Study on Corona Vaccines for Young Children Submitted to FDA

Study on Corona Vaccines for Young Children Submitted to FDA

Pfizer and BioNTech have studied how young children respond to their corona vaccine and sent the study results to the US regulator FDA. The vaccine makers expect to make a formal application in the coming weeks to get the drug approved via an urgent procedure for the age group 5-11.


The companies’ corona vaccine is already being administered to children from 12 years old in the US and the Netherlands. The US authorities previously took about a month to approve the application for the 12-15 age group. If the upcoming request for even younger children is handled as quickly, that age group could be vaccinated before the end of the year.

Pfizer and BioNTech had already announced earlier this month that the immune system of the younger children also responds in a desirable way to their corona vaccine. This emerged from a study with 2268 participants. As a result, children in the age group 5-11 do receive a much smaller dose of the drug than older children and adults.

The companies are still investigating how effective the drug is in children from six months old. More information about this may become clear later this year. Children are not seen as a vulnerable group during the pandemic but can transmit the virus to other people. Vaccinating young people is also seen as a way to prevent corona outbreaks in schools.

Pharmaceutical company Pfizer does not want the vaccine to be approved only in the United States for children as young as 5 years old. An application is also planned to the European regulator, the Amsterdam-based European Medicines Agency (EMA). However, it is still unclear when exactly that can be expected.

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