The FDA authorized booster doses for Americans who are 65 and older, younger adults with underlying health conditions, and those in jobs that put them at high risk for Covid-19. The ruling represents a drastically scaled-back version of the Biden administration’s sweeping plan to give third doses to nearly all American adults to shore up their protection amid the spread of the highly contagious delta variant.
However, more regulatory hurdles lie ahead before the dispensing of boosters can begin.
Advisers to the Centers for Disease Control and Prevention opened a two-day meeting Wednesday to make their own, more specific recommendations about who should get the extra shots and when. And in their first day of discussions, some experts were so perplexed by the questions surrounding the rationale for boosters that they suggested putting off a decision for a month in hopes of more evidence.
The uncertainties were yet another reminder that the science surrounding boosters is more complicated than the Biden administration suggested when the president and his top aides rolled out their plan at the White House last month.
The FDA decision Wednesday was expected after the agency’s own panel of advisers last week overwhelmingly rejected the Biden plan. The panel instead recommended boosters only for those most vulnerable to severe cases of Covid-19.
FDA acting commissioner Dr. Janet Woodcock said in a statement that the FDA authorization would allow for boosters in health care workers, teachers, grocery workers, and those in homeless shelters or prisons.
“As we learn more about the safety and effectiveness of Covid-19 vaccines, including the use of a booster dose, we will continue to evaluate the rapidly changing science and keep the public informed,” Woodcock said.
Under the FDA authorization, vaccinated Americans are eligible for a third dose six months after receiving their second Pfizer shot. That’s different than the Biden proposal announced in August, which called for boosters after eight months.
“Today’s FDA decision is a major step forward in our effort to provide Americans with additional protection from Covid-19,” White House press secretary Jen Psaki tweeted Wednesday night. “We have been preparing for weeks to administer booster shots to eligible Americans and are ready to do so following CDC’s final recommendation later this week.”
The timing of the FDA decision was highly unusual given that the agency typically takes action before the CDC convenes its own experts.
The CDC panelists heard a series of presentations Wednesday outlining the knotty state of science on boosters. On one hand, the Covid-19 vaccines continue to offer strong protection against severe illness, hospitalization, and death. On the other hand, there are signs of more low-grade infections among the vaccinated as immunity wanes.
Ultimately the committee must decide who is considered at high enough risk for an extra dose. Data provided by Pfizer and the Israeli government suggests a strong case for boosters in people 65 and older, but there is less evidence that extra shots provide many benefits for younger people with underlying health conditions.
Several CDC advisers agreed boosters are also important for keeping health care workers on the job.
“We don’t have enough health care workers to take care of the unvaccinated,” said Dr. Helen Keipp Talbot of Vanderbilt University. “They just keep coming.”
The CDC has already said it is considering boosters for older people, nursing home residents, and front-line health care workers, rather than all adults.