FDA's VRBPAC votes in favor of adapting the Covid-19 vaccine to the latest Omicron variant
The FDA’s Vaccine and Related Biological Products Advisory Committee on Tuesday gave the thumbs up — by a vote of 19-2 — that the FDA should require an Omicron-related component in this next season’s booster dose for Covid-19, which both Pfizer/BioNTech and Moderna are hard at work on.
And while neither booster will likely be ready to go with adequate supplies for all American adults by the beginning of the next school year, the situation is still complex and fluid, with CBER Director Peter Marks telling the committee that it’ll take companies at least three months to ready their supplies for this expected next wave.
“Right now the critical thing is the manufacturers need to know what to put into their vaccines,” Marks said. Over the coming months, there will be debate over who is most appropriate for a booster, but it seems like most panelists would agree that those aged 50 or 55 and up might be eligible for a booster in the fall, Marks added. He also warned that half of Americans still have not received a first booster, so FDA is hoping to convince people to sign on to the next booster campaign to help prevent another big wave of hospitalizations and deaths. Marks said he totally takes the point that “BA. 4 or 5 might not be circulating in the fall,” but by moving to this bivalent version, the US might be able to move close to what’s circulating.
The rise of Omicron in late 2021 has brought with it two new subvariants, BA.4 and BA.5 more recently, and Pfizer, Moderna and Novavax are developing booster doses to combat these variants and their sublineage better than their current vaccines, which are based on the coronavirus that emerged in late 2019.
Adcomm panelist Wayne Marasco, professor of medicine at Dana-Farber Cancer Institute, voted “yes” on the Omicron booster because, “I think it’s important to broaden immunity,” but adding, “I’m not sure if the data are going to show BA.4 or 5 peaks [in the fall]…but I was pretty impressed today that we can do better, and I’m not sure the mRNA vaccines as they have been presented so far are giving us the best immunity we can get here. This is a step in the right direction but we need to reevaluate.”
Panelist Bruce Gellin, chief of public health strategy at the Rockefeller Foundation, said after his “yes” vote that the process has been somewhat similar to the flu vaccine selection process but, “We weren’t asked to vote on sublineage, so we’re leaving that to the FDA, but we’ve heard a lot about the ‘4,5’, and I guess given that, the conversation between FDA and WHO if the recommendations are to make different vaccines. We’re going to have to think through the range of formulations and the different formulations of what’s included around the world.”
Henry Bernstein, a pediatrician at Cohen Children’s Medical Center, and Paul Offit, a pediatrician at the Children’s Hospital of Philadelphia, both voted against the inclusion of an Omicron component in future boosters. They argued that there is no assurance that the current dominant variant will still be the dominant variant in the fall.