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FDA advisers are not sure that a single annual booster vaccine is the appropriate response to COVID-19


Experts say that COVID-19, unlike the flu, is a very new disease that mutates frequently, so a standardized annual vaccination schedule may not be the best weapon against the pandemic.

By Berkeley Lovelace Jr. -

NBC News

The advisory committee of the Food and Drug Administration (FDA, for its acronym in English) raised doubts on Thursday about the appropriateness of recommending that vaccination against COVID-19 consist of a single annual booster dose, arguing that the coronavirus is too new and that mutates very frequently.

The FDA convened its Advisory Committee on Vaccines and Related Biologics to discuss a possible change to the coronavirus vaccination protocol recommendations in the future.

The agency proposed on Monday that vaccination consist of an annual booster dose to combat the latest variants of the virus,

an approach similar to that of the annual flu shot.

[FDA proposes an annual vaccination against COVID-19]

However, during Thursday's meeting, several committee members raised concerns about defining a recommended vaccination schedule, citing how much is still unknown about COVID-19. 

Unlike the flu, which spreads in the winter months, the transmission of COVID-19 has been erratic, mutating into new variants, without a predictable seasonal pattern.

A common comment at the meeting was that COVID-19 was not like the flu.

"We don't know what's going to happen," said Dr. Eric Rubin, managing editor of the New England Journal of Medicine.

"It's hard to say at this point that (the vaccine) will become an annual thing."

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COVID-19 can mutate several times a year, becoming more virulent or immunosuppressive, or not.

“We may or may not need an annual vaccine,” said Dr. Cody Meissner, a pediatrician at Tufts University School of Medicine.

"It seems to me that it is terribly early in this process to answer it

. "

Other committee members were uneasy discussing how protected people would be from the virus if the country were to set an annual vaccination schedule, and whether it would be better to wait for more effective vaccines. 

Thursday's meeting included a presentation by the National Institutes of Health on the next generation of vaccines, which could provide broad protection against both known and unknown strains of the virus, though officials noted that a vaccine that protects against all possible strains is in the offing. probably too far.

[Bivalent booster shots halve the risk of contracting subvariant XBB.1.5]

Although the effectiveness of Pfizer-BioNTech and Moderna's COVID-19 injections against severe disease appears to last for months or even years, their effectiveness against infection wanes within months.

“We need broader protection,” said Dr. Pamela McInnes, retired deputy director of the National Center for Advancing Translational Sciences at the National Institutes of Health.

"We don't want to be chasing this virus."

Free flu and COVID-19 shots in a file photo from October 2022, in Lynwood, California. Mark J. Terrill / AP

During Thursday's meeting, Dr. Peter Marks, the FDA's top vaccine regulator, acknowledged that

simplifying the COVID-19 vaccine schedule to match exactly that for flu might not be possible.

The FDA had proposed that the committee meet each June to select the strain or strains for annual immunization, which would allow enough time to manufacture doses for a fall campaign.

Dr. Jerry Weir, director of the Division of Viral Products in the FDA's Office of Vaccine Research and Review, said that even if an annual approach were taken, if a dangerous new variant emerged, the agency would probably call an emergency meeting. to discuss whether new reinforcements are necessary.

[Rising US COVID-19 hospitalizations increase risk for seniors]

Some experts insisted that they would prefer several annual meetings on COVID-19 vaccines.

According to them, doing it once a year can give the impression that the virus is only a threat in the fall and winter months, like the flu, which is not true.

"I think this pattern is not necessarily that of the flu," said Dr. Henry Bernstein, a professor of pediatrics at Hofstra University Zucker School of Medicine in New York.

“We need to communicate that it is still useful to get vaccinated outside of the typical flu window.”

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It was also questioned whether offering booster shots in the fall would mean people couldn't get immunized at any other time of the year, giving them a limited window of time to protect themselves.

Although the committee was undecided about whether to go ahead with annual booster vaccinations, they

were certain that there was a need to simplify their formulation.

Currently, the bivalent vaccine, which targets the BA.4 and BA.5 omicron subvariants as well as the parent virus strain first identified in Wuhan, China in 2019, is only available as a booster.

The primary vaccination series, which is given to anyone who is not immunized, continues to target only the parent strain.

In a unanimous vote, the committee recommended using the bivalent formula in all COVID-19 vaccines going forward, not just boosters.

The FDA is not required to accept its committee's recommendations, although it often does.

Source: telemundo

All news articles on 2023-01-27

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