Health · June 23, 2022

The CDC panel recommends Moderna’s two-dose Covid vaccine for children ages 6 to 17

The Centers for Disease Control and Prevention is expected to release Moderna’s two-dose Covid-19 vaccine for preschoolers by high school students for public distribution this week after the agency’s panel of independent vaccine experts voted unanimously to recommend the shots on Thursday Has.

The committee endorsed Moderna’s vaccine for children ages 6 to 17 after examining its safety and effectiveness during a public meeting. It is expected that CDC Director Dr. Rochelle Walensky will sign the recommendation later Thursday, the final step before pharmacies and doctor’s offices can start administering the shots.

The CDC on Saturday approved Moderna’s vaccines for infants to preschoolers ages 6 months to 5 years. Vaccinations started this week for this age group.

Moderna’s vaccines for older children will have no immediate impact on the US immunization campaign, other than giving parents another option to choose from. Previously, only Pfizer’s vaccine had been approved for preschoolers through high school students, although uptake was patchy. Two thirds of children aged 5 to 11 and 30% of young people 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. Almost 11 million children aged 5 to 17 have contracted Covid during the pandemic.

Children ages 6 to 11 receive smaller 50-mcg Moderna shots, while teens ages 12 to 17 receive the same adult dose of 100 micrograms.

Moderna originally asked the Food and Drug Administration more than a year ago to approve its vaccine for adolescents ages 12 to 17, but the regulator held back after other countries raised concerns that the company’s shots were using a higher Risk of heart inflammation or myocarditis could be associated than Pfizer’s vaccine.

In the US, there are no direct comparisons of heart inflammation in children who receive Pfizer or Moderna vaccines, since Moderna’s vaccine was only approved for adults up until this month. However, comparisons between Pfizer and Moderna vaccinations in young adults appear to show that the rate of myocarditis is slightly higher in Moderna recipients, although the data is inconsistent across the different US surveillance systems.

“Some evidence suggests that the risks for myocarditis and pericarditis may be higher according to Moderna than according to Pfizer. However, the results are not consistent across US surveillance systems,” said Dr. Tom Shimabukuro, an official with the CDC Division of Vaccine Safety, told the committee.

The available US data on myocarditis in children ages 6 to 17 is based on side effects reported from Pfizer’s vaccine, since Moderna’s vaccines were not yet approved for this age group. The Pfizer and Moderna recordings use similar messenger RNA technology.

The CDC has identified 635 cases of myocarditis in children aged 5 to 17 years after vaccination from 54 million administered doses of Pfizer. The risk of myocarditis after the Pfizer vaccination is highest after the second vaccination in boys aged 12 to 17 years. Myocarditis is slightly increased in boys aged 5 to 11 after the second dose of Pfizer vaccine, although it is much lower than in adolescents.

Boys ages 16 to 17 reported 75 cases of myocarditis per 1 million seconds of Pfizer doses administered, according to CDC data, while boys ages 12 to 15 reported about 46 cases of myocarditis. Boys aged 5 to 11 years reported 2.6 cases of myocarditis per million seconds of Pfizer doses administered.

People who develop myocarditis after vaccination are usually hospitalized for a few days as a precaution before being sent home. According to a CDC survey of health care providers, most patients made a full recovery 90 days after their diagnosis.

The CDC has determined that the risk of myocarditis from Covid infection is higher than from vaccination. Myocarditis in children is typically caused by viral infections.

dr Sara Oliver, a CDC official, said the risk of myocarditis after a Moderna vaccine in children and adolescents is unknown, although data from adults suggests the risk may be higher than Pfizer’s vaccines. However, Oliver said increasing the interval between the first and second doses to eight weeks could reduce the risk of myocarditis, based on data shared by public health officials in Canada.

The most common side effects in children aged 6 to 17 years during Moderna clinical trials were injection site pain, fatigue, headache, chills, muscle pain and nausea. There were no confirmed cases of myocarditis during the studies.

It’s unclear how effective the shots will be against the Omicron variant. The clinical trials were conducted at times when other strains of Covid were dominant. Vaccinations for adolescents aged 12 to 17 were about 90% effective in preventing disease from the original Covid strain and the alpha variant, while vaccinations for children aged 6 to 11 were effective in preventing Diseases caused by the Delta variant were more than 76% effective for review of clinical trial data by the Food and Drug Administration.

However, the Covid vaccines are struggling to combat the now dominant Omicron variant because it has so many mutations. Third shots significantly increased protection in other age groups. Moderna is investigating booster shots for kids targeting Omicron, with data expected later this summer.

“We expect to fill this gap in booster vaccination recommendations throughout the summer and into early fall,” said Dr. Doran Fink, a senior official in the FDA’s Vaccine Division.