COVID-19 vaccine from Pfizer Inc. and BioNTech SE showed 100% efficacy in a Phase 3 trial in adolescents 12 to 15 years of age with or without prior evidence of SARS-CoV-2 infection. Also Read: COVID-19 vaccination: Pregnant women pass immunity against coronavirus to their babies
Phase 3 trial details: The trial registered 2,260 adolescents 12 to 15 years of age in the United States. Also Read: Coronavirus and Pregnancy: Bringing new life into the world during COVID-19 pandemic
- In the trial, 18 cases of COVID-19 were observed in the placebo group (n=1,129) versus none in the vaccinated group (n=1,131).
- Vaccination elicited coronavirus-neutralizing antibody, representing strong immunogenicity in a subgroup of youngsters a month after the second dose.
What does it mean: Company plans to submit the data to FDA and other regulators around the world as a proposed amendment to Emergency Use Authorization with the hope of starting to vaccinate this age group before the start of the next school year. Also Read: COVID-19 and Pregnancy: Nine things to know about coronavirus if you are pregnant
CEO speaks: Albert Bourla of Pfizer said, “We share the urgency to expand the authorization of our vaccine to use in younger populations and are encouraged by the clinical trial data from adolescents between the ages of 12 and 15.”
Ugur Sahin, CEO and Co-founder of BioNTech, said: “Across the globe, we are longing for a normal life. This is especially true for our children. 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. 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.”