May 2, 2022 - Health

Pressure builds for COVID vaccines approval for littlest kids

Photo illustration of Robert Califf.

Photo illustration: Aïda Amer/Axios; Photo: Win McNamee/Getty Images

Moderna's request for authorization of its COVID-19 vaccine in children under six years is amping up pressure on the Food and Drug Administration to act quickly on the shots.

Why it matters: Thursday's request from the vaccine maker threw another wrinkle in the delicate regulatory dance over when kids under 5 can be vaccinated at a time when plenty of parents are expressing growing frustration with the wait.

Driving the news: Biden administration officials indicated they would prefer to evaluate data and simultaneously make decisions about how Moderna and Pfizer-BioNTech's vaccines work on small children, to give parents more of a comparison, the New York Times writes. That could take as long as June.

  • That prospect prompted Washington Post columnist Alyssa Rosenberg recently to call for the FDA to "stop treating parents like idiots."
  • "I hear from lots of parents every day, asking, 'Do you know, do you know? When's it going to be approved?'" Jessica Snowden, a doctor at Arkansas Children's Hospital, told the Times.
  • While this is entirely unscientific, my own email inbox of questions from parents would show they've been watching this news as closely as they've been watching the calendar days until their kid's fifth birthday — when they'd qualify for a shot.

What to watch: The FDA announced Friday it held the dates June 8, 21 and 22 for its key advisory committee to discuss the Moderna and Pfizer-BioNTech requests for emergency authorization for kids 5 and under.

A top official told Congress last week that the FDA would not delay any shots and that at least one shot could be available by June.

What he's saying: "I know how concerned parents are," FDA commissioner Robert Califf said on Friday, telling reporters the agency was still waiting for all the data. 'We'll act as quickly as we possibly can," he said.

  • "I have eight grandkids, including two that are between 1 and 4, so I'm very aware personally of the issues that are involved," Califf said.
  • But, he said: "You never know when you get an application what's in it until you look at it ... I know a lot of the people at Moderna from my past life. They're great people. But over the years we learned at the FDA: 'In God we trust. All others must bring data.'"
  • Moderna said in a statement it would finish submitting data from its research trials by May 9.
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