Children from the age of 5 can already be vaccinated.
(Photo: dpa)
Frankfurt According to a newspaper report, the Covid-19 vaccine from Biontech and Pfizer could be available for children under five in the United States by the end of February. The drug companies are expected to file an emergency use authorization application for the dual vaccine for children ages six months to five years with the FDA on Tuesday, the Washington Post reported, citing people familiar with the matter Persons.
The FDA has asked the companies to submit the application so that the agency can begin reviewing the data. A Biontech spokeswoman declined to comment on Tuesday, and Pfizer was initially unavailable for comment. It would be the first available Covid vaccine for this age group.
Mainz-based Biontech and its US partner Pfizer announced in mid-December that they would expand their study on the use of the vaccine in children aged six months to five years to include the administration of a third dose of vaccine at least two months after receiving the second dose. The reason for this was initial data, according to which the effectiveness after two doses in six to 24-month-old children was comparable to that in 16- to 25-year-olds. However, this was not the case in children aged between two and five years, which is why a third dose is now being tested to increase its effectiveness.
If the three-dose study is successful, Biontech and Pfizer plan to submit data to the authorities in the first half of this year in support of an emergency admission for children under five years of age, as the two manufacturers have announced. According to the report, the FDA is stepping up the pace. “We know two cans isn’t enough, and we understand that,” the Washington Post quoted an insider as saying. “The idea is that we should start checking two doses.” That would allow vaccination to start sooner than waiting for data on the third dose to be available. FDA advisors are expected to consider the two-dose application in mid-February.
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In the study, the babies and toddlers received a lower dose of three micrograms per vaccination. Children aged five to twelve years receive two doses of ten micrograms each. From the age of twelve, the dosage is 30 micrograms per dose, as for adults. In the EU, the use of the vaccine from the age of twelve was approved last May and in November from the age of five.
More: Vaccination campaign for children starts – What parents need to know