Until mid-June, 1 in 13 persons living in the United States — that’s all children age 5 and younger — weren’t eligible to get Covid-19 vaccines. On June 17, the Food and Drug Administration finally authorized the use of the Pfizer and Moderna Covid-19 vaccines for infants, toddlers, and preschoolers, based largely on advice from a panel of outside experts. By my accounting, it could have — and should have — made it possible for young children to be vaccinated much sooner.
I closely followed the Vaccines and Related Biological Products Advisory Committee meeting on June 15, as I’ve followed earlier meetings. This one felt like the others until it reached the open public hearing session, in which preregistered callers are allotted three minutes to share their thoughts with members of the advisory committee. That was the first time I can recall hearing a sitting U.S. congressman, Rep. Louie Gohmert (R-Texas), threaten “civil and criminal liability to vaccine providers and accessories” for any adverse events resulting from Covid-19 vaccination. It was startling to bear witness to such a blatant act of intimidation, especially coming from someone in his position.
Yet his threat was overshadowed by a stream of support from parents who desperately wanted to vaccinate their young children. One parent shared that her toddler had yet to meet their grandparents in person. Another parent pleaded, “We’re calling on you to help us take one step closer to normalcy.”
The advisory committee’s meeting in October 2021 included a handful of parents who expressed similar sentiments, but it was nothing like the June meeting, during which parents spoke with a sense of urgency and desperation.
This was the first time I heard comments in favor of vaccination delivered with audible frustration. One parent vented that he and his wife were “forced to be full-time employees and full-time parents while feeling like we’re failing at both.” Another expressed resentment toward CDC policies that made her family feel “invisible while [everyone else] lives life as normal.”
Parents supportive of Covid-19 vaccines for young children were angry — and they had every reason to be. They were reacting to comments made by FDA officials earlier in the day. On several occasions, FDA representatives seemed to confirm reporting by Politico from mid-April indicating that “regulators are leaning toward postponing any action until the early summer, arguing that it would be simpler and less confusing to simultaneously authorize and promote two vaccines to the public, rather than green-lighting [Moderna’s vaccine] on a faster timetable and [Pfizer’s vaccine] down the road.”
Several parents explicitly criticized the FDA for delaying its review of Moderna’s emergency use authorization application for children under age 5. As one parent phrased it, “The repeated reassurance that a vaccine would be available in the coming weeks or months has not brought hope to families but rather frustration and despair when these claims did not come to fruition.” Another parent called on the FDA to “strive to be nimble and to pivot quickly as the virus changes.”
Yet another shared that they were “frustrated that this process was stalled with Moderna since their studies were nearly complete in December when an expansion was requested by the FDA” while noting that “parents still long for a clear explanation regarding the reason for this expansion which was requested during the largest Covid surge of the pandemic. One that resulted in thousands of children under five being hospitalized.” At least one news report published since the meeting echoes these frustrations.
As a parent, I share their frustration. As a health data scientist and policy advocate, I agree with the implication that something other than good science and due process is responsible for the delay. I say this not based on anonymous sources in press reports, but because my own review of the meeting presentations and FDA documents have led me to this conclusion. After combing through the data, carefully reviewing each document, and watching once again more than 12 hours of presentations, question and answer sessions, and discussions, I believe there were at least three earlier dates when Moderna’s application for using its Covid-19 vaccine in children under age 5 should have been considered submitted for review and inexplicably was not.
On Feb. 10, 2022, several news outlets reported that the CDC told coronavirus vaccine providers to be “ready to receive shots for children younger than 5 by February 21.” This date aligns with a key FDA application milestone noted in agency documents. On Feb. 11, however, Pfizer issued a press release indicating that its clinical trials were still underway. The FDA then issued its own statement that an advisory committee meeting scheduled for Feb. 15 would be delayed until further notice. The FDA offered no explanation for its decision to postpone the meeting instead of moving forward with Moderna’s completed application for children ages 6 months through 5 years. As the CDC’s plans were reportedly contingent on the FDA’s authorization, the CDC had no choice but to pause its own process.
On March 23, 2022, Moderna issued a press release announcing that it was on the verge of finalizing its submission for emergency use authorization for its Covid-19 vaccine for children age 5 and younger. If the FDA had followed its usual process, it would have convened its vaccine advisory panel to decide on authorization sometime in early April. Pfizer had previously stated it “expect[ed] to have three-dose protection data available in early April.” Pfizer missed its self-imposed deadline, and the FDA failed to convene the advisory panel to review Moderna’s completed application.
Instead, there was silence until April 28, 2022. That’s when reporters pressed FDA Commissioner Robert Califf to answer if his agency was waiting on Pfizer’s data before moving forward with Moderna’s application. He responded, “Most of the experts that I’ve talked with would say it would be ideal if they could be considered together. But if they don’t come in at the same time, then there’s not going to be a hold up on the Moderna application, just to make it come in at the same time.” That same day, Moderna issued another press release reiterating its intent to submit its EUA application for children age 6 months through 5 years.
This sequence of events is particularly interesting in light of the fact that one FDA document cites April 18, 2022, as Moderna’s EUA submission date, while another agency document cites April 28, 2022. In either case, an April submission date should have prompted the FDA to convene the advisory panel to consider authorization. Had it done so, parents of children under 5 very likely would have been given the choice to vaccinate their children using Moderna’s Covid-19 vaccine no later than mid-May. But the agency did not convene the panel.
Again, weeks went by with no news. On May 18, 2022, White House Covid response coordinator Ashish Jha was pressed by journalists during a White House briefing to answer questions about vaccines for children under age 5. Here’s how he responded: “I’ll just say that I think there is actually quite a bit of urgency. The FDA now has all the — I think they have all the data for Moderna, and they’re going through it right now. And so that continues. And … we’ve been hearing from our colleagues at FDA that that evaluation is moving as quickly as possible.”
It’s clear, however, that the FDA was not moving as quickly as possible — FDA officials and documents disprove this assertion. It’s unclear why official FDA documents cite conflicting application dates for Moderna’s EUA application. The public deserves to know if Gohmert, or other members of Congress, have been meddling in a process that should be driven by science, not politics. I was unsettled by his public threat, and I can’t help but wonder if similar threats were issued to FDA officials behind closed doors, and whether that’s contributed to the inexplicable delays.
From a scientific standpoint, there is no justification for the FDA’s failure to move forward with Moderna’s application in February, March, or April. No member of the panel justified their vote to authorize Moderna’s vaccine for use in children age 6 months to 5 years based on data that was collected after Feb. 11. Based on the FDA’s own documents, it appears that Moderna’s application collected dust for several months due reasons unrelated to the scientific process.
Children suffered real harms while waiting for these vaccines. Thousands of children under age 5 were hospitalized during the Omicron surge. According to CDC data, many more have been admitted during the current Omicron-subvariant surge. The nearly 25 million U.S. children under age 5 were sitting ducks while the FDA grasped for reasons to delay action on Moderna’s application. Millions of frustrated parents deserve to know why.
Congress must seek to understand how millions of children were left behind, and commit resources to ensure that it never happens again. I applaud Rep. James Clyburn (D-S.C.) for his commitment to “rigorous oversight of the FDA to ensure that authorizations of future vaccines are not unnecessarily delayed” and call on him to direct his staff on the House Select Subcommittee on the Coronavirus Crisis to open an investigation that specifically looks at the role third parties may have played in the FDA’s otherwise inexplicable delays, starting with key dates in February, March, and April. I further call on Congress to investigate the extent to which members of Congress may have engaged in unethical conduct such as threatening criminal prosecution in politically motivated attempts to slow or derail the FDA’s well-established, scientifically grounded review processes.
The Covid-19 pandemic may be far from over. If the U.S. fails to learn from its mistakes, the country will continue to run in circles and leave millions behind.
Jorge A. Caballero is a California-based anesthesiologist and data scientist.