Pfizer and BioNTech said Monday that its Covid-19 vaccine remained 100 % effective four months after the second dose in adolescents aged 12 to 15 years based on data from a trial involving 2,228 trial participants.
Pfizer Says Its Vaccine Is 100% Effective In Children 12 to 15 Years Old
WASHINGTON – Pfizer and BioNTech said Monday that its Covid-19 vaccine remained 100 % effective four months after the second dose in adolescents aged 12 to 15 years.
The company said that the additional data, which included 2,228 trial participants, would assist in their application for full approval in the United States and across the world.
There were no severe safety issues in patients who had at least six months of follow-up following 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,” Pfizer CEO Albert Bourla said in a statement.
“This is especially important as we see rates of Covid-19 climbing in this age group in some regions, while vaccine uptake has slowed. We look forward to sharing these data with the FDA (Food and Drug Administration) and other regulators.”
In May, the US granted the vaccine “emergency use authorisation" for teenagers, and the companies aim to seek full approval soon. At the moment, the vaccine is fully licenced for use in people aged 16 and older.
There were 30 confirmed symptomatic Covid-19 cases without evidence of preexisting infection among the 2,228 patients in the placebo group.
This equates to a vaccination effectiveness of 100%. Efficacy was consistently high regardless of gender, race, level of obesity, or comorbidities.
In this age range, the greatest safety issue was vaccine-related myocarditis (heart inflammation) in men.
However, such situations are very uncommon, and studies indicate that the benefits of vaccination continue to exceed the risks.
Covid-19 may induce myocarditis, both in a more severe form and on a more frequent basis.