FDA advisers recommend Moderna shot for older children and teens

Placeholder while loading article actions

On Tuesday, independent advisers unanimously urged the Food and Drug Administration to authorize Moderna’s two-shot coronavirus vaccine for children ages 6 to 17, paving the way for agency clearance later this week.

A green light from the FDA, followed by approval by the Centers for Disease Control and Prevention, would give parents another vaccine choice for school-aged children and adolescents. The Pfizer-BioNTech vaccine is already available for children aged 5 to 17.

But having a second vaccine available may not translate to a large increase in vaccinations, at least in the 6-11 age group, where demand has been low. According to the CDC, only 29% of children in this group received the two-shot regimen of the Pfizer-BioNTech vaccine.

To increase uptake “is really going to take a lot of one-on-one conversations and educating providers and parents about the benefits,” said Amanda Cohn, chief medical officer of the CDC’s National Center for Immunization and Respiratory Diseases and member of the advisory committee.

Even with the unanimous support for the vaccine, some of the advisers expressed concerns that data on the vaccine was limited and outdated because trials were conducted before the emergence of the omicron variant of the coronavirus. They said the vaccine would likely be beneficial in preventing serious disease, but not as useful in blocking mild infections.

“We crossed a line,” when the highly transmissible omicron and its subvariants arrived, which require a third dose of protection, said Paul A. Offit, professor of pediatrics at Children’s Hospital of Philadelphia. He said he supports clearance – as long as a third dose of Moderna is on the way.

“We’re in a different stage of this pandemic,” Offit said. “I think the benefits clearly outweigh the risks, but I’m saying with the comfort provided, there will be a third dose.” Children who receive a two-dose series should not be considered “fully immunized”, he said.

Moderna told advisers it was testing a booster shot for age groups 6 to 17 and would seek FDA clearance in the coming months, possibly by July.

Tuesday’s meeting kicked off one of the busiest weeks for vaccine policy since the pandemic began. On Wednesday, the agency’s outside experts, the Advisory Committee on Vaccines and Related Biologics, are scheduled to discuss whether Moderna and Pfizer-BioNTech’s vaccines should be used for younger children. For the Pfizer-BioNTech vaccine, this includes babies and children 6 months to 4 years old. And for Moderna, it’s children from 6 months to 5 years old.

If the FDA and CDC give their blessing later this week, the vaccines will be available starting next week, Biden administration officials said. Babies and young children are the only group that does not have access to a vaccine.

Tuesday’s action, however, focused on the use of the Moderna vaccine for children aged 6 to 17. The counselors considered two groups: 6 to 11 years old and 12 to 17 years old. The two votes in favor of authorization were 22 to 0.

Last week, FDA scientists declared the vaccine safe and effective for all pediatric age groups. The staff report states that Moderna’s safety, immune response and efficacy data demonstrated “a favorable benefit-risk profile.”

Some parents wondered if vaccines were necessary for children now, given the relatively low risk posed by covid-19 for young people.

But Katherine E. Fleming-Dutra, physician in the coronavirus vaccine policy unit at the CDC’s National Center for Immunization and Respiratory Diseases, said it’s impossible to predict which children will develop severe illness.

“Granted, children with underlying medical conditions are more at risk, but half of children 6 months to 4 years old who have been hospitalized with covid-19 have no underlying medical conditions,” said she declared.

Moderna said in a presentation that for every million vaccine doses distributed in the United States, 95 hospitalizations and 24 intensive care unit stays for children ages 6 to 11 would be prevented. For children aged 12 to 17, 200 hospitalizations and 52 intensive care stays would be avoided, the company estimated.

In clinical trials, the Moderna vaccine has been shown to generate an immune response — virus-blocking antibodies — at least as strong as the protection offered to vaccinated young adults, the agency’s primary measure of effectiveness. The vaccine did not produce any concerning side effects, the FDA said.

Pediatric coronavirus vaccine tests are not designed primarily to directly measure whether injections prevented symptomatic illness. Instead, following a regulatory route often used to extend vaccine eligibility to younger age groups, scientists measured levels of virus-blocking antibodies in children’s blood and compared those measurements to levels protectors in young adults.

But the agency said the trials also produced limited “supporting evidence” on the effectiveness of the vaccine and the impact of coronavirus variants on the vaccine.

The studies showed that, based on the number of children who developed covid in the vaccine groups compared to the placebo groups, the effectiveness was 93% for children aged 12 to 17, who were tested when the original strain and the alpha variant were dominant. The rate was 77% for children aged 6 to 11 when the delta variant caused the most infections. Efficacy dropped to 51% and below for children under 6 who were tested during the omicron-induced surge, which also blunts the potency of the vacancy in adults. Overall the number of covid cases was low.

Moderna injections are given 28 days apart. Children 6 to 11 years old receive 50 micrograms with each injection, which is half the adult dose. Teens get the adult dose. The third dose, or booster dose, for both groups will be 50 micrograms, the company said.

Moderna applied for permission to use its vaccine in adolescents more than a year ago, but the permission was suspended due to concerns about the risk of rare cardiac side effects – inflammation of the heart muscle and surrounding tissues – called myocarditis and pericarditis. The Moderna and Pfizer-BioNTech vaccines have both been linked to heart problems in young adult men. Most cases are mild and the inflammation caused by covid tends to be more severe.

There were no confirmed cases of myocarditis or pericarditis in the Moderna trials for infants, children and adolescents – but the trials may have been too small to detect this. FDA officials said the risk-benefit balance was favorable, but the safety and effectiveness of the vaccine would be closely monitored as it enters the market and becomes more widely used.

Advisors raised questions about how long the Moderna vaccine would provide immune protection against the coronavirus and whether it would be effective against omicron subvariants circulating in the United States.

“At the start of the pandemic, it’s pretty clear that the bar was a little lower in terms of vaccine effectiveness because we were trying to get the vaccines out and protect the population,” said Wayne Marasco, professor of medicine. at Harvard Medical School. and the Dana-Farber Cancer Institute. But Marasco said he hopes companies will develop vaccines that have better durability and provide protection against infection that lasts more than a few months.

#FDA #advisers #recommend #Moderna #shot #older #children #teens

Add Comment