FDA delays highly anticipated meeting about the Pfizer vaccine to young children
Postponement of a highly anticipated meeting of experts to discuss the recommendation of the Pfizer BioNTech COVID-19 vaccination for young children has been made.
According to the Food and Drug Administration, Pfizer informed the agency that new data had recently been obtained regarding the emergency authorization request for Pfizer’s vaccine in children aged 6 months to 4 years.
According to the agency, its preliminary assessment and need for more time to assess additional data prompted it to postpone Tuesday’s meeting.
FDA officials stated in a statement that they believe additional information about the ongoing evaluation of a third dosage should be considered when making decisions regarding potential authorization.
Pfizer, BioNTech and others applied for authorization to administer the first two shots. They were given three weeks apart in a three-shot plan. While the companies collected data for the third dose, Pfizer, BioNTech, and BioNTech waited.
However, the companies issued a statement indicating that they had changed their minds. Access to the COVID-19 vaccine will not be available for children under five years old because of this decision. The statement stated that “Given the rapid progress of the study, the companies will delay the three-dose data as Pfizer & BioNTech continue believe it may provide higher levels of protection for this age group.” “The companies anticipate having three-dose protection data in April,” the statement said.
FDA requires time to review any new data
In a briefing Friday afternoon with reporters, Peter Marks, director at the FDA’s Center for Biologics Evaluation and Research said, “At this point, it makes sense not to wait to evaluate another dose before taking any action.” According to Marks, the agency needed time to analyze the new data from the omicon surge due to the rapid influx of cases.
Three shots are required for young children to receive full immunization. Eight weeks after the first shot, the third shot is not a booster. In December, the companies stated that two shots for children under 5 years old and older didn’t provide the protection expected.
The current vaccine dose is 3 micrograms per shot. This is tenth the amount that is given to teenagers and adults. The dose for children aged 5-11 years is 10 micrograms.
The scheduled meeting would have only considered the first two shots of the immunization series and not all data. This was an unusual regulatory move that could have helped to get vaccination authorizations and moving forward faster. Pfizer and BioNTech stated in a February 1 statement that they applied to authorization this way due to the “urgent public safety need.”
FDA stated that it would make every effort to quickly decide on the expansion of Pfizer’s vaccine for the youngest children.
FDA’s Marks stated that they are aware of the need to develop a vaccine against COVID-19, despite the drop in cases. “We will do everything we can to make sure that things move as quickly as possible.”
