Pfizer asks FDA to approve COVID-19 booster shots for all adults – Community News

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

Pfizer on Tuesday asked U.S. regulators to allow boosters of its COVID-19 vaccine to anyone 18 years or older, a move stemming from concerns about the increased spread of the coronavirus from vacation travel and gatherings.

Older Americans and other groups particularly vulnerable to the virus have had access to a third dose of the Pfizer and BioNTech vaccine since September. But the Food and Drug Administration has said it would soon be expanding boosters to younger ages if warranted.

Pfizer submits early results of a booster study of 10,000 people to prove it’s time to expand the booster campaign.

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.

The new study from Pfizer concluded 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.

A median of 11 months after their last Pfizer vaccination, trial participants received a third dose or a dummy injection. Researchers tracked any infections that occurred at least a week later and have so far counted five cases of symptomatic COVID-19 in booster recipients, compared with 109 cases among people who received dummy injections.

The Biden administration had originally envisioned boosters for all adults, but suffered a painful setback in September when the FDA’s scientific advisers rejected additional doses of Pfizer for everyone. The panel was not convinced that young healthy people needed another dose, especially when most of the world’s population is unvaccinated, and instead recommended boosters only for certain groups – one of a series of decisions on additional doses for all. three vaccines used in the US

The current rules: People who initially received Pfizer or Moderna vaccinations will be eligible for a booster six months later if they are 65 years of age or older, or are at high risk for COVID-19 due to health problems or their employment. or living conditions. Because the single-dose Johnson & Johnson vaccine has not proven as effective as its two-dose competitors, any J&J recipient can receive a booster at least two months later.

Also, anyone who is eligible for a booster does not have to stick to their original vaccination type and can get a vaccine from another company, which is called mixing and matching.

About 194 million Americans are fully vaccinated. Under current policies, authorities already estimate that about 2 out of every 3 adults vaccinated could qualify for a booster in the coming months. Many who do not meet the criteria often score an extra chance because many vaccine providers do not check the qualifications.

FDA spokeswoman Alison Hunt said the agency would review Pfizer’s application “as soon as possible” but would not set a timeline for a decision. She also said the FDA has not yet decided whether to convene a panel of outside experts to examine the data.

If the FDA approves Pfizer’s request for expanded boosters, the Centers for Disease Control and Prevention will make recommendations for their use.

Worldwide, boosters are also a mishmash. Some countries restrict them to elderly or medically frail people, while others have few restrictions. For example, Israel has allowed Pfizer boosters for anyone 12 years and older. Canada’s health regulator Tuesday approved Pfizer boosters for people age 18 and older.


AP Health writer Matthew Perrone contributed to this report.


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