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


A young man gets a Covid-19 vaccine at a vaccination room. People receive the Moderna vaccine in Milford, Pennsylvania.

Preston Ehrler | LightRocket | beautiful pictures

Moderna’s two-dose Covid-19 vaccine for children ages 6 to 17 received Food and Drug Administration panel endorsement of independent immunization experts on Tuesday, an important step. on the way to distributing it to children.

The committee unanimously voted to recommend the use of the shots for preschool through high school students after an all-day public meeting to weigh the safety and effectiveness of the shots.

The most common vaccine side effects are pain at the injection site, fatigue, headache, chills, muscle aches, and nausea. According to FDA.

Clinical trials were conducted before the omicron variant became dominant. Therefore, it is currently unclear how much protection the two shots provide in these age groups. A third injection in other age groups has been shown to significantly increase protection against omicrons. Doran Fink, a senior official in the FDA’s vaccine office, said Moderna intends to make data on the third dose available for these age groups soon.

Estimates of the vaccine’s effectiveness against other Covid variants no longer prevail. The shots given to adolescents 12 to 17 years of age are estimated to be 90% effective against illness from the alpha variant, and the original Covid strain was first discovered in Wuhan, China, according to the presentation. of the FDA. The shots given to children 6 to 11 years of age are estimated to be 76% effective at preventing illness from the delta variant.

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

“I think the benefits clearly outweigh the risks, but I would say that with the comfort provided comes a second dose,” said Offit, a pediatrician and infectious disease specialist at Children’s Hospital of Philadelphia. father”. “If that weren’t true, I wouldn’t feel the same way. We’re not in the same area of ​​this pandemic anymore. It’s a different time.”

Children 6 to 11 years old will receive the smaller injections of 50 micrograms, while adolescents 12 to 17 years old will receive the same dose as adults of 100 micrograms.

The FDA is expected to authorize the vaccine this week. Then, the Centers for Disease Control and Prevention must sign off on the shots before pharmacies and doctors can start administering them. Moderna vaccinations in this age group could begin as soon as next week.

Children 5 years of age and older are eligible for vaccination Pfizer and BioNTech’s vaccines, although many parents have not had their children vaccinated. About 30% of children 5 to 11 years old and 60% of adolescents 12 to 17 years of age are fully immunized by early June.

Authorizing Moderna’s vaccine for children ages 6 to 17 would provide matching eligibility for Pfizer shots. This would also allow the FDA to simultaneously authorize both Moderna and Pfizer vaccines for children under 5 years of age. The FDA committee will meet Wednesday to discuss vaccines for infants through preschoolers, the only remaining age group ineligible for vaccination.

Risk of myocarditis

Moderna asked the FDA to authorize its vaccine for adolescents 12 to 17 more than a year ago in June 2021. However, the FDA suspended the authorization of the injection because international data indicated that the vaccine -xin from Moderna has a higher risk of developing an inflammation of the heart, called myocarditis. , than Pfizer’s shot. Moderna requested authorization for the 6-11 age group in March.

However, US vaccine surveillance throughout May did not find a significantly higher risk of myocarditis with Moderna vaccination compared with Pfizer vaccination in men aged 18 to 25 years old, FDA official Hui said. -Lee Wong said during his presentation to the committee on Tuesday.

Photo of Pfizer and Moderna using the same messenger RNA technology. Both carry a risk of myocarditis, usually after the second dose and often in young men and teenage boys. However, the CDC found that higher risk of myocarditis due to Covid infection than vaccination. Myocarditis is usually caused by a viral infection.

The CDC detected 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 in teenage boys aged 12 to 17 years after the second dose. According to the CDC, there does not appear to be an increased risk for children aged 5 to 11 years.

According to CDC data, there were approximately 46 reports of myocarditis per second million doses of Pfizer in male adolescents aged 12 to 15 seven days after injection, and 75 reports per second dose per million in males aged between 12 and 15 years. 16 to 17 years old, according to CDC data.

“I’m a bit concerned by the data on myocarditis and how often it occurs,” said Dr Mark Sawyer, professor of pediatrics at the University of California San Diego and provisional voting member. “So obviously that needs to be watched closely going forward as we expand the use of the vaccine.”

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

A profound impact on children

Although Covid is generally less severe in children than it is in adults, more children are hospitalized with the virus during an omicron outbreak than at any other time during the pandemic, according to the CDC. About two-thirds of children ages 5 to 17 admitted to hospital with Covid have 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 children are hospitalized with Covid-19. In other words, most of them did not test positive for the virus after being hospitalized for another health reason.

Covid killed 202 children aged 6 months to 4 years, 189 children aged 5 to 11 years old and 443 children aged 12 to 17 years 12 to 17 years old from January 2020. Covid is one of the top five causes of death. deaths for children under 19 – years old, according to the CDC.

In total, more than 13 million children under the age of 18 have been infected with Covid during the pandemic, according to the CDC. It is not clear how many children in the US have long lived Covid. However, a national survey in the UK found that up to 8% of children had Covid symptoms for more than 12 weeks. Long Covid can occur even after a mild infection.

Ruth Link-Gelles, a CDC official, said it is “very likely” that another wave of infections will occur as the new omicron subvariables, BA.4 and BA.5, begin to circulate more frequently.

“It is important to note that we are vaccinating children, or potentially vaccinating children, with the expectation that vaccination will protect them in the months to come, when,” said Link-Gelles. We expect more.”

CNBC Health & Science

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