Pfizer Asks FDA to Approve COVID-19 Booster Vaccines for All Adults

Pfizer Asks FDA to Approve COVID-19 Booster Vaccines for All Adults.

Pfizer called on U.S. regulators Tuesday to allow boosters of its COVID-19 vaccine for anyone 18 years of age or older, a step that comes amid concerns about the further spread of the coronavirus with travel and gatherings. vacation.

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 (FDA) has said it would act quickly to expand boosters to younger ages if warranted.

Pfizer is submitting the first results of a booster study on 10,000 people to argue that it is time to further expand the booster campaign.

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

The new Pfizer study concluded that a booster could restore protection against symptomatic infection to nearly 96%, even when the extra-contagious delta variant was increasing. Side effects were similar to those seen with the company’s first two shots.

A median of 11 months after their last Pfizer vaccination, trial participants received a third dose or a sham injection. The researchers tracked down any infection that occurred at least a week later, and so far they have counted five cases of symptomatic COVID-19 among booster recipients compared to 109 cases among people who received sham injections.

The Biden administration had originally planned boosters for all adults, but faced a severe setback in September when FDA scientific advisers rejected additional doses of Pfizer for all. The panel was not convinced that healthy young people needed another dose, especially when the majority of the world’s population remains unvaccinated.

Still, under current policies, about 2 out of 3 vaccinated adults are expected to qualify in the coming months, and many of those who don’t can get an extra shot because most vaccine providers don’t check qualifications.

The current rules: People who initially received the Pfizer or Moderna vaccines are 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 underlying health problems or their work or working conditions. life. Because the Johnson & Johnson single-dose vaccine has not been shown to be as effective as its two-dose competitors, any J&J recipient can receive a booster at least two months later.

And regardless of the initial vaccination, the US has approved getting a booster vaccine from a different company, which is called mix and match.

If the FDA authorizes Pfizer boosters for all adults, the Centers for Disease Control and Prevention will make recommendations on how to use them.

Globally, the drivers are also a hodgepodge. Some countries restrict them to the elderly or medically fragile, while others have few restrictions. Israel, for example, has authorized Pfizer boosters for anyone 12 years of age or older.