booster shots

FDA Panel Recommends Booster Shots for Those 65 and Over, But Not Everyone

A pedestrian wearing a face mask passes in front of Pfizer’s world headquarters in New York. Photo: Michael Nagle/Xinhua News Agency via Getty Images

On Friday, the Food and Drug Administration’s vaccine expert panel — known as the Vaccines and Related Biological Products Advisory Committee or VRBPAC — voted to recommend that a booster shot of the Pfizer-BioNTech COVID vaccine be administered to people aged 65 and over as well as anyone at high risk for severe illness from COVID-19. The panel did not, however, recommend that a booster be given to everyone 16 and older. Pfizer had applied for authorization to administer the third dose of the company’s messenger RNA vaccine to any healthy American aged 16 and up six months after they have received their second dose. The Biden administration has also been pushing the strategy of boosters for all and planned to start rolling them out next week — but that plan now faces an uncertain fate.

The panel also agreed that boosters should be made available to Americans who are at higher risk of exposure to COVID-19 because of their professions, like health-care workers.

Whether booster jabs should be offered to most Americans has been a hotly debated topic in recent weeks. At the beginning of Friday’s meeting, an FDA official posed the central question surrounding boosters to the committee: Does the evidence show that a Pfizer booster would be safe and effective for people 16 and older? Then, FDA’s top vaccine regulator, Dr. Peter Marks, spoke to limit the scope of the day’s discussions: “As we proceed, I would ask that we do our best to focus our deliberations on the science related to the application under consideration today and not on operational issues related to a booster campaign or on issues related to global vaccine equity.“

Many experts on the committee argue that it’s not yet time for boosters in this country and that the Pfizer vaccine is still highly protective against severe illness and death even amid the spread of the highly contagious Delta variant. Marion Gruber, an outgoing FDA official who earlier this week signed on to a letter saying boosters are not needed, told the committee that “available data should support the effectiveness of a booster dose, specifically against currently circulating SARS-CoV-2 variants. The benefit of the booster dose should be considered relative to the benefit provided by previous vaccination with the primary series.”

On the pro-booster side, Joohee Lee from the FDA presented the agency’s analysis of the Pfizer data presented in support of the application for a booster shot. It showed data indicating that the booster amps up antibody levels in all age groups at the one-month mark about 17-fold. Drugmaker Pfizer, meanwhile, estimates a booster dose could prevent roughly 1.86 million cases over a year per 100 million people.

Israeli health officials presented their country’s data from their experience offering extra doses to nearly 3 million adults since late July and what led them to recommend an additional jab. Sharon Alroy-Preis, the head of Israel’s public-health services, told the committee that long COVID and the need to control the pandemic had prompted the country to offer boosters to not just seniors. “We needed to vaccinate a larger proportion of the population in order to get the numbers down quickly,” Alroy-Preis said, adding that modeling showed that if Israel had not started booster doses at the end of July, hospitals would have reached capacity.

After the proceedings wrapped up on Friday afternoon, the VRBPAC voted overwhelmingly against recommending boosters for everyone 16 and older, then, in another vote, unanimously for recommending boosters for seniors and anyone at high risk of severe COVID. The vote is nonbinding — the FDA is not required to follow the committee’s recommendations, but it generally does so. On Friday, the CDC advised state health officials not to offer booster shots until a key advisory group meets and has an official vote, which will happen next week.

FDA Panel Advises Booster Shot for Seniors But Not Everyone