European regulator recommends Pfizer vaccine for children 12-15

BERLIN — The European Medicines Agency on Friday recommended that the use of the coronavirus vaccine made by Pfizer and BioNTech be expanded to children ages 12 to 15, a decision that offers younger and less at-risk populations across the continent access to a COVID-19 shot for the first time.

The Pfizer-BioNTech vaccine was the first one granted authorization across the European Union in December, when it was given the green light for use in anyone 16 and over. Since then, about 173 million doses have been administered in the EU, which is about three-quarters of all vaccine shots given so far in the 27-nation bloc.

“Extending the protection of a safe and effective vaccine in this younger population is an important step forward in the fight against this pandemic,” said Marco Cavaleri, head of health threats and vaccine strategy at the Amsterdam-based EMA.

The EU regulator authorized the vaccine for younger adolescents after receiving data from the United States showing it to be highly effective against infection. In a study involving 2,000 adolescents, none of those who received the vaccine got COVID-19, compared with 16 in a control group that received a placebo, Cavaleri said.

“The vaccine was well-tolerated, and the side effects in this age group were very much similar (to) what we’ve seen in young adults and not raising major concern at this point in time,” he said.

The EMA decision needs to be rubber-stamped by the European Commission, and national regulators can decide whether the vaccine will be offered to children under 16 in each country.

The recommendation follows similar decisions by regulators in Canada and the U.S. last month, as rich countries slowly approach their vaccination targets for adults and look to immunize as many people as possible.