On Tuesday, a committee of independent vaccine experts from the Food and Drug Administration is discussing the benefits of Moderna’s coronavirus vaccine for children ages 6-17. So far, Moderna shots are only allowed for adults.
The committee members Vote Whether to recommend the company’s double-dose vaccine to 6 to 11 years of age, half the intensity of the adult version, and 12 to 17 years of age, the same intensity as adults. ((((You can watch the meeting on youtube.. )
The FDA then decides whether to allow the children to administer for emergency use after a considerable waiting time. A month after Pfizer, Moderna requested federal regulators to clear the vaccine for adolescents and teens last June. Get an emergency permit Because the coronavirus vaccine is used between the ages of 12 and 15.
The Tuesday meeting first focused on the effects of Covid-19 on children. Dr. Katherine E. Fleming-Dutra, Head of Health Care at the Centers for Disease Control and Prevention, shows that while adults are at high risk, children and adolescents are at significant risk of serious illness. I checked.
According to CDC data as of June 7, there are more than 10 million cases between the ages of 5 and 17, with approximately 50 million children in that age group.Its infection rate Can be quite underestimated This is because it is often not reported.
As of last month, 189 children aged 5 to 11 and 443 adolescents and teens died of Covid during the pandemic process, according to CDC data. The surge from Omicron variants during the winter led to the highest number of pediatric Covid cases, emergency department visits, and hospitalization rates. Approximately two-thirds of children aged 6 to 17 years hospitalized with Covid-19 had an underlying condition.
Dr. Fleming-Dutra also displayed a chart showing the social impact of the virus. She said it caused thousands of school turmoil each week during the Omicron wave and exacerbated the educational inequality. Many parents, especially low-income parents, quit their jobs or rescheduled their work to take care of their children, she said. She said the pandemic also led to mental health problems, reduced physical activity, and a decrease in children’s regular immunity.
Moderna was first applied a year ago to cover ages 12-17.However, federal health officials said the Moderna vaccine Rare heart disease, Myocarditis chose to delay the decision. Later, Moderna postponed the application for ages 6-11.
According to the company, concerns about myocarditis subsided after further research and actual evidence. Federal health officials spent the morning submitting data on the risk of its side effects to the advisory board.
Dr. Tom Shimabukuro, CDC’s Vaccine Safety Officer, told the Commission that some data on people between the ages of 18 and 39 are of Moderna’s recipients compared to those who received the Pfizer-BioNTech vaccine. He said it suggests an increased risk of myocarditis. The dose of Moderna is significantly higher than the dose of Pfizer.
But he warned that the evidence was inconsistent across the US surveillance system. He emphasized that myocarditis, which can also be caused by the virus itself, is a rare side effect.
Dr. Shimabukuro said the CDC identified 635 cases of myocarditis in children aged 5 to 17 years out of approximately 55 million doses of the Pfizer-BioNTech vaccine given. The condition was concentrated in adolescent boys after receiving the second dose.
Based on the health care provider’s assessment, he said, about 80 percent of those diagnosed seemed to have fully recovered. An additional 18% has improved, but not completely.
To evaluate how the vaccine works, Moderna Study immune response It was produced in children aged 6 to 17 years and was compared to the levels of neutralizing antibodies in 18 to 25 post-vaccination. The FDA has found that the vaccine meets the criteria for success, but to combat the diminished efficacy of the vaccine against infection, a third time for children and teens, as in adults. Warned that administration may be required.
The FDA’s assessment, coupled with the conclusion that side effects in the age group are minimal, suggests that the advisory board may recommend it and federal regulators may approve it.
Another committee advising the CDC is expected to address the issue this weekend, after which Dr. Rochelle P. Warrensky, director of the agency, will publish her own recommendations. Immediately after Dr. Wallensky’s approval, the children were able to begin receiving shots.
At its second all-day meeting on Wednesday, the FDA Panel will consider a Moderna vaccine for children under the age of 6 and a Pfizer-BioNTech vaccine for children under the age of 5.
Given that the Pfizer-BioNTech vaccine has already been available for several months, it will be clear at a meeting on Tuesday whether there is a real demand for the Moderna vaccine among children over the teens. This is a likely problem. Pfizer vaccine intake using the same technique has ceased between the ages of 5 and 11. Over one-third of 28 million children in this age group receive at least one dose, compared to nearly 70% of children between the ages of 12 and 17.
Jason L. Schwartz, a public health graduate vaccine policy expert, said that approval of the Moderna vaccine for children aged 6 to 17 would be useful, even if it was received by a relatively small number of children. ..
He said Moderna’s options would be like an “insurance policy” in the event of manufacturing problems or new safety concerns with Pfizer’s vaccine. He said pediatricians and primary care physicians may choose to stock both products in the office.
Dr. Schwartz said Moderna’s approval could also prove to be valuable in the long run.
“We are still learning how these vaccines work, both in terms of level and duration of protection,” he said. “Over time, you may find that one vaccine is better.”