Pfizer and BioNTech have requested the Food and Drug Administration give emergency-use authorization for booster doses of the companies’ coronavirus vaccine for people 18 and older.
The request, filed Tuesday, is based on findings of a phase 3 trial involving more than 10,000 participants, which found the boosters were safe and had an efficacy of 95% against symptomatic coronavirus compared with the two-dose schedule in the period when the delta variant was the dominant strain, CNN reported.
The data, released last month, has not been peer-reviewed or published, CNN reported.
The Pfizer/BioNTech vaccine had previously been approved for people ages 16 and older and recently received the green light for ages 5-15.
Boosters for the Pfizer vaccine are currently limited by the FDA to people over 65 and those with underlying medical conditions or high-risk occupations or living conditions.