Pfizer-BioNTech on Monday, 22 November, said that their COVID-19 vaccine remained 100 percent effective in 12- to 15-year-old children, four months after the second dose.
The companies are hoping that the new data, which involved 2,228 trial participants, will help them get full approval in the United States (US) and worldwide.
Meanwhile, noting that no serious safety concerns were observed in individuals with at least six months of follow-up after the second dose, Pfizer CEO Albert Bourla was quoted as saying, "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,” news agency AFP reported.
Bourla added, "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 and other regulators”.
The US Food and Drug Administration (FDA) had authorised the emergency use of Pfizer-BioNTech COVID-19 vaccine in adolescents aged 12 to 15 years in May this year.
Currently, the vaccine is only fully approved in people aged 16 and older.
The only main safety concern among the 12 to 15 age group is vaccine-linked myocarditis (heart inflammation) in males.
Out of the trial group of 2,228 participants, there were 30 confirmed symptomatic COVID-19 cases without evidence of prior infection, who were all in the placebo group, corresponding to a vaccine efficacy of 100 percent, AFP reported.
(With inputs from AFP.)
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