Moderna Kids Vaccine Review Will Be Unaffected by Pfizer Timing

The FDA will proceed with reviewing Moderna Inc.'s request to authorize its Covid-19 shot for the nation’s youngest children even as a similar vaccine from Pfizer Inc. faces delays, the agency’s head confirmed.

Moderna announced Thursday it applied for emergency use authorization for its Covid-19 vaccine in children from 6 months to under 6 years old. There have been reports that the Food and Drug Administration would wait to authorize Moderna’s under 6 vaccine and Pfizer-BioNTech’s vaccine for children under 5 at the same time, potentially pushing the availability of these vaccines to early summer.

“Most of the experts that I’ve talked with would say it would be ideal if they could be considered together. But if they don’t come in at the same time, then there’s not going to be a hold up on the Moderna application, just to make it come in at the same time,” FDA Commissioner Robert M. Califf told reporters Thursday after an appropriations hearing.

“I can’t really say how this would relate to a Pfizer application until we see what Pfizer has and what the timing is from both groups,” he added.

Moderna’s vaccine is currently only available for adults 18 and older, which is administered in two shots of 100 micrograms each. The kids vaccine that the FDA just started to review offers a lower dose—two shots of 25 micrograms.

Pfizer offers vaccines for everyone 5 and up in various doses. But its application to inoculate the youngest children has faced setbacks after regulators decided in February to wait for more data on the impact of a third dose of its vaccine.

Timeline Unknown

If authorized, the vaccines would offer for the first time Covid-19 vaccines for the youngest age group. Parents of young kids have been pushing the FDA to clear Moderna’s vaccine.

“We’re going to look at it as quickly as we possibly can, while making sure that we do it right,” Califf said.

But the FDA commissioner, who’s a prolific clinical trialist, was reluctant to offer a more specific timeline, noting that unexpected events occur frequently in the clinical trial process. “It’s not good for people to expect the timeline when we don’t really know. So as soon as we know something, we’ll let you know,” he said.

Califf noted that he was very involved in the pediatric rules that required clinical trials in children. “It’s really important for people to understand that as a child goes from birth to 5 years, a lot changes,” he said. “Sometimes the results are different in children, and we just won’t know that until we see the data.”

The commissioner noted he has two grandchildren under 5 himself. “I’m just as anxious or in some ways as anxious as anyone to have the vaccine available.”