FDA Panel Votes Against Boosters for All, Unanimously Recommends Them for Elderly and High-Risk Groups

FDA Panel Votes Against Boosters for All, Unanimously Recommends Them for Elderly and High-Risk Groups
Photo: Grant Hindsley/AFP, Getty Images

On Friday, outside experts assembled by the U.S. Food and Drug Administration delivered a blow to the White House’s ambition to roll out covid-19 booster doses to most Americans. The panel largely voted no on a recommendation to give third doses to vaccinated Americans over the age of 16, based on clinical trial evidence provided by vaccine maker Pfizer. However, they did unanimously recommend boosters for people over 65 and others at high risk of severe covid-19. Their votes are non-binding, and the FDA has yet to make its official call.

The question of boosters has been looming since last month, when the Biden administration announced its intentions to sanction booster doses for all Americans who received two doses of an mRNA covid-19 vaccine by September 20. The decision, as was noted at the time, had to be first approved by the FDA and Centres for Disease Prevention and Control, however.

While the heads of these agencies endorsed the White House plan, some scientists soon expressed their scepticism. Both internally and publicly, these critics have argued that the evidence for boosting everyone simply isn’t robust enough, at least for the time being. Others, including the president’s chief medical advisor Anthony Fauci, have argued otherwise, saying widespread boosters will prevent meaningfully more cases of serious illness and death among the vaccinated — a goal that would especially be worthwhile with the fall and winter ahead.

During today’s meeting by the Vaccines and Related Biological Products Advisory Committee (VRBPAC), an exhaustive amount of research supporting either side of these arguments was laid out.

Studies from the U.S. and elsewhere, particularly Israel, were discussed. Some studies suggested a substantial decrease in protection against infection, symptomatic illness, and even hospitalisation and death among those who first got vaccinated last year and in early 2021. Other studies, presented by officials from the Israeli Ministry of Health, suggested that their booster campaign, which began last month, had led to fewer hospitalizations and deaths in the country.

Yet other data showed much less waning in efficacy for the general public overall, as well as continued high effectiveness against hospitalisation and death, even as the more transmissible Delta variant has emerged to become the dominant strain in the U.S. Some researchers also discussed the state of the current research, arguing that there are messy confounding factors that could bias real-world data.

During the public comment period, some researchers urged caution in recommending boosters without enough data, while other commentators had unrelated concerns. At one point, Paul Alexander, a former assistant professor at McMaster University in Canada and controversial Trump advisor, cited Nicki Minaj’s cousin’s friend and his supposed genital problem post-vaccination as a reason for why the mRNA vaccines could be unsafe and need longer term safety data before any further use for children should be approved. There is no established link between infertility or other sexual issues and the covid-19 vaccines, and the issue at hand was not about the vaccines being authorised for younger children.

Ultimately, when the committee was asked whether boosters of the Pfizer/BioNTech should be recommended for eligible adults over 16, only two out of 18 members voted yes. The panel then agreed to discuss the issue of boosters for high-risk individuals and those over 65. After a shorter discussion, the members came back and unanimously voted yes to recommending boosters for these groups. In the time given to discuss their votes, many experts cited the stronger evidence showing that older people specifically may lose more protection over time than others.

The recommendation mirrors a decision by the UK to approve vaccine boosters for people over 50 and high-risk individuals, including frontline health care workers and those with health conditions that raise their risk of severe illness. After the initial vote, the FDA requested that members also weigh in on whether health care workers should be considered high-risk individuals; the panel unanimously voted yes.

Recommendations by the VRBPAC and other advisory committees are non-binding, so the FDA can choose not to follow their advice. But the agency tends not to disregard their input, and some top officials involved with the FDA’s vaccine approval process have recently stated their own opinion that only some people should be eligible for boosters at this time.

The FDA is not the only agency that will have some say in who should get boosters in the U.S. On Monday, an expert panel assembled by the CDC will meet and give their recommendation on the matter.