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Moderna is ‘satisfied’ with the test results of the children vaccine, but is that enough for the FDA?

This uncertainty comes after Covid’s cases are still high Thanks to BA.2, Omicron, a rapidly spreading subvariant in Europe and China, which It now accounts for almost 55 percent of all cases In the U.S., although incidence and hospitalization in the U.S. are low for eight months, many fear that infections will soon increase, adding to the new urgency of vaccinating about 19 million children under the age of 5 in the U.S. .

Children under the age of 5 accounted for about 3 percent of U.S. covitis cases and 0.1 percent of deaths, according to the Centers for Disease Control and Prevention, but in Omicron’s time this age group was more likely to be hospitalized than older children.

Moderna, which did not submit its findings to the FDA or other scientists for review, said last week that two strokes of the Covid vaccine reduced the incidence of symptomatic disease by 43.7 percent in children 6 months to 2 years and 35.7 percent in children 2 years. 6. This is below the 50 percent threshold set by the FDA for adults, but Moderna officials said the regimen meets a metric called immunobrogging, which means that pediatric doses produce the same immune response seen in young people.

This indicates that this shot is suitable for children, said Diego Hijano, an assistant faculty member in the Infectious Diseases Unit at the St. Judy Children Research Hospital.

“He really has good immunogenicity data and good data on protection against symptomatic disease,” he said. The fact that the vaccine offers some protection against mild to moderate disease indicates that it will have a higher protection against severe disease, he added. None of the children in the trial needed to be hospitalized.

But others argue that at this stage of the pandemic, immunogenicity alone may not be enough as it does not guarantee better protection. The FDA may need to raise its level and demand a higher standard, said Peter Hotes, professor of pediatrics and molecular virology and microbiology at Baylor College of Medicine.

“Given the other data that surrounds it, I do not know that the FDA will move forward in terms of releasing it for emergency use,” he said. “We are still studying the relationship between virus neutralizing antibodies and efficacy.”

The FDA has not commented on Moderna’s submission as it awaits evaluation. “Our approach has always been to conduct regulatory reviews that address the urgent public health needs created by the pandemic, while adhering to our strict standards of safety and effectiveness,” the agency spokesman said.

The FDA has said it will schedule a meeting of its advisory committee when Moderna completes its application for the Covid vaccine for younger children. Last month, the FDA scheduled a meeting in a matter of hours Pfizer and BioNTech say They requested authorization for their two-dose regimen, only later Postponement of the meeting. Although the agency declined to explain its decision, regulators suggested that the two dose data were insufficient to consider authorization.

But Moderna’s test results, according to its press release, show what Pfizer and BioNTech did not do. The pharmaceutical company said its 25 microgram dose – about a quarter of what is taken in adults – triggered an immune response in all children aged 6 and younger, which was similar in adults aged 18 to 25 years.

Data from a Pfizer clinical trial showed that the vaccine elicited an immune response in children 6 to 24 months of age, compared with relatively young adults, but not in children 2 to 5 years of age.

“We believe these latest findings from the KidCOVE study are good news for parents of children under the age of six,” Moderna CEO Stephan Bansel said in a statement.

And most public health experts agree that the efficacy rates advertised when vaccines were first introduced in 2020 are unlikely to be replicated with variants such as Omicron. This may cause regulators to neglect the seemingly low protection of the vaccine against infection.

“It may seem like a low number, but in the Omicron era it was actually quite comparable to the effectiveness of the infection we now see in other vaccines,” Anthony Fauci, the county’s chief infectious disease specialist, told reporters. At a White House press briefing last week.

Still, the company itself Press releaseHe said he appreciates the potential for booster doses for children and some suspect the FDA and its independent advisory group may prefer to wait for this data, as they did with Pfizer and BioNTech. These two companies are expected to have amplifying data next month.

Peter Marks, head of the FDA’s Center for Biological Assessment and Research, told reporters Tuesday that safety and efficacy data for young children are crucial to the agency’s decision on vaccine authorization.

“We have to do our job extremely well to make sure we have a very good rating of safety and effectiveness so that when we do our recommendation, people will trust that recommendation,” he said.

Sean O’Leary, a professor of pediatrics and infectious diseases at the University of Colorado School of Medicine and vice chair of the Infectious Diseases Committee of the American Academy of Pediatrics, noted that even with two doses, the Moderna vaccine appears to protect children from serious diseases. Disease.

“I think we can expect it to offer stronger protection from heavier consequences, which is really our ultimate goal,” he said.

Moderna is ‘satisfied’ with the test results of the children vaccine, but is that enough for the FDA?

Source link Moderna is ‘satisfied’ with the test results of the children vaccine, but is that enough for the FDA?

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