Until recently, the Pfizer-BioNTech COVID-19 vaccine was available for all individuals 5 years of age and older, while the Moderna vaccine was authorized for individuals at least 18.
Now, the FDA has authorized the use of both vaccines in children from 6 months to four years old. In addition, the agency also agreed to allow the use of the Moderna vaccine in children aged 5 to 17.
“We know that many parents, caregivers and clinicians have been anxiously awaiting today’s authorizations,” said FDA Commissioner Dr. Robert M. Califf in a press briefing. “We’re acutely aware of the importance of having vaccines available for our youngest children. And as we’ve seen with the older age groups, we expect that the vaccines for younger children will provide protection for the most severe outcomes of COVID-19 such as hospitalization and death.”
Califf went on to stress that robust data support the use of safety and effectiveness of the COVID-19 vaccines in young children. “For both vaccines, the immune responses of participants in all age groups were compared to the immune responses of adults in previous studies that determined the vaccines to be effective in preventing COVID-19,” he said.
A CDC advisory panel will likely meet over the weekend to discuss vaccination in young children over the weekend.
On June 15, an FDA advisory committee unanimously supported the authorization of the Pfizer and Moderna vaccines in children as young as 6 months old.
In young children, the Pfizer-BioNTech and Moderna mRNA vaccines will be administered differently. The former will be offered as a three 3-μg dose series, while the latter will be provided in two 25-μg doses.
PFE shares fell 2.25% to $46.44 in mid-day trading, while BNTX shares dropped 1.63% to $127.05. MRNA shares were up 4.81% to $126.91.
Filed Under: clinical trials, Drug Discovery, Infectious Disease
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