‘Forgotten’ parents of kids under 5 push FDA to clear Moderna shot

Bloomberg: Pediatric hematologist and oncologist Alissa Kahn treats some of the most vulnerable kids with cancer and sickle cell diseases at St. Joseph’s Children’s Hospital in Paterson, New Jersey. She said the omicron variant was a disaster for her patients under 5, who are still ineligible for Covid vaccines.

At the height of the wave, multiple preschool-age patients had to be admitted to the hospital due to dangerous Covid infections. Other young children with cancer had life-saving chemotherapy delayed, potentially reducing their chances of a cure.

Kahn said she had no good answer for distraught parents asking her why their children still couldn’t get vaccinated.

“Our public health establishment failed to prioritize young children,” said Kahn, who is part of a Facebook group of 3,500 parents and doctors pushing for the Food and Drug Administration to act quickly to review and clear vaccines for the youngest children. The group, Protect Their Future, wants the agency to move fast on Moderna Inc.’s application for authorization of its vaccine in kids ages 6 months to 5 years old.

On Wednesday, Moderna said that two shots — each a quarter of the adult dose — produced a strong immune response in children under 6, according to preliminary results of a study of 6,700 young children. But efficacy in preventing symptomatic infection was underwhelming, ranging from 44% for the youngest kids down to 38% for those aged 2 to 5 years. Moderna shares closed down over 4%.

In its statement, Moderna said that the trial data identified no new side effect concerns or other red flags. Fever occurred in fewer than 1 in 5 of the younger kids. The data hasn’t been published in a scientific journal or reviewed by outside experts, and Moderna didn’t release detailed efficacy or side effect results.

There were no severe Covid cases in Moderna’s trial, which means there is no information on the most important outcome: Whether the shot prevents hospitalization and death in the youngest cohort.

With the Moderna trial meeting its primary goal, the FDA will be under enormous pressure from desperate parents.

“Many parents of younger children do feel forgotten,” said Lee Beers, a professor of pediatrics at Children’s National Hospital and former president of American Academy of Pediatrics.

Katherine Matthias, a South Carolina pediatrician and co-founder of Protect Their Future, said she can’t wait until a vaccine is available for her two kids under the age of 5.

“It has been so hard to watch everyone go on with their lives like Covid is not here anymore,” she said. With a vaccine, she would be confident her children can finally be protected against the worst outcomes like everybody else.

There is the risk that racing to authorize a vaccine in young kids that has mediocre efficacy could backfire, further confusing many other parents who are on the fence about using a vaccine in their younger kids, because they are worried about safety or uncertain about the necessity.

A two-shot vaccine in young kids will likely be only the first step, and Moderna plans to study third shots in the younger age group as well.

Moderna’s efficacy numbers are hardly spectacular, but Anthony Fauci, the director of the National Institute of Allergy and Infectious Diseases, said in a White House briefing Wednesday that 44% was not such bad news.

“Now that may seem like a low number, but in the era of omicron this is actually quite comparable to the efficacy against infection in what we’re seeing now with other vaccines,” he said. Meanwhile, this season’s flu shot was only 16% effective in preventing mild to moderate cases in the U.S., government researchers recently found.

While the FDA has previously given guidance that Covid vaccines should be at least 50% effective in preventing symptomatic cases, some doctors argue that that standard should be reconsidered in light of omicron.

“The 50% mark was created early in vaccine development when we were dealing with the original ancestral strain,” said Buddy Creech, director of the Vanderbilt Vaccine Research Program, who participated in trials of Moderna’s vaccine in older kids. “I’m not sure if any of the vaccines that we have available as a two-dose series would enjoy authorization right now if we had kept that metric.”

The FDA didn’t immediately respond to questions on its 50% efficacy guideline for Covid vaccines.

The new data raised the possibility that Moderna could vault ahead of Pfizer to become the only vaccine approved in all age ranges. Rival mRNA vaccine maker Pfizer Inc. was once ahead in developing a shot for the youngest kids but has been hit by delays. In February, the FDA cancelled a scheduled advisory panel meeting on the Pfizer shot in young kids, saying it wanted more data.

Moderna also said it was submitting for clearance for its vaccine in 6 to 11-year-olds after consultation with the FDA. It was also updating its application for clearance in kids aged 12 to 17 years, which has been held up at the agency for months over concerns about rare cases of heart inflammation, with additional follow-up data.

White House coronavirus coordinator Jeffrey Zients said in a briefing Wednesday that the government had secured a supply of vaccines for kids under 6. “We will be ready operationally if the vaccine is authorized,” he said.