Pfizer delays request for vaccine for kids under 5
Pfizer said it has postponed its application to the FDA to expand the use of its COVID-19 vaccine for kids under 5.
Pfizer instead will continue with its study on the three-dose vaccine and seek authorization when that data is available.
"We believe additional information regarding the ongoing evaluation of a third dose should be considered as part of our decision-making for potential authorization," Pfizer said.
Dr. Peter Marks, the FDA’s vaccine chief, told reporters Friday, “We realized now, in data that came in very rapidly because of the large number of cases of omicron, that at this time, it makes sense for us to wait until we have the data from the evaluation of a third dose before taking action."
Marks acknowledged that the change was “late breaking” -- the FDA’s committee of independent advisers was scheduled to review and vote on authorizing the vaccine next week -- but said the job of the FDA was to “adjust” to new data amid an unpredictable virus.
“The data that we saw made us realize that we needed to see data from a third dose as in the ongoing trial in order to make the term determination that we could proceed with doing an authorization,” Marks said.
Pfizer has predicted it will be able to submit data on the third dose in early April.
-ABC News' Eric M. Strauss, Cheyenne Haslett