FDA postpones review of Pfizer data on vaccine for kids under 5
ABC News
The vaccine for kids under five is expected to be a three-dose vaccine.
The Food and Drug Administration on Friday postponed its review of Pfizer’s COVID-19 vaccine for kids under 5.
“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,” Dr. Peter Marks, the FDA’s vaccine chief, told reporters.
Marks acknowledged the change was “late breaking” — the FDA’s committee of independent advisors was scheduled to review and vote on authorizing the vaccine next Tuesday — but said the job of the FDA was to “adjust” to new data amid an unpredictable virus.
Pfizer applied for an emergency use authorization for its vaccine for kids ages 6 months to 4 years nearly two weeks ago. Studies on a three-shot regimen continue, which Pfizer ultimately expects will be the most effective dosage for the youngest age group.
