FDA committee recommends two-dose Moderna Covid vaccine for children ages 6 to 17

A young man receives his Covid-19 vaccination at a vaccination clinic. People receive the Moderna vaccine in Milford, Pennsylvania.

Preston Ehrler | flare | Getty Images

Moderna’s two-dose Covid-19 vaccine for children ages 6 to 17 received approval from the Food and Drug Administration’s Committee of Independent Immunization Experts on Tuesday, an important step on the way to distribution to children.

The committee voted unanimously to recommend the injections for children from kindergarten through high school after a day-long public session to weigh up how safe and effective the injections are.

The most common side effects of the vaccines were pain at the injection site, fatigue, headache, chills, muscle pain and nausea. According to the FDA, no cases of myocarditis, a type of heart inflammation, were found in children in these age groups during Moderna’s clinical trials.

The clinical trials were conducted before the Omicron variant became dominant. As a result, it is currently unclear how much protection two shots would provide in these age groups. A third vaccination in other age groups has been shown to significantly increase protection against Omicron. dr Doran Fink, a senior official in the FDA’s vaccines office, said Moderna intends to provide data on a third dose for these age groups soon.

Estimates of the effectiveness of the vaccines compare to other Covid variants that are no longer dominant. The syringes for teenagers aged 12 to 17 had an estimated 90% efficacy against disease caused by the alpha variant and the original strain of Covid first discovered in Wuhan, China, according to an FDA presentation. The shots for children ages 6 to 11 had an estimated 76% effectiveness in preventing disease from the Delta variant.

Children aged 6 to 11 would receive smaller 50 microgram shots, while teenagers aged 12 to 17 would receive the same adult dose of 100 micrograms.

dr Paul Offit, a member of the committee, said that two doses would probably not protect against mild disease from Omicrons subvariants, but would probably protect against severe disease with a third dose.

“I think the benefits clearly outweigh the risks, but I’m saying that with the convenience there will be a third dose,” said Offit, a pediatrician and infectious disease expert at Children’s Hospital of Philadelphia. “If that weren’t true, I wouldn’t feel the same way. We are no longer in the same part of this pandemic. It’s a different time.”

dr However, Eric Rubin said the FDA will always evaluate the vaccine’s effectiveness based on previous Covid variants because the virus is evolving rapidly and data collection takes time.

“We need to make decisions based on the best data we have, which will always be old data in an outbreak that’s constantly moving,” said Rubin, a member of the FDA committee and an infectious disease expert at Harvard.

The FDA is expected to approve the vaccines this week. The Centers for Disease Control and Prevention must then approve the vaccinations before pharmacies and doctors can start administering them. Moderna vaccinations in this age group could start as early as next week.

Children as young as 5 can be vaccinated with the Pfizer and BioNTech vaccine, although many parents do not vaccinate their children. About 30% of children aged 5-11 and 60% of teenagers aged 12-17 are fully vaccinated by early June.

Approving Moderna’s vaccine for children ages 6 to 17 would bring eligibility in line with Pfizer’s vaccines. This would also allow the FDA to simultaneously approve Moderna’s and Pfizer’s vaccines for children under the age of 5. The FDA committee will meet Wednesday to discuss the vaccine for infants through preschoolers, the only age group not yet eligible for vaccination.

risk of myocarditis

Moderna asked the FDA for approval of its vaccine for teens ages 12 to 17 more than a year ago, in June 2021. However, the FDA held back approval of the vaccine because international data suggested that Moderna’s vaccine carried a higher risk of a heart infection known as myocarditis than Pfizer’s shot. Moderna applied for approval for the 6- to 11-year-old age group in March of this year.

However, U.S. vaccine surveillance through May did not find a significantly higher risk of myocarditis with Moderna’s vaccine compared to Pfizer’s vaccines in men ages 18 to 25, FDA official Hui-Lee Wong said during a presentation before the committee on Tuesday.

Pfizer and Moderna shots use the same messenger RNA technology. Both carry a risk of myocarditis, typically after the second dose and usually in young men and teenage boys. However, the CDC has found that the risk of myocarditis from Covid infection is higher than from vaccination. Myocarditis is typically caused by viral infections.

The CDC has identified 635 cases of myocarditis in children and adolescents ages 5 to 17 from more than 54 million doses of Pfizer administered. The risk is highest in teenagers ages 12 to 17 after the second dose, according to the CDC. According to the CDC, there doesn’t appear to be an increased risk for children ages 5 to 11.

According to CDC data, there were about 46 reports of myocarditis per million second doses of Pfizer in teenagers ages 12 to 15 seven days after receiving the vaccine and 75 reports per million second doses in boys ages 16 to 17.

“I’m a little sobered by the myocarditis data and the frequency with which it occurs,” said Dr. Mark Sawyer, professor of pediatrics at the University of California San Diego and temporary voting member. “So that needs to be watched closely in the future as we expand the use of the vaccine.”

People who develop myocarditis after vaccination are usually hospitalized for several days as a precaution. However, most patients appear to make a full recovery about three months after their diagnosis, according to a CDC survey of cardiologists and other health care providers.

Effects of Covid on children

Although Covid is generally less severe in children than adults, more children were hospitalized with the virus during the Omicron surge than at any other time of the pandemic, according to the CDC. About two-thirds of children aged 5 to 17 hospitalized with Covid had at least one underlying health condition, such as diabetes or obesity.

dr Katherine Fleming-Dutra, a CDC official, told the FDA committee that the majority of the children were hospitalized because they had Covid. In other words, most of them did not test positive for the virus after admission for some other health reason.

Covid has killed 202 children aged six months to 4 years, 189 children aged 5 to 11 and 443 youth and teenagers aged 12 to 17 since January 2020. Covid is among the top five causes of death for children under 19-years old, according to the CDC.

Overall, more than 13 million children under the age of 18 have contracted Covid during the pandemic, according to the CDC. It is unclear how many children in the US have long been ill with Covid. However, a national survey in the UK found up to 8% of children have Covid symptoms for more than 12 weeks. Long Covid can also occur after mild infections.

Ruth Link-Gelles, a CDC official, said it is “extremely likely” that another flare-up of infection will occur as new omicron subvariants, BA.4 and BA.5, become more circulated.

“It’s important to keep in mind that we’re vaccinating children now, or potentially vaccinating children with the expectation that vaccination will protect them in the coming months as we anticipate additional flare-ups,” Link-Gelles said.

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