The Food and Drug Administration (FDA) postponed the meeting of an expert panel in which they would analyze whether to recommend an emergency use authorization for the vaccine Pfizer-BioNTech vs. COVID-19 in children from 6 months to four yearsto give the pharmaceutical company time to evaluate new data on a third dose for this age group.
The regulatory agency was to meet on February 15, but the pharmaceutical company withdrew its request and asked for time to submit new information.
The federal agency had asked the multinational to submit an application for the emergency use of extremely low doses to be administered to minors, despite the fact that the clinical trials had not concluded, due to the effects that the omicron variant has had on this population.
However, the FDA backed down, admitting that it needed to wait for full trial data on the effectiveness of two doses of the vaccine and whether a third injection was necessary. Pfizer said that they expect to have the data by the beginning of April.
“In December 2021, Pfizer and BioNTech announced that the ongoing clinical study would evaluate a third dose of 3 µg (micrograms) at least two months after the second dose of the two-dose series in this age group. As the study proceeds at a rapid pace, the companies will wait for data from the third dose, as Pfizer and BioNTech continue to believe it may provide a higher level of protection in this age group,” Pfizer said in a statement.
“The extension gives the FDA time to receive updated data on the two- and three-dose regimen, conduct a thorough evaluation of the regimen, and facilitate a robust and public debate,” the drugmaker added.
The director of the FDA’s division of vaccines, Dr. Peter Marks, said he hopes parents can understand that the decision to postpone dosing in this population is part of the mechanisms of carefully reviewing the data before taking a decision.
“We take this responsibility to review the efficacy of vaccines very seriously because we are parents, too,” Marks said.
Preliminary data collected by Pfizer showed that two small doses were safe for children under five and promoted a good immune response even in babies up to six months old. However, the two-dose cycle was less effective in children between two and four years of age.
Similarly, the study on the effectiveness of a reduced third dose has not been completed, so the FDA would have deliberated whether or not to authorize two injections with the potential to have to approve a third dose later, an unusual move.
Some 18 million children in this age group do not currently qualify to be vaccinated against COVID-19.