In September, FDA advisers rejected Pfizer boosters for all, saying they were not convinced that healthy adults needed extra doses.
Pharmaceutical giant Pfizer has asked US health regulators to authorize booster of his COVID-19 vaccine for everyone 18 years and older, amid concerns that coronavirus infections could rise again in the coming winter months in the US.
Older Americans and those who are more vulnerable to infections are already eligible for a third booster sting in the US.
Pfizer-BioNTech on Tuesday asked the US Food and Drug Administration (FDA) to be eligible for all adults in the country.
The request comes amid concerns that COVID-19 infections could increase again, as the holiday season and colder weather usually bring more people indoors for large gatherings of friends and family.
According to the US Centers for Disease Control and Prevention (CDC), new coronavirus infections, hospitalizations and deaths have declined across the country in recent weeks. But a significant portion of the U.S. population remains unvaccinated.
The CDCs latest figures shows 70 percent of American adults were fully vaccinated and about 21.5 million booster doses were administered to fully vaccinated people. The US also recently authorized the Pfizer vaccine to children between the ages of five and 11.
The administration of President Joe Biden originally envisioned boosters for all adults but faced a sharp setback in September when FDA scientific advisers rejected extra Pfizer doses for everyone.
The panel was not convinced that young, healthy people still need a dose, especially when most of the world’s population remain unvaccinated.
Pfizer said it was submitting the early results of a booster study in 10,000 people to make its case that it’s time to expand the US-based campaign.
The study concluded that a booster can restore protection against symptomatic infection to almost 96 percent, even if the extra-infectious Delta variant has risen. Side effects were similar to those seen with the company’s first two shots.
The US has approved three vaccines and boosters in the US: Pfizer-BioNTech, Moderna and Johnson & Johnson.
Under the current rules, people who initially received Pfizer or Moderna stimuli six months later are eligible for a booster if they are 65 or older, or are at high risk of developing COVID-19 due to underlying health problems or their work or living conditions.
Because the single-dose Johnson & Johnson vaccine has not been as effective as its two-dose competitors, any Johnson & Johnson recipient can receive a booster at least two months later.
Under this policy, approximately two out of every three vaccinated adults are expected to qualify within the next few months.
The US has also released people to get a boost from another company’s vaccine, often referred to as “mix and match“.
If the FDA authorizes Pfizer boosters for all adults, then the CDC will make recommendations on how to use them.