Protect Their Future welcomes news that Pfizer reported positive top-line results for its three dose regimen for children under 5. However, the news that the FDA will not meet to review Moderna’s EUA submission until June 15 is extremely disappointing and unacceptable. Drs. Califf and Marks are both on the record denying that the FDA is waiting for Pfizer and saying that they’re working on Moderna’s submission as fast as they can. Today’s news from the FDA does not appear consistent with those statements. It is concerning that even if the Moderna review is completed sooner, the FDA is still going to wait for this scheduled VRBPAC meeting despite the fact that Dr. Marks specifically told the House Select Subcommittee on May 6th that they would move up the VRBPAC if they completed the review sooner.
With the country in the midst of a surge, every day counts. Each EUA application for children under 5 should be considered on its own merits and accorded the urgency of prior EUA submissions for every other age cohort. Every day the review process is delayed means that more children will be infected and put at risk. Furthermore, for many children, Moderna’s two dose regimen may be the only chance they will have to start a new school year fully vaccinated. The FDA must review Moderna’s data, and if proven to be safe and effective, approve without delay. And when Pfizer’s application is ready to submit, review that data urgently as well.
