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Monday, March 27, 2023

Pfizer and BioNTech ask EU to clear vaccine for 12 to 15-year-olds

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Pfizer and BioNTech have submitted a request for European Union drug regulators to extend the approval of the companies’ coronavirus vaccine to include children aged 12 to 15.

In a statement on Friday, the two companies said their submission to the European Medicines Agency (EMA) 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 younger and less at-risk populations in Europe access to the jabs for the first time.

BioNTech and Pfizer had previously requested their emergency use authorisation with the US Food and Drug Administration to be extended to children aged 12-15.

The Covid-19 vaccine made by Pfizer and BioNTech was the first to be approved by the EMA in December, when it was licensed for anyone aged 16 and over across the 27-nation EU.

German health minister Jens Spahn welcomed the news, saying: “This can make a further real difference to our vaccine campaign, if approval is granted.”

Most Covid-19 vaccines being rolled out worldwide are for adults, who are at higher risk from coronavirus, but vaccinating children of all ages will be critical to stopping the pandemic, especially since some research has shown that older children may play a role in spreading the virus.

Children represent about 13% of Covid-19 cases documented in the US, and while they are far less likely than adults to become seriously ill, at least 268 have died from Covid-19 in the US alone and more than 13,500 have been admitted to hospital, according to a tally by the American Academy of Paediatrics.

That is more than die from flu in an average year. A small number have also developed a serious inflammatory condition linked to coronavirus.

Immunising children against Covid-19 might also give authorities more confidence in reopening schools, since getting children to comply with physical distancing and mask-wearing has been challenging.

Other vaccine manufacturers including AstraZeneca, Moderna and Johnson & Johnson are also studying whether their jabs can safely be used in children

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