By Jen Christensen and Carma Hassan, CNN
Updated: Fri, 24 Jun 2022 22:07:25 GMT
US Centers for Disease Control and Prevention Director Dr. Rochelle Walensky signed off on a recommendation of Moderna's Covid-19 vaccine for people ages 6 to 17, the agency announced Friday. The move clears the way for the vaccine to be administered to this age group.
The recommendation comes after the CDC's vaccine advisers, the Advisory Committee on Immunization Practices, voted unanimously on Thursday to support recommending the two-dose Moderna Covid-19 vaccine for use in people ages 6 through 17. The vaccine received emergency use authorization from the US Food and Drug Administration last week.
"It is critical that we protect our children and teens from the complications of severe COVID-19 disease," Walensky said in a statement on Friday. "Today, we have expanded the options available to families by recommending a second safe and effective vaccine for children ages 6 through 17 years. Vaccinating this age group can provide greater confidence to families that their children and adolescents participating in childcare, school, and other activities will have less risk for serious COVID-19 illness."
The CDC's 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 both messenger RNA Covid-19 vaccines, most cases have prompt improvement in symptoms. A follow up survey suggests most fully recovered from myocarditis," said Dr. Helen Keipp Talbot, an associate professor of medicine from Vanderbilt University during ACIP's discussion of the vaccine Thursday. She added that myocarditis after vaccination has been generally mild compared to those who developed myocarditis after getting sick from Covid-19.
The CDC said that the risk of myocarditis "may be higher" with the Moderna vaccine than from vaccination from Pfizer, but there are limitations to what scientists know about the condition in this age group since the data is observational and limited.
Overall, the data presented from the company showed that most children got the vaccine without incident.
"In general, most adverse events reported after Covid vaccines are mild and transient events like injection site and systemic reactions," said Dr. Tom Shimabukuro, the Deputy Director of the H1N1 Vaccine Task Force at the CDC. "We will continue to monitor the safety of these vaccines and we will 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."
During the pandemic over 5.1 million Covid-19 cases have occurred among children ages 5 through 11 according to a presentation at the meeting from the CDC's Dr. Sara Oliver.
In April unvaccinated children between the ages of 5 to 17 overall had a two times greater risk of testing positive for Covid-19 than unvaccinated children with the primary series of the vaccine.
There's also been an increase in hospitalizations among this age group, particularly during the Omicron surge. Among adolescents ages 12 to 17, the cumulative rates of Covid-19 hospitalizations are "considerably higher" than for flu during all prior flu seasons, Oliver, a member of the CDC's Epidemic Intelligence Service told the committee. The possibility that children could develop long Covid, even if they had a mild or asymptomatic Covid case, is also a significant concern.
Children are the least vaccinated group among all the age groups in the US. About 65% of children in the 5 through 11 age group and 30% of adolescents have not been vaccinated, the CDC said. The CDC hopes more parents will protect their children with a vaccination.
"We can predict with future Covid-19 surges, the unvaccinated will continue to bear the burden of disease," said Oliver.
For children ages 6 through 11, the Moderna vaccine is administered as a two-dose series at 50 micrograms per dose.
Adolescents ages 12 through 17 receive the same amount that is administered in adults -- a two-dose series at 100 micrograms per dose.
Moderna's vaccine is already available for people ages 6 months through 5 years and 18 and older.
People ages 6 to 17 were already eligible to be vaccinated with the Pfizer/BioNTech Covid-19 vaccine.
"There are 25 million unvaccinated children and adolescents right now. We know that the benefits outweigh the risks for mRNA Covid-19 vaccine in all ages," Oliver said. "Receipt of this primary series continues to be the safest way to prevent serious Covid-19."
The CDC did not take up a booster dose issue for the Moderna vaccine, since it is not authorized by the FDA yet, but Dr. Doran Fink, the deputy director of the clinical division of vaccines and related products applications of the FDA said they would address this gap during the summer.
"We would expect to be addressing 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 necessary.
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 adviser committee that it would create multiple fact sheets and more education opportunities for vaccine administrators due to what it called a "confusing label situation" with Moderna's vaccine vials.
To distinguish between vials, Moderna has used different color caps and has used a different color border around the label. For the six months through 5 years age group that gets a smaller 25 microgram dose, for example, the cap is dark blue and the border is magenta. For children ages 6 through 11, who will get a bigger dosage size at 50 micrograms, the vial has a dark blue cap as well, but the border is purple. The same vial is used for booster doses for adults 18 years of age and older. The label on that product also says it can be used for booster doses.
"We recognize that that label for ages 6 through 11 stating 'BOOSTER DOSES' in all caps is very confusing," the CDC's Dr. Elisha Hall, the clinical guidelines lead for the Covid-19 emergency response told the committee Thursday. "There will be multiple education and communication materials and efforts to communicate the authorized use of this vial for ages 6 through 11."
She said the CDC will also offer educational webinars to help providers.
"With all of these new products out, there may be more opportunities for vaccine administration errors. Besides just the number of products, of course, the products that are not labeled for the indicated age group. Additionally, new pediatric providers may be unfamiliar with Covid-19 vaccines and there are some stark differences between routine vaccines," Hall said.
Several vaccine advisory committee members urged Moderna and Pfizer to simplify the Covid-19 vaccine vial design. They also expressed concern that vaccine administrators who are color blind will not be able to distinguish between the vials.
"I really appreciate the CDC putting together the types of training and support when we need to implement it, but just recognize that this does impact acceptability from a provider standpoint, because it's a lot of complexity to incorporate into the busy practice," said ACIP Chair Dr. Grace Lee, the associate chief medical officer for practice innovation at the Lucile Packard Children's Hospital. "To me, this is quite overwhelming and I feel like I know Covid pretty well."
Moderna told the committee that they are "actively working" on the design issue.