On Monday, Pfizer and BioNTech announced that their COVID-19 vaccine remained 100 percent effective in children 12 to 15 years old, four months after the second dose.
Both companies said that the new data, which involved over 2,228 trial participants, will help support their applications for full approval in the United States and across the globe.
So far, no major safety concerns were witnessed in individuals with at least six months of follow-up after the second dose of the vaccine.
“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,” said Pfizer CEO Albert Bourla in a statement.
It should be noted that the vaccine was granted “emergency use authorization” for adolescents by the United States back in May and the companies plan to seek full approval. The vaccine is currently fully approved in people aged 16 and older.
Among a total number of 2,228 participants, there were 30 confirmed symptomatic COVID cases without evidence of prior infection, all in the placebo group.
This, however, corresponds to a vaccine efficacy of 100 percent. Efficacy was consistently high across gender, race, obesity levels, and comorbidity status.
The primary safety concern among this age group is vaccine-linked myocarditis (heart inflammation) in males.
Such cases are very rare, and data has revealed that the benefits of vaccination continue to outweigh the risks. COVID itself can cause myocarditis, both more often and in a more severe form.