Statement on FDA Delay for Moderna Data Review

May 23, 2022– 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.

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About Protect Their Future:

Protect Their Future is a grassroots group of physicians, parents, and activists advocating to prioritize children in public health policy and have access to COVID-19 vaccines as the pandemic rages on.  The organization is calling on health leaders to PUT KIDS FIRST and allow parents and doctors the option to protect children with a safe and effective vaccine.

Previous Press Releases:

Statement by Protect Their Future On Delays On Children Vaccines

Protect Their Future Urges FDA to Speedy Review of Moderna Data for Young Children

Protect Their Future Calls on Incoming FDA Commissioner to Prioritize Children Under 5 and Make Covid Vaccine Accessibility a Priority

The End of Mask Mandates Fails the Youngest and Most Vulnerable

Protect Their Future Decries FDA Decision to Deny Children Safe Vaccine

Protect Their Future Applauds News that Vaccines May be Available for Children Under 5 by Next Month

Physician Coalition Demands FDA Take Urgent Action to Make COVID-19 Vaccines Available to Children Under 5

About Protect Their Future: 

We are a grassroots group of physicians, parents and activists advocating on behalf of our young children and patients to have access to COVID-19 vaccines as the pandemic rages on. As parents, we have waited patiently for our kids to be protected while the rest of the country seems to have put the pandemic behind them. Omicron is the most infectious of all variants to date and early reports are showing potential increased hospitalization in children under 5. With nearly 6,000 cases of MIS-C in children and 1,000 kids who have died of COVID-19 kids under 18, we need to do all we can as parents to protect our children. We currently have the data and science, but bureaucratic and procedural red tape is leaving young children unprotected. We need that to change. We need the FDA and regulatory agencies to PUT KIDS FIRST and allow parents the option to protect their children with a safe and effective vaccine.

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