KUALA LUMPUR, Nov 25 — Pfizer-BioNTech’s Covid-19 vaccine is 100 per cent effective in preventing the disease among young adolescents, based on a longer-term analysis of Phase 3 trials.
The follow-up data from Phase 3 trials showed that the two-dose series vaccine prevented Covid-19 completely among kids aged 12 to 15, with no serious safety concerns identified, measured from seven days to over four months after the second dose.
“As the global health community works to increase the number of vaccinated people around the world, these additional data provide further confidence in our vaccine’s safety and effectiveness profile in adolescents,” Albert Bourla, Chairman and Chief Executive Officer of Pfizer mentioned in a statement on November 22.
“This is especially important as we see rates of Covid-19 climbing in this age group in some regions, while vaccine uptake has slowed.”
Bourla stated that the company will share its findings to the United States Food and Drug Administration (FDA) and other regulators to get expanded approval of the vaccine usage for adolescents aged above 12.
The FDA granted emergency use authorisation for Pfizer-BioNTech’s Covid-19 vaccine for children aged 12 to 15 in the US last May.
“These are the first and only disclosed longer-term data demonstrating the safety and efficacy of a Covid-19 vaccine in individuals 12 to 15 years of age,” Ugur Sahin, CEO and co-founder of BioNTech, mentioned in the joint Pfizer-BioNTech statement.
“The growing body of data we have compiled from clinical trials and real-world surveillance to date strengthen the base of evidence supporting the strong efficacy and favourable safety profile of our Covid-19 vaccine across adolescent and adult populations.”
The data collected among 2,228 participants, from November 2020 to September 2021, revealed there were no serious safety concerns identified, following up for a period of at least six months after the second dose.
Malaysia’s National Pharmaceutical Regulatory Agency (NPRA) conditionally approved Pfizer-BioNTech’s Covid-19 vaccine for use in children aged 12 years and above last June and started offering the shots from September.