FDA advisors specific doubts about seasonal updates

A person receives a COVID-19 vaccine dose as part of a free distribution of rapid COVID-19 test kits for those who have received immunizations or booster shots at Union Station on January 7, 2022 in Los Angeles, California.

Mario Tama | Getty Images

The US Food and Drug Administration’s independent advisory panel has expressed doubts about the need to update Covid vaccines “regularly”, noting that it is unclear whether the virus, like the flu, is seasonal.

Advisors unanimously voted on Thursday that new vaccines for the fall should be monovalent – that is, designed against a variant of Covid – and target one of the Omicron-XBB strains. These are now the dominant variants nationwide.

But the original poll question included a statement on whether the panel recommends “regular updating” of Covid vaccinations.

dr Peter Marks, head of the FDA’s vaccines division, urged the panel’s chair to remove the wording from the question after concerns were expressed by several advisers.

“The way it’s worded, it seems to say: do we agree that there will be a need for regular updates? 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 suggest there is still uncertainty about what the Covid pandemic will look like in the years to come, even as cases and deaths decline across the country.

Concerns also include recent opposition to the FDA’s proposed switch to annual Covid vaccinations earlier this year – a simplified vaccination approach that would involve annual vaccination updates. That’s similar to how the US rolls out new flu vaccines every fall and winter as cases rise.

However, several advisers warned against labeling Covid as seasonal like the flu.

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

dr Mark Sawyer, a 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 to get vaccinated and how often.”

“I’m going to join the choir here. I think using the word season is just as problematic,” he said. sawyer “It links the campaign to the flu vaccine. I understand that it is convenient and most efficient to give the vaccines together, but that was only a few years ago and we really don’t know what the Covid season is like.”

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

In response to the advisers, the FDA’s Marks stressed that the Covid vaccinations will likely require another update “at some point”.

“This will not be the final formulation of this vaccine forever,” he said.

A pharmacist prepares to administer booster shots for COVID-19 during a Chicago Department of Public Health event at the Southwest Senior Center September 9, 2022 in Chicago, Illinois.

Scott Olson | Getty Images

The move to an annually updated Covid vaccine is being endorsed by former White House health officials Dr. Ashish Jha and Dr. Anthony Fauci, who believe the country can benefit from a similar approach to flu vaccination.

Each year, researchers assess the flu strains in circulation and estimate which will be most common in the fall and winter before updating vaccinations.

“People get the flu shot every year if they see it as a routine part of care. I don’t think every flu shot is my 28th or 29th flu shot — I just think it’s my annual flu shot,” Jha said in an interview with PBS News Hour on Wednesday.

“If most people think of it as their annual COVID shot, they get it when they get their flu shot. I think that will make an important difference,” he continued.

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

According to a survey by public health organization KFF in April, more than half of approximately 1,200 US adults surveyed said they would likely receive an annual Covid vaccine if it was offered in a manner similar to an annual flu shot. This includes 32% who are “very likely” to do so.

It’s unclear how many Americans will be rolling up their sleeves for up-to-date shots this fall and winter.

Adoption of the latest bivalent boosters – targeting the original Covid strain and the Omicron BA.4 and BA.5 – has been sluggish.

Only about 17% of the US population—about 56 million people—have received it Pfizer And modern They have not received a booster shot since they were admitted in September, according to the Centers for Disease Control and Prevention.

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

The postponement could help people see Covid vaccinations as another “very natural part” of protecting their health, said Dr. Mikael Dolsten, Chief Scientific Officer at Pfizer.

Pfizer is already preparing to move to an annual plan by developing “next-generation” versions of its vaccine aimed at expanding and extending people’s protection from the virus to a full year.

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