A HIGHLY anticipated meeting between U.S. Food and Drug Administration expert advisors on the Pfizer vaccine for children under five years of age has been postponed.
The meeting was to discuss whether or not to recommend the use of the Pfizer-BioNTech Covid-19 vaccine for the youngest age group.
According to the U.S. health regulator, the agency recently received new data from Pfizer pertaining to its emergency use authorization request for the vaccine to be administered to children between 6 months and 4 years of age.
The FDA said it needed more time to evaluate this additional data, hence the postponement of the meeting.
Pfizer and BioNTech did not meet a key target in their clinical trial of children 2 to 4 years of age, but submitted their data for emergency use authorization of this vaccine at the FDA’s request.
According to Reuters, the FDA had 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 5- to 11-year-olds and 30 micrograms for people 12 years and older.
However, the companies said they expect to have an ample supply of the three-microgram shots should the FDA authorize the vaccine.
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 Janet 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 5 years of age, with a third booster dose approved for individuals 12 years of age or older.
