Its findings were based on trials involving 4,500 children up to 11 years of age in the United States, Finland, Poland and Spain.
Pfizer and BioNTech intend to ask the European Medicines Agency (EMA) health authority for authorization to administer their vaccine to children under 11 in Europe “as soon as possible”.
Dr Ugur Sahin, CEO and Co-Founder of BioNTech, said in the report: “We are delighted to be able to submit data to regulatory authorities for this group of school-aged children before the start of the winter season. .
“The safety profile and immunogenicity data in children aged 5 to 11 years vaccinated at a lower dose are consistent with those we have observed with our vaccine in other older populations at a higher dose. “
When can children under 12 be vaccinated in France?
Approval in the EU (including France) could be granted by the end of the year, towards the end of November.
This will depend on the time that elapses between the publication of the results by the laboratories and the approval by the European Medicines Agency, as well as by the High Authority of Health in France.
What are the current age group rules in France?
For now, only children and adolescents over 12 years old can receive the Covid vaccine, the Pfizer / BioNTech vaccine having been approved for the 12 to 17 age group in mid-June and Moderna approved in July.
The adoption was prompted in part by the decision to extend the health card program to those under 18 from October, which could prevent some from accessing places like restaurants and cinemas.
The government currently remains focused on immunizing as many adolescents as possible. In the summer, he said he had no plans to vaccinate under 12s.
What are other countries doing for this age group?
Most countries around the world do not currently immunize children under 12. Cuba is the only one to have authorized Covid vaccines for children as young as two.
In the UK, Chief Medical Officers of Health have recommended healthy 12-15 year olds be offered a dose of a Covid vaccine in a bid to minimize disruption to their education.
However, “the health benefits of universal immunization in children and youth under the age of 18 do not outweigh the potential risks,” the Joint Committee on Vaccination and Immunization (JCVI) has so far said. UK.
The JCVI “recommends that children and youth aged 12 and over with specific underlying health conditions that put them at risk for severe COVID-19, should be offered the COVID-19 vaccination” only.
Still, it was reported yesterday that the Pfizer vaccine could be approved for children aged 5 to 11 as early as next month in the United States.
Covid France: More research needed before children under 12 are vaccinated
No vaccines for children under 12, according to the French minister