A highly anticipated meeting of expert advisers to discuss whether to recommend the use of the Pfizer-BioNTech COVID-19 vaccine for young children has been postponed.
The Food and Drug Administration said Pfizer told the agency that new data have recently emerged regarding its emergency use authorization request for the Pfizer vaccine in children 6 months through 4 years of age.
The agency said its preliminary assessment and need to allow more time to evaluate additional data led it to postpone the meeting scheduled for Tuesday, Feb. 15.
“We believe additional information regarding the ongoing evaluation of a third dose should be considered as part of our decision-making for potential authorization,” FDA officials said in a statement.
In young kids, three shots appear necessary to achieve the full immunization. The third shot, given eight weeks after the second, isn’t a booster. The companies said in December that two shots for children older than age 2 but under 5 didn’t prompt the expected protection.
The vaccine dose under regulatory review is 3 micrograms per shot, a tenth of the amount given to adults and teenagers. For children ages 5-11, the dose is 10 micrograms.
The application covering only the first part of the immunization series is an unorthodox regulatory move that could get vaccination moving faster. Pfizer and BioNTech said in a Feb. 1 statement that they applied for authorization this way because of the “urgent public health need.”
They said in the statement that they expected to submit clinical data on the third dose to FDA “in the coming months.”