Health
FDA advisors are considering COVID shots of Moderna for older children
New York – A government advisory board met on Tuesday to decide whether to recommend a second brand of COVID-19 vaccine for school-aged children and teens.
External experts from the Food and Drug Administration will vote on whether the Moderna vaccine is safe and effective for children aged 6 to 17 years. If the panel approves the shot and the FDA agrees, it will be the second option to participate in Pfizer’s vaccine. ..
The same expert panel will meet on Wednesday to consider tot-sized shots from Moderna and Pfizer for children under the age of five.
Moderna’s COVID-19 vaccine has long been available to adults in the United States and other countries, and is also available to children in dozens of countries. In the United States, children between the ages of 12 and 17 receive two full doses. From 6 to 11 years old, take half the dose.
The FDA held up Moderna’s teen vaccine for several months while investigating a rare side effect, heart inflammation. This is primarily a risk for teenage boys and young men and can also occur with the Pfizer vaccine. Moderna was further scrutinized because the shot was at a much higher dose.
In their review, FDA scientists said there were no confirmed cases of heart inflammation in a study of children in Moderna. However, experts say that the number of participants in the study may have been too small for these rare side effects to occur.
In a phone call with reporters earlier this week, former FDA vaccine chief Dr. Jesse Goodman of Georgetown University said that if a problem arises, “there aren’t enough people to detect the problem in clinical trials.” rice field.
Regarding other side effects, FDA officials said nothing of concern was reported, primarily arm pain, headaches and fatigue.
Two doses of Moderna are effective in preventing symptomatic COVID-19 disease in children under the age of teens, and the level of antibody that fights the virus is comparable to that developed in young adults, according to FDA analysis. To do.
According to FDA analysis, vaccine efficacy was estimated to be 93% in the 12-17 group and 77% in the younger group. However, studies were conducted when previous versions of the coronavirus were causing most US infections, and it is not clear how well they work against more recent variants. Also, the estimate is a bit rough, as it is based on a limited number of COVID-19 cases.
According to an FDA review, booster doses are likely to be needed, as recommended for all adults, not just children vaccinated against Pfizer.
It’s not clear how much demand there is for Moderna shots. Teens were targeted by Pfizer’s vaccine, which uses the same technique, and only 60% were vaccinated twice. Shots for younger kids started in November. According to the Centers for Disease Control and Prevention, about 29% are fully vaccinated.
If the FDA approves a modeler shot for teens and school children, the issue will move next to the CDC and make recommendations for vaccination to doctors and the general public. A CDC spokesman said authorities were not expected to address the question until later this month.
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The Associated Press’s Department of Health Sciences is supported by the Science Education Department of the Howard Hughes Medical Institute. AP is solely responsible for all content.
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