European regulator to decide on third shot of Pfizer vaccine in October

The European Medicines Agency (EMA) said on Thursday it will decide on whether a third shot of the Pfizer-BioNTech vaccine is needed in October. 

“With an increase in breakthrough cases that we’ve seen over time, we do understand that member states in Europe and countries elsewhere want to consider now the option of a booster, particularly in vulnerable groups and that is why we have been expediting our review,” Marco Cavaleri, the agency’s head of vaccines strategy, said Thursday, Reuters reported. 

EMA said at the beginning of September it was reviewing data given by Pfizer in order to determine if a booster shot is necessary for those above the age of 16. 

“The outcome of this evaluation is expected in early October, unless supplementary information is needed,” Cavaleri said.  

An EU document said Moderna will also be submitting data for a booster shot to the EMA soon, according to Reuters. 

“The evidence is becoming clearer on the need to consider this option for people who may respond poorly to COVID-19 vaccination, such as immunocompromised individuals,” Cavaleri said.

The announcement by the agency comes a day after the U.S. announced that those who are immunocompromised and those older than 65 can receive a third shot of Pfizer’s vaccine. 

A third shot of a vaccine in rich countries has been condemned by some who say the focus should be getting the vaccine to countries where most people haven’t received a single shot.