- An expert panel will weigh the authorization of Pfizer Inc and BioNTech’s COVID-19 vaccine for children aged 5 to 11.
- The FDA need not follow the advice of its outside experts but usually does.
- Vaccine development is a long, complex process.
- The director of the agency will make the final call.
An expert panel will weigh the authorization of Pfizer Inc and BioNTech’s COVID-19 vaccine for children aged 5 to 11 on Tuesday as it prepares to vote on a recommendation for the US Food and Drug Administration as reported by Money Control.
Vote on recommendation
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 have cleared COVID-19 vaccines for children in this age group and younger.
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 authorized for ages 12-15 since May and cleared for everyone over 16 since December.
Administration of vaccine
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 approval and the recommendation from the CDC, it’s entirely possible if not very likely that vaccines will be available for children from 5 to 11 within the first week or two of November,” top US infectious disease expert Anthony Fauci said on Sunday.
Pediatric vaccinations are crucial
If the number of myocarditis cases in the younger age group turns out to be similar to that in 12- to 15-year-olds, the hospitalizations prevented for COVID-19 would outnumber those prevented for myocarditis in most scenarios analyzed, FDA staff reviewers said.
Pediatric vaccinations are an important public health tool to prevent infectious diseases, even ones that do not cause high rates of mortality or hospitalization for children.
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Source: Money Control
