The US Food and Drug Administration late Wednesday authorized booster doses of the Pfizer/BioNTech COVID-19 vaccine for people ages 65 and up. Also eligible for boosters will be those ages 18 to 64 who are at high risk of severe COVID-19 or at high risk from frequent occupational or institutional exposures to SARS-CoV-2, such as healthcare workers and teachers.

The single booster dose should only be given at least six months after the two initial doses. The authorization comes as an amendment to an Emergency Use Authorization.

The FDA’s authorization largely follows the recommendations from a committee of independent experts that advises the agency, known as the Vaccines and Related Biological Products Advisory Committee or VRBPAC. The committee met all day Friday to review and deliberate over the data surrounding boosters. The meeting concluded with an 18-0 vote in favor of recommending boosters for people 65 and up plus high-risk groups. But, prior to that, the committee voted 16-2 against recommending boosters for everyone ages 16 and up, rejecting the Biden administration’s plans to rollout additional doses to nearly all vaccinated people.

Eligibility

Though the FDA seems to have heeded the committee’s advice, it’s still not entirely clear who will qualify for a booster dose. During the discussion Friday, experts suggested that those considered at high risk of severe disease could include people with conditions such as diabetes and obesity. It’s unclear what other conditions may be included.

The committee did make it clear that boosters should be available to healthcare workers, who are at high risk of exposure. Those workers are already in short supply as healthcare systems are being overwhelmed in the current surge of COVID-19. The experts and FDA officials also discussed frontline workers, teachers, and prison workers.

The FDA’s authorization Wednesday is worded more vaguely, as people “whose frequent institutional or occupational exposure to SARS-CoV-2 puts them at high risk of serious complications of COVID-19 including severe COVID-19.” In an accompanying statement, Acting FDA Commissioner Janet Woodcock elaborated, saying the authorization covered “certain populations such as health care workers, teachers and day care staff, grocery workers and those in homeless shelters or prisons, among others.”

Detailing who those “others” are and what medical conditions will be included will fall to an advisory committee for the Centers for Disease Control and Prevention. The committee—the Advisory Committee on Immunization Practices or ACIP—will meet tomorrow to set recommendations for use of the booster.

“Dynamic and evolving”

Another key issue that will likely come up at the ACIP meeting is whether people who received two doses of the Moderna mRNA vaccine or the one-shot Johnson & Johnson vaccinate could also be allowed to get the Pfizer/BioNTech mRNA booster. The FDA’s authorization applies only to those who received two initial doses of the Pfizer/BioNTech vaccine. And boosters for the Moderna and Johnson & Johnson vaccines are in the works, but have not yet been authorized.

Hanging over the discussion is also speculation that whatever booster policies are set tomorrow will be short-lived. Movement on boosters for the other vaccines are expected in the coming weeks and eligibility for the Pfizer/BioNTech booster may also open up. Top infectious disease expert Anthony Fauci told NPR’s Morning Edition Monday that he expected more data in the coming weeks that will lead the FDA to “actually modify and expand the recommendation.”

In her statement Wednesday, FDA’s Woodcock noted that “This pandemic is dynamic and evolving, with new data about vaccine safety and effectiveness becoming available every day. 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.”

https://arstechnica.com/?p=1797594