Biontech applied for EU approval for five- to 11-year-olds

Spread the love

Read Time:51 Second

German pharmaceutical company Biontech and its U.S. partner Pfizer have now filed for European approval of their Corona vaccine for children ages five to 11. Both said Friday that they had submitted clinical trial data to the EU’s Medicines Agency (EMA) in Amsterdam. The same data have already been submitted to the U.S. Food and Drug Administration. An emergency pediatric application was filed there on Oct. 7.

According to Biontech and Pfizer, the clinical trials show that the vaccine is well tolerated by children in this age group and produces a stable immune response. Unlike adolescents, children in this age group were given only one-third of the dose. According to the companies, a total of 4,500 children between the ages of six months and eleven years are participating in the study; data on five- to eleven-year-olds are based on 2,268 participants. More than 90 clinics in the United States, Finland, Poland and Spain were involved.