Corona pandemic
Biontech vaccination for children receives emergency approval in USA
A dose of vaccine from Pfizer / Biontech
© Patrick T. FALLON / AFP
Not only have many parents and children in the USA waited a long time for this news: The FDA has now given the Biontech / Pfizer corona vaccine emergency approval for use in children. The vaccination should start soon.
The corona vaccine from Biontech / Pfizer has now also received emergency approval in the USA for use in children between the ages of five and eleven. After an FDA advisory panel voted in favor of it on Tuesday, the US Medicines Agency granted emergency approval on Friday. Afterwards, the CDC health authority has to deal with it formally.
This means that the vaccination campaign for the approximately 28 million affected children in the USA can now – as the White House already planned – start in November. Within the next few days, 15 million doses of the vaccine are to be delivered to paediatricians, clinics and pharmacies. The necessary accessories, such as smaller syringes, should also be delivered directly. The vaccine can be stored for up to ten weeks at normal refrigerator temperature, it said.
In Europe, the decision will be made before Christmas
The vaccine from the German manufacturer Biontech and its US partner Pfizer is already approved in the USA for children and adolescents from the age of twelve and for adults. The active ingredients from Moderna and Johnson & Johnson have so far only been approved for use in adults.
Biontech and Pfizer have also applied for approval of their corona vaccine for children of this age group in Europe, as they announced in mid-October. Accordingly, they transmitted the relevant data to the EU Medicines Agency (EMA). A decision by the EMA is planned before Christmas.
According to Biontech / Pfizer, a clinical study showed that the vaccine was “well tolerated” for children of this age group and produced a “strong immune response” one month after the second dose. Compared to adults and adolescents, the five to eleven year olds were given a significantly lower dose of the vaccine. They received the second necessary spades after 21 days. The study included 2,268 children of that age.