Covid: Pfizer and BioNTech announce first positive results for their vaccine over 5-11 years

Posted on Sep 20, 2021 at 2:17 PMUpdated Sep 20, 2021, 3:14 PM

Still first. The Pfizer and BioNTech laboratories unveiled this Monday the partial results of the clinical trial of their vaccine against Covid-19 on children aged 5 to 11. According to them, Comirnaty is “safe” and “well tolerated” by children aged 5 to 11. The “robust” immune response is “comparable” to that seen in 16 to 25 year olds who received a higher dose vaccine.

For the time being, this vaccine is only authorized in the United States as in the European Union for more than twelve years. But these first data could pave the way for an extension of the marketing authorization and the vaccination of the youngest. The two companies plan to submit this data to the authorities “as soon as possible”.

The injections have already started

The study, the results of which have just been published are partial, is carried out on 4,500 children between 6 months and 11 years old in the United States, Finland, Poland and Spain. Children aged 5 to 11 received a dose of 10 micrograms compared to 30 for those over 12 years old. The side effects are “generally comparable” to those seen in 16-25 year olds.

The two companies expect to publish results “from the fourth quarter” on 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. 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.

In France, data reported by the Ministry of Health shows 492 vaccinations of children aged 5-9 and 8,700 aged 10-11. Here again, these are children who present very serious risk factors in the event of Covid-19 contamination and who therefore justify disregarding the marketing authorization.

A Delta variant more virulent on children?

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,” recalled Albert Bourla, CEO of Pfizer. In addition, the vaccination of the youngest could make it possible to achieve collective immunity because if children are less at risk of serious forms, they can be vectors of the coronavirus.

However, this raises ethical questions. The authorization of a vaccine is based on the assessment of the benefit / risk balance. However, even if the risks appear low in view of the data transmitted by the laboratories, it is still necessary that the individual and collective benefits be considered sufficiently important to open vaccination to children.

With AFP

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