Protect Their Future Statement on Moderna's Request for Vaccine Authorization for Children Under 5


April 28, 2022– Protect Their Future welcomes the news that Moderna has asked the Food and Drug Administration (FDA) to authorize its vaccine for children under 5. Six months after the rest of the country has had access to Covid vaccines, almost 20 million children finally see a light at the end of the tunnel for their turn.

Now, the FDA must prioritize America’s youngest population and act urgently to review the submitted data, and if proven to be safe and effective, approve Moderna’s application.  Discussion of the <6 vaccine data must be prioritized over discussions pertaining to boosters and older age groups.  Earlier this year, Pfizer applied for a rolling submission on February 1, 2022 for an EUA for children under 5.  The FDA scheduled a review meeting for February 15, 2022, giving the committee two weeks to review data.  The FDA should treat Moderna’s submission with the same sense of urgency and schedule a review meeting within 2 two weeks of receiving data.  Anything less would be unacceptable and unethical. 

In a March 23 press release, Moderna indicated that the trial concluded successfully with immunobridging criteria met and efficacy against infection on par with two doses in other age groups during the period of Omicron predominance. Moderna’s reported efficacy of about 51% for children 6 months - 2 years and 37% for 2 - <5 years is consistent with expectations during Omicron and similar to the level of protection enjoyed by the majority of “fully vaccinated” adults who have not yet received a booster dose. While any reduction in infections is desirable, families prioritize the vaccine's ability to lower our children’s chances of severe outcomes: hospitalization, death, MIS-C, and pediatric long COVID.

As much of the country has rolled back on risk mitigation policies and made masks optional, families of young children have been left behind, struggling with impossible choices between keeping their families safe and shouldering increased risks to continue their jobs and other responsibilities.  Our children have waited too long and our leaders have the responsibility and obligation to ensure that life-saving vaccines are made available to our youngest.  America’s families are waiting for the FDA to do the right thing and act with the same urgency they did to protect the adult population. 

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About Protect Their Future:

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 and allow parents and doctors the option to protect children with a safe and effective vaccine.


 

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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.

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