Moderna aims to be number one on COVID shots for young children

On Thursday, Moderna requested US regulatory authorities to approve low-dose COVID-19 vaccines for children under the age of six. This is a long-awaited move towards the possibility of launching millions of tonnes of injections by the summer.

Frustrated families are eagerly awaiting the opportunity to protect the country’s youngest children, as the people around them are stripping off masks and other ordinary people. health Precautions-Despite the continued spread of highly contagious coronavirus variants. Already about three-quarters of children of all ages show signs of infection at some point during the pandemic.

Moderna wants to submit data to the Food and Drug Administration to prove that two low-dose injections can protect babies, toddlers, and preschoolers.

“These youngest children have important unmet medical needs,” Moderna’s Chief Medical Officer, Dr. Paul Burton, told The Associated Press. The two kid-sized shots “keep them safe. I think it’s likely that additional doses will be needed over time. But we’re working on that.”

Currently, in the United States, only children over the age of 5 can be vaccinated with rival Pfizer’s vaccine, leaving 18 million young children unprotected.

Moderna vaccines are not the only ones participating in the race. Pfizer will soon announce whether three of the smaller shots will work for the youngest child, months after the disappointing discovery that the two doses were not strong enough.

FDA Vaccine Director Dr. Peter Markes, whether it’s a shot from one company or both, the agency has “criteria” in determining whether tot-sized doses are safe and effective. Act quickly without sacrificing. “

Earlier this week, Marks told lawmakers that the FDA would not be able to evaluate the product until the manufacturer completed its application, while questions about what would take so long were swirling. In a statement Thursday, the FDA is planning a meeting to publicly discuss the evidence of Moderna with an independent scientific adviser, but said the company still has to submit some additional data. .. Moderna expects to do so within a few weeks.

“It’s very important to make a proper assessment so that parents can trust the vaccines we approve,” Marks told the Senate.

If the FDA clears any vaccinations, then the Centers for Disease Control and Prevention should recommend who needs vaccination.

“It’s very important to vaccinate the youngest children,” but “moving fast doesn’t mean moving sloppy,” says pediatrician and civilian Dr. Philip Landrigan. I did. health Boston University expert. The FDA says, “We need to make sure it’s safe. They need to make sure it’s effective. And they need to do it quickly. But they don’t cut corners.”

Many parents are anxious about which vaccine will reach the scientific finish line first.

A 6-year-old daughter, a marine biologist at Duke University, has been vaccinated, and Meagan Dunphy-Daly, 3 years and 18 months old, said: The older son is part of Pfizer’s trial.

The family will continue to wear masks and take other precautions until it is clear whether the boys have received a real vaccine or a dummy injection. If Pfizer’s investigation unprotected and Moderna’s shots were found to be cleared first, Dunphy-Daly said he would look for them for her son.

“I would feel that reassured when I learned that a boy was vaccinated and had a very low risk of getting a serious infection,” she said.

The FDA will face some complex issues.

In a study of children aged 6 months to 5 years, two model nashots (each a quarter of the usual dose) induced antibodies that fight high levels of the virus, according to Burton. .. There were no serious side effects and the shot caused less high fever than other routine immunizations.

However, the vaccine has proven to be approximately 40% to 50% effective in preventing symptomatic COVID-19 during trials. Burton condemned the ability of the Omicron variant to partially evade vaccine immunity and noted that unboosted adults were similarly less effective against mild Omicron infections. No child became seriously ill during the study, but he said high antibody levels were a substitute for protection against more serious illnesses — and the company tests child booster doses.

“It’s not completely out of the realm of what we expected,” said Dr. Bill Muller of Northwestern University, who helped study Moderna’s children. “In the future, I think it will be a 3-shot series.”

Another issue: So far, in the United States, Moderna vaccines are restricted to adults. In other countries, we are expanding shots to children up to 6 years old. However, Moderna has also applied for the FDA for older children, but the FDA has not decided on them. A few months ago, the agency quoted concerns about a rare side effect, heart inflammation, in teenage boys. This has not been reported in much younger children.

It’s not clear whether the FDA is currently considering Moderna vaccines for children of all ages, or whether it will focus first on the smallest ones. But Mueller has already asked many parents why shots were so mass tested before older children — and pediatricians and pharmacists have to prepare an answer.

Burton said safety data for millions of older children vaccinated with Moderna abroad should help reassure their parents.

COVID-19 is generally not as dangerous to young people as adults, but some people can become severely ill or die. According to the CDC, about 475 children under the age of five have died of COVID-19 since the start of the pandemic, and child hospitalization has skyrocketed at the peak of Omicron.

Still, it is not clear how many parents intend to vaccinate their youngest child. Less than one-third of children aged 5 to 11 years are vaccinated twice, and 58% of children aged 12 to 17 are vaccinated.

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AP journalist Matthew Perrone contributed to this report.

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The Associated Press’s Department of Health Sciences is supported by the Science Education Department of the Howard Hughes Medical Institute. AP is solely responsible for all content.