Pfizer Asks for Authorization for Boosters for Adults

The Four Percent

[ad_1]

Pfizer and BioNTech asked federal regulators on Tuesday to expand authorization of their coronavirus booster shot to include all adults, a move that could significantly expand the number of recipients who are eligible for booster shots.

The Food and Drug Administration is considered likely to grant the request, perhaps before Thanksgiving, according to people familiar with the situation. If it does so, all adults who have been fully vaccinated with shots made by Pfizer-BioNTech, Moderna or Johnson & Johnson would all be eligible for a Pfizer booster, the people said.

The federal government has been intent on broadening the categories of people eligible for additional injections since the first booster shots were authorized for emergency use in late September.

An advisory board of outside experts to the Food and Drug Administration voted in September against a request from Pfizer to offer shots to all adults who had received two injections of its vaccine.

Instead, the committee recommended booster shots on an emergency basis for those 65 and older or at high risk of Covid-19 because of their medical conditions or jobs. Those categories, later authorized for both the Pfizer-BioNTech and Moderna vaccines, were still broad enough to cover at least 60 percent of the population, administration officials said.

Experts remain divided on whether booster shots are necessary for the rest of the population, with many insisting that the vaccines continue to offer robust protection against severe disease and hospitalization, especially for younger people without underlying medical conditions. And there is virtually unanimous agreement that vaccinating the roughly 60 million Americans ages 12 and older who have yet to receive even their first shot should remain the government’s highest priority.

For younger, healthy people, the benefits of a booster injection will be marginal, according to Dr. Eric Rubin, a member of the F.D.A.’s advisory panel and an adjunct professor of immunology at the Harvard T. H. Chan School of Public Health.

Even so, some leading experts argue that the case for booster shots for the general population is stronger now than it was two months ago. Dr. Anthony S. Fauci, the federal government’s top infectious disease expert, said earlier this month that most recent data from Israel shows that nation’s aggressive booster campaign has dramatically limited rates of severe disease, hospitalization and death.

The F.D.A. has the authority to modify Pfizer-BioNTech’s current emergency use authorization and is not expected to reconvene its advisory panel.

President Biden said in August that he wanted all adults to be eligible for booster shots because of concerns that the vaccines’ protection against infection wanes over time. The administration was aiming to roll out boosters by the third week of September, but was forced to delay after regulators said they needed more time to analyze the data.

At this point, adult recipients of both the Pfizer-BioNTech and Moderna vaccines are eligible for a third shot six months after their second injection if they are at least 65 years old or considered at special risk.

All Johnson & Johnson recipients are eligible for a second shot as a booster. And adult recipients of all three vaccines are allowed to pick which vaccine they would prefer as a booster shot.

Nearly 25 million people have received additional shots so far, according to the Centers for Disease Control and Prevention, including those who are eligible because of immune deficiencies. That’s about 14 percent of people who have been fully vaccinated.

Moderna is also expected to soon request a broadening of its emergency use authorization for its booster dose, according to people familiar with the situation. But experts have said that request may be more complicated because of concerns about rare cases of myocarditis, or inflammation of the heart muscle, especially in men under the age of 30 who have received two doses of Moderna’s vaccine.

Similar concerns have been raised about the Pfizer-BioNTech vaccine, but to a lesser extent. One possibility is that health officials agree to lower the age restriction for a Moderna booster, but not to 18.

At a White House press briefing earlier this month, Dr. Fauci said new data shows “rather dramatic results” from Israel’s booster campaign with the Pfizer-BioNTech vaccine.

An Israeli study published in the scientific journal The Lancet in late October compared about 730,000 people who have received a booster dose in August or September with individuals who received only two doses at least five months earlier. The study included recipients 12 and up; the median age was 52.

Compared to the two-dose recipients, the boosted recipients had a 93 percent lower risk of hospitalization, 92 percent lower risk of severe disease and 81 percent lower risk of death, the study found. The boosted recipients were evaluated at least one week after their third dose.

Dr. Rubin, the F.D.A. advisory committee member, said Israeli booster data presented to the panel in September was mostly limited to people 60 and older. Israel’s more recent data is reassuring, he said, because “as they moved into younger groups they really weren’t seeing any significant safety signals.”

Dr. Rubin also said that many Americans appear to be getting booster shots whether or not they are officially eligible, so maintaining complicated eligibility categories may not work anyway. “People are voting with their feet,” he said.

[ad_2]

Source link Most Shared