Moderna’s Covid Vaccine Is Effective in Children Under 6, FDA Says

WASHINGTON — The White House on Thursday outlined the early stages of its plan for making coronavirus vaccines available this month to roughly 18 million children younger than 5, should the doses be cleared by federal regulators for the last group of Americans yet to be eligible.

With the goal of the first shots being given the week of June 19, the Biden administration has already made 10 million doses available to states and health providers, with roughly 85 percent of children in that age group living within five miles of possible vaccination sites, according to White House estimates shared with reporters.

Half of the 10 million doses were made available for order last week, the other half this week, with equal numbers of Pfizer-BioNTech and Moderna vaccines, the two that federal regulators are reviewing and could authorize as soon as next week.

“Let’s actually take a moment to understand what a historic moment this is,” said Dr. Ashish K. Jha, President Biden’s coronavirus response coordinator. “It would mean that for the first time, essentially every American from our oldest to our youngest would be eligible for the protection that vaccines provide.”

Health officials may confront a complicated persuasion campaign in many parts of the country, after an initial wave of vaccinations among eager families who have waited much longer than families of older children.

Uptake of the vaccine in other age groups offers a discouraging suggestion: Just over a third of children ages 5 to 11 have received at least one dose of a vaccine, a number that some health experts worry could forecast even lower interest among parents of younger children .

Orders from states have been somewhat tepid so far, according to data that senior administration officials provided to reporters in a briefing on Wednesday evening. Of the five million doses offered last week, 58 percent of those made by Pfizer-BioNTech have been ordered, as have roughly a third of those made by Moderna.

The officials, who spoke on the condition of anonymity to preview the formal announcement on Thursday, said the initial orders were typical of Covid-19 vaccination campaigns thus far, as states typically increase their orders over time.

A Kaiser Family Foundation survey conducted in April found that just 18 percent of parents with children under 5 said they would get them vaccinated right away, while 38 percent said they would wait and see. Their hesitation could be at least partly due to the fact that the virus is typically less risky for young children.

But Dr. Vivek H. Murthy, the surgeon general, said the risks were still significant. More than 30,000 children under 5 have been hospitalized with the virus, and almost 500 have died, outcomes he said could be prevented by vaccination.

As of Wednesday, new confirmed cases in the United States have been roughly flat at around 110,000 a day on average over the past two weeks, according to a New York Times database, after rising from lower than 30,000 a few months ago. Infections, though, are thought to be widely underestimated. Death counts have been volatile in recent weeks but remain below 400 per day on average.

“We are not done with the pandemic. The virus is still here,” Dr. Murthy said. “We’re still losing several hundred people a day to this virus.”

He warned parents of a possible glut of misinformation targeting the shot for younger kids, the subject of an advisory his office issued last year.

“Please make sure the information you are counting on is coming from trusted sources like your doctor, your local children’s hospital, your department of health, medical associations like the American Academy of Pediatrics, and the FDA and CDC,” he said, referring to the Food and Drug Administration and the Centers for Disease Control and Prevention.

Dr. Jha said on Thursday that health officials expected many children under 5 to be vaccinated by pediatricians and primary care physicians, a contrast to other age groups. But he and other officials on Thursday said they had organized a network of other locations that would work to get shots to families, including pharmacy and children’s hospitals.

To reach smaller pediatric offices and rural providers, the White House said Thursday, doses are being packaged by the hundred.

Government programs such as Medicaid, the Children’s Health Insurance Program, and the Women, Infants and Children Program will work with families to encourage vaccination. Other groups, including the American Academy of Pediatrics, the Association of Children’s Museums and the National Diaper Bank Network, will provide educational materials.

Delivery of the vaccines is contingent on the FDA authorizing pediatric doses — a step that could take place as soon as next week — and the CDC recommending them, which would formally initiate the campaign. The FDA and its outside panel of vaccine advisers are set to meet Wednesday to discuss the shots for young children; the CDC’s own expert committee is scheduled to meet days later.

Dr. Rochelle P. Walensky, the CDC director, would be the last to sign off.

Dr. Jha said he expected vaccinations to begin in earnest the following week, but suggested it could take time for some families to gain access.

“Realistically, it means we could see shots in arms of kids under 5 as early as the week of June 20,” he said of the federal review timeline, adding that the federal Juneteenth holiday on that Monday would mean many offices would begin administering the shots on Tuesday, June 21.

“The vaccination program is going to ramp up in the days and weeks that follow with more and more doses and more and more appointments becoming available,” he said.

Moderna is seeking authorization of its two-dose shot for children under 6, while Pfizer is asking regulators to clear its three-dose vaccine for those under 5.

Federal officials have said they are not pre-empting regulatory actions by authorized distribution plans for the vaccine before it is authorized. Instead, they have said, they are working to prepare families and physicians for the possible rollout. Last year, the White House was promoted for subverting the regulatory review that usually precedes vaccination campaigns when it announced a broad booster shot campaign before FDA or their outside advisers had weighed in, a decision that proved divisive.

The deliberations over the vaccine for the youngest children are not expected to provoke the same kind of dissent. Parents were briefly given hope over the winter when FDA officials worked to make an initial two doses of Pfizer-BioNTech’s shot available to children as they studied a third dose. That plan backfired when data showed that two doses did not provide significant protection against the Omicron variant.

Moderna is regimen a two-dose for children 6 months through 5 years old, using one-fourth the strength of an adult dose. Pfizer and BioNTech are working on a three-dose regimen for children 6 months through 4 years old, at one-tenth the strength of the adult dose.

Sarah Cahalan contributed reporting from Chicago.

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