Pfizer and BioNTech said Monday that their COVID-19 vaccine is still 100 percent effective in children ages 12 to 15, four months after the second dose.
The companies said the new data, which includes 2,228 participants in the trial, will help support their applications for full approval in the United States and around the world.
No serious safety concerns were observed in individuals who had at least six months of follow-up after the second dose.
“As the global health community works to increase the number of people being vaccinated worldwide, this additional data provides more confidence in the vaccine’s safety and efficacy profile in adolescents,” Pfizer CEO Albert Burla said in a statement.
“This is particularly important because we are seeing rising rates of COVID-19 in this age group in some areas, while vaccine uptake has slowed. We look forward to sharing this data with the Food and Drug Administration and other regulators.”
The vaccine was granted an “emergency use authorization” for teens by the United States in May and the companies plan to gain full approval soon. The vaccine is currently only approved for people 16 years of age or older.
Of the 2,228 participants, there were 30 confirmed cases of Covid symptoms without evidence of previous infection, and all were in the placebo group.
This corresponds to a vaccine efficacy of 100 percent. Efficacy was consistently high across levels of gender, race, obesity, and comorbidity status.
The main safety concern among this age group is vaccine-associated myocarditis (carditis) in males.
Data has shown that such cases are very rare, and the benefits of vaccination still strongly outweigh the risks. Covid disease itself can cause myocarditis, more often and more severely.
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