This archive report was first published on 19 November 2021.
On November 19, 2021, the Food and Drug Administration (F.D.A.) made a significant move in the fight against the COVID-19 pandemic by authorizing booster shots of both the Pfizer-BioNTech and Moderna vaccines for everyone 18 and older.
This decision simplifies eligibility and fulfills a pledge by President Biden to offer the shots to every American adult. The move was justified by currently available clinical trial data as well as real-world evidence.
Dr. Peter Marks, who leads the F.D.A. division that regulates vaccines, stated, “Streamlining the eligibility criteria and making booster doses available to all individuals 18 years of age and older will also help to eliminate confusion about who may receive a booster dose and ensure booster doses are available to all who may need one.”
Dr. Anthony S. Fauci, the federal government’s top infectious disease expert, has argued relentlessly for booster shots for all adults, a position shared by most of Mr. Biden’s other health advisers. He emphasized that healthy younger adults do not need them, are ignoring the risks of symptomatic Covid-19.
“Enough is enough. Let’s get moving on here,” Dr. Fauci said at an event Wednesday night. “We know what the data are.”
According to the F.D.A., the expansion was justified by currently available clinical trial data as well as real-world evidence. The agency said that it did not convene its independent vaccine advisory committee because the panel had already had discussed the use of booster shots extensively and “the requests do not raise questions that would benefit from additional discussion.”
For Moderna, regulators said, the data showed that 149 clinical trial participants who received a booster dose had higher antibody levels compared with 1,055 study volunteers who received only two doses. They said Pfizer’s data for 200 participants in a clinical trial showed the booster shot raised antibody levels compared to one month after a second shot.
More than 182 million adults in the United States, or 71 percent, are fully vaccinated. So far, more than 32 million of them have gotten an additional shot.
Until now, those eligible for boosters included people 65 and older, residents of long-term care facilities, people with underlying medical conditions, and those whose jobs or institutional living conditions heightened their risk.
Dr. Doran Fink, a key F.D.A. regulator, said at the C.D.C. meeting Friday that the impact of broadening booster eligibility would be clear “on the individual level,” offering protection against breakthrough cases of Covid-19. But he said the “greatest impact on a population level is still dependent on increasing vaccine uptake among” the unvaccinated.
