EU regulator to decide on Pfizer booster at the start of October--report

EXCLUSIVE EU regulator to decide on Pfizer booster at the start of October The European Medicines Agency (EMA) expects to decide in early October on the possible use of a booster dose of the Pfizer-BioNTech , COVID-19 vaccine, a source with direct knowledge of the matter told Reuters. Emilio Parodi,Francesco Guarascio Reuters

BRUSSELS, Sept 23 (Reuters) - The European Medicines Agency (EMA) expects to decide in early October on the possible use of a booster dose of the Pfizer-BioNTech (PFE.N), COVID-19 vaccine, a source with direct knowledge of the matter told Reuters.

It will be the EU drugs regulator's first decision on boosters, the source said, after the U.S. Food and Drug Administration on Wednesday authorized a third dose of Pfizer for those 65 and older, all people at high risk of severe disease, and others who are regularly exposed to the virus. read more   ...

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. read more

Moderna (MRNA.O) is also expected to submit data to the EMA this month on its booster dose, an EU document said. ...