The recommendation comes after CDC vaccine advisors, the Advisory Committee on Immunization Practices, voted unanimously Thursday in favor of recommending the two-dose Modern Covid-19 vaccine for use in people ages 6 to 17. . The vaccine received US emergency use authorization. Food and Drug Administration last week.
“It is critical that we protect our children and adolescents from the complications of severe COVID-19 disease,” Walensky said in a statement Friday. “Today, we have expanded the options available to families by recommending a safe and effective second vaccine for children ages 6 to 17. Vaccination in this age group can provide more confidence to families than their children. and teens participating in daycare, school and other activities will be less likely to suffer from severe COVID-19 disease. ”
CDC advisers endorsed the vaccine after hearing details about Moderna’s application to the FDA and the latest safety data.
“There is a risk of myocarditis / pericarditis after the two Covid-19 messenger RNA vaccines, most cases have a rapid improvement in symptoms. A follow-up survey suggests that I have recovered more completely from myocarditis.” said Dr. Helen Keipp Talbot, associate professor of medicine. from Vanderbilt University during the ACIP discussion on the vaccine on Thursday. He added that myocarditis after vaccination has been generally mild compared to those who developed myocarditis after getting Covid-19.
The CDC said the risk of myocarditis “may be greater” with the Modern vaccine than with the Pfizer vaccination, but there are limitations to what scientists know about the disease in this age group, as the data are observational and limited.
Overall, the data presented by the company showed that most children received the vaccine without incident.
“In general, most of the adverse events reported after Covid vaccines are mild and transient events, such as injection site and systemic reactions,” said Dr. Tom Shimabukuro, deputy director of the vaccine working group. CD1 H1N1. “We will continue to monitor the safety of these vaccines and continue to work with partners, both within the federal government and with health care providers and provider organizations to better understand these types of adverse events.”
More than 5.1 million cases of Covid-19 have occurred during the pandemic among children ages 5 to 11, according to a presentation at the CDC’s Dr. Sara Oliver meeting.
In April, unvaccinated children between the ages of 5 and 17 were generally twice as likely to test positive for Covid-19 than unvaccinated children with the primary vaccine series.
There has also been an increase in hospitalizations among this age group, especially during the rise of Omicron. Among teens between the ages of 12 and 17, the cumulative hospitalization rates for Covid-19 are “considerably higher” than those for the flu during all previous flu seasons, said Oliver, a member of the CDC Epidemic Intelligence in committee. The possibility that children may develop a long Covid, even if they have a mild or asymptomatic case of Covid, is also a major concern.
Children are the least vaccinated group among all age groups in the US. About 65 percent of children in the 5 to 11 age group and 30 percent of teens have not been vaccinated, the CDC said. The CDC hopes more parents will protect their children with a vaccine.
“We can predict that with future increases in Covid-19, the unvaccinated will continue to bear the burden of the disease,” Oliver said.
Vaccine details
For children 6 to 11 years of age, the Modern vaccine is administered in series of two doses at 50 micrograms per dose.
Adolescents ages 12 to 17 receive the same amount that is administered to adults: a two-dose series at 100 micrograms per dose.
The Moderna vaccine is now available for people 6 months to 5 years of age and 18 years of age or older.
People aged 6 to 17 were already eligible to be vaccinated with the Pfizer / BioNTech Covid-19 vaccine.
“Right now there are 25 million unvaccinated children and adolescents. We know the benefits outweigh the risks of the Covid-19 mRNA vaccine at all ages,” Oliver said. “Receiving this primary series remains the safest way to prevent severe Covid-19.”
Modern enhancers
The CDC did not take on a booster dose problem for the Modern vaccine, as it is not yet authorized by the FDA, but Dr. Doran Fink, the deputy director of the FDA’s clinical division of vaccines and related product applications, to say they would. address this gap during the summer.
“We hope to address this gap in booster doses over the summer,” Fink told the committee.
The agency is collecting more data to determine if a booster dose is needed.
Some children and adolescents, depending on their age, who have received the Pfizer Covid-19 vaccine are eligible for a booster dose.
Addressing confusing labels
The CDC promised its independent vaccine advisory committee that it would create multiple fact sheets and more educational opportunities for vaccine administrators because of what it called a “confusing etiquette situation” with Moderna’s vaccine vials.
To distinguish between vials, Moderna has used caps of different colors and has used a different colored border around the label. For the six-month to 5-year-old age group receiving a smaller dose of 25 micrograms, for example, the lid is dark blue and the edge is magenta. For children ages 6 to 11, who will get a larger dose size with 50 micrograms, the vial also has a dark blue cap, but the edge is purple. The same vial is used for booster doses for adults 18 years of age and older. The label on this product also says it can be used for booster doses.
“We recognize that this label for ages 6 to 11 indicating ‘BOOSTER DOSES’ in capital letters is very confusing,” Dr. Elisha Hall of the CDC, who is responsible for the clinical guidelines for emergency response, told the committee on Thursday. Covid-19. “There will be various educational and communication materials and efforts to communicate the authorized use of this roadway for ages 6 to 11.”
He said the CDC will also offer educational webinars to help providers.
“With all these new products out, there may be more opportunities for vaccine administration errors. In addition to the number of products, of course, products that are not labeled for the indicated age group. In addition, new pediatric providers may not be familiar with Covid-19 Vaccines and there are some marked differences between routine vaccines, ”Hall said.
Several members of the vaccine advisory committee urged Moderna and Pfizer to simplify the design of the Covid-19 vaccine vial. They also expressed concern that vaccine administrators who are colorblind cannot distinguish between vials.
“I am very grateful that the CDC brings together the types of training and support when we need to implement it, but I only recognize that this affects acceptability from a vendor’s point of view, because it is very complex to incorporate into busy practice,” he said. ACIP. President Dra. Grace Lee, associate medical director for practice innovation at Lucile Packard Children’s Hospital. “For me, that’s pretty overwhelming and I feel like I know Covid pretty well.”
Modern told the commission that they are “actively working” on the design issue.