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Reflections on Procedural Barriers to Pediatric COVID Vaccine Access

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By Fatima Khan

When news broke last week that Pfizer-BioNTech was submitting for Emergency Use Authorization (EUA) a two-dose COVID vaccine regimen for children under 5 to the U.S. Food and Drug Administration (FDA), many parents felt a glimmer of hope after a long time.

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Up until a few days before, the public was expecting approval to possibly drag into summer. While the regimen would likely require a third dose, it became a possibility that children could start getting some level of protection as early as March. Finally children were acknowledged during a time when their needs have often been neglected or even ignored.

The shift in the FDA’s decision process is a critical moment to reflect on how we got here, and what we should strive for to ensure children aren’t repeatedly left behind amidst our new COVID reality.

Prior to the Pfizer-BioNTech announcement, Omicron had been raging through the country for almost two months, causing a record number of cases in young children. While over 11.5 million children have tested positive for COVID since the pandemic, over 3.5 million of those cases were reported in January alone. Over 1,000 children have died of COVID, and many more are dealing with complications due to the virus.

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Nevertheless, many in the U.S. have called for a return to “normal” throughout this period, even as an entire segment of the population has gone without vaccine protection.

Advocacy for Vaccine Access

While there was a loud, organized anti-vaccine voice in the public discourse, the voices calling to urgently approve vaccines for children were scattered.

Frustrated by the lack of acknowledgement of children in the discourse, we decided, as a group of parents, to create a space where others could convene and make their voices heard. That community quickly grew into “Protect Their Future,” a grassroots group consisting of over 2,000 physicians, scientists, and parents passionately organizing so that children are prioritized and get access to COVID vaccines.

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Protect Their Future created a space where doctors and parents could advocate with a unified voice. One key strategy centered on organizing physicians to send a clear message: COVID is harming too many children, the mRNA vaccines we currently have are safe, and bureaucratic tape is causing delays in distributing these critical vaccines to our youngest children. For example, the group organized a physician coalition letter where several hundred doctors called on the FDA to urgently cut the bureaucratic tape and make vaccines accessible to young children.

Doctors and parents used the group to collectively make public calls to agencies like the FDA and U.S. Centers for Disease Control and Prevention (CDC), demanding urgent access. By mid-January, amid some of the darkest news of how Omicron could harm children, we started to see a shift in the public and media discourse, with greater acknowledgement of the barriers preventing doctors from offering vaccines to their youngest patients. And ultimately, we started to see openness toward prioritizing children and adapting conventional procedures to build a safe path to vaccine accessibility.

The possibility of an approved vaccine regimen, even if it will require a third shot later, is an important step toward protecting our children. While we have yet to see the full data, this regimen appears to offer strong protection — sources with knowledge of the trial revealed that children between the ages of 6 months and 2 years who received the vaccine became infected at a 50% lower rate than the placebo group, and children 2 to 4 years old developed infections at a 57% lower rate. But even if the FDA and ultimately CDC approve this new submission for children under 5, the conversation on vaccine accessibility is far from over.

Solutions for the Future

We need to address the root issues that caused these delays so that future vaccines and treatments don’t face similar obstacles. Reflecting on the past two years of public health decision-making, it is abundantly clear that children are systemically not a priority. But there are a few tangible steps that can help course correct in a rapidly evolving pandemic.

As a first step, we need our health agencies to keep the public informed. Physicians and scientists have been particularly frustrated by the lack of transparency from our health agencies about the trial and evaluation process. For example, there was no explanation on why Moderna was asked to add a few hundred more children to their trial late last year. We don’t even have the full data from Pfizer’s trial for children between the ages of 6 months to 4 years old, even though results were available in December. Understanding why decisions during the trials are made (and the data used to make those decisions) are critical to maintaining public trust and allowing doctors to advocate for their patients.

Second, we need to remove procedural red tape that has played a role in delays.

For example, removing age de-escalation requirements would have allowed age groups to move forward in the EUA process once a vaccine dose had been shown as effective and safe. The two-dose Pfizer regimen hit the target goals for the 6-month to 2-year age group back in December, but couldn’t move forward in the approval process because the 2, 3, and 4-year-olds didn’t hit the same numbers.

Further, the CDC inexplicably restricted off-label use of these vaccines, closing the door for doctors to use their expertise and customize a plan that could include COVID vaccines for young children. Physicians, particularly pediatricians, frequently prescribe off-label and use informed consent to provide the best care for their patients.

These are just two examples of ways that our process — not science — restricted vaccine access. We need to apply these learnings to current and future trials, both within and outside the COVID context.

We still do not know the long term impacts of COVID, and denying children a safe vaccine that offers a level of protection against the immediate and long-term risks of COVID is unconscionable. Many families in underserved communities or those with medically high-risk family members are being forced into impossible decisions: choosing between the health of your family, especially when there is a safe vaccine available, and your financial security should never happen. But it is the reality of countless struggling families.

If we are able to successfully fix the procedural barriers we’re facing today, we won’t have to keep fighting for vaccine access every time the next COVID vaccine or treatment comes out, and we could save more lives and prevent countless cases of illness. How we handle the pandemic right now will have an impact on the future of children’s public health. And unfortunately, we’re not out of the woods with COVID — just like Omicron, a new variant could surprise us at any time. We saw our leaders move mountains to safely bring vaccines to the adult population in record time. And they should be applauded for those efforts. Now, they need to do the same for our children.

Fatima Khan is the co-founder of Protect Their Future, a grassroots group of physicians, parents and activists advocating on behalf of our young children and patients to have access to COVID-19 vaccines.

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