The Centers for Disease Control and Prevention is expected to clear Moderna’s two-dose Covid-19 vaccine for children in kindergarten through high school for public distribution this week after the agency’s panel of independent vaccine experts voted on the unanimity on Thursday to recommend vaccines.
The committee approved Moderna’s vaccine for children ages 6 to 17 after reviewing its safety and effectiveness at a public meeting. CDC Director Dr. Rochelle Walensky is expected to approve the recommendation later Thursday, the final step before pharmacies and doctors’ offices can begin administering the injections.
The CDC on Saturday approved Moderna’s vaccines for infants through preschoolers, ages six months to 5 years. Vaccinations started this week for this age group.
Moderna’s vaccines for older children won’t have an immediate impact on the US vaccination campaign, other than giving parents another option to choose from. Previously, only Pfizer’s vaccine was licensed for children in kindergarten through high school, although uptake has been lackluster. Two thirds of children aged 5 to 11 and 30% of adolescents aged 12 to 17 have not yet been vaccinated against Covid.
More than 600 children in these age groups have died from Covid during the pandemic and more than 45,000 have been hospitalized, according to the CDC. Nearly 11 million children aged 5 to 17 caught Covid during the pandemic.
Children 6 to 11 years old receive smaller injections of Moderna at 50 micrograms, while teenagers 12 to 17 years old receive the same dose as adults at 100 micrograms.
Moderna originally asked the Food and Drug Administration to license its vaccine for teens ages 12 to 17 more than a year ago, but the regulator waited after other countries raised concerns that the company’s injections may be associated with a higher risk of heart inflammation or myocarditis. , than the Pfizer vaccine.
In the United States, there are no direct comparisons of heart inflammation in children who receive injections from Pfizer or Moderna, because Moderna’s vaccine was only licensed for adults until this month. -this. However, comparisons between Pfizer and Moderna injections in young adults seem to show that the rate of myocarditis is slightly higher among Moderna recipients, although the data is not consistent across different US surveillance systems.
“Some evidence suggests that the risks of myocarditis and pericarditis may be higher after Moderna than after Pfizer. However, the results are not consistent across all US surveillance systems,” Dr. Tom Shimabukuro, a head of the CDC’s Vaccine Safety Unit.
The available US data on myocarditis in children ages 6 to 17 is based on reported side effects from Pfizer’s vaccine, as Moderna injections had not yet been authorized for this age group. Injections from Pfizer and Moderna use similar messenger RNA technology.
The CDC has identified 635 cases of myocarditis in children ages 5 to 17 after vaccination out of 54 million doses of Pfizer administered. The risk of myocarditis after vaccination with Pfizer is highest after the second injection in boys aged 12-17 years. Myocarditis is slightly elevated in boys 5-11 years old after the second dose of the Pfizer vaccine, although it is much lower than in adolescents.
Boys ages 16 to 17 reported 75 cases of myocarditis per million seconds of Pfizer doses administered, while boys ages 12 to 15 reported about 46 cases of myocarditis, according to CDC data. Boys ages 5 to 11 reported 2.6 cases of myocarditis per million seconds of Pfizer doses administered.
People who have developed myocarditis after vaccination are usually hospitalized for a few days as a precaution before being sent home. The CDC found that the risk of myocarditis is higher from Covid infection than from vaccination. Myocarditis in children is usually caused by viral infections.
The most common side effects in children aged 6 to 17 during Moderna clinical trials were pain at the injection site, fatigue, headache, chills, muscle aches and nausea. There were no confirmed cases of myocarditis during the trials.
It is unknown how effective the shots will be against the omicron variant. The clinical trials were conducted during times when other strains of Covid were dominant. According to the Food and Drug Administration’s review of clinical trial data.
However, Covid vaccines are struggling to combat the omicron variant, which is now dominant, as it has many mutations. The third injections significantly increased protection in other age groups. Moderna is studying booster shots for children that target omicron with data expected later this summer.