Parents of kids under 5 fed up with lack of FDA action on a vaccine

"We've been ... living in Groundhog's Day, every day for two years," one said.

April 27, 2022, 10:29 AM

Parents eager to vaccinate their toddlers and preschoolers last fall were told a COVID shot for the youngest age group was on its way, with data expected by the end of the year. That deadline slipped. Then it slipped again.

Now, with summer travel just around the corner, parents of kids under 5 are fed up. They describe feeling stuck in a kind of cruel pandemic time warp, even as much of the country moves on and people have stopped wearing masks, including on airplanes.

Many parents are ready to assign blame.

"I want you, Joe Biden, to call the FDA (US Food and Drug Administration) and tell them that they need to act with all possible speed because every day they delay there are children being infected and some of those children could die," said Sarah Liebman, a mom outside Portland, Oregon, whose 2-year-old remains too young for a shot.

Emmie Fital and her husband Steve Fital with their sons Sam, age 4, and Oliver, age 1.
Courtesy Emmie Fital

Emmie Fital, a mom of two boys ages 4 and 1, living outside Philadelphia, has opted to keep her kids home from school because her oldest son's asthma has resulted previously in a hospital stay after he contracted the common cold.

"We've been kind of living in Groundhog's Day, every day for two years … It is ludicrous what we are having to deal with as parents right now," Fital told ABC News.

In coming weeks, the nation's two big vaccine makers -- Pfizer and Moderna -- are poised to deliver key pieces of data that the FDA needs to authorize a vaccine.

Moderna was expected by week's end to submits its official request for FDA authorization for its two-shot version. Pfizer says it expects to have final data on its three-shot version by the end of June.

How soon though regulators will give either shot a green light remains unclear. Government and industry officials say the data sets for vaccine trials can be complex, and Moderna will likely submit additional information on a rolling basis even after its official request is made.

PHOTO: Sam was hospitalized for Bronchiolitis in 2018. He has since been diagnosed with asthma and his parents have been reluctant to enroll him in preschool until there is a vaccine.
Sam was hospitalized for bronchiolitis in 2018. He has since been diagnosed with asthma and his parents have been reluctant to enroll him in preschool until there is a vaccine.
Courtesy Emmie Fital

The FDA has declined to comment on pending vaccine applications -- necessary to avoid legal hot water -- but suggested its hands are tied until company officials submit their data. The agency also has promised to make public a new tentative timeline for advisory committee meetings, a final step before authorization of any vaccine.

"Just remember that we can't actually finish our reviews until we actually have complete applications in the FDA," said Peter Marks, director of the FDA's Center for Biologics Evaluation and Research, told a Senate panel on Tuesday.

Parents though say they are frustrated by these kinds of cryptic comments and that they seem to be learning more about the vaccine's progress from press leaks than regulators. Last week, a Politico report suggested the FDA might wait on Moderna's authorization request until Pfizer could offer more data on its version.

In an interview with CNN+, Biden's top medical adviser Dr. Anthony Fauci confirmed there were concerns within the FDA about authorizing the two different vaccines -- with different amounts of dosing and shots -- on separate timelines. Authorizing them together would give parents a side-by-side comparison before they made their choice, some officials thought.

"What the FDA wants to do is to get it so that we don't confuse people," Fauci said.

His comments sparked swift pushback from frustrated parents, including Liebman.

"We were told over and over that the best shot was the first one to get into your arm," she said. "So I don't understand why the FDA seems confused. I am not confused. I'm not at all confused."

Fatima Khan, who helped to start up a grassroots advocacy group and Facebook page called "Protect Their Future," which advocates for swift authorization of a pediatric vaccine, said she wishes the FDA was more transparent about what it needs from vaccine makers and what concerns it has.

"I feel like we've been getting yanked around a lot. You know, no one really gives anyone a clear answer, and it shouldn't be that difficult," said Khan.

Still plenty of questions remain, including whether at the FDA should send parents down the path of a two-dose vaccine if an alternative three-dose is found to be more effective just a couple of weeks later.

Moderna has said its two-dose vaccine produced the same level of immune response as seen in adults. But because none of the participants in the study became severely sick, Moderna couldn't give an estimate of how effective the vaccine is at preventing severe illness.

Dr. Julie Morita, a pediatrician who has advised the Centers for Disease Control and Prevention in the past, said premature or complex data can make speaking openly difficult for regulators.

"You want to be careful about what information you're sharing because you don't want to have misunderstandings. Because once you the information is out there it's really hard to pull it back," said Morita, executive vice president of the Robert Wood Johnson Foundation.

Overall, children are at significantly less risk of hospitalization and death of COVID-19 compared to adults.

Still, the number of children who became infected in recent weeks due to the omicron variant is staggering. The American Academy of Pediatrics estimates that nearly 124,000 kids were infected in the past month alone.

Since the pandemic began two years ago, 468 children under 5 have died as a result of complications from the virus.

Fital said she is irked hearing public health officials say repeatedly that the best way to protect yourself and others is to get vaccinated, when so many kids can't.

"What do you say to the 20 million children that have no option?" she asked. "They have nothing."

ABC News' Sony Salzman contributed to this report.

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