Moderna on Thursday asked US regulators to authorize reduced doses of its COVID-19 vaccine for children under 6 by the summer, a long-awaited step toward potential early shots for millions of tots .
Desperate families wait impatiently to protect the nation’s youngest children as people around them wear masks and other public health precautions – even as highly contagious coronavirus mutants continue to spread.
Moderna has submitted data to the Food and Drug Administration that it hopes the two low-dose shots can protect infants, toddlers and preschoolers — though not as effectively in the pandemic as before during the Omicron surge.
Moderna’s chief medical officer, Dr. Paul Burton, told the Associated Press: “There is a significant unmet medical need here with these youngest children.” Two kid-sized shots will “safely protect them.” I think it is likely that over time they will need additional doses. But we are working on that.”
Now, only children 5 years of age or older can be vaccinated in the US using rival Pfizer’s vaccine, leaving 18 million young children vulnerable.
Moderna’s vaccine isn’t alone in the race. Pfizer is expected to announce soon whether its three lower-dose shots work for the youngest children, months after the disappointing discovery that two doses weren’t strong enough.
Whether it’s shots from one company or both, FDA vaccine chief Dr. Peter Marks said the agency will “move quickly without sacrificing our standards” in deciding whether aggregate-size supplements are safe and effective.
While questions swirled as to what’s taking so long, Marks explicitly told lawmakers this week that the FDA can’t evaluate a product until a manufacturer has completed its application. The FDA will publicly debate the evidence with its scientific advisors before making a decision, and Marks said several meetings will be scheduled to cover the many expected applications.
“It is critically important that we have a proper evaluation so that parents can have confidence in any vaccines that we authorize,” Marks told a Senate committee.
If the FDA approves vaccinations for the youngest children, the Centers for Disease Control and Prevention will have to recommend who needs them — all vaccines or just those who are at greater risk from COVID-19.
Many parents are desperate that whichever vaccine reaches the scientific finish line first.
“We’re kind of lagging behind, as everyone else leads,” said Duke University marine biologist Megan Dunphy-Daly, whose 6-year-old daughter has been vaccinated – but who is 3 years and 18 months old. The sons are part of Pfizer’s lawsuit.
Until it is clear whether the boys have received the real vaccine or the dummy shot, the family remains masked and other precautions are taken. If it turns out they weren’t safe in the Pfizer study and Moderna’s shots had been approved earlier, Dunphy-Daily said she would find them for her sons.
“I will feel a sense of relief when I find out that my boys have been vaccinated and that their risk of serious infections is so low,” she said.
Some parents have also urged the government to let families choose the shots before all the evidence is in place.
Dana Walker, the mother of an 8-month-old, tearfully told a CDC meeting last week, “It seems almost impossible to dodge this strain of COVID.” “Cut out the red tape and allow parents to protect their children.”
The FDA will be faced with some complex questions.
Burton said that in a study of children ages 6 months to 5 years, two Moderna shots — each a quarter of a regular dose — triggered higher levels of virus-fighting antibodies, the same amount proven to protect young adults. it occurs. There were no serious side effects, and the shots produced a lower fever than other routine vaccinations.
But the vaccine proved to be between 40% and 50% effective in preventing symptomatic COVID-19 during trials. Burton blamed the ability of the Omicron version to partially evade vaccine immunity, noting that adults without the boost showed equally low effectiveness against mild Omicron infections. While none of the children became seriously ill during the study, he said high antibody levels are a proxy for protection against more serious illness — and the company will test a booster dose of one child.
Another issue: So far Moderna’s vaccine in the US is limited to adults. Other countries have expanded the shot to children under the age of 6, but months ago the FDA cited concerns about heart inflammation, a rare side effect in teenage boys, and this has led to Moderna’s earlier pediatric applications. has not ruled.
Burton said the FDA may consider its vaccine for children of all ages — but also open it up first to the youngest of children who have no other options. He said the safety data of millions of older children given for Moderna’s vaccinations abroad should help reassure parents.
While COVID-19 is generally not as dangerous in young people as in adults, some become seriously ill or even die. According to the CDC, 475 children under the age of 5 have died of COVID-19 since the start of the pandemic, and children’s hospitalizations are at Omicron’s peak.
Yet it is not clear how many parents intend to vaccinate the youngest children. Less than a third of children aged 5 to 11 years have had two vaccines, and 58% of children aged 12 to 17 years.
The Associated Press Department of Health and Science receives support from the Howard Hughes Medical Institute’s Department of Science Education. Associated Press is solely responsible for all content.