Vaccine manufacturers ask EU to clear jabs for 12-year-olds

Pfizer and BioNTech have filed with European Union drug regulators to extend approval of the companies’ Covid-19 coronavirus vaccine to children ages 12-15.

In a statement on Friday, the two companies said their filing with the European Medicines Agency (EMA) was based on an advanced study of more than 2,000 teenagers that showed the vaccine was safe and effective.

The children will be monitored for long-term protection and safety for another two years.

The move could give younger and less vulnerable populations in Europe access to the bumps for the first time.

BioNTech and Pfizer had previously filed with the US Food and Drug Administration to extend their emergency approval to children ages 12-15.

The Covid-19 vaccine, manufactured by Pfizer and BioNTech, was the first to be approved by the EMA in December when it was approved for people aged 16 and over in the EU of 27 countries.

Federal Health Minister Jens Spahn welcomed the news and said: “This can make another real difference for our vaccination campaign if the approval is given.”

.

Leave a Comment