Covid-19 vaccine authorization for younger children delayed as FDA seeks more data

CNN

Parents will have to keep waiting to find out when their youngest children can get a Covid-19 vaccine.

Pfizer and BioNTech filed a request with the US Food and Drug Administration in the first week of February for an emergency use authorization of their vaccine in children 6 months to 5 years old. The FDA’s Vaccines and Related Biological Products Advisory Committee was scheduled to meet February 15 to go over data from vaccine trials and make a recommendation and whether a two-dose vaccine regimen should be authorized.

But the FDA announced Friday that it had postponed the meeting because “new data have recently emerged.”

The agency needs to see data from an ongoing trial of a third vaccine dose in these younger children in order to move forward with emergency use authorization, Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said during a news briefing.

Pfizer and BioNTech said Friday that they expect to have data on three doses available in early April.
Information came in “so rapidly” during the Omicron wave “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 said.

“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 determination that we could proceed with doing an authorization.”

The delay is a sharp change of pace.

There are about 18 million children ages 6 months through 4 years in the United States who would be eligible for the vaccine. Jeff Zients, the White House’s coronavirus response coordinator, said Wednesday that planning was well underway to roll out vaccines, needles and syringes as soon as the FDA made an authorization decision. A US Centers for Disease Control and Prevention planning document posted online had said deliveries could begin as soon as February 21.