EU Watchdog Studying Data on Pfizer COVID-19 Vaccine Booster Dose

By Reuters Staff

September 07, 2021

(Reuters) - Europe's medicines regulator said on Monday it was evaluating data on a booster dose for Pfizer/BioNTech's COVID-19 vaccine, to be given six months after the second dose in people 16 years of age and older.

The drugmakers filed an application with the European Medicines Agency (EMA) which said it would carry out a speedy evaluation of the data, with an outcome expected "within the next few weeks".

On Friday, U.S.-based Moderna said it had asked the EMA for conditional approval of a booster shot of its coronavirus vaccine at a 50 microgram dose. Moderna's and Pfizer's two-dose shots are both based on new mRNA technology.

The EMA on Monday also said it was assessing data on the use of an additional dose of mRNA vaccines in people with weak immune systems. The outcome of that review would be given in due course, it said.

Last week, the European Centre for Disease Prevention and Control said there was no urgent need for booster doses of COVID-19 vaccines for the fully vaccinated.

The United States is, however, gearing up to roll out booster doses, after top U.S. infectious disease expert Anthony Fauci said on Sunday that officials were likely soon to get the regulatory go-ahead for booster shots from Pfizer.