The Food and Drug Administration's outside panel of advisers will have a lot to consider this month, as multiple meetings on booster shots and COVID vaccines for kids are now on the schedule.
According to the agency, the Vaccines and Related Biological Products Advisory Committee is scheduled to meet three times in October to discuss whether to recommend emergency use authorization of Moderna and Johnson & Johnson's booster shots and vaccinations for children ages 5 to 11.
The booster shot meetings are slated for Oct. 14-15, where the panel will review booster data from both J&J and Moderna. It’s the first step in a review process that also includes sign-off from the leadership of both the FDA and the Centers for Disease Control and Prevention. If both agencies give the go-ahead, Americans could begin getting J&J and Moderna boosters later this month.
After that, the same panel will consider vaccinations for children under the age of 12. The group will consider whether emergency use authorization should be granted for Pfizer's COVID vaccine for children 5 to 11 years old.
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Chicago's Department of Public Health on Tuesday cited the meetings in a discussion about quarantine guidelines for city schools.
CDPH Commissioner Dr. Allison Arwady said those who received the Moderna and Johnson & Johnson vaccines can expect additional guidance likely around Oct. 20.
But it's the Oct. 26 meeting that Arwady said was "really exciting."
"I know that's a date that a lot of people have been waiting for," she said. "As a reminder, that's just the first step. The FDA has to do its review, and then the CDC comes in and puts more details around it. But if all goes as we have historically seen in terms of timing, and as long as the data of... we'd expect that we may have a vaccine starting to be available for those younger children in early November."
Pfizer and its German partner BioNTech said in a joint release that formal submission to request emergency use authorization of the companies' vaccine for this age group is slated to follow in the coming weeks.
The FDA is expected to take at least several weeks to analyze data collected in a trial that included more than 2,000 kindergartners and elementary school-aged kids.
The two-dose vaccine is already authorized in teens aged 12 to 15 and fully approved for ages 16 and up. But with kids now back in school and the extra-contagious delta variant causing a huge jump in pediatric infections, many parents are anxiously awaiting vaccinations for their younger children.
Meanwhile, Johnson & Johnson asked the FDA on Tuesday to allow extra shots of its COVID-19 vaccine as the U.S. government moves toward expanding its booster campaign to millions more vaccinated Americans.
The timing of the J&J filing was unusual given that the FDA had already scheduled its meeting on the company's data. Companies normally submit their requests well in advance of meeting announcements. A J&J executive said the company has been working with FDA on the review.
“Both J&J and FDA have a sense of urgency because it’s COVID and we want good data out there converted into action as soon as possible,” said Dr. Mathai Mammen, head of research for J&J's Janssen unit.
Bloomberg, citing people familiar with the matter, reported last week that the FDA was leaning toward authorizing half-dose booster shots for those who received Moderna's two-shot mRNA vaccine.
Moderna submitted data to the FDA seeking evaluation for its booster shot on Sept. 1.
“We are pleased to initiate the submission process for our booster candidate at the 50 µg dose with the FDA. Our submission is supported by data generated with the 50 µg dose of our COVID-19 vaccine, which shows robust antibody responses against the Delta variant,” Stéphane Bancel, Moderna's CEO, said in a statement.
Moderna previously released data on breakthrough cases, saying it supports the push for wide use of COVID-19 vaccine booster shots.