FDA advisors raise doubts about seasonal updates
A person receives a COVID-19 vaccination dose, during a free distribution of COVID-19 rapid test kits for those who received vaccination shots or booster shots, at Union Station on January 7, 2022 in Los Angeles, California.
The U.S. Food and Drug Administration's independent panel of advisors raised doubts about the need to "periodically" update Covid vaccines, noting that it's unclear if the virus is seasonal like the flu.
Advisors on Thursday unanimously voted that new jabs for the fall should be monovalent — meaning they are designed against one variant of Covid — and target one of the omicron XBB strains. Those are now the dominant variants nationwide.
But the original voting question included language about whether the panel recommends a "periodic update" to Covid shots.
Dr. Peter Marks, head of the FDA's vaccine division, asked the panel's chair to strike the wording from the question after several advisors raised concerns.
"As worded, it seems to be saying, do we agree that there's gonna be a regular need to update? And I don't think that's clear," said Dr. Arthur Reingold, professor of epidemiology at the University of California, Berkeley.
The panel's concerns indicate there is still uncertainty around what the Covid pandemic will look like in the years ahead, even as cases and deaths decline nationwide.
The worries are also the latest pushback against the FDA's proposed shift to annual Covid shots earlier this year – a simplified approach to vaccination that would involve yearly updates to the jabs. That's similar to how the U.S. rolls out new flu vaccines every fall and winter, which is the season when cases flourish.
But several advisors cautioned against calling Covid seasonal like the flu.
"It's not clear to me that this is a seasonal virus yet," said Henry Bernstein, a pediatrician at Cohen Children's Medical Center.
Dr. Mark Sawyer, professor of clinical pediatrics at the University of California, San Diego, added that describing Covid as "seasonal" could ultimately confuse the public about "when and where they should get vaccinated, and how frequently."
"I'll join the choir here. I think using the word season is equally problematic," said. Dr. Sawyer. "It links the campaign to the influenza vaccine. I understand that it may be convenient and most efficient to give the vaccines together, but it's only been a few years and we really don't know what the Covid season is."
Unlike the flu, Covid's spread has often been erratic. The virus constantly mutates into new variants and has yet to settle into a predictable seasonal pattern.
In response to the advisors, FDA's Marks emphasized that Covid shots will likely require another update "at some point."
"This is not going to be the final formulation for this vaccine forevermore," he said.
Source: CNBC
