Parents Demand FDA to Immediately Review Moderna Data after Final Submission
Demands come at heels of reports that the FDA may delay review to allow Pfizer to catch up
May 9, 2022–Parents rallied today at the Food and Drug Administration (FDA) headquarters to demand the agency conduct an immediate review of Moderna’s vaccine data for children under 6, and approve if the data shows that the vaccine is safe and effective. The rally comes on the day Moderna is expected to complete its application for an Emergency Use Authorization for the youngest segment of children who currently have no access to any COVID vaccine.
“The FDA has a moral and ethical obligation to review Moderna’s data with the same urgency it did for other age groups,” said Dr. Katherine Matthias, pediatrician and co-founder of Protect Their Future, which organized the rally. “Every day matters–the FDA must act with the integrity the American public should expect from its vital health institutions. There should be no favoritism between companies, and I hope the FDA acts accordingly by scheduling a review meeting, and if the data show a safe vaccine that meets the immunobridging endpoint in its trials, approves Moderna’s vaccine within the month of May. Approving Moderna in May will also ensure that our children can return to school fully vaccinated in the fall. Favoring Pfizer over Moderna for political reasons will not only delay vaccine access, but will also send our children back to school next year without the protection they deserve.”
Moderna submitted its trial data for children under 6 on April 28 and is expected to complete its full submission today, May 9th. While the FDA has typically taken 17-20 days to conduct a review of vaccine data for all other age groups, there have been signals from the agency that it will delay review and the approval process for Moderna so that Pfizer can catch up, giving a strong appearance of the government agency giving preferential treatment and playing favorites at the cost of young children’s lives.
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Protect Their Future is a grassroots group of physicians, parents, and activists advocating on behalf of young children and patients to have access to COVID-19 vaccines as the pandemic rages on. The organization is calling on health leaders to PUT KIDS FIRST in public health policies. Follow us on Twitter at @ImmunizeUnder5s
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
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
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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.
Join us on Facebook at Protect Their Future.