The Pfizer / BioNTech vaccine against Covid-19 is "safe" and "well tolerated" by children aged 5 to 11 and the right dosage triggers a "robust" immune response, according to the results of a study announced Monday by the laboratories.
The two companies plan to submit this data to the authorities "as soon as possible", according to a statement, which specifies that the immune reaction was "comparable" to that observed in 16 to 25 year olds who received a higher dose vaccine.
These are the first clinical data for this age group.
The European Medicines Agency (EMA) and the US FDA have authorized Pfizer / BioNTech and Moderna vaccines, based on messenger RNA technology, 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", commented Albert Bourla, CEO of Pfizer, seeing in the data a "solid basis for authorization requests".
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 2-5 year old age group as well as the 6 month-2 year old group, who received two injections of 3 micrograms.
The study on children under 12 for the Moderna vaccine is ongoing.
In Israel, children aged 5 to 11 at risk of serious complications from Covid-19 have been vaccinated since August 1.
This is a "special authorization" without waiting for clinical data, and each injection is "studied on a case-by-case basis", according to the Ministry of Health.
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