Pfizer postpones FDA request for COVID vaccine for kids under 5
Pfizer and BioNTech announced Friday that they are postponing their application to the Food and Drug Administration for the companies' COVID-19 vaccine for children between the ages of six months and four years old.
The big picture: The companies said they "will wait for the three-dose data" because they "believe it may provide a higher level of protection in this age group."
- Data on a third dose is expected to become available in early April.
Details: "The trial in children 6 months through 4 years of age is ongoing and data on the first two ... doses in this age group are being shared with the FDA on an ongoing basis," Pfizer said in a statement.
- "Cases continue to accumulate according to the study protocol and more data are being generated because rates of infection and illness remain high in children of this age, especially due to the recent Omicron surge," the company added.
- "The extension allows the FDA time to receive updated data on the two and three-dose regimen, conduct a thorough evaluation of it and facilitate a robust, public discussion."
What they're saying: The FDA later said that it is postponing its advisory panel meeting for the Pfizer-BioNTech vaccine — originally scheduled for Feb. 15 — after it was notified by the companies "that new data have recently emerged regarding its emergency use authorization request."
- "As part of its rolling submission, the company recently notified the agency of additional findings from its ongoing clinical trial."
- "Based on the agency’s preliminary assessment, and to allow more time to evaluate additional data, we believe additional information regarding the ongoing evaluation of a third dose should be considered as part of our decision-making for potential authorization," the FDA added.
Catch up fast: Pfizer asked the FDA to authorize its vaccine for children 6 months to 4 years old earlier this month.
- At the time, Pfizer said its vaccine would be available for kids in that age group as a two-dose regimen. However, data showed that two doses did not produce a sufficient immune response in children aged 2 years old to 4 years old.
Between the lines: The decision by regulators on the vaccine for children under 5 was highly awaited, but considered to be controversial due to ongoing questions around its effectiveness.
Editor's note: This headline has been corrected to note that Pfizer postponed its FDA request, not withdrew it.