Pfizer CEO says omicron vaccine will probably be prepared in March

Pfizer CEO Albert Bourla said Monday a vaccine that targets the Omicron variant of Covid will be ready in March and the company has already started making the cans.

“This vaccine will be ready in March,” Bourla told CNBC.Squawk box.” “We [are] are already starting to manufacture some of these endangered quantities. “

Bourla said the vaccine will target the other variants in circulation as well. He said it was still not clear whether an Omicron vaccine would be needed or how it would be used, but Pfizer will have some doses ready as some countries want it ready as soon as possible.

“The hope is that we can achieve something that offers much better protection against infection, especially, because protection against hospitalization and serious illness is reasonable right now, with the current vaccines, as long as you say,” the third dose “said Bourla.

Real-world data from the UK have shown that Pfizer and Moderna vaccines are only about 10% effective at preventing symptomatic infection from Omicron 20 weeks after the second dose, according to a study by the UK Health Authority. However, the two original doses still offer good protection against serious illness, the study found.

According to the study, booster vaccinations are up to 75% effective in preventing symptomatic infection.

Dr. White House chief medical officer Anthony Fauci said in December that it was no need for a booster shot specifically targeting omicrons, because the current boosters work well against the variant.

Modern CEO Stephane Bancel said CNBC on Monday The company is working on a booster targeting Omicron for this fall and will enter clinical trials shortly. Bancel said governments are in high demand as they prepare regular vaccinations for the virus.

Bourla said it was not clear whether a fourth dose would be needed. He said Pfizer would conduct experiments to see if another dose is needed.

Israel has made a fourth dose of Pfizer and BioNTechVaccine for people over 60, people with compromised immune systems, and healthcare workers.

Israel found that a fourth dose of the vaccine increased the antibodies that protect against the virus five-fold a week after receiving the vaccine.

Pfizer, Peloton, Carnival and extra

Paxlovid, a coronavirus disease (COVID-19) pill made by Pfizer, is made in Ascoli, Italy in this undated handout photo by Reuters on November 16, 2021.

Pfizer | Handout | via Reuters

Check out the companies that are making the headlines in midday trading.

Pfizer – Shares rose 1.1% after UK regulators approved the use of Paxlovid, the drug company’s Covid-19 antiviral pill, for people over 18 with mild to moderate illness. The USA Approval from the Food and Drug Administration last week the use of paxlovid in patients aged 12 and over with mild to moderate Covid who are very likely to be hospitalized or not survive.

carnival, Norwegian Cruise Line Cruise ship stocks continued to struggle after the U.S. Centers for Disease Control and Prevention announced Thursday shouldn’t travel on cruisesregardless of vaccination status. Carnival was down 2%, Norwegian Cruise Line was down 1.3% and Royal Caribbean was also down.

Peloton – Peloton stocks fell 3.8% after JMP Securities has downgraded the share’s performance to market value outperform the market. JMP said consumer interest in the home fitness company is waning.

Coterra energy – The oil company fell 2.8% on the last day of 2021. Coterra announced Thursday that Vice President and Chief Technology Officer Kevin William Smith sold nearly 40,000 shares earlier this week.

Novavax The drug maker’s shares fell more than 7% after it was revealed it had renewed manufacturing agreements with Korea-based SK Bioscience. Novavax has also received emergency approval for its Covid-19 vaccines in India.

I have – The Chinese ride-hailing company continued to decline through year-end, down 4.7% on Friday. Didi went public in June, but the stock has since fallen as Chinese regulators took action against the company.

– CNBC’s Jesse Pound and Yun Li contributed to the coverage

Exxon Mobil, Pfizer, Peloton and others

Before the doorbell rings, check out the companies that are making the headlines:

Exxon Mobil (XOM) – The energy giant has signaled that it will post a quarterly profit for the fourth straight year, largely thanks to stronger oil and gas prices. The snapshot of the fourth quarter results was released in an SEC filing prior to the official February 1 results.

modern micro devices (AMD) – The chipmaker said it now expects to complete a $ 35 billion acquisition of all shares for the rival Xilinx (XLNX) during the first quarter of 2022, shifted from its previous year-end 2021 target. Companies said they have not yet received all of the required permits. Xilinx lost 2.2% in the premarket.

Pfizer (PFE) – UK regulators have approved the use of Paxlovid – the drug company’s Covid-19 antiviral pill – for people over 18 with mild to moderate illness.

Peloton (PTON) – The fitness equipment maker lost 1.3% in pre-listing operations after JMP Securities downgraded its stock from “Market Above Average” to “Market Performance”. JMP reports declining website visits and page views.

Colfax (CFX) – The medical technology company is planning a meeting of shareholders to approve a reverse stock split, with the exact ratio to be determined at a later date. Colfax lost 2.7% in pre-trading.

MP materials (MP) – The rare earth materials maker has submitted a shelf offering of up to $ 2 billion in debt securities. The MP share lost 1.1% before the trading session.

Lexicon Medicines (LXRX) – The drugmaker’s shares rose 6.5% in pre-trading hours after filing a new drug application with the FDA for its heart drug sotagliflozin, which is believed to reduce the risk of heart failure in diabetics.

CDC panel recommends Pfizer, Moderna vaccines over J&J attributable to uncommon blood clot circumstances

A health care worker holds a dose of the Johnson & Johnson vaccine.

Phill Magakoe | AFP | Getty Images

An advisory board for the Centers for Disease Control and Prevention on Thursday recommended Pfizer and Modern‘s vaccines over Johnson & Johnson‘s shot for adults ages 18 and up after dozens of people found a rare blood clot after the J&J vaccination, all of whom were hospitalized and nine of them died.

The Advisory Committee on Immunization Practices has unanimously decided to recommend Pfizer and Moderna over the Johnson & Johnson vaccine. CDC director Rochelle Walensky has yet to accept the recommendation.

The CDC has confirmed 54 cases of people who develop blood clots and have low blood platelet levels, a new condition known as thrombosis with thrombocytopenia syndrome that mainly affects younger women. All patients were hospitalized, nine people died and 36 were treated in the intensive care unit.

The US has administered more than 17 million J&J doses since the Food and Drug Administration approved the emergency syringe in February.

“TTS case reporting rates after Janssen vaccines are higher in men and women in a wider age range than previous estimates,” said Dr. Keipp Talbot, chairman of the CDC’s vaccines and safety subgroup, the advisory body.

Although the panel’s recommendation was unanimous, some members struggled with the vote. The CDC experts could also have recommended giving up the shot altogether or restricting it to certain age or demographic groups.

Dr. Pablo Sanchez, a professor of pediatrics at Ohio State University, said he was not recommending J&J admission to any of his patients, despite ultimately standing for the panel’s proposal.

“I just can’t recommend a vaccine associated with a disease that can lead to death,” Sanchez told the committee. “I don’t recommend it to any of my patients’ parents.”

Seven of the patients who died were women and two men, with a mean age of 45 years. Most of the deceased had previous health conditions such as obesity, high blood pressure and diabetes. The death reporting rate was 0.57 deaths per million doses administered, according to the CDC.

“In reviewing these cases, we noticed how quickly patient status deteriorates and leads to death,” said Dr. Isaac See of the CDC’s Vaccine Safety Team joined the advisory board.

According to the CDC, patients typically developed symptoms 9 days after vaccination and were hospitalized 5 days after symptoms appeared. The overwhelming majority of patients were women, 37 total, and the mean age was 44. Seventeen men developed TTS.

Johnson & Johnson’s director of global therapeutic vaccines Penny Heaton defended the company’s shot during the meeting, saying it “saves lives here in the US and on every continent around the world”.

“It’s easy to store and transport,” said Heaton. “In many low- and middle-income countries, our vaccine is the primary and sometimes even the only option in the US as its permanent protection may be the preferred choice for people who cannot or do not want to return for multiple vaccinations.”

Heaton said J&J recognizes the incidents of TTS related to the vaccine and that the condition can be fatal, although cases are rare. She said patient safety and wellbeing remain a top priority for J&J, and the company has several studies underway to identify risk factors related to developing TTS.

In April, the Food and Drug Administration and the CDC stopped briefly the use of the Johnson & Johnson single vaccine after six adult women developed blood clots and low platelet counts at the same time.

A week later, the FDA and the CDC did canceled the break on J&J shots after the independent advisory panel said the benefits of the shots outweigh the risks. At the time, the panel did not recommend restricting admissions based on age or gender. It suggested that the FDA put a warning label on for women under 50.

The FDA has advised health care providers not to give a J&J booster to people who have developed TTS in the past after the first injection. The FDA also said the J&J syringe should not be given to people who received the vaccine from AstraZeneca, even though AstraZeneca is not approved for use in the United States

CDC experts said Thursday that people who received J&J booster doses have not seen any cases of TTS, although the number of boosters is relatively small.

“Currently available evidence supports a causal relationship between TTS and the Janssen COVID-19 vaccine,” the FDA said in the factsheet for healthcare providers.

In October, the FDA and CDC approved authorized J&J boosters for all adults at least two months after receiving their first J&J syringe. More than 800,000 people have received J&J boosters, according to CDC data. People who received their primary vaccination with the J&J shot can also be boosted with the Pfizer or Moderna vaccines.

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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.

This is the latest news. Please check again for updates.

Pfizer says its Covid tablet with HIV drug cuts the chance of hospitalization or dying by 89%

Pfizer said Friday that its easy-to-use Covid-19 pill, used in combination with a widely used HIV drug, increased the risk of hospitalization or death in high-risk adults exposed to the virus by 89% lowers.

It’s now the second antiviral pill behind it Merck‘s to demonstrate strong efficacy in treating Covid at the first sign of disease. If approved by regulators, it would likely mark a turning point in the ongoing global battle against the pandemic.

Pfizer CEO Albert Bourla told CNBC the company plans to submit its data to the Food and Drug Administration before Thanksgiving.

“I think this drug is going to change the way things are happening, that are going to save millions and millions of lives, it has the potential to do that,” Bourla said in an interview with CNBC.Squawk box“He said the company has” the current capacity of 500 million pills, “which in his opinion equates to 50 million treatments.” The very high level of effectiveness comes as a surprise even to us and exceeds our most visionary expectations about it. “

Pfizer’s pill, scientifically known as PF-07321332, belongs to a class of drugs called protease inhibitors and works by blocking an enzyme that the virus needs to multiply in human cells. Protease inhibitors are used to treat other viral pathogens such as HIV and hepatitis C.

The HIV drug helps slow the metabolism or breakdown of the Pfizer pill so that it stays active in the body for longer periods of time at higher concentrations, the company said.

The company said its data on the drug is based on a mid-to late-stage study of 1,219 adults who had at least one underlying disease and one laboratory-confirmed infection within five days. Participants also received a low dose of ritonavir, a drug often used in combination treatments for HIV.

Pfizer said there were six hospitalizations and zero deaths of the 607 study participants who received the pill in combination with the HIV drug within five days of the onset of symptoms. That compares to 41 hospitalizations and 10 deaths for the 612 people who received a placebo.

“These data suggest that our oral antiviral candidate, if approved by regulators, has the potential to save patients’ lives, reduce the severity of COVID-19 infections and achieve up to nine out of ten hospital stays Avoid, “said Albert Bourla, CEO of Pfizer in a statement.

not how Gilead SciencesThe intravenous drug Remdesivir, Pfizer and Merck drugs can be taken orally. While vaccinations remain the best form of protection against the virus, health experts hope pills like these will prevent the progression of the disease in those who become infected and prevent hospitalizations.

Biotherapeutics from Merck and Ridgeback said on October 1st that they developed a drug that, when given on its own, reduces the risk of hospitalization or death in patients with mild or moderate cases of Covid by about 50%.

Merck’s antiviral pill was approved by The UK Medicines Agency on Thursday.

June Raine, chief executive of the UK’s drug and health products regulator, said the Merck pill is the treatment of Covid, a disease that has cost the lives of more than 5 million people worldwide and has put an enormous strain on health systems.

Bourla told CNBC in April that Pfizer’s pill could be available to Americans by the end of this year.

Covid vaccine boosters are actually out there. This is who’s eligible for Pfizer, Moderna and J&J’s pictures

A patient receives on 29.

Emily Elconin | Reuters

Nearly 100 million people across the country are immediately entitled to a Covid booster vaccination after the Centers for Disease Control and Prevention has additional doses of. have approved Modern and Johnson & Johnson‘s vaccines Thursday night.

The agency’s decision also allows fully immunized individuals to combine their booster vaccinations with doses from different manufacturers after research by the National Institutes of Health showed that combining and combining vaccines was safe and effective. Pfizer and BioNTech‘s boosters were largely released for use in the United States on September 24th.

About 11.6 million people across the country have already received their boosters, and CDC approvals have opened them up to tens of millions more people. But not everyone is eligible. Here’s who gets the extra doses in the U.S. based on their first round of shooting:

Pfizer-BioNTech

More than 47 million Pfizer vaccine recipients who received both vaccinations at least six months ago were eligible for a booster on Friday, according to data presented to the CDC’s advisory committee on Thursday. This contains:

  • Everyone who is 65 and older.
  • All adults between the ages of 18 and 64 who have cancer, dementia, diabetes, heart disease, HIV, and other conditions that make Covid complications more likely.
  • Anyone over the age of 18 who live or work in a long-term care facility, homeless shelter and prison or other community facility.
  • Frontline workers aged 18 and over who are at higher risk of Covid exposure due to their work, including first responders, teachers, supermarket workers and local transit workers.

Modern

According to the CDC presentation, more than 39.1 million Moderna vaccine recipients who received both vaccinations at least six months ago were able to receive a booster on Friday. The CDC has adopted the same criteria for Moderna recipients as Pfizer, as the two companies use the same mRNA technology in their Covid vaccines. They include.

  • Everyone who is 65 and older.
  • All adults between the ages of 18 and 64 who have cancer, dementia, diabetes, heart disease, HIV, and other conditions that make Covid complications more likely.
  • Anyone over the age of 18 who live or work in a long-term care facility, homeless shelter and prison or other community facility.
  • Frontline workers aged 18 and over who are at higher risk of Covid exposure due to their work, including first responders, teachers, supermarket workers and local transit workers.

Johnson & Johnson

The CDC has adopted slightly different criteria for J & J’s one-time Covid vaccine, making nearly 13 million recipients eligible as of Friday. This contains

  • All adults who were vaccinated with J & J’s Covid vaccine at least two months ago, instead of Pfizer and Moderna six months ago.
  • All adult J&J recipients are entitled to a booster vaccination, even if they do not have any underlying medical conditions or work or live in an occupation where there is a higher risk of Covid.

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.

CDC endorses third Pfizer doses for high-risk adults

The Centers for Disease Control and Prevention did on Friday the distribution of Pfizer and BioNTech‘s Covid-19 booster vaccinations for older Americans and other vulnerable people, including those in high-risk professional and institutional settings.

Millions of Americans at the highest risk of Covid can now get a Pfizer BioNTech booster shot to increase their protection.

The Agency’s Advisory Committee on Vaccination Practices had previously unanimously endorsed Pfizer’s third vaccination for people 65 years and over and residents of nursing homes and made further recommendations.

CDC director Dr. However, Rochelle Walensky made a recommendation that the advisory panel rejected. The panel voted against giving a booster vaccination to those ages 18 to 64 who were at higher risk of exposure to the virus because of their work place or institutional setting, but Walensky reintroduced that recommendation.

Here’s what the CDC recommends:

  • Individuals 65 years of age and older and residents in long-term care facilities should receive a booster of Pfizer-BioNTech’s Covid vaccine at least 6 months after their Pfizer BioNTech Primary Series;
  • People between the ages of 50 and 64 with pre-existing conditions should receive a booster vaccination from Pfizer-BioNTech at least 6 months after their Pfizer BioNTech primary series;
  • Individuals aged 18 to 49 with underlying conditions may receive a booster dose of Pfizer BioNTech vaccine for at least 6 months after their Pfizer BioNTech Primary Series, depending on individual benefit and risk;
  • Individuals aged 18 to 64 who are at increased risk of exposure and transmission of Covid-19 due to their professional or institutional environment can, depending on the individual, receive a booster dose of the vaccine for at least 6 months after their Pfizer BioNTech primary vaccination course Pfizer-BioNTech receive benefits and risks.

“I believe that we can best meet the country’s public health needs by providing booster doses to the elderly, those in long-term care facilities, those with underlying medical conditions, and adults at high risk of illness from occupational and institutional exposure to COVID. 19, “said Dr. Walensky.

The move is in line with FDA booster approval, she added.

Earlier Thursday, the CDC advisory panel battled a controversial proposal to boost large swaths of the US population and rejected the plan by 9-6 votes. It would have distributed the shots to nursing home staff, people who live or work in prisons and homeless shelters, frontline health workers, unpaid caregivers, and other key workers like teachers.

“I mean, we might as well say give it to anyone over the age of 18,” said committee member Dr. Pablo Sanchez before voting against the proposal.

Lisa Wilson receives a syringe of the Pfizer vaccine at a mobile COVID-19 vaccination center in Orlando, Florida.

Paul Hennessy | SOPA pictures | LightRakete | Getty Images

Dr. Leana Wen, emergency doctor and former Baltimore health commissioner, called the CDC panel’s vote to reject boosters more generally a “mistake” on Twitter.

“Really, are we not allowing health workers, many of whom were vaccinated back in December, to be boostered? What about teachers in cramped classrooms that don’t require masks? ”She tweeted, adding that CDC Director Dr. Walensky should override the recommendation.

The recommendation goes nowhere near as far as President Joe Biden sought. His government said it plans to give booster shots to people aged 16 and over this week. While the CDC panel’s recommendation doesn’t give the Biden administration everything it wanted, boosters will still be around for millions of Americans who originally received Pfizer’s shots.

Confirmation comes a day after the Food and Drug Administration issued emergency use authorization give many Americans third Pfizer shots six months after completing the first two doses. While the CDC committee’s recommendation is non-binding, Walensky is expected to accept the committee’s approval shortly.

Walensky addressed the committee on Thursday ahead of the vote, thanking them for their work and setting out what is at stake.

“These dates are not perfect, but together they paint a picture for us, and they are what we have right now to make a decision about the next phase of this pandemic,” she said.

Before the vote, some committee members expressed concern that the wide range of boosters on offer could affect efforts to get unvaccinated vaccines or reduce confidence in the vaccines’ effectiveness. Others were frustrated that only Pfizer recipients were eligible for the syringes, leaving millions of Americans out of the picture for receiving the Modern and Johnson & Johnson Vaccinations.

The vote came at the end of a two-day meeting during which CDC advisors listened to several presentations of data to support the widespread adoption of booster vaccinations, including one from a Pfizer executive showing data showing a third Injection appears to be safe and increases antibody levels in recipients.

During a presentation on Thursday, CDC officer Dr. Sara Oliver observational studies from Israel in which officials in front of many other countries began vaccinating the country’s population and offering third vaccinations to their citizens in late July.

The Israeli data has been criticized by at least one FDA official for being based on so-called observational studies, which do not meet the same standards as formal clinical studies.

“We can use Israel’s experience to reinforce our knowledge of booster safety,” Oliver said, adding that the country reported only one case of a rare heart infection known as myocarditis out of nearly 3 million third doses administered .

CDC officer Dr. Kathleen Dooling said the data also suggest a third dose may reduce the risk of serious illness in older adults and people with comorbidities. Possible risks include myocarditis, although this risk is very rare and mostly occurs in men under 30, she said.

“The third dose of the Pfizer-BioNTech Covid-19 vaccine appears to have a similar reactogenicity as the second dose,” she added.

The issue of who and when to get boosters has been a controversial issue in the scientific community since the Biden government outlined its plan last month to distribute them widely.

In published a paper Days before an FDA advisory session last week, 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, claimed 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 boosters this 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.

– CNBC’s Robert Towey contributed to this report.

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.”