On Friday, an expert advisory panel assembled by the U.S. Food and Drug Association (FDA) voted overwhelmingly to reject President Biden’s plan to roll out Pfizer-BioNTech booster shots.
In a vote of 16 to 2, the committee of outside experts quashed the President’s efforts, citing a lack of data on the safety of additional mRNA vaccines.
“I don’t think a booster dose is going to significantly contribute to controlling the pandemic,” said Dr. Cody Meissner of Tufts University. “And I think it’s important that the main message we transmit is that we’ve got to get everyone two doses.”
“There are too many questions for me to feel comfortable saying ‘yes’ to this,” said A Oveta Fuller, a member and associate professor of microbiology and immunology at the Medical School University of Michigan
However, both FDA leaders and the committee said they would likely vote a second time on whether the elderly and at-risk immunocompromised should receive additional doses, which most indicated they would be in favour of such a proposal.
Dr. Eric Rubin, a Harvard assistant professor of microbiology and molecular genetics, said he does not expect additional vaccines to pose a considerable risk, “but we don’t have [the data] right now, and I don’t think I’d be comfortable giving it to a 16-year-old for all the reasons everyone has raised”.
For Pfizer’s role in the discussion, representatives of the pharmaceutical giant argued that Americans would likely need booster shots as vaccine effectiveness appears to wane significantly over time. In one of their studies, Pfizer admitted that effectiveness against symptomatic COVID cases dropped from at least 96 per cent to 84 per cent in just four months.
Additionally, Meisner cited higher levels of myocarditis seen in younger age groups and worried about the effect of taking extra doses.
Dr. Paul Offit, a vaccine expert at Children’s Hospital of Philadelphia, concurred, saying that he may support booster shots for adults over 60 or 65 but that he “really [has] trouble” supporting booster shots for anyone 16 or under.
Offit also doubted the long-term efficacy of additional shots, stating, “… the question becomes what will be the impact of that on the arc of the pandemic, which may not be all that much.”
