RELATED: If You Got Pfizer, This Is When You’re More Likely to Get Breakthrough COVID.ae0fcc31ae342fd3a1346ebb1f342fcb Pfizer and BioNTech released a statement on Nov. 9, announcing that they had just submitted a request to the FDA to expand the authorization for their booster. The vaccine manufacturers are asking the agency to authorize the Pfizer booster dose for everyone 18 and older. In mid-October, Pfizer CEO Albert Bourla told MarketWatch that he had received a booster shot and said he expected federal regulators to make booster shots more widely available in the U.S. soon. “Likely, they will start moving the recommendations to earlier ages as they did in England and other places,” he said. In the U.K., boosters are available to those over the age of 50 and in Israel, boosters have been distributed to people as young as 12. Currently, people in the U.S. under the age of 65 years old are only permitted to get a Pfizer booster if they are at high risk of severe COVID due to medical, occupational, or institutional reasons. The only exception is Johnson & Johnson recipients 18 years and older, who are all eligible to get a booster shot and can choose Pfizer for their additional shot thanks to the FDA and CDC authorizing mixing and matching of vaccines. According to The New York Times, the FDA is expected to grant Pfizer’s expansion request before Thanksgiving and well ahead of Christmas travel. This would likely make every U.S. adult eligible for an additional dose. And that’s in line with the views of several experts, who argue that there is now “stronger data” highlighting the need for booster shots than there was in September, when the FDA made its first decision on Pfizer’s booster. “I think that the boosters now seem to look like they may help prevent severe disease for a lot more people than we thought previously,” Nahid Bhadelia, MD, director of Boston University Center for Emerging Infectious Diseases Policy and Research, told The New York Times. An Israeli study published in The Lancet on Oct. 29 analyzed nearly 730,000 people who had received a booster dose of Pfizer and found that boosted recipients had a 93 percent lower risk of hospitalization, 92 percent lower risk of severe disease, and 81 percent lower risk of death than those who had only received two shots of this vaccine. RELATED: For more up-to-date information, sign up for our daily newsletter. Pfizer and BioNTech said their new request is based on data from their own clinical trial—which was partly done in the U.S.—that showed similar results. According to the data which was released in late October, a trial of more than 10,000 volunteers 16 years and older showed that a booster shot restored vaccine protection against COVID to a vaccine efficacy of 95.6 percent. “These important data add to the body of evidence suggesting that a booster dose of our vaccine can help protect a broad population of people from this virus and its variants,” Ugur Sahin, MD, the CEO and co-founder of BioNTech, said in a statement at the time. But when officials were first voting on the authorization of Pfizer’s booster two months ago, the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) explicitly recommended against expanding boosters for all adults who originally received the Pfizer vaccine. Several members of the committee at the time raised concerns about the need for young, healthy people to have access to boosters—and some officials are still taking this stance. Anna Durbin, MD, an internal medicine infectious diseases trained physician, and professor of international health at the Johns Hopkins Bloomberg School of Public Health, told CNBC that the benefit of a booster for young, healthy individuals is “limited.” An additional shot does increase antibody levels, “but you don’t need that now” if you’re young and healthy, Durbin said. “You want to save that for later.” Despite this, Moderna is expected to submit its own request to the FDA to broaden the eligibility of its booster as well, per The New York Times. However, according to the news outlet, some experts predict that even broadened authorization of Moderna’s booster might still exclude one group of people: young men. Younger men are more at risk of a rare, serious side effect called myocarditis, or heart inflammation, after getting the Moderna vaccine. The FDA has even recently delayed expanding Moderna’s initial two-vaccine dose series to adolescents in order to review this reaction, The Wall Street Journal reported. “As we go into younger and younger age groups, they’re less and less at personal risk of severe COVID, and on the other hand, somewhat more at risk of this inflammatory heart condition with the mRNA vaccine,” Ofer Levy, a voting VRBPAC member, said on CNBC’s Closing Bell. RELATED: You Need a Booster Before This Date, Virus Experts Warn.
