Pfizer asks European drug regulator for approval of Covid vaccine to include children

Pfizer vaccine
PA Wire

Pfizer and BioNTech have sought permission from EU drug regulators to extend the approval of the companies’ Covid-19 vaccine to include children.

The company has requested to use the jab on 12 to 15-year-olds.

This is not the first time they have made such a request - as BioNTech and Pfizer previously requested approval to extend the vaccines use from the US Food and Drug Administration in April.

In a statement on Friday, the two companies said their submission to the European Medicines Agency was based on an advanced study in more than 2,000 adolescents that showed the vaccine to be safe and effective.

The children will continue to be monitored for longer-term protection and safety for another two years.

The move could offer young people in Europe access to the jabs for the first time and German Health Minister, Jens Spahn, welcomed the news.

“This can make a further real difference to our vaccine campaign, if approval is granted,” he told the Associated Press during a visit to a vaccine manufacturing plant in the German town of Reinbek.

The Covid-19 vaccine made by Pfizer and BioNTech was the first one to be granted a greenlight by the EMA last December, when it was licensed for anyone 16 and over across the 27-nation EU bloc.

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