The companies said the submission is based on the results of a Phase 3 study with more than 10,000 participants; it found that boosters were safe and had 95% efficacy against symptomatic Covid-19 compared to the two-dose vaccination schedule during the period when the highly transmissible Delta was the dominant strain. Pfizer released the booster efficacy data last month; it has not yet been peer-reviewed or published.
Authorization would bring the country one step closer to President Joe Biden’s prediction by mid-August that boosters would be available to all adults in the United States. When Pfizer initially sought FDA approval for booster doses, it sought full approval of boosters for everyone 16 years and older. Instead, the FDA approved boosters for a more limited group of adults once they were far enough past their initial vaccine doses.
Since then, eligibility has expanded to the majority of adults, including people who have received other types of vaccines. People who have received the Pfizer/BioNTech or Moderna Covid-19 vaccine for six months or more can receive a booster if they are 65 years of age or older; are at risk of severe Covid-19 from a breakthrough infection due to a medical condition such as diabetes, kidney disease, or pregnancy; or be endangered by living conditions or work. Anyone who has received the Johnson & Johnson injection two months or more ago is eligible two months after receiving their first injection. The J&J vaccine is only allowed for people 18 years and older. The FDA and CDC have also signed to mix and match boosters.
The new request from Pfizer and BioNTech comes after federal health officials expressed concern about declining immunity as the nation enters the winter months.
The Pfizer/BioNTech vaccine is already approved for use in people ages 5 to 15 and approved for people ages 16 and older.