US to weigh authorisation of Pfizer COVID vaccine for children aged five to 11
The panel's vote is an important regulatory step in getting the vaccine into the arms of millions of children in the US where schools are largely open for in-person learning
An expert panel will weigh authorisation of Pfizer Inc and BioNTech’s COVID-19 vaccine for children aged five to 11 yesterday as it prepares to vote on a recommendation for the US Food and Drug Administration (FDA).
The panel’s vote is an important regulatory step in getting the vaccine into the arms of millions of children in the United States where schools are largely open for in-person learning.
The FDA need not follow the advice of its outside experts, but usually does.
Only a few other countries including China, Cuba and the United Arab Emirates (UAE) have cleared COVID-19 vaccines for children in this age group and younger.
The advisers are expected to pay close attention to the rate of rare cases of heart inflammation called myocarditis that have been linked to both the Pfizer/BioNTech and Moderna vaccine, particularly in young men.
Pfizer and BioNTech are seeking clearance for a lower, 10 microgram dose version of the vaccine in children, versus 30 micrograms for everyone over the age of 12. The shot has been authorised for ages 12-15 since May and cleared for everyone over 16 since December.
The companies have said their vaccine showed 90.7 per cent efficacy against the coronavirus in a clinical trial of children aged five to 11.
After the FDA, a panel to the US Centers for Disease Control and Prevention will make a recommendation on the administration of the vaccine. The director of the agency will make the final call.
“If all goes well, and we get the regulatory