Pfizer Inc. and BioNTech have asked the European Medicines Agency to expand the approval of their coronavirus vaccine to children aged 12 to 15, potentially allowing younger and less at-risk populations in Europe to receive the vaccine for the first time.
The two pharmaceutical companies said in a statement released Friday that their application to the European Medicines Agency is focused on a large study involving more than 2,000 adolescents that found the vaccine to be safe and effective.
For another two years, the children will be tracked for longer-term protection and safety.
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.
The majority of COVID-19 vaccines being distributed around the world are for adults who are at higher risk of contracting the coronavirus.
Vaccinating children of all ages, however, would be crucial in halting the pandemic, particularly because some research suggests that older children could be involved in the virus’s spread.
In the United States, children account for about 13% of COVID-19 incidents.
Although children are much less likely than adults to become critically ill as a result of COVID-19, the American Academy of Pediatrics reports that at least 268 people have died and more than 13,500 have been hospitalized as a result of the virus.
That is more than the number of people who die from the flu in a typical year. A limited number of people have also acquired a serious illness.
Immunization against COVID-19 could also give authorities more interest in reopening schools, as getting children to comply with physical distancing and mask-wearing can be difficult.
AstraZeneca, Moderna, and Johnson & Johnson are among the companies researching whether their COVID-19 vaccines can be used safely in infants.
The COVID-19 vaccine, developed by Pfizer and BioNTech, was the first to be approved by the European Medicines Agency (EMA) in December, when it was approved for use in people aged 16 and up across the EU’s 27 member states.