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Moderna will ask the FDA to approve the Covid-19 vaccine for young children

The application means the FDA may begin to consider Moderna’s shots for distribution to the public. But a decision may still be weeks away.

The FDA declined to comment when asked about the upcoming application.

During questioning on Tuesday from Sen. Patty Murray (D-Wash.), The top FDA vaccine regulator Peter Marks, told lawmakers that the agency planned to publish a preliminary timeline next week showing when it planned to hold external advisory committee meetings on vaccines for young children – a step that be able to offer more accurate insights into when the agency plans to approve shots.

“Just remember that we can not actually complete our reviews until we actually have complete applications in the FDA,” Marks testified to the Senate Aid Committee. “We will continue at all necessary speed when we have complete applications, some of these are complicated because they relatively cover larger sections of the pediatric population than others,” he added.

Moderna is also expected to apply for authorization for children aged 6 to 11 and soon submit an update to its emergency use permit for youth ages 12 to 17, said people with knowledge of the case, though it is unclear when these will be officially filed. Currently, the only Covid-19 vaccine available for children ages 5-11 is made by Pfizer and BioNTech.

A spokesman for Moderna declined to comment.

The application is likely to increase pressure on the FDA over its timeline for vaccine approval, after POLITICO reported that the agency had discussed postponing a verdict until drug firm Pfizer seeks permission for a competing shot.

Some federal regulators privately argued that approving the competing vaccines at the same time would make it easier for the agency to roll them out to the public and cut down on the potential for confusion. Unlike Moderna, Pfizer’s vaccine is a three – shot regimen.

But it would probably also mean waiting until June, extending the wait for a first Covid shot for millions of children and triggering backlash from parent groups and lawmakers.

“Many families with young children are reluctant to resume their normal activities until the vaccine is available to their children,” Colorado Governor Jared Polis said in an interview. “Just put the facts in front of the parents and let them make that decision.”

The criticism touched on a behind-the-scenes battle to deal with the fallout, said two people familiar with the dynamic, with health officials discussing exactly how to proceed once Moderna’s full application is submitted in early May.

“Let me be very clear, being thorough does not mean that we are delaying the review of these vaccines,” Marks said in a statement. video submitted by FDA Tuesday and stresses the importance of ensuring that parents have confidence in all approved vaccines. “We will move with all expediency without sacrificing our standards to complete our evaluations.”

The White House, for its part, has made it clear that the decision is up to the FDA alone, the people said. Some officials over the past week have even gone out of their way not to discuss the vaccines with FDA regulators for fear of being accused of political interference.

The application is expected to be based on evidence generated from a clinical trial with approximately 6,700 children. In March, Moderna reported that two-quarter doses of their Covid-19 vaccine produced an immune response in children 6 years of age and below the level of the immune response in young adults receiving two full doses of the shot. Real-world evidence gathered under Omicron showed that the vaccine reduced symptomatic Covid-19 cases by 43.7 percent among children aged 6 to 24 months, and by 35.7 percent among children aged 2 to 6 years, compared with adult protection. at the time.

Children who received the vaccine experienced mild side effects and no children in the trial developed severe Covid-19.

The FDA had originally told vaccine manufacturers that their products were needed to reduce symptomatic Covid cases by 50 percent in adults. For children or other groups that are more difficult to study in large numbers, the agency issued a guide that said it would allow manufacturers to use a metric called immunbridging, which compares the immune response generated by the vaccines.

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