“In Europe, we are in the final stages before shipping,” The data from clinical trials at the European Medicines Agency (EMA) and their validation are expected to take four to six weeks, co-founder and director of the company Ugur Sahin told German magazine Spiegel.
This vaccine is currently only approved for people aged 16 and over.
In the United States, BioNTech and its partner Pfizer already filed a request in early April for an extension of the urgent vaccine authorization for adolescents aged 12 to 15.
Authorization requests are based on data from Phase 3 clinical trials in this age group, published at the end of March. “which have been proven to be 100% effective” to prevent disease, according to laboratory tests.
Herd immunity this summer?
The vaccine was also “Well tolerated and side effects are broadly in line with those observed” in people between the ages of 16 and 25, Pfizer and BioNTech added on Friday.
For children aged 5 to 12, Mr. Sahin continues to rely on the results of the clinical trial conducted in July and remains “on track” to obtain approval by early September.
The results of a study on children, even young children, may be available from September.
“Verification lasts from four to six weeks”, Said Mr. Sahin.
On Wednesday, the co-founder of the Mainz laboratory with his wife found it possible “Herd immunity” in Europe “In July, no later than August” and confirmed his “trust” in the effectiveness of the vaccine against the so-called Indian variant of the coronavirus.