These are the first clinical data on the reaction of children under 12 to the vaccine, while the question of their vaccination arises.
Pfizer / BioNTech vaccine against Covid-19 is “sure” and “Well tolerated” by children aged 5 to 11 and the correct dosage triggers an immune response “robust”, 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 diffusion 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”.
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Side effects “comparable” to the rest of the population
The side effects of the vaccine, dosed at 10 micrograms by injection compared to 30 micrograms usually for the elderly, are “Generally comparable” to those observed in people aged 16 to 25, 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.
Both companies expect to publish “From the fourth trimester” results concerning 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.
In Israel, children aged 5 to 11 at risk of serious complications from Covid-19 have been vaccinated since August 1. It’s about 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.