FDA says COVID-19 vaccines remain effective without boosters

The FDA released the findings Wednesday in a report analyzing data presented by Pfizer Inc. and BioNTech SE as part of a request for authorization for their vaccine as a booster shot in people 16 years of age and older. will be given in

An external panel of scientific advisors will review the FDA report on Friday, along with a companion analysis from Pfizer and other information, as part of a discussion on who needs booster shots and when.

The Biden administration had targeted next week to begin widely distributing additional shots to combat infectious forms like Delta and strengthened signs of reduced immunity amid vaccinations. The evidence supporting the need for additional doses, at least in the general public, has not been conclusive.

The booster campaign hinges on FDA approval of additional shots and input by a panel meeting Friday, as well as a separate committee of outside experts who advise the Centers for Disease Control and Prevention. The CDC recommends who and when to get vaccines.

A favorable recommendation from the panel to authorize boosters for the general population could be followed by the FDA approving the distribution of booster shots of the vaccine within a few days.

The findings that the FDA released Wednesday could complicate that decision. According to people familiar with the matter, one possible outcome would be for the panel to recommend booster shots for only certain groups, such as healthcare workers or people 65 and older, for now.

White House Press Secretary Jen Psaki said Wednesday that the data will inform the deliberations of the panel advising the FDA and CDC. The CDC committee, which will meet next week to discuss boosters, last month expressed initial support for booster doses, particularly for groups at high risk for serious illness and death.

FDA scientists wrote Wednesday that they considered concerns that recent studies suggest that decreased antibody levels and weakened protection against symptomatic COVID-19 may result in additional serious illness, and that excessive The infectious delta variant has further spread the virus.

Yet he expressed doubts that a markedly lower protection is making vaccines less effective. Some observational studies have suggested that Pfizer-BioNTech’s vaccine provides, over time, less protection against symptomatic disease or delta, while others have not.

“Overall, the data indicate that currently US-licensed or authorized COVID-19 vaccines still provide protection against serious COVID-19 illness and death in the United States,” the scientists wrote.

The FDA’s assessment indicates that it may not support a widespread booster campaign for now, while a Pfizer briefing report said such an approach is necessary because data from Israel and other sources indicate that the vaccine Efficacy is declining.

Israeli researchers will present data on Friday to a panel making the case for the booster, which is cited by some senior US officials to support additional doses. Israeli data released Wednesday in the New England Journal of Medicine showed that rates of infection and serious illness were significantly lower among study participants aged 60 and older who were vaccinated at least five months before and then A booster dose of Pfizer was received. Vaccination.

The FDA reviewed data submitted by Pfizer from its clinical trials on more than 300 subjects who received their third dose of the shot. The data showed a significant increase in neutralizing antibodies, which are important in the immune response to prevent COVID-19.

No new serious safety concerns were found in people receiving booster shots, the FDA said, and side effects such as fatigue or fever were previously reported in test subjects. The agency said Pfizer’s analysis of the third dose met its criteria for a safe and effective vaccine.

It is not known whether there will be an increased risk of myocarditis, an inflammatory heart condition, or other adverse reactions following a booster dose of the Pfizer-BioEntech vaccine, the FDA wrote.

The FDA in August fully approved the Pfizer-BioNTech vaccine, which is sold under the name Comirnati, to people 16 years of age and older.

The FDA released its report Wednesday, two days before a meeting of the Vaccines and Related Biological Products Advisory Committee, an advisory panel that will decide whether to recommend Americans receive booster shots.

The FDA is not required to approve any decision by the panel, but generally it is. Panel members include infectious disease specialists, professors and practicing physicians.

Gregory Poland, director of the Mayo Clinic’s vaccine research group, said the decision to expand the booster to the general population should be based on more data than those presented Wednesday, including more than 300 people cited by Pfizer.

“To me this is insufficient evidence to support a national booster program,” said Dr. Poland, a former VRBPAC member.

Federal officials in August recommended that adults receiving a two-dose dose of mRNA vaccines such as Pfizer begin getting a booster shot this month. Officials said at the time that shots would be administered approximately eight months after the second dose for people 18 years of age and older. The Wall Street Journal has reported that officials could approve a booster shot at least six months later.

The timetable could still be pushed back, at least for Moderna Inc. and Johnson & Johnson, makers of other vaccines that have been approved by regulators in the US.

Pfizer and Moderna have submitted data to the FDA for authorization of booster shots, while J&J is expected to do so soon.

Moderna released an analysis of clinical trial data Wednesday that the company said showed a lower risk of breakthrough infection in recently vaccinated participants compared to participants who were vaccinated last year. The company said the findings add support for its vaccine booster doses. Moderna president Stephen Hoge said the third dose could boost immunity until next year.

Health officials have already authorized booster shots for people age 12 and older whose immune systems are compromised.

According to federal health officials, people 65 and older and individuals in chronic care facilities are expected to get additional shots first, along with healthcare workers and anyone else who was vaccinated as soon as possible.

An additional dose of a vaccine boosts the body’s immune system’s defense against COVID-19, especially the delta-like variants. Pfizer and BioNTech said early testing indicates antibody levels are five to 10 times higher after two doses than a booster shot given at least six months after the second vaccine dose.

A trial late last year of more than 44,000 people found that two doses of the vaccine were more than 95% effective in preventing symptomatic COVID-19. Data from Pfizer indicates that the vaccine is highly effective in people six months after the second dose, but every two months after the second dose, its protection drops by about 6%.

In its briefing document, Pfizer said that “the totality of the available data supports the public health need” for an additional dose six months after the second. The company cited real-world data from Israel and the US that suggest the decline in safety has more to do with reduced effectiveness than the Delta version.

The FDA noted in its own briefing document that the decision to approve booster authorizations should consider whether current dosage courses work against the variants.

At the request of the FDA, Pfizer submitted data showing how the booster would fare compared to the Delta version. In 11 subjects aged 18 to 55 who received the booster, neutralizing antibodies one month after their second shot were five times higher than those one month after their second shot, the data showed. The increase was 12-fold in the 12 older subjects.

The Biden administration and drug companies have said there should be enough supplies for boosters if distribution begins more widely this month. The US has jointly purchased one billion doses from Pfizer and Moderna.

This story has been published without modification to the text from a wire agency feed