Pfizer on Tuesday asked U.S. regulators to allow recalls of its COVID-19 vaccine for anyone 18 years of age or older, a step that comes amid concerns about the increased spread of the coronavirus with 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 said it would move quickly to roll out boosters to younger people if warranted.
Pfizer submits initial results of a 10,000-person recall study to show it is time to expand the recall campaign further.
While the three vaccines used in the United States continue to offer strong protection against serious illness and death from COVID-19, the effectiveness of injections against milder infections may decline over time.
The new study from Pfizer concluded that a booster could restore protection against symptomatic infection to almost 96%, even as the extra-contagious delta variant increased. The 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 dummy injection. Researchers have tracked all infections that occurred at least a week later and have so far found five cases of symptomatic COVID-19 among booster recipients compared to 109 cases among people who received dummy injections.
The Biden administration initially considered boosters for all adults, but faced a stinging setback in September when FDA science advisers rejected additional doses of Pfizer for everyone. The panel was not convinced that healthy young people need another dose, especially when most of the world’s population is still unvaccinated.
Yet under current policies, around 2 in 3 vaccinated adults are expected to qualify over the next few months – and many of those who do not may still score an extra blow as most vaccine suppliers do not verify 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 or older, or are at high risk of COVID-19 due to underlying health conditions or their working or living conditions. Because the single-dose Johnson & Johnson vaccine has not been shown to be as effective as its two-dose competitors, any recipient of J&J can be boosted at least two months later.
And regardless of the initial vaccination, the United States has allowed a booster of the vaccine to be obtained from another company, which is called mixing and matching.
If the FDA allows Pfizer boosters for all adults, then the Centers for Disease Control and Prevention will make recommendations on how to use them.
Overall boosters are a mishmash too. Some countries limit them to the elderly or medically frail while others have few restrictions. Israel, for example, has authorized Pfizer boosters for anyone 12 years of age and older.