Pfizer-BioNTech Covid Shot Cleared for Children in Europe

(Bloomberg) -- European regulators cleared Pfizer Inc. and BioNTech SE’s Covid-19 vaccine for children ages 12 and up, preparing the way for mass inoculations of younger teenagers across the continent.

The European Medicines Agency is expanding authorization of the shot, which is already cleared for people as young as 16, it said in a statement on Friday. The green light gives Europe, whose immunization campaign was initially fraught with difficulties, the first vaccine in its arsenal for younger children.

“It’s an important step in the fight against the pandemic,” said Marco Caveleri, the regulator’s head of biological health threats and vaccines strategy.

Germany, Europe’s largest economy, has already outlined plans to inoculate younger teens and will expand inoculations to those ages 12 and older starting June 7. Europe follows U.S. regulators, who authorized the vaccine for young teens earlier this month. President Joe Biden has since asked states to make shots available immediately to help children return to schools and summer camps safely.

New York-based Pfizer and Germany’s BioNTech said in March that their two-shot Comirnaty-branded vaccine was 100% effective in the 12-to-15 age group in a final-stage trial. The shot produced antibodies exceeding the level in vaccinated young adults and didn’t result in any new or worrisome side effects.

The duo sought authorization from the EMA at the end of April. Caveleri said trials raised no major concerns about using the shot on adolescents.

The 27-nation EU is relying on Pfizer and BioNTech to help it accelerate an immunization campaign that still lags behind the U.K. and U.S., even after gaining ground in recent weeks. The bloc has committed to buying another 1.8 billion doses from the partners through 2023, some of which will be used for children.

“Now we have data that show the vaccine is safe also in the age of 12-15 years,” Cavaleri said. “It will be up to each individual member state to decide if and when to use the vaccine in adolescents in the future.” He added that he expects Moderna Inc. to seek authorization to use its shot for teens soon.

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