Protect Their Future Takes Legal Action to Determine FDA’s Plans to Delay Children’s Vaccines

May 3, 2022– As COVID cases start to surge again, Protect Their Future spearheaded a Freedom of Information Act (FOIA) request for documents from the Food and Drug Administration (FDA) related to internal decisions to delay vaccine access for COVID vaccines for children under 5.  The FOIA request comes at the heels of the FDA signaling to press that it will wait to approve Moderna’s vaccine application until Pfizer can catch up with its application.  Subsequently, the FDA also scheduled meetings to consider any applications on June 8, 21, and 22. While previous EUAs for older age groups have been considered in under three weeks, the scheduled meetings will be held six to eight weeks after Moderna’s completed application, which is expected to be fully filed by May 9, 2022.

“Vaccine access is an equity issue, through and through and the FDA needs to provide answers,” said Tamara Spira, co-founder of Protect Their Future and applicant of the FOIA request.  “The FDA has signaled that the reasons for delaying Moderna’s vaccines have nothing to do with science or safety, but rather a flimsy excuse to keep things ‘simpler and less confusing.’ We know who is able to remain sheltered in place: those with the economic resources for a nanny or a stay at home parent. This willful delay invariably widens the racial health gap. Low income children and children of color will be forced to suffer the consequences of the FDA's inaction for generations to come.” 

As risk mitigations like masks have rolled back, young children continue to be sitting ducks to a virus that has taken the lives of almost 500 children under 5 and left many more with complications like MIS-C, neurological damage and long COVID.  Hospitalizations among children ages 0-4 during the recent omicron wave were 5 times higher than when Delta was the predominant variant, according to the CDC, and unvaccinated children are at increased risk of severe disease and death. Protect Their Future has previously called for the FDA to conduct its review expeditiously. Each day in delay means greater risk of hospitalization and death for children under 5.

The FOIA request covers documents and communications from December 1, 2021 through the present concerning timing of the reviews for EUA applications of both Pfizer's and Moderna's vaccines for use in young children. Specifically:

  • Documents and communications regarding the FDA's request that Pfizer submit an application for its vaccine in February, 2022, followed by the scheduling and then abrupt cancellation of the February meeting at which that application could be discussed and approved, along with the FDA's messaging surrounding this application. 

  • Documents and communications regarding the timing and scheduling of the advisory committee meetings in June, 2022 and any communication and documents relevant to the statement that granting an EUA for Moderna's vaccine alone would be "confusing" or other speculation on parental reactions. 

  • Documents and communications with Moderna and Pfizer regarding the timing of EUA submissions, in addition to communications involving any other third party, including official or unofficial advisors to the FDA and non-FDA government officials.

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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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