Pfizer and BioNTech yesterday announced promising results for their Covid-19 vaccine in young children aged 5 to 11. These are the first clinical data for this age group. The two laboratories have thus announced that they want to apply for a provisional authorization in the United States and then in Europe.
Pfizer-BioNTech vaccine is “safe” and “well tolerated” by children 5 to 11 years old
Pfizer and BioNTech unveiled this Monday, September 20, 2021, that their Comirnaty vaccine against Covid-19 has shown promising results in children aged 5 to 11. Indeed, according to the results of a phase 2 study, “ in participants aged 5 to 11 years, the vaccine is safe, well tolerated, and exhibits robust neutralizing antibody responses As stated by the American giant Pfizer and its German partner in a press release.
These partial results are based on data from 2,268 children who received two injections in this study. According to the scientists, administering a lower dose (10 micrograms per injection versus 30 micrograms for individuals over 12 years of age), twice and three weeks apart, resulted in ” strong response »In antibodies and side effects comparable to those observed for 16-25 year olds.
Soon results for 2-5 year olds and 6 month-2 year olds
If these are the first clinical data for the 5-11 age group, the laboratories should soon publish results for two other age groups: 6 months to 2 years and 2 years to 5 years. . In total, more than 4,500 children took part in the study through 90 clinical trials. Therefore, Pfizer and BioNTech announced that “ the first results for the two other age cohorts of the trial (children 2 to 5 years old and children 6 months to 2 years old) are expected as early as the fourth quarter of this year “. The latter received two injections of 3 micrograms.
Request for provisional authorization in the United States and then in Europe
While awaiting the results for the little ones, the laboratories have announced that they want to request an authorization for emergency use from the American authorities (the FDA) with a view to vaccination for 5-11 year olds. They have also said they want to get an update of their conditional marketing authorization in Europe. Faced with these promising results, Dr Ugur Sahin, CEO and co-founder of BioNTech declared: “ 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. “.
