AN expert panel of advisers to the U.S. Food and Drug Administration will meet on Feb. 15 to discuss the authorization of the Pfizer-BioNTech Covid-19 vaccine for children under five years of age.
The biotechnological companies did not meet a key target in their clinical trial of children two to four years of age, but submitted their data for emergency use authorization of this vaccine at the FDA’s request.
According to Reuters, the FDA requested that the companies submit their data in order to address an urgent public health need in the age group, following the rise of cases positive for the Omicron variant of Covid-19.
Pfizer and BioNTech are requesting emergency use authorization for two doses of a planned three-dose regimen.
The third dose is anticipated to be administered eight weeks after the second dose.
The companies have been testing a three-microgram dose of the vaccine in the age group, compared with a 10-microgram dose in five- to 11-year-olds and 30 micrograms for people 12 years old and older.
However, the companies said they expect to have ample supply of the three-microgram shots should the FDA authorize the vaccine.
In a public statement, FDA Commissioner Janet Woodcock said having a safe and effective vaccine available for children in this younger age group is a priority.
If the expert panel of advisers to the FDA recommend this pediatric Covid-19 vaccine for emergency use, it will then go to FDA Commissioner Woodcock for approval.
Upon her approval, the vaccine will still need to be signed off by an expert panel of advisers to the U.S. Centers for Disease Control and Prevention, and ultimately, CDC Director Dr. Rochelle P. Walensky.
If approved, this Covid-19 vaccine will be the first to be approved for administration to children in this younger age group.
Currently, the vaccine is only approved for emergency use in individuals at least five years of age, with a third booster dose approved for individuals 12 years of age or older.
As of Wednesday afternoon, 99.4% of the eligible population in the CNMI had been fully vaccinated against Covid-19.
