Demonstrators demand immediate review of COVID vaccine for youngest children in the U.S.

About 20 organizers, parents and their children rallied outside the headquarters of the U.S. Food and Drug Administration on Monday to demand COVID-19 vaccinations for children under 5-years-old without delay.

A brass band joined the protest and even played “Baby Shark Dance” for the young demonstrators, said Amanda Makulec, an organizer with Protect Their Future, a grassroots group of volunteers, parents and physicians working to ensure that children are prioritized in public health policy.

They had intended to demonstrate right by the front doors of the FDA headquarters in Silver Spring, Maryland, but security asked them to stay near the main entrance gate.

They piled 482 stuffed animals on a pair of tables, with some cascading onto the sidewalk. Each toy represented a child under 5 who has so far died of COVID-19 in the U.S., according to official statistics.

There are nearly 20 million children under age 5 in the U.S., according to the Census. They have no legal way to get the vaccine in the United States, said Emily Bates, an associate professor in pediatrics at the University of Colorado. Other countries have been vaccinating children under 5 for months now, including China, Hong Kong, Bahrain, Chile, Argentina and Cuba, Business Insider reports.

Moderna announced on March 23 that its COVID-19 vaccine is effective against infection for children aged 6 months to 5 years, on par with two doses in other age groups during the omicron wave.

Before the FDA authorizes any vaccine for the youngest children, it must review the data from the vaccine manufacturers. The agency has said it will not hold those review meetings until June 8 at the earliest, after Pfizer has time to conduct its trial.

Anonymous FDA officials told Politico in April 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.

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Now activists are demanding that the FDA prioritize official discussion of the Moderna data over other discussion about boosters and older age groups. They say it’s urgent that the vaccine for children 5 and under be reviewed and approved to limit the severe outcomes when unvaccinated children get infected like hospitalization, death, multisystem inflammatory syndrome, and pediatric long COVID.

Janeth Nuñez del Prado, a licensed clinical social worker and the New Mexico Hub Leader for Marked By COVID, said it is incredibly urgent for the FDA to start the review process.

“As a parent of a 2-year-old who can’t get vaccinated, I am very concerned that approving vaccines for young children has not been a priority,” she said. “With the mask mandate being lifted and no vaccines for this age group, we are being left basically defenseless.”

For other age groups, the FDA has typically taken about 17 to 20 days to get things done, but with children under 5, “they have been dragging their feet,” said Fatima Khan, a co-founder of Protect Their Future.

Monday was also the day when Moderna was supposed to have completed submitting data to the FDA.

“Moderna has publicly said that they already gave in all of their data. Today is basically their final electronic submission date,” Khan said. “So we want the FDA to review — and if shown to be safe, meeting the trial criteria — to approve this vaccine ASAP.”

U.S. Rep. James E. Clyburn (D-South Carolina) is the chairman of the Select Subcommittee on the Coronavirus Crisis. After meeting with the FDA’s Director Peter Marks, Clyburn said in a statement released during Monday’s rally that the meetings could be moved up if reviews are done sooner, and the FDA won’t wait for Pfizer to review Moderna.

“They’re saying a lot of the things that we want to see, which is really exciting,” Makulec said. “I hope they stick to them and that they hold the FDA accountable.”

Will the vaccine come before the next school year?

Organizers say if the FDA delays the approval process any further, children will once again be going back into the pandemic unvaccinated when school restarts in the fall.

“There’s a very real concern, not just an urgency to review and approve as soon as possible, but also recognizing that every day matters right now. Because if you wait long enough, then our kids might not even have the option of being fully vaccinated come the next school year,” Khan said.

Equity issues are very intertwined with the struggles parents are facing right now, she pointed out. Families of color and working families have overall been the most impacted by COVID, Khan said, and not being able to vaccinate your child, having to send them to daycare, and not having the luxury of being able to self-isolate put parents in nearly impossible situations.

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“What we’re seeing today, unfortunately, is the result of a very broken health care system, and one where we don’t prioritize people of color, we don’t prioritize children, we don’t prioritize the moms,” Khan said. “It is ugly.”

Makulec is a public health data professional who has worked on data visualizations for more than a decade. She is also the parent of a 3-year-old child. No other age group or population, it seems, have had to wait this long to wait for review meetings, Makulec said.

“We’re at a place where we need to move as fast and as expediently as possible, not just for the kids but also to protect their families and communities,” she said.

Nuñez del Prado pointed out that messaging around the pandemic emphasizes a layered approach to intervention and “having the tools,” chief among them: vaccination and masking.

“But most children under 5 can’t wear a mask consistently or properly,” she said. “They don’t even make N95 masks for children. And vaccines for this age group are not approved. So where is their protection? As society moves forward, we are leaving young children behind.”

We don’t know the long-term impact of COVID-19 on children, Nuñez del Prado said, and because we don’t know, we should be cautious. That caution is especially warranted in a state like New Mexico with so many multigenerational households and grandparents raising their grandchildren, she added.

“Vaccinating young children not only protects them, but it protects everyone the children come into contact with,” she said. “The less transmission of COVID-19, the fewer variants, and the less chance of a vaccine-resistant variant. So we should all care that vaccines for this age group have not yet been approved and urge CDC to start this review process. Our children have waited long enough.”