The FDA committee recommends the current two-dose Covid vaccine for children aged 6 to 17.

A young man receives a Covid-19 vaccination at a vaccination clinic. People get the Modern vaccine in Milford, Pennsylvania.

Preston Erler | Light rocket | 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 experts on immunization on Tuesday, a key step towards its distribution to children.

The committee voted unanimously to recommend vaccines for use in kindergartens and high school students after an all-day meeting that assessed the safety and effectiveness of the vaccines.

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

Clinical trials were conducted before the omicron variant became dominant. As a result, it is not clear what protection two shots would provide in these age groups right now. A third shot in other age groups has been shown to significantly increase protection against omicrons. Dr. Doran Fink, a senior official with the FDA’s Vaccine Division, said Moderna intends to provide third dose data for these age groups soon.

Estimates of vaccine effectiveness refer to other variants of Covid that are no longer dominant. The vaccines for adolescents aged 12 to 17 had an estimated efficacy of 90% against the disease from the alpha variant and parent strain of Covid, which was first identified in Wuhan, China, according to an FDA presentation. Vaccinations for children aged 6 to 11 years had an estimated effectiveness of 76% in preventing the disease from the delta variant.

Children aged 6 to 11 years will receive smaller doses of 50 mcg, and adolescents aged 12 to 17 years will receive the same dose as adults, 100 mcg.

Dr. Paul Offit, a member of the committee, said two doses were unlikely to provide protection against mild disease caused by omicron subvariants, but they would likely protect against severe disease with a third dose.

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

However, Dr. Eric Rubin said the FDA will always evaluate the effectiveness of a vaccine based on previous Covid variants given how quickly the virus evolves and how long it takes to collect data.

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

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

Children aged 5 years and over are already eligible for vaccination against pfizer as well as BioNTech vaccine, although many parents did not vaccinate their children. As of early June, about 30% of children aged 5 to 11 and 60% of adolescents aged 12 to 17 are fully vaccinated.

Moderna’s approval of the vaccine for children aged 6 to 17 would result in eligibility consistent with Pfizer’s vaccines. It will also allow the FDA to simultaneously authorize Moderna and Pfizer vaccines for children under 5 years of age. The FDA committee will meet on Wednesday to discuss the vaccine from infants to preschoolers, the only age group not eligible for vaccination.

Risk of myocarditis

Moderna asked the FDA to approve its vaccine for teens 12 to 17 years old over a year ago, in June 2021. However, the FDA delayed issuing the vaccine’s approval because international data showed that the Moderna vaccine comes with a higher risk of an inflammation of the heart known as myocarditis. than a Pfizer shot. Moderna requested permission for the 6-11 age group in March of this year.

However, U.S. vaccine surveillance during May did not reveal a significantly higher risk of myocarditis with the Moderna vaccine compared to Pfizer vaccines in men aged 18 to 25, FDA spokesman Hui-Lee Wong said during a presentation to the committee during Tuesday.

The Pfizer and Moderna vaccines use the same messenger RNA technology. They both carry a risk of myocarditis, usually after the second dose and usually in young men and adolescent boys. However, the CDC determined that risk of myocarditis is higher from Covid infection than vaccination. Myocarditis is usually caused by viral infections.

The CDC found 635 cases of myocarditis in children and adolescents aged 5 to 17 years out of more than 54 million doses of Pfizer administered. According to the CDC, the risk is highest among teenage boys between the ages of 12 and 17 after the second dose. According to the CDC, the risk of myocarditis in boys aged 5 to 11 years after the second dose is slightly increased, although it is much lower than in adolescents.

According to the CDC, there were about 46 reports of myocarditis per million second doses of Pfizer among teenage boys aged 12 to 15 years seven days after vaccination and 75 reports per million second doses among boys aged 16 to 17 years. Boys aged 5 to 11 reported 2.6 cases of myocarditis per million doses administered.

“I am a little sobered by the data on myocarditis and the frequency with which it occurs,” the doctor said. Mark Sawyer, UC San Diego professor of pediatrics and temporary voting member. “So this clearly needs to be closely monitored going forward as we scale up the use of the vaccine.”

People who develop myocarditis after vaccination are usually hospitalized for a few days as a precaution. However, according to a CDC survey of cardiologists and other healthcare professionals, most patients make a full recovery about three months after diagnosis.

Impact of Covid on children

Although Covid tends to be less severe in children than in adults, according to the CDC, more children with the virus were hospitalized during the micron wave than at any other point in the pandemic. About two-thirds of children aged 5 to 17 hospitalized with Covid had at least one underlying condition, such as diabetes or obesity.

Dr. Katherine Fleming-Dutra, a spokeswoman for the CDC, told the FDA committee that most of the children were hospitalized because they had Covid. In other words, most of them did not test positive for the virus after being hospitalized for another health reason.

Since January 2020, Covid has claimed the lives of 202 children aged six months to 4 years, 189 children aged 5 to 11, and 443 teenagers and teens aged 12 to 17. Covid is one of the top five causes of death for children under 19. years, according to the CDC.

In total, more than 13 million children under the age of 18 have contracted Covid during the pandemic, according to the CDC. It is not clear how many children in the US have long been ill with Covid. However, a national study in the United Kingdom found that up to 8% of children have Covid symptoms for more than 12 weeks. Prolonged Covid can occur even after mild infections.

Ruth Link-Gelles, a CDC spokesperson, said it was “extremely likely” that there would be another spike in infection as the new omicron sub-variants, BA.4 and BA.5, began to circulate more.

“It’s important to remember that we are vaccinating children, or potentially vaccinating children now, with the expectation that vaccination will protect them in the coming months when we expect additional surges,” Link-Gelles said.

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Correction: This story has been updated to reflect the slightly increased risk of myocarditis in boys aged 5 to 11 years after a second dose of Pfizer vaccine. The previous version of the story distorted the data.