EU approves Biontech/Pfizer vaccine for adolescents
The decision theoretically extends the reach of the vaccine, which is approved in the EU for use in uninfected individuals over the age of 16. Although experts estimate that the targeted herd immunity will not be achieved until 70-80% of the EU population has been vaccinated, national vaccination authorities such as the German STIKO are hesitant to recommend it because of concerns about the vaccines benefit-to-risk ratio. EU-wide, the proportion of children and adolescents is just under 20%.
The EMA, however, believes the benefits of Comirnaty outweigh the risks in the 12- to 16-year-old age group. However, it also said that given the limited number of study participants (2,260), rare side effects could not yet be identified.
Targeting the U.S. market first in this age group is U.S. competitor Moderna Inc. which has now started rolling data submissions to the FDA and is seeking Emergency Use Authorization in the U.S. A few days earlier, the company announced that it had met the primary endpoint in Phase III trials.