The Pfizer- BioNTech COVID-19 vaccine has actually shown one hundred percent effectiveness and robust antibody actions in a Phase 3 trial in teenagers 12 to 15 years of age, the 2 business revealed on Wednesday.
The trial registered 2,260 teenagers 12 to 15 years of age in theUnited States In the trial, 18 cases of COVID-19 were observed in the placebo group versus none in the immunized group.
The vaccine, BNT162b2, generated SARS-CoV-2-neutralising antibody geometric mean titers (GMTs of 1,239.5, showing strong immunogenicity in a subset of teenagers one month after the 2nd dosage, according to a report of the 2 business.
The results surpassed those taped previously in immunized individuals aged 16 to 25 years of ages, stated the report.
“The initial results we have seen in the adolescent studies suggest that children are particularly well protected by vaccination, which is very encouraging given the trends we have seen in recent weeks regarding the spread of the B.1.1.7 UK variant,” stated Ugur Sahin, CEO and co-founder of BioNTech.
“It is very important to enable them to get back to everyday school life and to meet friends and family while protecting them and their loved ones,” Sahin stated.
The 2 business prepare to send these information to the U.S. Food and Drug Administration (FDA and the European Medicines Agency as quickly as possible to demand growth of the Emergency Use Authorisation and EU Conditional Marketing Authorization for BNT162b2.
“We plan to submit these data to FDA as a proposed amendment to our Emergency Use Authorisation in the coming weeks and to other regulators around the world, with the hope of starting to vaccinate this age group before the start of the next school year,” stated Albert Bourla, Chairman and Chief Executive Officer of Pfizer.
The FDA authorised Pfizer- BioNTech COVID-19 vaccine for emergency situation usage in the United States in December in 2015.
The vaccine, the very first that got FDA approval in the nation, was authorised for usage in people 16 years of age and older.