WASHINGTON (Washington Insider Magazine) – The Food and Drug Administration established preliminary dates in June for a public evaluation of COVID-19 vaccinations for young children in the United States, which is usually the last step before the doses are approved.
According to ABC NEWS, the meeting comes after months of dissatisfaction from parents eager to vaccinate their young children, as well as comments from legislators lamenting the sluggish pace of the procedure.
The FDA announced that its outside committee of vaccine experts would meet on June 8, 21, and 22 to consider petitions for child vaccinations from Pfizer and Moderna. The dates are tentative, and the FDA stated that further information will be provided once each firm completes its application.
While speculation has spread over what’s taking so long, FDA Commissioner Robert Califf said on Friday that the agency won’t be able to review the vaccinations until all of the data is in.
Pfizer’s vaccine is now only available to children aged 5 and up in the United States, keeping 18 million younger kids vulnerable.
Moderna presented data to the FDA on Thursday in the aim of proving that its 2 low-dose vaccines can protect infants under the age of six. Moderna has submitted FDA petitions for older children, but the agency has yet to make a decision. It’s unclear whether those data youngsters will be taken into account during the June sessions.
Pfizer is scheduled to report shortly if 3 of its much smaller-dose injections are effective for the tiniest children, months after the disheartening revelation that 2 doses were insufficient.
Following news reports that the FDA was considering postponing its work on Moderna’s petition in order to jointly assess it with Pfizer’s at a later date, a senior House Democrat sought a hearing from the agency on the status of vaccinations for children on Monday.
The FDA has also scheduled a meeting on June 7 to discuss Novavax’s COVID-19 vaccine for adults. The Maryland-based company’s injections have been approved in Europe and abroad, but production issues have caused delays.
On June 28, the advisory panel will meet to explore whether the current COVID-19 vaccinations in the United States should be upgraded to effectively target coronavirus variants.
