Covid-19: the Pfizer-BioNTech vaccine is “safe” for children aged 5 to 11, according to a study by the two laboratories

Pfizer and BioNTech plan to submit the data to authorities “as soon as possible,” according to a statement.

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Posted on 9/20/2021 1:22 PM Updated 9/20/2021 1:41 PM

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The Pfizer-BioNTech vaccine against Covid-19 is “safe” and “well tolerated” by children aged 5 to 11, according to the results of a study announced Monday, September 20 by the two laboratories. The companies add that the right dosage triggers an immune response “robust” and “comparable” to that seen in 16 to 25 year olds who have received a higher dose vaccine. Pfizer and BioNTech plan to submit the data to authorities “as soon as possible,” according to a statement.

These are the first clinical data for this age group. The European Medicines Agency (EMA) and the US FDA have authorized messenger RNA vaccines from the age of 12. Due in particular to the spread of the Delta variant, “since July, pediatric cases of Covid-19 have increased by 240% in the United States, highlighting the need for vaccination” of the youngest, commented Albert Bourla, CEO of Pfizer. He considered that these data constitute a “solid basis for applications for authorization”.

The side effects of the vaccine, dosed at 10 micrograms by injection against 30 micrograms usually for the oldest, are “in general comparable” to those observed in people 16 to 25 years, note the two laboratories. These are partial results of a study carried out on 4,500 children between 6 months and 11 years old in the United States, Finland, Poland and Spain. The two companies expect to publish results “as early as the fourth quarter” for the age group 2-5 years as well as 6 months-2 years, who received two injections of 3 micrograms. The study on children under 12 for the Moderna vaccine is ongoing.

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