Moderna says it has officially filed an application with the Food and Drug Administration to authorize two doses of its COVID-19 vaccine for children under the age of 6, beginning a long-awaited federal review process that will soon give the green light to the first shots could these youngest Americans.
“We believe in mRNA-1273 [the Moderna vaccine] will be able to safely protect these children from SARS-CoV-2, which is so important in our ongoing fight against COVID-19, and will be particularly welcomed by parents and caregivers,” said Stéphane Bancel, CEO of Moderna, in an explanation.
Moderna’s request is based on data the company first touted in March when it studied two 25-mcg doses of its vaccine in the age group. These doses are lower than the two 100 microgram doses given to adults.
The company says that when they tested the vaccines in two groups of children – 6 months to 23 months old and 2 years to under 6 years old – they found a “robust neutralizing antibody response” and a “favorable safety profile”.
In a preliminary analysis of laboratory tests collected during the Omicron wave, Moderna said the vaccine’s effectiveness against infection was 51% in children under the age of 2 and 37% in children between the ages of 2 and 5.
“These efficacy estimates are similar to estimates of the efficacy of adult vaccines against Omicron after two doses,” the company said in a statement.
KidCOVE Phase 3 Clinical Trial of Moderna COVID Vaccine in Children Ages 2-5 Years, University of Wisconsin School of Medicine and Public Health. Courtesy: John Maniaci/UW Health
Next steps: How long does it take?
Moderna’s move is the biggest tangible step in the process of making vaccines available to young children since the FDA postponed a scheduled meeting of its outside vaccine advisors to discuss the issue back in February.
At the time, officials had braced for the possibility that two doses of Pfizer and BioNTech’s COVID-19 vaccine could be rolled out for the youngest children by the spring.
But after a disappointing performance on the immune response induced by two doses of their vaccine in the youngest children, the companies are now awaiting results from three doses which they say will offer “a higher level of protection”. Data from this clinical study are expected by June of this year.
Moderna also says it’s working to expand its own booster shot studies to evaluate a third dose in children as young as 6 months.
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As with older age groups, the FDA must now work to review Moderna’s filing before granting emergency use authorization. After that, the Centers for Disease Control and Prevention will also have to sign updated recommendations before the shots can be fired, under federal supply contracts that govern the use of the shots.
Spokesmen for both agencies say they plan to call a meeting of their outside vaccine advisors before Moderna’s recordings are deleted.
The FDA’s Chief Vaccine Official, Dr. Peter Marks, speaking at a Senate hearing on Tuesday, said the agency would release a “tentative” schedule for its Vaccines and Related Biologicals Advisory Committee meeting next week.
However, the company must first complete its filing with the FDA and turn over reams of data on its clinical trials and manufacturing.
“The FDA cannot make a decision on a vaccine without a completed EUA application, which allows us to conduct a thorough review that includes, among other things, a comprehensive review of all adverse events and repeat key analyses,” said Abby Capobianco, an FDA spokesman. said in a statement.
Moderna said Thursday that their filing “will be completed next week.”
“We recognize that parents are very anxious to get their young children vaccinated against COVID-19, and while the FDA cannot predict how long it will take for the data and information to be evaluated, we will respond to any EUA request, we receive as soon as possible using a scientific approach. based approach,” said Capobianco.
The entire process of releasing Pfizer-BioNTech’s vaccines for children ages 5 and older last year took about 27 days, from the time they submitted their request on Oct. 6 to the CDC director signing off on the updated recommendations on Nov. 2.
Federal health officials have warned that clearing up Moderna’s shooting may not come anytime soon.
In an interview with CNN last week, when asked about reports that the FDA may be delaying its decision on filing Moderna, the president’s chief medical adviser, Dr. Anthony Fauci that regulators wanted to avoid confusion between the two vaccines, which were given the green light within weeks.
“So it will be two separate companies, two products that are similar but not identical, particularly in terms of dose. And what the FDA wants to do is get it so we don’t confuse people when we say that’s the dose, that’s the dosing schedule for kids in that 6 month to 5 year age group,” he said fauci
The FDA has downplayed suggestions it is delaying reviews of COVID-19 vaccines for the youngest children. Asked about the issue at the Senate hearing, Marks hinted that Moderna’s proposal could simply be taking longer for regulators to comb through.
“Some of these are complicated because they are relatively larger and cover larger swaths of the pediatric population than others,” Marks said.
While Moderna is already approved in several countries for children as young as 6, in the US only adults are allowed to take the 100-mcg shots, which has rare side effects of heart inflammation associated with the shots.
In recent weeks, Moderna says it has also submitted data from its 6- to 11-year filing for other countries, as well as safety follow-up data in adolescents covering 6 months post-vaccination, to the FDA.
Company executives told investors earlier this year that they had reached an agreement with the FDA to study a smaller 50-mcg primary series in adolescents, but insisted the company remains confident that the “strong efficacy profile” of 100 micrograms the risks in this age group outweigh.
“The health and well-being of children is very important to us. Therefore, providing a safe and effective COVID-19 vaccine to children under the age of 5 is absolutely one of our highest priorities. But it doesn’t matter if only one vaccine is available, parents are reluctant to vaccinate their children,” Marks said in a video posted by the FDA on Tuesday.
Only about 28% of children aged 5 to 11 are fully vaccinated, and vaccination reluctance among parents in this age group has increased in recent months. Nearly four in 10 parents of children in the age group say they are unlikely or definitely not to have their children vaccinated, according to the CDC’s latest immunization survey.
“But let me be very clear: thoroughness absolutely does not mean that we are delaying the review of these vaccines. We will proceed with all expediency without sacrificing our standards to complete our assessments,” Marks later added.
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