For an archived version of live coverage of the hearing of the FDA’s advisory panel, click here.
A Food and Drug Administration advisory panel voted unanimously Thursday in favor of authorizing booster shots of the Moderna Covid-19 vaccine to people 65 and older, those 18 to 64 with risk factors for severe Covid-19, and those whose jobs put them at high risk for serious complications of Covid-19, such as health care workers.
After hours of deliberation, the Vaccines and Related Biological Products Advisory Committee voted 19-to-0 that the Moderna booster should be authorized for these groups at least six months after receiving their second dose. The panel also discussed at what point boosters should be recommended to all adults over 18, saying that at this point it is far too soon to consider the matter.
The Moderna booster consists of a 50-microgram dose, half the normal dose of the shot.
The groups recommended for the Moderna booster are the same ones authorized for the booster made by Pfizer and BioNTech.
The FDA is not bound by the votes of its advisory committees, which it convenes to ask for guidance, but it generally follows their advice. The booster shot would be granted an emergency use authorization, used to speed the approval of products during public health emergencies, not a traditional approval.
Many panelists said they thought there were holes in Moderna’s data regarding the background of patients studied, but that they were not big enough to justify recommending boosters for groups different than for the Pfizer-BioNTech vaccine. Stanley Perlman, a microbiologist at the University of Iowa, said that although he had concerns, he thought not granting a similar approval would leave people in the U.S. “completely confused.”
Members of the committee were far less willing to consider opening up availability for both the Pfizer and Moderna vaccines to all people over the age of 18.
“I’m uncomfortable with how we’ve sort of tripped down the line for the thought of universal booster dosing, which I just think is wrong,” said Paul Offit, a pediatrician and director of the Vaccine Education Center at the Children’s Hospital of Philadelphia.
Michael Kurilla of the National Institutes of Health worried about the durability of the two vaccines and about how often boosters will be needed, how much space there should be between vaccine doses, and what dose of vaccine to use.
“[It’s] going to be very critical to understand whether or not a six-month boost actually does change the trajectory of the antibody response and provide some better durability,” Kurilla warned.
This summer, the Biden administration said it intended to make booster shots broadly available as early as September. But many scientists have pushed back, saying that there is not enough evidence that the efficacy of the vaccines against severe Covid, hospitalizations, and death is waning.
On Friday, the FDA advisory committee will meet to discuss data regarding giving a booster shot to all people who have received the Johnson & Johnson Covid vaccine, as well as a study that suggests it might be possible, or even advantageous, to mix and match boosters of different vaccines.
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