FDA Approves Pfizer, Moderna COVID-19 Boosters for All U.S. Adults, Pending CDC Approval – Community News

FDA Approves Pfizer, Moderna COVID-19 Boosters for All U.S. Adults, Pending CDC Approval

The U.S. Food and Drug Administration has authorized Pfizer and Moderna COVID-19 booster shots for all U.S. adults, the companies announced Friday, pending approval from the U.S. Centers for Disease Control and Prevention.

The latest move expands the government’s campaign to bolster protections and get ahead of the escalating coronavirus cases that could worsen over the holiday season. The CDC’s influential advisory panel, called the Advisory Committee on Immunization Practices, will meet from noon to 3 p.m. ET to discuss expanding booster shot eligibility.

The final step — the CDC’s official recommendation — could come soon after the meeting.

Pfizer and Moderna announced the FDA’s decision after at least 10 states had already started offering boosters to all adults. The latest move simplifies what has been a confusing list of eligibility by allowing anyone 18 or older to choose a booster from both companies six months after their last dose — regardless of which vaccine they had first.

Pfizer filed its filing with the U.S. Food and Drug Administration last week, and Moderna announced Wednesday that it had filed for emergency use approval.

Final signing by the CDC would significantly expand eligibility. Boosters are now recommended for people who received their second Pfizer or Moderna shot at least six months ago if they are 65 years of age or older or are at high risk for COVID-19 due to health problems or their working or living conditions. Boosters are also recommended for people who received the Johnson & Johnson single-dose vaccine at least two months ago.

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FILE – A registered nurse makes a dose of the Pfizer COVID-19 booster at Park Avenue Health Center in Arlington, MA on November 9, 2021. (Photo by Jessica Rinaldi/The Boston Globe via Getty Images)

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Nearly 31 million Americans have already received a dose higher than their original vaccination, including those with weakened immune systems, such as cancer patients and organ transplant recipients who need an extra dose to be fully vaccinated.

While all three vaccines used in the US continue to provide strong protection against severe illness and death from COVID-19, the effectiveness of the injections against milder infections may diminish over time.

Pfizer has submitted the first results of a booster survey of 10,000 people to prove it’s time to expand the booster campaign. The study found that a booster could restore protection against symptomatic infection to about 95%, even while the extra-infectious delta variant was on the rise. Side effects were similar to those seen in the company’s first two shots.

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Members of the CDC panel have debated in past meetings whether there is enough evidence that boosters are currently needed for all adults.

dr. Anthony Fauci, the country’s top infectious disease expert, said earlier this week he believes COVID-19 vaccine boosters will be needed to counter a potential “double whammy” of the highly transmissible coronavirus delta. variant and declining immunity this winter.

“The somewhat unnerving aspect of it is that if you keep the level of the virus dynamics in the community at a high level – obviously the people who are the most and most vulnerable are the unvaccinated – but if you have a virus that As transmissible as delta, in the context of waning immunity, that dynamic will negatively affect even the vaccinated people. So it’s a double whammy,” Fauci said in a pre-recorded interview broadcast on the 2021 STAT summit Tuesday.

“You’ll see breakthrough infections, even more than we’re seeing now in the vaccinated,” he added. Fauci even suggested that a third shot of the COVID-19 vaccine may no longer be a “luxury” but part of the required vaccination process.

“I happen to believe … that a third injection boost to an mRNA should probably be part of the actual standard regimen,” he said.

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