A young man gets vaccinated against Covid-19 at a vaccination clinic. People get the Moderna vaccine in Milford, Pennsylvania.
Preston Ehrler | light 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 Independent Immunization Expert Panel on Tuesday, a key step on the way to its distribution to children.
The committee voted unanimously to recommend the vaccines for use in kindergarten through high school after a day-long public 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 aches and nausea. According to the FDA, no cases of myocarditis, a type of heart inflammation, were found in clinical trials of Moderna in children in these age groups.
Clinical trials were conducted before the omicron variant became dominant. As a result, it is unclear how much protection two injections would provide to these age groups at this time. A third vaccine in other age groups has been shown to significantly increase protection against omicron. Dr. Doran Fink, a senior official in the FDA’s Office of Vaccines, said Moderna intends to provide data on a third dose soon for these age groups.
Vaccine effectiveness estimates are against other Covid variants that are no longer dominant. Injections aimed at teenagers 12 to 17 years old had an estimated 90% effectiveness against the alpha variant disease and the original Covid strain that was first detected in Wuhan, China, according to an FDA presentation . Injections for children aged 6 to 11 had an estimated 76% effectiveness in preventing delta-variant disease.
Children aged 6 to 11 would receive smaller injections of 50 micrograms, while adolescents aged 12 to 17 would receive the same dose as adults at 100 micrograms.
Committee member Dr. Paul Offit said two doses were unlikely to provide protection against mild disease caused by omicron subvariants, but would likely protect against severe disease with a third dose.
“I think the benefits clearly outweigh the risks, but I’m saying with the comfort provided, there will be a third dose,” said Offit, a pediatrician and infectious disease expert at Children’s Hospital of Philadelphia. “If it wasn’t true, I wouldn’t feel the same way. We’re not in the same part of this pandemic anymore. It’s a different time.”
However, Dr. Eric Rubin said the FDA will still assess the effectiveness of the vaccine based on previous Covid variants given how quickly the virus evolves and the time it takes to gather data.
“We have to make decisions based on the best data we have, which will always be old data in an ever-changing epidemic,” said Rubin, an FDA committee member and Harvard infectious disease expert.
The FDA is expected to clear the vaccines this week. The Centers for Disease Control and Prevention must then approve the injections before pharmacies and doctors can begin administering them. Moderna vaccinations in this age group could begin as early as next week.
Children aged 5 and over are already eligible for vaccination with the vaccine from Pfizer and BioNTech, although many parents have not had their children vaccinated. About 30% of children aged 5 to 11 and 60% of adolescents aged 12 to 17 are fully vaccinated by early June.
Moderna’s vaccine authorization for children ages 6 to 17 would align eligibility with Pfizer’s shots. It would also allow the FDA to simultaneously license Moderna and Pfizer vaccines for children under 5. The FDA committee will meet on Wednesday to discuss the vaccine for infants through preschoolers, the only age group not eligible for vaccination.
Risk of myocarditis
Moderna applied to the FDA to authorize its vaccine for adolescents 12 to 17 over a year ago in June 2021. However, the FDA delayed the authorization of the vaccine because international data indicated that the vaccine from Moderna carried a higher risk of heart inflammation, known as myocarditis. , than the Pfizer shot. Moderna applied for clearance for the 6-11 age group in March this year.
However, vaccine monitoring in the United States through May did not reveal a significantly higher risk of myocarditis with Moderna’s vaccine compared to Pfizer’s vaccines in men aged 18 to 25, said Tuesday. an FDA official, Hui-Lee Wong, during a presentation to the committee.
Both Pfizer and Moderna injections use the same messenger RNA technology. They both carry a risk of myocarditis, usually after the second dose and normally in young men and adolescents. However, the CDC found that the risk of myocarditis is higher from Covid infection than from vaccination. Myocarditis is usually caused by viral infections.
The CDC found 635 cases of myocarditis in children and adolescents ages 5 to 17 out of more than 54 million doses of Pfizer administered. The risk is highest in adolescents ages 12 to 17 after the second dose, according to the CDC. According to the CDC, there does not appear to be an elevated risk for children ages 5 to 11.
There were approximately 46 reports of myocarditis per million second doses of Pfizer in adolescents aged 12 to 15 seven days after receiving the vaccine, and 75 reports per million second doses in boys aged 16 to 17. , according to CDC data.
“I’m a little sobered by the data on myocarditis and how often it happens,” said Dr. Mark Sawyer, professor of pediatrics at the University of California, San Diego and temporary voting member. “So that clearly needs to be watched closely 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.
The impact of Covid on children
Although Covid is generally less severe in children than in adults, more children were hospitalized with the virus during the omicron wave than at any other time during 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 a majority of children had been hospitalized because they had Covid. In other words, most of them did not test positive for the virus after being admitted for another health reason.
Covid has killed 202 children aged six months to 4 years, 189 children aged 5 to 11 and 443 tweens and adolescents aged 12 to 17 since January 2020. Covid is among the top five causes of death in children under 19 years old. -years, 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’s unclear how many children in the United States have had Covid for a long time. However, a national survey in the UK has found that up to 8% of children have Covid symptoms for more than 12 weeks. Long Covid can occur even after mild infections.
Ruth Link-Gelles, a CDC official, said it’s “extremely likely” another wave of infection will occur as new omicron subvariants, BA.4 and BA.5, begin to circulate more.
“It’s important to keep in mind that we are vaccinating children, or potentially children, now in the hope that vaccination will protect them in the months to come as we expect additional surges,” said Link-Gelles.
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