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EMA head sees OK for BioNTech vaccine in 12-year-olds potentially in late May

FILE PHOTO: Empty vials of the Pfizer-BioNTech coronavirus disease (COVID-19) vaccine are seen at The Michener Institute, in Toronto, Canada January 4, 2021 in this file photo. REUTERS/Carlos Osorio

FRANKFURT (Reuters) - Pfizer and BioNTech’s COVID-19 vaccine could potentially receive European approval for use in 12-year old children as early as the end of this month, the EU drug regulator’s executive director told daily Handelsblatt.

“At the moment, the target we give for approval is sometime in June. We are trying to see whether we can accelerate this to the end of May,” European Medicines Agency (EMA) head Emer Cooke was quoted as saying in a joint interview by Handelsblatt and other European newspapers.

“We have been promised data from the review done by Canada in the next couple of weeks and this could expedite the review,” she said, adding that it was up to EU member states when to start giving the shot to the 12-15 year-old age group after EMA’s go-ahead.

EMA started evaluating here use of the Comirnaty-branded vaccine in the 12-15 age group on May 3, saying it expected the results of its review in June.

U.S. regulators authorised the vaccine for 12-year olds on Monday. It had previously been cleared for use in people as young as 16 in the United States and in Europe.

Reporting by Ludwig Burger, editing by Louise Heavens