This is the coronavirus vaccine for children 6 months to 4 years old. The company decided to wait for data on a three-dose series of the vaccine.
Pfizer-BioNTech postponed its request for the Food and Drug Administration (FDA) to approve its coronavirus vaccine for children 6 months to 4 years old, as reported this Friday from the US pharmaceutical company.
In this way, vaccines for this age group will not be available in the coming weeks, which translates into a setback for parents eager to vaccinate their young children.
According to the news network NBC News, Pfizer communicated its decision to wait for the data on a series of three doses of the vaccine , because they understand that three doses “may provide a higher level of protection in this age group.”
From the company it was indicated that the data on the third dose is expected in early April .
Last December, Pfizer said that two doses did not elicit a strong enough immune response in its trial of children 2 to 4 years old. For young children, Pfizer’s vaccine has a 3-microgram dose, while for boys ages 5 to 11, the dose is higher, at 10 micrograms.
Still, the company applied to the FDA this month to authorize these first two doses, with a plan to submit additional data in the coming weeks on a third dose. The complete vaccination series would be three doses.
The FDA was expected to release an analysis of the Pfizer data in the coming days, ahead of an advisory committee meeting scheduled for next week, but the agency said the meeting has been postponed.
The regulator wanted to start reviewing data on two doses of the vaccine, while Pfizer continued to collect data on a three-dose regimen.
The FDA estimated that two doses would provide sufficient protection, but the increase in pediatric cases due to the Omicron variant of the coronavirus changed their opinion.
Peter Marks, director of the FDA’s Center for Biological Evaluation and Research, explained that after reviewing the company’s two-dose data, they decided they needed to see three-dose data before considering authorization. Marks added that the agency takes its “responsibility to review these vaccines” very seriously.
On Tuesday, Pfizer CEO Albert Bourla told CNBC that the chances are “very high” that the FDA will license the vaccine for young children.
“I think they will be satisfied with the data and approve it,” Bourla said, noting that the regulatory process has yet to unfold.
Pfizer’s two-dose authorization request was an unusual request, given that the first two injections did not work and there is no guarantee that adding a third dose will be sufficient.