The lower dose of its two-shot vaccine triggers a healthy and robust immune response in children in this age group.
As for even younger age groups, BioNTech said it has laid out plans to seek approval for the vaccine in children between 6 months and 2 years old later this year.This news comes months after the Food and Drug Administrationin the United States. In early May, the agency amended the current emergency-use authorization to reflect the extended age minimum and include this adolescent group.
That announcement came less than a week after reports revealed Pfizer was expecting to apply to the FDA in September fornone of the 2,260 12- to 15-year-old subjects of its clinical trial who received the vaccine developed symptomatic infections , a sign of significant protection. The drug company said the volunteers produced strong antibodies and experienced side effects similar to those aged 16 to 25.
After it was authorized by the FDA, an immunization advisory committee within the Centers For Disease Control and Prevention met to determine if the CDC would recommend its use in the new age group. This authorization — which, like the adult vaccine, came much earlier than anticipated — opened up the US vaccination campaign to millions more individuals and was another major step forward in raising the level of immunity in the population, with the ultimate goal to lower the amount of hospitalizations and deaths.
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