Pfizer and BioNTech yesterday announced promising results for their Covid-19 vaccine in young children aged 5 to 11 years. This is the first clinical data for this age group. The two laboratories have thus announced that they want to apply for provisional authorization in the United States and then in Europe.
Pfizer-BioNTech vaccine is "safe" and "well tolerated" by children aged 5 to 11 years
Pfizer and BioNTech unveiled on Monday, September 20, 2021, that their Comirnaty vaccine against Covid-19 has shown promising results in children aged 5 to 11 years. Indeed, according to the results of a phase 2 study, "in participants aged 5 to 11 years, the vaccine is safe, well tolerated and has robust responses in neutralizing antibodies" as stated by the American giant Pfizer and its German partner in a statement.
These partial results are based on data from 2,268 children who received two injections as part of this study. According to the scientists, the administration of a lower dose (10 micrograms per injection versus 30 micrograms for individuals over 12 years of age), twice and three weeks apart, resulted in a "strong response" in antibodies and side effects comparable to those observed for 16-25 year olds.
Soon results for 2-5 years and 6 months-2 years
If this is the first clinical data for the 5-11 age group, 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 4500 children participated in the study through 90 clinical trials. For this reason, Pfizer and BioNTech announced that "the first results for the other two age cohorts of the trial (children aged 2 to 5 years and children aged 6 months to 2 years) are expected as early as the fourth quarter of this year". The latter received two injections of 3 micrograms.
Application for provisional authorization in the United States and then in Europe
While waiting for the results for the smallest, the laboratories have announced that they want to apply for an emergency use authorization from the US authorities (the FDA) with a view to vaccinating 5-11 year olds. They also said they wanted to get an update of their conditional marketing authorisation in Europe. Faced with these promising results, Dr. Ugur Sahin, CEO and co-founder of BioNTech said: "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."
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