Pfizer asks FDA to approve COVID-19 booster injections for all adults

Pfizer asks FDA to approve COVID-19 booster injections for all adults

Pfizer asked US regulators on Tuesday to allow a booster for its COVID-19 vaccine for anyone 18 or older, a move that comes amid concerns that the coronavirus will spread further with holiday travel and gatherings.

Older Americans and other groups particularly vulnerable to the virus have received a third dose of the Pfizer and BioNTech vaccine since September. But the Food and Drug Administration said it would move quickly to extend the boosters to younger ages if necessary.

Pfizer is providing early results for a booster study in 10,000 people to prove it’s time to expand the booster campaign.

While the three vaccines used in the United States continue to provide strong protection against severe COVID-19 illness and death, the effectiveness of vaccines against milder infections could wane over time.

The new Pfizer study concluded that the booster could restore protection against symptomatic infection to about 95%, even with a high, highly infectious delta variant. The side effects were similar to those seen in the company’s first two shots.

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Eleven months after the last Pfizer vaccine, trial participants were given either a third dose or a placebo. The researchers tracked any infections that occurred at least a week later, and so far they have counted five cases with symptoms of COVID-19 among the booster dose recipients compared to 109 cases among people who got the dummy injections.

The Biden administration originally envisioned boosters for all adults, but faced a stinging setback in September when scientific advisors to the U.S. Food and Drug Administration rejected additional Pfizer doses for everyone. The committee was not convinced that healthy young people would need another dose, especially when most of the world’s population remains unvaccinated, and instead recommended the use of boosters only for certain groups – one of a series of decisions regarding additional doses for all three vaccines used in the United States

Current rules: People who initially received the Pfizer or Moderna vaccines are eligible for a booster after six months if they are 65 or older, or are at risk of contracting COVID-19 due to health problems or their working or living conditions. Because a single dose of Johnson & Johnson’s vaccine has not been shown to be as effective as its two-dose competitors, any J&J recipient can get a booster dose after at least two months.

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Also, anyone who qualifies for a booster dose does not have to stick to their type of primary vaccination and can get a different company vaccine, which is called mix-and-match.

About 194 million Americans have been fully vaccinated. Under today’s policies, authorities have already estimated that about 2 in 3 adults who have been vaccinated could be eligible for a booster dose within the next few months. Many who do not meet the criteria often get an extra chance because many providers of vaccines do not check qualifications.

FDA spokeswoman Alison Hunt said the agency would review Pfizer’s request “as soon as possible,” but would not set a timeline for making a decision. She also said that the Food and Drug Administration has not yet decided whether to hold a meeting of the external expert group to examine the data.

If the FDA authorizes Pfizer’s request for extended boosters, the Centers for Disease Control and Prevention will make recommendations on how to use them.

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Globally, boosters are also a hodge. Some countries limit it to the elderly or people with medical frailty while others have few restrictions. Israel, for example, has allowed the use of Pfizer’s boosters for anyone 12 years of age or older. Health Canada on Tuesday approved Pfizer’s boosters for people 18 and older.

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Associated Press health writer Matthew Perrone contributed to this report.

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The Associated Press’s Department of Health and Science receives support from the Howard Hughes Medical Institute’s Division of Science Education. AP is solely responsible for all content.

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