The FDA authorized a booster dose of the Pfizer-BioNTech COVID-19 vaccine on Wednesday for older Americans, healthcare workers, and others at serious risk of severe cases, following tense debates over whether additional shots were needed.
The move follows an FDA expert panel's recommendations late last week supporting Pfizer boosters for those groups, whom they argued would clearly benefit from increased immunity. The panel overwhelmingly rejected giving the boosters to all individuals 16 and older, citing the need for more safety data in younger age groups.
"After considering the totality of the available scientific evidence and the deliberations of our advisory committee of independent, external experts, the FDA amended the EUA for the Pfizer-BioNTech COVID-19 Vaccine to allow for a booster dose in certain populations such as health care workers, teachers and day care staff, grocery workers and those in homeless shelters or prisons, among others,” acting FDA Commissioner Janet Woodcock said in a statement Wednesday.
Some experts believe this wording on at-risk occupations may open the door to the broad use of booster shots. "The unknown is how it’s going to be interpreted and by whom," John Moore, a virologist at Weill Cornell Medical College in New York, told BuzzFeed News. "Physicians are already under pressure from ‘the worried well,’ claiming their health status qualifies them. Now their occupations provide another pressure point on vaccine providers.”
A CDC expert panel meeting on Wednesday started discussions over its own recommendation about which at-risk groups are the highest priority for the booster shots. Its recommendation, in turn, has to be accepted by the CDC director to trigger federal payment of insurance costs for the extra doses. But states can choose to disregard the CDC's suggestions, setting their own rules for who can get shots.
The FDA booster authorization applies only to the Pfizer mRNA vaccine, given to nearly 55% of people in the US who've gotten vaccinated.
On Tuesday morning, Johnson & Johnson released data showing that a booster dose of its single-shot vaccine given after two months increased its effectiveness to 94% against severe or moderate COVID-19. Johnson & Johnson has submitted that data to the FDA for emergency use authorization, according to a company news release. Moderna submitted its data to the FDA for authorization earlier this month.
As the CDC's Advisory Committee on Immunization Practices reviewed data on the Pfizer booster Wednesday, several members expressed concerns about the situation for people who were given Moderna or Johnson & Johnson shots. Some asked whether the panel could defer from making a recommendation on Pfizer boosters until it was able to address boosters for the other vaccines too.
Sarah Long, a specialist in infectious diseases at Drexel University in Philadelphia, said she feared a "public health panic" among recipients of the Moderna vaccine. Pablo Sánchez, a professor of pediatrics at Ohio State University, said people who got the single-shot Johnson & Johnson vaccine "are really left out."
"We really need to come up with some recommendations" for the recipients of other vaccines, Sánchez said.
And CDC panelist Natalie Thornburg noted that though antibody levels have been shown to wane over time, leading to an increased likelihood of breakthrough infections, longer-living immune cells still offered strong protection against severe disease and death in vaccinated individuals who get infected.
A CDC study released last Friday found only slight drops in effectiveness against hospitalization in all three vaccines offered in the US from March to August, down to 93% for the Moderna shots, 88% for the Pfizer vaccine, and to 71% for Johnson & Johnson's single shot.
In August, the Biden administration announced it would offer boosters to everyone in the US eight months after their vaccination was completed. Top public health experts, including those at the World Health Organization and the FDA, have publicly opposed the use of boosters, arguing instead for distributing the vaccines worldwide to prevent the spread of disease and the potential development of new, more dangerous variants. Some scientists have also raised concerns about the White House overstepping the FDA's authority.
About 20 nations now offer booster shots to some part of their population, typically older adults, medical personnel, or those with compromised immune systems, with around twice that number considering the option.
This story has been updated to include comments by John Moore, a virologist at Weill Cornell Medical College.