Pfizer Inc. and BioNTech have submitted a request to the European drug regulator for the approval of their coronavirus vaccine to be extended to include children 12 to 15 years old, in a move that could offer younger and less at-risk populations in Europe access to the shot for the first time.
In a statement Friday, the two pharmaceuticals said their submission to the European Medicines Agency is based on an advanced study in more than 2,000 adolescents that showed their vaccine to be safe and effective. The children will continue to be monitored for longer-term protection and safety for another two years.
BioNTech and Pfizer have previously requested their emergency use authorization with the U.S. Food and Drug Administration also be extended to children 12 to 15 years old.
German Health Minister Jens Spahn welcomed the news that the vaccine might soon get the green light for older children.
“This can make a further real difference to our vaccine campaign, if approval is granted,” he said on the sidelines of a visit to a vaccine manufacturing plant in the German town of Reinbek.
Most COVID-19 vaccines being rolled out worldwide are for adults, who are at higher risk from the 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 U.S. And while children are far less likely than adults to get seriously ill, at least 268 have died from COVID-19 in the U.S. alone and more than 13,500 have been hospitalized, according to a tally by the American Academy of Pediatrics. That’s more than die from the flu in an average year. A small number have also developed a serious inflammatory condition linked to the coronavirus.
Immunizing 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 sometimes been challenging.
Other COVID-19 vaccine manufacturers including AstraZeneca, Moderna and Johnson & Johnson are also studying whether their shots can safely be used in children.
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.