Pfizer vaccines also for those under the age of 12? The efficacy studies are ongoing and requests for the green light for Pfizer / BioNTech’s Covid vaccine in the 2-5 and 5-11 age groups could arrive in September on the desks of various regulatory bodies. This was announced by the two companies, commenting on the first authorization obtained in the European Union for their shield product for adolescents (yesterday’s announcement by the European drug agency EMA of the green light for the 12-15 age group).
“The pediatric study that is evaluating the safety and efficacy of Pfizer / BioNTech’s Covid vaccine in children between 6 months and 11 years is ongoing,” the note reads. The two companies expect to have definitive readings and, based on the data generated, to be able to “submit an application for authorization for emergency use, for example in the US, or request for a change to the conditional authorization for trade, for example in Europe, for the two cohorts 2-5 years and 5-11 in September “. While the reading of the results and the submission of a green light request for the cohort of children, between 6 months and 2 years, “is expected in the fourth quarter” of the year, therefore between October and December.
Pfizer vaccine 12-15 years: Aifa meeting on Monday
The meeting of the Italian drug agency will be held early next week for Pfizer vaccines to be administered to the 12-15 age group. After the green light from the European Medicines Agency, Aifa’s Technical-Scientific Commission will meet on Monday afternoon – according to what is learned – to examine the dossier on authorization in Italy. Practically discounted authorization, as anticipated by the president of Aifa, Giorgio Palù.
Meanwhile, as regards the green light of the Ema, the doses will be two, with the second dose administered 21 days after the first. “The vaccine response in 12-15 year olds is like that of adults or better,” explains the European Medicines Agency Ema. This is the first Covid vaccine approved for children and young people of this age group in the EU.
The use of the Comirnaty vaccine in children aged 12-15 will be the same as in people aged 16 and over, for which it is already authorized. It is given in two doses, three weeks apart.
“We have data showing that Pfizer / BioNTech’s ‘anti-Covid’ vaccine is safe even in the age of 12-15 and showing that the immune response in this group is similar or even better than what we see in young people. adults “said Marco Cavaleri, head of Vaccines and Therapeutic Products for Covid-19 of the European Medicines Agency (EMA). Looking at the trial data, it emerges that “the vaccine is highly effective in protecting and preventing disease” in this age group.