Pfizer and BioNTech said on Monday that their COVID-19 vaccine was 100% effective in children aged 12 to 15 years after four months of the second dose.
The companies said the new data, which included 2,228 trial participants, would help support their applications for full approval in the United States and around the world.
No serious safety concerns were observed in individuals with at least six months of follow-up after the second dose.
Pfizer CEO Albert Bourla said in a statement, “As the global health community works to increase the number of people vaccinated around the world, these additional data provide further confidence in the safety and effectiveness profile of our vaccines in adolescents.” We do.”
“This is especially important as we see rates of COVID-19 climbing in this age group in some regions while vaccine development has slowed. We look forward to sharing these data with the FDA and other regulators.” Huh.”
The vaccine for teens was given “emergency use authorization” by the US in May, and the companies plan to seek full approval soon. The vaccine is currently only fully approved in people 16 years of age and older.
Among the 2,228 participants, there were 30 confirmed symptomatic COVID cases without any prior infection, all in the placebo group.
This corresponds to a vaccine efficacy of 100 percent. Efficacy was consistently high across gender, race, obesity level and comorbidity status.
The main safety concern among this age group is vaccine-associated myocarditis (inflammation of the heart) in men.
But such cases are rare, and the benefits of vaccination still far outweigh the risks, the data show. COVID itself can cause myocarditis, both more frequently and in more severe forms.
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