FDA advisors raise doubts about seasonal updates

The FDA’s independent panel of advisors has cast doubt on the need for Covid vaccines to be “periodically” updated, noting that it is unclear whether the virus is seasonal like the flu.

advisors on Thursday They voted unanimously The new fall stabs should be monovalent — meaning designed against a single variant of Covid — and target one of the omicron XBB strains. Those are now dominant variables nationally.

But the Original vote question It included language about whether the panel recommends a “periodic update” of Covid shots.

Dr. Peter Marks, chief of the FDA’s vaccine division, asked the committee chair to delete the wording from the question after several advisors raised concerns.

“As it was phrased, it seems to say, Do we agree that there will be a regular need for updating? And I don’t think that’s clear,” said Dr. Arthur Reingold, a professor of epidemiology at the University of California, Berkeley.

The committee’s concerns indicate that there remains uncertainty about what the Covid pandemic will look like in the coming years, even as cases and deaths decline nationwide.

The concerns are also the latest opposition to the Food and Drug Administration proposed transformation To annual Covid shots earlier this year – a streamlined approach to vaccination that would include yearly updates to the punches. This is similar to the way the United States rolls out new flu vaccines each fall and winter, which is the season when cases boom.

But many advisors cautioned against describing Covid as seasonal as the flu.

“It’s not clear to me if this is a seasonal virus yet,” said Henry Bernstein, MD, a pediatrician at Cohen Children’s Medical Center.

Calling Covid “seasonal” could ultimately confuse the public about “when and where they should get vaccinated, and how often,” added Dr. Mark Sawyer, clinical professor of pediatrics at the University of California, San Diego.

“I’m going to join the choir here,” he said. “I think the use of the word season is just as problematic.” Dr. Sawyer. “He associates the campaign with the flu vaccine. I realize it might be more appropriate and more effective to give the vaccines together, but it’s only been a few years and we don’t really know what Covid season is.”

Unlike influenza, the spread of Covid has often been erratic. The virus is constantly mutating into new variants and has not yet settled into a predictable seasonal pattern.

In response to the advisors, Marks of the FDA confirmed that the Covid shots will likely require another update “at some point.”

“It’s not going to be the final form of this vaccine forever,” he said.

The shift to the annually updated Covid vaccine is being supported by former White House health officials Dr. Ashish Jha and Dr. Anthony Fauci, who believe the country could benefit from adopting a similar approach to a flu vaccine.

Each year, researchers evaluate the flu strains in circulation and estimate which will be most prevalent during the fall and winter before updating the punches.

“People go to get their annual flu shot, if they see this as a routine part of care. I don’t — every time I get a flu shot, I don’t think, ‘Is this the 28th or the 29th flu?'” Jha said Wednesday in a statement. interview On the PBS News Hour.

He continued, “For most people, if they think of it as the annual COVID vaccine they get when they get their flu shot, I think it makes an important difference.”

Recent polls indicate that the public is open to the idea.

More than half of the nearly 1,200 American adults surveyed said they would be more likely to get an annual Covid vaccine if it was offered similar to the annual flu vaccine, according to April. reconnaissance by the health policy organization KFF. This includes the 32% who are “very likely” to do so.

It’s unclear how many Americans will roll up their sleeves to get updated shots this fall and winter.

Uptake of the latest bivalent boosters — targeting the original Covid strain and omicron BA.4 and BA.5 — has been slow.

just about 17% of the US population – Almost 56 million people – greeted Pfizer And the talk Boosters since their approval in September, according to the Centers for Disease Control and Prevention.

Leading Covid maker Pfizer told CNBC last month that the annual Covid schedule could encourage more people to get vaccinated each year.

The shift could help people see Covid shots as just a “very normal part” of protecting their health, said Dr. Mikael Dolsten, Pfizer’s chief scientific officer.

Pfizer is already preparing to move to an annual schedule by developing “next-generation” versions of the shot, which aim to extend and extend the protection people get from the virus to a full year.