EU drugs regulator to decide on Pfizer vaccine booster in early October
The European Medicines Agency (EMA) aims to decide in early October whether to endorse a third dose of the Pfizer-BioNTech COVID-19 vaccine to be given half a year after the initial two-shot course, saying breakthrough infections added some urgency to its review.
“The outcome of this evaluation is expected in early October unless supplementary information is needed,” EMA’s head of vaccines strategy, Marco Cavaleri, told a press briefing on Thursday, Reuters reports.
Cavaleri’s statement confirmed a Reuters report earlier in the day on EMA’s expected review time on the matter.
The U.S. Food and Drug Administration on Wednesday authorized a third dose of Pfizer for those aged 65 and older, all people at high risk of severe disease, and others who are regularly exposed to the coronavirus.
The EU regulator said on Sept. 6 it had begun its evaluation of data submitted by Pfizer and BioNTech for a booster dose to be given six months after the second dose in people 16 years of age and older.