Almost 1,700 Individuals File Citizen’s Petition With FDA Calling for Urgent Review and Approval of Moderna’s Vaccines for Children Under 5

April 25, 2022- Protect Their Future filed a citizen petition on behalf of almost 1,700 petitioners, demanding that the Food and Drug Administration (FDA) immediately and expeditiously review any application received for Emergency Use Authorization for a COVID-19 vaccine for children under 5 without delay. The petition argues that under Section 564 of the Federal Food, Drug, and Cosmetic Act as well as the FDA's own policies, the agency must act urgently, with no delay unrelated to safety or efficacy concerns. Communicating only through secret leaks to the press, the FDA has hidden behind the cloak of "following the science" while expanding and delaying pediatric clinical trials as millions of young children become infected and reinfected.

The FD&C Act requires the Secretary of the HHS or their delegate, the Commissioner, to base drug approval decisions on evidence of safety and effectiveness, quality of manufacturing and processing, and accuracy of labeling. Notably absent is the consideration of messaging, promotion or public confusion.

Unnamed regulators told Politico last week that it would be “simpler and less confusing to simultaneously authorize and promote two vaccines to the public” – even if that means delaying one application to wait for a second. The Petition filed by concerned parents and physicians of Protect Their Future asserts that any delay for reasons unrelated to safety and efficacy, such as “potential confusion” or any issue pertaining to promotion or messaging of a product, violates section 564 of the FD&C Act, which sets forth grounds for authorization of emergency use of drugs and biological products during the current declared public health emergency, as well as the FDA’s own guidelines.

Parents, pediatricians, and caregivers eager for authorization are not confused about the benefits of vaccination for their children, nor are they confused about the risks of delay. Every day of inaction leads to more preventable suffering, borne disproportionately by the most medically, socially, and economically vulnerable children.

The FDA must move quickly to approve applications from manufacturers as soon as they are ready and the data is sufficient. This petition asks the agency to halt all plans to delay approval and release of a safe and effective pediatric vaccine and to instead follow its regulatory charge to act expeditiously and on a purely scientific basis to approve these life-saving pharmaceuticals.

It is unscientific, immoral, and well outside of the FDA’s purview to delay review for reasons unrelated to the results of the clinical trials under evaluation. Holding back one manufacturer’s application to allow time for another submission would create the appearance of favoritism and undermine the credibility of a vital institution. FDA must commit to reviewing each submission at the earliest opportunity and on an independent timeline.

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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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