Covid vaccine 12-15 years, Pfizer: “100% efficacy and safe”

Two doses of Pfizer-BioNTech’s covid vaccine (30 micrograms each) are 100% effective against Covid-19 in the age group 12 to 15 years, measured from 7 days to over 4 months after the second injection. It is one of the main results of a long-term analysis shared today by the two companies, the American and the German. Safety data also confirmed: the adverse event profile was “generally consistent with other clinical safety data for the vaccine, without serious safety concerns” observed in boys with at least 6 months of safety follow-up after the second dose . The long-term data, Pfizer and BioNTech explain, will now form the basis for the request for full approval of the vaccine in the US also for this segment of the population. This is an additional application for a license for biological products (sBla), already obtained for those over 16. In the States, the vaccine is currently available for 12-15 year-olds based on the authorization for emergency use (Eua), granted by the Fda in May 2021. “We look forward to sharing this data with the FDA and other regulators,” said Albert Bourla, Pfizer president and CEO. These are additional data that “provide further confidence in the safety and efficacy profile of our vaccine in adolescents – he adds – And it is particularly important, as we see that Covid rates increase in this age group in some regions, while the spread of the vaccine has slowed down. ” These are the “first and only long-term data disclosed demonstrating the safety and efficacy of a Covid-19 vaccine in people aged 12-15,” said Ugur Sahin, CEO and co-founder of BioNTech. who spoke in detail about the “strong efficacy and favorable safety profile” observed “among adolescent and adult populations”. The companies plan to submit data for regulatory approvals for this age group in other countries where they were initially granted use permits or equivalent.