The FDA is considering authorization of a COVID-19 vaccine for children under the age of five.
Pfizer and BioNTech have developed a vaccine for children under the age of five — without evidence yet that it would be protective.
Has it been tested?
Pfizer and BioNTech confirmed that the FDA had asked them to submit an application for the use of a two dose COVID-19 vaccine. This dose would be for children six months to four years old. Additional details are available here.
Before Christmas, Pfizer announced the results of their clinical trial for kids between two and four years old. Two doses of the COVID-19 vaccine failed to generate antibody levels in range of other age groups.
However, in babies six months to 23 months old, the two dose vaccine was more effective. The level of antibodies generated was similar to the levels seen in 16-25 year old’s. These levels were deemed “to equate with protection.”
In both groups, the vaccines appeared to be safe and having tolerable side effects.
Is this kind of authorization normal?
This dose of the COVID-19 vaccine hasn’t been proven effective for the entire age group by Pfizer. Authorization doesn’t usually happen if there isn’t proof of protection for the entire age group.
This dose could potentially be available sometime this month.
The FDA felt that it would be wise to request Pfizer’s application for the vaccine (aged under five) given the “rise in illnesses and hospitalization in this youngest age group.”