Health
The FDA Panel recommends the Moderna COVID vaccine as an option for children 6 years and older
Parents will soon be able to choose between the two vaccines when vaccinating their children against COVID-19.
After hours of testimony on Tuesday, the Federal Advisory Board unanimously voted to recommend making Moderna’s vaccine available to children over the age of six. So far, only Pfizer-BioNTech vaccines are allowed for children.
As expected, the Centers for Disease Control and Prevention will review Moderna’s vaccine data later this week, and shots may be available soon next week, assuming the Commissioner of Food and Drugs approved the panel’s recommendations.
Children do not need to be vaccinated against COVID-19 to attend public school.
The Moderna vaccine is given at the same dose as adults in adolescence, at half doses for children 6-11 years, twice at 8-week intervals. Both the company and the FDA expect that a third booster dose will be encouraged later. , Same as for Pfizer-BioNTech vaccine.
On Wednesday, the same FDA advisory board will discuss the COVID-19 vaccines from both companies for infants who have not yet accessed the shot.
The risk of serious infections and death from COVID-19 decreases with age, but children and adolescents become ill during a pandemic. The virus has killed more than 800 children among children. According to FDA data..
Since the beginning of the pandemic, about 70% of American children have been infected with COVID-19. According to evidence from blood sampling During daily medical care.
Data show that the Pfizer-BioNTech vaccine prevents childhood hospitalization during the Omicron surge, and vaccinated teens and children are less likely to be hospitalized than unvaccinated peers. Is shown.
Data show that teens are more likely to be hospitalized with COVID-19 than young children and that the vaccine is more effective during outbreaks than when the virus is not widespread.
In terms of dosage, children aged 6 to 11 years will be given two 50 microgram shots of the Moderna vaccine, and older children will be given the same 100 microgram shots as adults.
The Tuesday review included only two doses of the Moderna vaccine, but the FDA expects a third dose to be required. As Moderna presents more data on the safety and efficacy of booster vaccines, “it works well to make booster doses available,” FDA staff Dr. Doran Fink told the committee.
Moderna is studying childhood boosters at half the dose of the original shot, specifically directed to the original strain of the virus that causes COVID-19 and the Omicron-specific version of the virus. The company will soon begin researching Omicron-specific boosters for children under the age of six.
Dr. Paul Offit, a member of the Philadelphia Children’s Hospital Vaccine Expert Committee, said that children, regardless of manufacturer, would have a third vaccine to receive appropriate protection against the currently circulating variants. We believe it is essential to receive the dose.
According to Offit, the two injections were very protective against the previous COVID-19 mutant, but protection against serious disease by Omicron requires a third dose.
Regarding vaccine safety, the data suggest that Moderna’s vaccine causes more myocarditis, or inflammation of the heart muscle, than the Pfizer-BioNTech vaccine, but it is not conclusive. The FDA has postponed approval of the Moderna vaccine in teens for a year to await further data on potentially serious side effects.
The incidence of myocarditis after firing of Moderna in young adults appears to be higher than that after firing of Pfizer-BioNTech, but side effects are so rare that it may have caused this apparently increased incidence. FDA staff told the panel that there was.
Of the approximately 55 million COVID-19 vaccines given to minors, approximately 430 cases of myocarditis were reported to the CDC. By age group, 153 cases of myocarditis were seen in every 1 million doses of vaccine to men aged 12 to 15 years, and 139 cases were seen in 1 million men aged 16 to 17 years. FDA data analysis shows..
The risk of myocarditis is highest in men from adolescence to age 40, especially after the second COVID-19 shot. Almost 60% were hospitalized, most of them for 1-3 days.
Most cases after vaccination are milder than those seen after infections such as COVID-19, with 80% reported to resolve in 3 months.
Although rarely seen with the COVID-19 vaccine, severe allergic reactions are consistently the only potentially serious side effect, with the exception of myocarditis. According to the company, none of the children who participated in the Moderna trial had an allergic reaction to the vaccine.
Dr. Peter Markes of the FDA concludes the eight-hour meeting with no doubt that vaccines and treatments can be harmful.
“Vaccines are associated with several adverse effects in the short term, and we are closely monitoring them in the long term,” said Marks, who heads the FDA’s Center for Biologics Evaluation and Research. “We are very concerned about ensuring that we detect adverse events, and when we detect them, we have transparency in them. By making vaccines available, we can increase the population. I want to protect it. “
The COVID-19 vaccine for children is comparable to other pediatric vaccines in terms of safety and importance, said Fink, deputy director of the FDA’s Vaccine Clinical Division and Related Product Applications of the Vaccine Research Review Bureau. I am.
Dr. Arthur Raingold, a member of the University of California, Berkeley Public Health Epidemiologist Committee, said he was old enough to remember the arrival of the polio vaccine. Polio caused as many asymptomatic illnesses as COVID-19, and although serious consequences were equally rare, vaccination was still justified, he said.
The committee is made up of experts in pediatrics, infectious diseases and immunology, all of which are screened to avoid financial conflicts of interest.
In the discussion, the members of the committee Support for the Moderna vaccine states that its benefits should outweigh the risks in children over the age of 6 and allow parents to choose which vaccine to inoculate.
“I believe this provides an important option for families,” said Dr. Ofer Levy, director of the Precision Vaccine Program at Boston Children’s Hospital. “I don’t know what this fall will bring, but even in the current situation, this can be a valuable tool.”
Please contact Karen Weintraub ([email protected]).
Health and patient safety coverage at USA TODAY is partially made possible by grants from the Masimo Foundation for ethics, innovation and competition in health care. The Masimo Foundation does not provide editorial input.
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