Plans to attempt to authorize the Pfizer/BioNTech Covid vaccine for children under 5 before full data are available appear to have run aground.
The Food and Drug Administration on Friday canceled a key meeting planned for next week to discuss the submission, saying that the delay “will give the agency time to consider … additional data.”
Pfizer and BioNTech had previously said they would submit an application for the use of a two-dose vaccine at the FDA’s request, despite concerns that that regimen was not shown to be effective in clinical trials. Now Pfizer and BioNTech say that they will extend their submission until data on a three-dose regimen are available — expected in early April.
“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 agency said in a statement.
The FDA had been publicly contemplating an aggressive timeline for making the shots available to younger children, even before full data are in on an expected three-shot series they would likely eventually receive.
Pfizer announced late last year that in a clinical trial of children aged 2 to 4 years old, two doses of vaccine failed to generate antibody levels on par with those seen in people aged 16 to 25 after two shots. Paradoxically, two doses given to infants aged 6 months to 23 months did generate antibody levels similar to those seen in the 16- to 25-year-olds, levels that are deemed to equate with protection.
The companies said on Feb. 1 that they were asked by the FDA to submit an application for the use of a two-dose vaccine in children 6 months to 4 years old. Data on a third shot would be submitted to regulators when they became available in the spring. Some outside experts have characterized this strategy as aggressive and unusual, and have worried it could backfire by making some parents less inclined to vaccinate their kids.
Story continues at: Back off Jab