Parents and advocates scrutinize FDA delays in approving vaccines for young kids

Young children in the United States received for the first time this month the basic level of protection offered by coronavirus vaccines.

But questions linger among parents and advocates about why the Food and Drug Administration didn’t act earlier to protect this age group.

Justine Fox-Young is an Albuquerque-based attorney and mother of three children aged 4 years, 3 years and 15 months. She said her family has taken “some pretty dramatic measures” to limit high-risk activities since March 2020.

“Academically, socially, and in terms of what it takes to live a good and fulfilling, happy life, those restrictions are hard for kids to bear, and they are hard for parents to bear,” Fox-Young said. “And of course, that has effects that ripple beyond our household, all kinds of social effects that lots of people are dealing with.”

Even with the Moderna and Pfizer vaccines authorized on June 18, families of children under 5 have been excluded for nearly four months from the benefits of vaccination, and many have been infected without being protected during the delay, said Sophia Bessias, a health informaticist from Durham, N.C, and member of Protect Their Future.

“And now the protection that they’re getting, while still meaningful and very much worth getting, is significantly attenuated,” said Bessias, a mother of two children under age 5 who are patients in the Pfizer trial. At the time of our interview, they were still “blinded,” meaning they were unaware if they had received the vaccine or a placebo.

When a manufacturer wants to produce a new drug or treatment in an emergency, it must submit an emergency use authorization (EUA) to an independent advisory panel created by FDA called the Vaccines and Related Biological Products Advisory Committee.

Through the approval process, these advocates saw a lack of urgency as the true reason for the delays, and not because of any scientific explanation or safety need to wait to approve Moderna’s vaccine.

Dr. Jorge Caballero is a board-certified anesthesiologist, health policy advocate and parent of a child younger than 5. He can’t shake the feeling that there was favoritism for Pfizer, and that Moderna’s vaccine was being held back in order to allow Pfizer an opportunity to catch up.

“If that’s the case, then I think it’s reasonable to ask for some accountability there,” Caballero said.

Why wasn’t Moderna’s application reviewed sooner? 

Caballero said he has pored over the publicly available information published by FDA, Moderna, Pfizer and the White House COVID-19 Response Team, and found that there have been at least three different dates when FDA could have moved forward with the Moderna vaccine but did not.

One was in March, when Moderna announced topline results to its investors. Jacqueline Miller, senior vice president of infectious disease development at Moderna, said its 25-microgram dose for children between 6 months and 6 years old was “acceptable” and “consistent with what we’ve seen in young adults, adolescents and older children.”

Another was in April, when Moderna submitted its EUA request for children under 6.

And one was in May, when Moderna completed its full EUA application.

“There’s nothing that the committee discussed about Moderna’s application as a point of emphasis that was not available back in March, April or May,” Caballero said. “So it begs the question: Why wasn’t the application for Moderna reviewed back then?”

Dr. Peter Marks, director of the division at FDA responsible for ensuring the safety and effectiveness of vaccines, said in an official public service announcement on YouTube that the agency could not evaluate Moderna’s application until the company submitted all of the needed information, “including the data to complete their emergency use authorization request or application for approval.”

But the FDA had already received Moderna’s data for children under 6 weeks earlier on April 18, according to FDA’s own documents.

Those records show the data the panel was waiting for was actually an update to the applications for 6- to 11-year-olds, and 12- to 17-year-olds. Those groups already had access to the vaccine, but children younger than 6 did not.

Bessias said the FDA was not transparent about the incomplete data being for the older cohorts.

“So it was a choice by someone — either the FDA, or Moderna, or some combination — with an unknown role of the Biden administration, to not prioritize review of the application for the one age group with unmet medical need,” she said.

She would like to understand who made that decision, she said, and to hear some justification for it.

Ten days after Moderna completed its application, FDA Commissioner Dr. Robert Califf on May 19 appeared in a congressional hearing and denied that the FDA was waiting on Pfizer’s EUA submission in order to begin reviews. He committed to reviewing the two applications separately.

However, the FDA still did not commit to a date for a committee meeting to review Moderna’s submission.

In April, Politico published an article saying the FDA was considering holding off on taking action on Moderna’s application until the early summer because it would be “simpler and less confusing” to approve two vaccines at the same time to the public rather than one after the other.

After the article came out, FDA and White House officials repeatedly said in Congressional hearings and news conferences that they were not delaying approval of Moderna’s vaccine in order to allow Pfizer to catch up.

“Everyone’s been so indignant about that reporting, and about the suggestion that the FDA would do this, and yet here we are in June, and that’s precisely what has happened,” Bessias said.

By contrast, when Pfizer announced on May 23 its topline results and plans to update its application, the FDA that same day set a committee meeting for June 15 to review both companies’ applications.

Why it matters

It is important for the public to learn as much as possible about delays moving forward because we’re probably going to have more vaccines that will require emergency use authorizations in the future, Bessias said.

“It is really crucial that we understand why these delays occurred because we don’t want them to happen again,” she said.

That applies both to COVID vaccine boosters and next generation vaccines, she said.

“I truly believe this has been bungled by many different parties,” Bessias said. “But there is also a bigger question of including children and pregnant people and lactating people in research earlier, so that they can get the benefits of vaccines and other interventions.”

She said children must get caught up and on the same cycle of vaccination as adults. She sees getting young children their primary series as opening the door to any future technology related to coronavirus vaccines.

Caballero said it will continue to be important that we vaccinate younger children because there are pockets in several states — including New Mexico — where the percentage of young children who haven’t been vaccinated is so high that even in areas where the surrounding communities are highly vaccinated, young children become a sort of reservoir and a place from which the virus spreads.

There are retirement communities in New Mexico where there are pockets of very high vaccination rates among clusters of predominantly older people, Caballero said, but at the same time, there are also parts of the state where there are many children.

“And because of the seasonality of the emergence of variants, it’s not this one-directional transmission chain,” Caballero said. “It becomes this back and forth.”

Canned responses and delayed records

As of Wednesday, a spokesperson for the White House COVID-19 Response Team also had not responded to questions about the delays sent via email on June 22.

At the request of the FDA, Source New Mexico sent a list of detailed questions asking why the agency chose not to move forward with Moderna’s application earlier in the year. As of Monday morning, the FDA had not answered any of the questions and only provided a canned response nearly identical to one that it had already published in April.

When Source New Mexico on Monday asked for an interview with Califf, Marks or any other agency expert on the topic, FDA Spokesperson Abigail Capobianco refused to make anyone available and would not specify when anyone might have the time to do so.

The lack of communication is familiar to Protect Their Future, which filed a records request with FDA on May 3 asking for documents and communications between the agency and the two companies about the timing of the committee meetings.

As of Wednesday, the agency had not provided a single document in response to the request, said Protect Their Future Co-Founder Fatima Khan. The FDA denied the group’s request to quickly hand over the records, and they are appealing that denial.

“We do think that there is an urgent need for this to be expedited,” Khan said. “We do think the answers to our questions are very much needed immediately, because this problem is not going away.”

No one wants to meddle with the science, Khan said. Everyone involved agrees that these vaccines need to be tested, the trials need to happen, and we need to ensure that our children are getting safe and effective vaccines.

“There is no argument there, and no dispute,” Khan said.

The problem, Khan said, comes when FDA makes decisions that delay approval with no explanation.

“We just need to understand this process so that we can ensure this doesn’t ever happen again to any other kid, as future treatments and therapeutics become available,” Khan said.

Right now, there’s nothing to stop this from happening again, Bessias said.

“So we still really need to know the ‘why’ to help us set up a better process going forward,” she said.