The News
The News
Friday 07 of October 2022

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


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Pfizer asked US regulators on Tuesday to allow boosters of its COVID-19 vaccine for anyone over the age of 18, a step that comes amid concerns about further spread of the coronavirus with holiday 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 move quickly to expand boosters to younger ages if warranted.

Pfizer is presenting the first results of a 10,000-person booster study to make the case that it’s time to expand the booster campaign further.

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

The new Pfizer study concluded that a booster could restore protection against symptomatic infection to almost 96%, even when the extra-infectious 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 either a third dose or a sham injection. The researchers traced back any infection that occurred at least a week later, and have so far counted five cases of symptomatic COVID-19 among the booster recipients compared with 109 cases among the 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 from Pfizer for everyone. The panel was not convinced that healthy young people needed another dose, especially when the majority of the world’s population remains unvaccinated.

A median of 11 months after their last Pfizer vaccination, trial participants received either a third dose or a sham injection. The researchers traced back any infection that occurred at least a week later, and have so far counted five cases of symptomatic COVID-19 among the booster recipients compared with 109 cases among the 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 from Pfizer for everyone. The panel was not convinced that healthy young people needed another dose, especially when the majority of the world’s population remains unvaccinated.