the public.

“If we’re trying to prevent the inevitable, which is a decline in neutralizing antibodies and an erosion of protection against mild or asymptomatic infections, that’s a high bar that we don’t hold any other vaccine by,” he told his colleagues.

The Biden government hopes the extra dose will provide long-term and permanent protection for the US population from serious illness, hospitalization, and death as the fast-paced Delta variant continues to spread.

Dr. Peter Marks, the FDA’s chief vaccine regulator, reached the committee Thursday before the vote, telling the panel of experts that the agency is promoting “all the different viewpoints” on the “complex and evolving” data.

“However, I would ask you, as we move forward, to do our best to focus our reflections on the science related to the proposal under consideration today and not on operational issues related to a booster campaign or related issues global vaccine justice. ”he added.

Moderna filed for FDA approval of a booster dose on September 1. The company said the results are based on a clinical study of about 170 adults, fewer than the 318 people screened for Pfizer’s booster vaccination. Moderna said a third half-dose shot – 50 micrograms – was safe for the first two injections and produced a strong immune response.

Once approved, the company plans to send a letter to health care providers explaining the dose difference for the third injection, said Dr. Jacqueline Miller, the company’s director of infection research, during a presentation Thursday.

The side effects of Moderna boosters were similar to those after the second dose, the company wrote in a document released Tuesday by the FDA. Most of the side effects were of minor severity and Moderna reported no cases of rare heart inflammation, myocarditis, or pericarditis in subjects for up to 29 days after receiving the booster.

Before recommending the third shots, the panel listened to several presentations, including from Israeli health officials, who began to offer boosters to their populations before many other countries. The country has mainly used Pfizer’s vaccine, but some Moderna boosters have been given.

Israel has given 3.7 million third vaccinations since its booster campaign began in late July, with about a third of the extra vaccinations going to people aged 60 and over, Sharon Alroy Price, director of public health at Israel’s Ministry of Health, told the panel.

She presented data suggesting that people receiving a booster dose are less likely to get infected with Covid or become seriously ill. She said officials have so far identified 17 cases of myocarditis or pericarditis after third doses.

“I think we can say, if we look at all of the data in Israel so far, that the use of booster doses has helped Israel reduce the infections and the severe cases,” she said.

– CNBC’s Robert Towey contributed to this report.

FDA scientists strike favorable tone forward of vote this week

The Janssen Johnson & Johnson COVID-19 vaccine.

Allen J. Cockroaches | Los Angeles Times | Getty Images

The Food and Drug Administration staff adopted a more favorable tone on Wednesday Johnson & Johnson Covid-19 booster vaccination, which states that giving a second dose two months after the first vaccination may be beneficial.

However, staff admitted that data to support boosters was limited and the agency has not yet verified all of the information.

“Although not independently confirmed by the FDA from independent datasets, summaries of the data suggest that a second dose administered approximately 2 months after the primary dose may have a benefit compared to efficacy in the pivotal study COV3001,” they wrote in a 54-page document published on Wednesday.

They also said that a J&J dose was consistently less effective than the Pfizer and Moderna mRNA vaccines in both clinical trials and real-world trials.

“The highest effectiveness estimates (including for more severe COVID-19 illnesses) in clinical trials and real-world effectiveness studies evaluating the Janssen COVID-19 vaccine are consistently below the highest effectiveness estimates for the mRNA COVID-19 vaccines,” they said.

Overall, the data shows that the J&J single-shot vaccine “still offers protection from severe COVID-19 illness and death in the United States”.

The report by FDA scientists is set to brief the agency’s Advisory Committee on Vaccines and Related Biological Products, which will meet on Friday to discuss data on the safety and effectiveness of a second J&J syringe in adults. The published documents give an insight into the agency’s perspective on additional recordings.

Unlike Pfizer and Moderna’s two-step mRNA vaccines, J&J hoped to offer a one-shot solution that would protect the public adequately to contribute to the Coronavirus pandemic. But its 72% protection in the US was viewed by some as inferior to the Moderna and Pfizer vaccines, both of which touted efficacy rates of over 90%.

A second dose of J & J’s Shot provides similar performance to the mRNA vaccines and increases protection against symptomatic infection to 94% when given two months after the first dose in the United States, according to company data released Sept. 21 became. J&J, the a. used modified adenovirus In order to trigger an immune response, the agency asked on October 5 for approval of a booster dose of its single-dose vaccine for people aged 18 and over.

However, in the documents released on Wednesday, FDA scientists suggested that there wasn’t enough data on the elderly or the fast-paced Delta variant to draw any conclusion about the benefits of boosters.

They said the sample size J&J provided for people 60 years and older “limits the possibility of inferring an increase in efficacy after the second dose in this group.”

“Finally, the small number of defendants who have been confirmed to be caused by the Delta variant precludes any conclusion as to effectiveness against the variant,” they added.

Staff said no new safety issues were observed after a second dose given two or three months after the first dose, but noted that it is currently unknown “if after” an increased risk of these or other side effects there is an additional dose.

The FDA advisory group is due to discuss data on the safety and effectiveness of booster vaccinations for Moderna in adults on Thursday and J&J on Friday. The agency could make a final decision within days of the meetings and hand it over to the Centers for Disease Control and Prevention and their Vaccine Advisory Committee, expected to make their own decision next week.

FDA scientist refused to take a stand whether on Tuesday, in an unusual move, booster shots of the Covid vaccine from Moderna will be supported, with the data showing that currently approved vaccines in the US still protect against serious illness and death

Last month, US regulators authorized Covid booster recordings from Pfizer and BioNTechs Vaccine for a wide variety of Americans, including the elderly, adults with pre-existing conditions, and those who work or live in high-risk environments such as health and food workers.

Norman Baylor, former director of the FDA’s vaccines office, said last week that he did not recommend presenting Moderna’s vaccine to an advisory committee because it uses a similar platform to Pfizer’s vaccination, which has already been approved for booster vaccination. J&J is different, however.

It “gets a little trickier” because a second dose of J & J’s vaccine appears to work “extremely well,” Baylor said. “Maybe it should have been a two-dose [vaccine] at the beginning.”

Pfizer asks FDA to authorize Covid vaccine for teenagers ages 5 to 11

Jamie Blank (L) holds her son Ari Blank’s hand when he was born on Jan.

Jeff Kowalsky | AFP | Getty Images

Pfizer said Thursday it had asked the Food and Drug Administration to co-approve its Covid-19 vaccine BioNTech for children from 5 to 11 years.

The news couldn’t come sooner for parents anxious to get their children vaccinated as the kids start the new school year and the Delta variant spills across America. The stress has led to an increase in hospital admissions in the United States, including among young children that currently cannot be vaccinated.

Last month, Pfizer new data published This showed that a two-dose regimen of 10 micrograms – one third of the dose used for adolescents and adults – is safe and elicits a “robust” immune response in a clinical study in young children. The syringes are well tolerated and have caused an immune response and side effects that are comparable to those observed in a study with 16 to 25 year olds.

Common side effects in teenagers and adults include fatigue, headache, muscle aches, chills, fever, and nausea, according to the Centers for Disease Control and Prevention.

The company’s request on Thursday could mean the footage won’t be available until November, when the FDA spends as much time reviewing the data for this age group as it does for 12-15 year olds. Pfizer and BioNTech filed for expanded use of their adolescent syringe on April 9 and received FDA approval on May 10.

A key FDA vaccine advisory group is scheduled to meet on October 26th to discuss Pfizer’s data. The shots could be approved shortly after that meeting, depending on how fast the FDA and CDC move.

Dr. Scott Gottlieb, who sits on Pfizer’s board of directors and served as FDA commissioner in the Trump administration for two years, said CNBC last week that the recordings for young children could come by Halloween.

The FDA has a lot of experience with the Pfizer vaccine, noted Gottlieb, adding that the Covid vaccination is for young children the same two-dose regimen like adults, but given in smaller amounts. The agency has already approved the recordings for Americans aged 12 and over.

“I wouldn’t rule out the possibility that this could come out in October,” he said.

Gottlieb says FDA approval for younger youngsters by Halloween potential

Aidan Mohl, 13, will be born on November 11th.

Christopher Aluka Berry | Reuters

Dr. Scott Gottlieb told CNBC on Wednesday that it is still possible for the Food and Drug Administration to grant approval Pfizer and BioNTechCovid-19 vaccine for young children by Halloween.

“I wouldn’t rule out the possibility that this could come out in October,” said Gottlieb, who sits on Pfizer’s board of directors and served as FDA commissioner in the Trump administration for two years.

Pfizer submitted an initial Covid Vaccine study data for children ages 5 to 11 with the FDA on Tuesday, and the company should file a formal application for emergency approval “shortly,” Gottlieb said in an interview Wednesday “Squawk Box.”

The Food and Drug Administration has a lot of experience with the Pfizer vaccine, noted Gottlieb, adding that the Covid vaccination is for young children the same two-dose regimen like adults, but given in smaller amounts. The agency has already approved the recordings for Americans aged 12 and over.

“You saw a lot of clinical data,” he said. “I’ve said for a long time that October is a possibility, but it’s an optimistic possibility. If it fails, it could fall by mid-November.”

Gottlieb’s comments come a day after the Wall Street Journal reported that regulatory clearance of the Pfizer vaccine for children ages 5-11 may not come before November.

Last week, Pfizer released new data showing that in a clinical study in children ages 5-11 years old, a two-dose 10 micrograms dose – one third of the dose for adolescents and adults – is safe and elicits a “robust” immune response .

Pfizer was expected to apply for emergency approval to use the vaccine in young children by the end of this month, but now the company says it will apply “in the coming weeks”.

That could mean the footage might not be available until November, when the FDA spends as much time reviewing the data for this age group as it does for 12-15 year olds. Pfizer and BioNTech filed for expanded use of their syringe in adolescents on April 9th ​​and were approved by the FDA on May 10th.

A Pfizer spokesman declined to comment on an approval schedule, saying the company couldn’t speculate on exactly when the FDA would make a decision on whether or not to approve the vaccine’s use.

“We are still on track to formally apply for EEA very soon,” Jerica Pitts told CNBC.

Approval couldn’t come sooner as children are starting the new school year, the Delta variant spills across America, and many parents are anxious to get their younger children vaccinated. The stress has led to an increase in hospital admissions in the United States, including among young children that currently cannot be vaccinated.

Disclosure: Scott Gottlieb is a CNBC employee and a member of the board of directors of Pfizer, genetic testing startup Tempus, health technology company Aetion, and biotechnology company Illumina. He is also co-chair of the Healthy Sail Panel of Norwegian Cruise Line Holdings and Royal Caribbean.

FDA backs Pfizer Covid booster photographs for older and weak folks

The Food and Drug Administration authorized Pfizer and BioNTechCovid-19 booster vaccination for people 65 and older and other at-risk Americans six months after completing their first two doses, leaving many Americans now eligible to receive the vaccinations.

The FDA’s decision on Wednesday, which has yet to be reviewed by the Centers for Disease Control and Prevention, largely follows the recommendations it received more than on Friday from its main vaccine advisory committee eight-hour agency meeting.

The CDC’s Vaccine Advisory Committee is expected to vote on the FDA’s proposal on Thursday afternoon. If she recommends approval and the CDC approves it, the booster shots could start right away.

Last week, the FDA Advisory Committee on Vaccines and Related Biological Products voted 16-2 against distributing the vaccines to Americans 16 and older, before unanimously adopting an alternative plan to older Americans and those at high risk of developing serious illnesses to get sick to give a booster if they get the virus.

Although Americans 65 and older make up about 17% of the US population, they are most at risk of dying from Covid and account for more than 77% of all Covid deaths, according to the CDC.

The FDA has issued emergency clearance to administer Pfizer shots to elderly Americans and people ages 18 to 64 with conditions that put them at serious risk of disease. The agency also added a broad definition of anyone between the ages of 18 and 64 “whose frequent institutional or professional exposure” to the virus puts them at high risk of developing serious complications from Covid. That leaves enough room for the CDC to potentially release third doses for people in nursing homes, prisons, frontline health workers, and other key workers who were among the first Americans to receive their first syringes in December.

“The FDA took into account the committee’s input and conducted its own thorough review of the submitted data in order to make today’s decision,” said Dr. Peter Marks, the agency’s lead vaccines agency, in a statement. “We will continue to analyze the data submitted to the FDA regarding the use of booster doses of COVID-19 vaccines and, if necessary, make further decisions based on the data.”

The non-binding decision of the vaccination board it was expected to be controversial As the Biden administration has announced, it plans to start offering booster shots to the public as early as this week pending approval from US health regulators.

Although the agency has not always followed the advice of its committee, it often does. Still, Marks reminded the panel on Friday that federal regulators did not have to accept their written recommendation.

“We’re not tied to your vote at the FDA just for you to understand. We can adjust this as needed, ”he said.

In releasing the vaccinations, which will only apply to people who received the original Pfizer vaccine, the FDA cited a small study by the company of around 300 people who received the booster, data from the UK, as well as more comprehensive but less stringent data , from the Israeli health authorities.

Some scientists, including at least two to the FDA, had said they were not entirely convinced that every American who had received the Pfizer vaccine would need extra doses at this point. The country’s leading health authorities, including CDC director Dr. Rochelle Walensky, Acting FDA Commissioner Dr. Janet Woodcock and White House Senior Medical Advisor Dr. Anthony Fauci, however, already approved Biden’s booster plan in August.

Friday’s vote put the FDA panel in an “uncomfortable position” as the government had already announced that it would begin distributing boosters to the general public this month, said Dr. Bruce Farber, Head of Infectious Diseases at healthcare provider Northwell Health, before the panel’s recommendation.

Some committee members said they were concerned that there wasn’t enough data to make a recommendation, while others argued that the third vaccination should be limited to certain groups, e.g. Some members raised concerns about the risk of myocarditis in younger people and said more research was needed.

Dr. Phil Krause, an FDA vaccine regulator who is leaving the agency under pressure from the Biden administration to approve the shots, criticized the results presented at the meeting, saying that much of the data has not been verified by the federal agency or a peer-reviewed . He said the models used are complex and scientists need to make sure they are “getting the right results.”

“That’s part of the difficulty of looking at this type of data without a way for the FDA to review it,” he said.

In the outlines of the plans for last month’s launch Distribute boosters this week, administration officials cited three CDC studies showing that vaccines protection against Covid has waned over several months. Senior health officials said at the time they feared protection from serious illness, hospitalizations and deaths could “wear off” in the coming months, especially for those at higher risk or vaccinated during the earlier stages of vaccination.

Pfizer said in documents released last week that an observational study in Israel showed that a third dose of the Covid vaccine restored infection protection to 95% six months after a second vaccination. The data was collected from July 1 to August 30 when the rapidly expanding delta variant emerged across the country.

In a presentation on Friday, Dr. Sharon Elroy-Price of the Israeli Ministry of Health said that if officials there had not started distributing boosters in late July, the country would likely have exceeded its hospital capacity. She said health officials had seen a trend in fully vaccinated people in their 40s and 50s who became seriously ill with Covid.

“We didn’t want to wait to see these results, and we knew we had to vaccinate a larger section of the population to get the numbers down quickly,” she told the committee. Israeli health officials expected an average of 2,000 serious cases by the end of August, she said. “We have been able to dampen this effect and our severe cases are around 700 or less and have remained stable even though we still have days with 10,000 confirmed cases.”

Fauci defends FDA panel determination to reject third doses for all People

The leading expert on infectious diseases, Dr. Anthony Fauci, responds to allegations made by Senator Rand Paul (R-KY) as he testifies before the Senate Health, Education, Labor, and Pensions Committee on Capitol Hill in Washington, DC on July 20, 2021.

J. Scott Applewhite | Swimming pool | Reuters

Dr. Anthony Fauci defended the Decision of the Board of the Food and Drug Administration refuse to offer a third booster shot PfizerBioNTech Covid-19 vaccine for the general US population.

“I don’t think you made a mistake,” the White House chief medical officer told CNN’s State of the Union on Sunday.

Fauci added that he would support a third dose if future data shows it is effective. As the FDA continues to gather new information about boosters, persuading unvaccinated Americans to get vaccinated remains a priority.

Fauci’s comments come after the FDA advisory committee on Friday Voted against giving third shots of Pfizer’s Covid-19 vaccine to all Americans, although she recommended booster doses for people aged 65 and over and those with underlying medical conditions.

The FDA panel’s decision added to the confusion over the booster dose after President Joe Biden said last month that boosters would be available to all Americans starting the week of September 20th.

“I understand why there might be confusion because I think people have not understood the difference between planning something and actually not understanding what element of it, what portion of it is actually being introduced, and that’s exactly what happened,” he said “Meet the Press” from NBC.

He later told ABC’s This Week that the government had set the September 20 deadline as a wildcard, depending on input from the FDA and the Centers for Disease Control and Prevention.

“The plan was that we have to be ready to do this as soon as a decision is made,” he said. “And when you have a plan, put a date on it and say, ‘We want to be able to prepare for the week of September 20th'” “

Current data from Israel indicates the effectiveness of the vaccine As time decreases, a third shot of Pfizer could restore infection protection to 95% six months after a second dose.

As of September 18, more than 181 million Americans were fully vaccinated. Nationwide, more than 670,000 people have died of Covid-19.

Data on boosters from Modern and Johnson & Johnson is expected in the coming weeks, said Fauci. He also said “This Week” that there will “certainly” be a vaccine for children this fall.

FDA panel recommends Pfizer’s Covid booster doses for individuals 65 and older

An influential advisory committee to the Food and Drug Administration on Friday rejected a proposal to distribute booster vaccinations from Pfizer and BioNTech Covid-19 Vaccine to the general public and scaled back those plans, unanimously recommending the third vaccination to people 65 and older and other at-risk Americans.

“In my opinion it is likely to be beneficial for the elderly and eventually could be indicated for the general population. I just think we’re not there yet in terms of the data, ”said Dr. Ofer Levy, a vaccine and infectious disease specialist at Boston Children’s Hospital.

The panel voted 16-2 against distributing the vaccines to Americans 16 and older before unanimously adopting an alternative plan to give boosters to older Americans and those at high risk of developing serious illness if they got the virus receive. This previously included people with diabetes, heart disease, obesity and other so-called comorbidities.

Pfizer stock closed 1.3% while BioNTech’s shares fell 3.6%.

The non-binding decision of the FDA’s Advisory Committee on Vaccines and Related Biological Products comes as the Biden government announced that it would begin offering booster vaccinations to the general public as early as next week pending approval from US health regulators . Although the agency has not always followed the advice of its committee, it often does. A final FDA decision could be made in a matter of hours. The Centers of Disease Control and Prevention has scheduled a two-day meeting next week to discuss plans to distribute the third syringes in the United States

“We’re not tied to your voice at the FDA just for you to understand. We can adjust this as needed,” recalled Dr. Peter Marks, the agency’s top vaccine regulator, joined the panel after the votes. He asked the group for suggestions on what other populations the FDA should consider for boosters, such as frontline health workers and other professions exposed to higher levels of exposure to Covid.

It was expected that the committee vote would be controversial, as some scientists included two senior FDA Officials involved in Friday’s meeting said they were not entirely convinced that every American who received the Pfizer vaccine now needs extra doses.

White House senior medical advisor Dr. Anthony Fauci said he wasn’t surprised they didn’t recommend the shots for anyone 16 and older. Fauci, who publicly supported Booster, hesitated in an interview on Friday “Closing bell“To guess what the committee would ultimately decide.

“I don’t want to pre-empt the advisory committee at the time they are deliberating,” he said.

Liesl Eibschutz, a Dartmouth University medical student, loads a syringe of Pfizer COVID-19 vaccine before giving the vaccine on the first day people 16 and older get the vaccine at Kedren Health on Thursday, Angeles, California.

Allen J. Cockroaches | Los Angeles Times | Getty Images

In published a paper Days before the advisory committee meeting, a leading group of scientists said the available data showed that vaccine protection against serious illnesses persists, even as efficacy against mild illness wears off over time. The authors, including two senior FDA officials and several World Health Organization scientists, argued Monday in the medical journal The Lancet that widespread use of booster syringes to the general public is currently inappropriate.

In the outlines of the plans for last month’s launch Distribute booster next week, Biden administration officials cited three CDC studies showing that vaccine protection against Covid has waned over several months. Senior health officials said at the time they feared protection from serious illnesses, hospitalizations and deaths could “wear off” in the coming months, especially for those at higher risk or vaccinated during the earlier stages of vaccination.

Before the vote, some committee members said they were concerned that there wasn’t enough data to make a recommendation, while others argued that the third shot should be limited to specific groups, e.g. illness. Some members raised concerns about the risk of myocarditis in younger people and said more research was needed.

Dr. Hayley Gans, a voting member, said she was “concerned” that the FDA asked the committee to review the entirety of the evidence presented Friday because some data, including on safety, were still inadequate.

Another member, Dr. Paul Offit said he would support boosters for people over 60 but struggled to support a third vaccination for younger groups due to a higher risk of myocarditis.

Ahead of Friday’s vote, the committee listened to several presentations on data supporting the widespread use of booster vaccinations, including by health officials in Israel, where officials began vaccinating the country’s population before many other countries and their citizens later July.

Phil Krause, an FDA vaccine regulator and co-author of The Lancet, criticized the results presented Friday, saying that much of the data had not been federally vetted or peer-reviewed. He said the models used are complex and scientists need to make sure they are “getting the right results.”

“That’s part of the difficulty of looking at this type of data without a way for the FDA to review it,” he said.

In documents released by the FDA on Wednesday, Pfizer said an observational study in Israel showed that a third dose of the Covid vaccine restored infection protection to 95% six months after a second vaccination. The data was collected from July 1 to August 30, when the rapidly expanding delta variant emerged across the country.

In a presentation on Friday, Dr. Sharon Elroy-Price of the Israeli Ministry of Health said that if officials there had not started distributing boosters in late July, the country would likely have exceeded its hospital capacity. Health officials began to see a trend that people in their 40s and 50s who were fully vaccinated became seriously ill with Covid.

“We didn’t want to wait for these results and we knew we had to vaccinate a larger section of the population to get the numbers down quickly,” she told the committee. Israeli health officials expected an average of 2,000 serious cases by the end of August, she said. “We have been able to dampen this effect and our severe cases are around 700 or less and have remained stable even though we still have days with 10,000 confirmed cases.”

She also said the booster was well tolerated by many people, citing data showing that out of approximately 2.9 million people who received the additional doses, there was only one case of myocarditis, a rare inflammation of the heart that occurred with mRNA vaccines.

Pfizer’s booster side effects are also similar to those seen after receiving the second dose of vaccine, said Dr. Joohee Lee, an officer with the FDA’s Office of Vaccines Research and Review, during the meeting.

Of the 289 booster recipients, ages 18 to 55 years old, observed in Pfizer’s Phase 3 study, 63.8% developed fatigue, 48.4% headache, and 39.1% muscle pain. The FDA examined side effects in 2,682 recipients of Pfizer’s second dose of Covid aged 16 to 55 years and reported fatigue in 61.5% of patients, headache in 54%, and muscle pain in 39.3%. One adverse event – swelling of the lymph nodes – occurred in 5.2% of booster recipients but only 0.4% of those who received their first two doses.

“The majority were mild to moderate and they resolved,” Lee said of the lymphadenopathy cases. “Though one is reported to be underway right now.”

FDA assembly places Biden’s plan to fight virus in danger

An important part of the president Joe BidenCovid-19’s plan to fight Covid-19 is in jeopardy as a Food and Drug Administration vaccine advisory committee meets on Friday to debate and vote Pfizer and BioNTech‘s application to offer booster shots to the general public.

The vote by the Agency’s Advisory Committee on Vaccines and Related Biological Products – scheduled for about 2:30 p.m. ET – comes as some scientists, including at least two to the FDA, say they are not entirely convinced that every American who has received the Pfizer vaccine is currently in need of additional doses.

In documents released prior to the advisory committee meeting, FDA scientists have refused to take a stand on whether to support third shots, saying US regulators have not independently reviewed or verified all available data to support use of boosters. They also appeared to be skeptical of some of the data provided, including frequently quoted effectiveness figures from Israelwhere researchers have published observational studies showing that the Pfizer vaccine’s effectiveness against infections has waned over time.

It sets the stage for a tense meeting on Friday as the Biden government has announced that it will offer booster injections to the public as early as next week pending FDA approval. The move is part of the administration wider plan to counter a higher number of Covid cases in the USA, which is fueled by the rapidly spreading Delta variant.

The country’s leading health authorities, including CDC director Dr. Rochelle Walensky, Acting FDA Commissioner Dr. Janet Woodcock and White House Senior Medical Advisor Dr. Anthony Fauci, approved Biden’s booster plan back in August. While the FDA has not always followed its committee’s advice, it often does. The agency surprised investors and the public earlier this year when it abandoned the recommendation of its independent panel of external experts to approve Biogen’s Alzheimer’s drug.

If the committee doesn’t pass a positive vote, it could force the Biden administration to postpone its plan and potentially restrict third shots to certain groups of Americans, including disease, said Lawrence Gostin, director of the World Health Organization’s Collaborating Center on National and International Global Health Law.

The FDA group could give Biden’s booster plan a “cool reception,” Gostin said. “While there is good evidence that vaccine immunity may decline, two doses of mRNA hold up robust by preventing serious illness, hospitalization and death.”

The vote puts the committee in an “uncomfortable position” as the government has already announced that it would start distributing boosters in the week of September 20, said Dr. Bruce Farber, chief of infectious diseases at Northwell Health.

“I’m sure they will disagree at all on what they said because we already know they are not unanimous,” he said.

Scientists and other health experts had already expressed their criticism Biden’s move to boost all Americans 16 and older when senior health officials outlined the plan last month. The scientists and other experts said the data cited by federal health officials are not compelling and characterize government pressure on boosters as premature.

In the outlines of the plans for launch Distribute booster next week, administrative officials cited three CDC studies showing that vaccines protection against Covid has waned over several months. The government’s plan is for people to receive or a third dose of Pfizer Modern Vaccination eight months after the second vaccination. Biden has since said that scientists are considering whether to postpone the third shot up by three months. US health officials said they needed more data Johnson & Johnsons Vaccine before they can recommend boosters of these shots.

Pfizer and Moderna each have theirs too own analyzes The incidence of breakthrough Covid cases – which occur in fully vaccinated people – was less common in clinical trial participants who were recently vaccinated, suggesting that the protection of Covid vaccines wears off over time. In separate documents released Wednesday, Pfizer said an observational study in Israel showed that a third dose of the Covid vaccine restored infection protection to 95% six months after a second shot.

Still, some scientists argue that booster vaccinations are not currently required for the general public.

A leading group of scientists published a paper Monday in the medical journal The Lancet, which said that available data shows that vaccination protection against serious illnesses remains in place even as efficacy against minor illness wears off over time. The authors, including two outgoing senior FDA officials and several World Health Organization scientists, said the widespread distribution of booster syringes to the general public is “not appropriate” at this time.

There is currently no consensus in the biomedical community on boosters for the general public, said Harvard Medical School immunologist Dan Barouch. “There are high-level experts who fall on different sides of the debate.”

Dr. Arturo Casadevall, Chair of Molecular Microbiology and Immunology at the Bloomberg School of Public Health at Johns Hopkins University, supports boosters for the general public.

He said a third shot would boost immunity and reduce the chance of breakthrough infections, including the variant strains. “With all vaccines, immunity degrades over time, and Covid-19 vaccines are no different.”

Yale School of Medicine immunologist Akiko Iwasaki contradicts the widespread distribution of boosters in the United States.

Still, she said, booster shots are currently needed for some more vulnerable people as breakthrough cases lead to serious illness and hospitalizations.

These severe cases “mostly occur in older people and older adults such as 65 years of age and older,” she said. “I think it really makes sense now to give it to the seniors.”

Pfizer submits information to FDA for approval

Walgreens health professional Luis S. Solano prepares a dose of Pfizer BioNTec’s vaccine against coronavirus disease (COVID-19) on February 22, 2021 at the Victor Walchirk Apartments in Evanston, Illinois.

Kamil Krzaczynski | Reuters

Pfizer and BioNTech announced on Monday that they had submitted early-stage clinical trial data to the Food and Drug Administration as part of their U.S. filing to approve a Covid vaccine booster for all 16 and older – not just people with weak immune systems.

In a phase 1 study, a booster dose of the vaccine produced “significantly higher neutralizing antibodies” against the original coronavirus strain and the beta and delta variants, the companies said in a press release. Study participants received a third dose of the two-dose vaccine around eight to nine months after the second vaccination, they said.

“The data we’ve seen so far suggest that a third dose of our vaccine elicits antibody levels well in excess of those on the primary two-dose schedule,” said Albert Bourla, Pfizer CEO. “We are excited to provide this data to the FDA as we continue to work together to address the evolving challenges of this pandemic.”

The companies said the results of the late-stage trial evaluating the third dose are expected shortly and will also be presented to the FDA and other regulatory agencies worldwide.

The announcement by the drug manufacturer comes according to federal health officials Friday approved Giving Covid booster shots of Pfizer and Moderna vaccines to Americans with compromised immune systems, including cancer and HIV patients, and people who have had organ transplants.

New data from the US suggests that immunocompromised individuals do not generate adequate immune responses after receiving two doses of a Covid vaccine.

The latest data from Pfizer investigates the booster’s safety and immune response in people with otherwise healthy immune systems.

Federal health officials are not currently recommending booster doses for the general public, but Dr. White House Chief Media Officer Anthony Fauci said: Everyone is “likely” to need a booster at some point.

Covid vaccine manufacturers including Pfizer and Modern, have repeatedly argued that everyone will need a booster dose at some point and possibly additional doses each year, just like seasonal flu.

Pfizer has cited data from Israel where state officials said last month the two-dose vaccine was only 39% effective against the disease, which attributed the drop in performance to the highly contagious Delta variant. When Pfizer submitted its original application to the FDA in December, it said its vaccinations were about 95% effective at preventing Covid infections.

The vaccine is still considered highly effective against serious illness, hospital admissions and deaths, according to Israeli health officials.