The vaccine received emergency use from the US Food and Drug Administration last week.
All 15 voting members of the CDC’s Advisory Committee on Immunization Practices (ACIP) voted yes to the statements:
“A modern two-dose (50mcg) COVID-19 vaccine is recommended for children ages 6-11, under the EUA issued by the FDA.”
“A modern two-dose (100mcg) COVID-19 vaccine is recommended for adolescents aged 12 – 17 years, under the EUA issued by the FDA.”
The CDC’s Advisory Committee on Immunization Practices approved the vaccine after hearing details about Moderna’s filing with the FDA and the latest safety data.
“There is a risk of myocarditis/pericarditis after both messenger RNA Covid-19 vaccines, most cases have an immediate improvement in symptoms. A follow-up study suggests most have fully recovered from myocarditis,” said Dr. Helen Keipp Talbot, an associate professor of medicine at Vanderbilt University during ACIP’s discussion of the vaccine Thursday. She added that myocarditis after vaccination was generally mild compared to those who developed myocarditis after becoming ill with Covid-19.
The CDC said the risk of myocarditis “may be higher” with the Moderna vaccine than with Pfizer’s vaccination, but there are limitations to what scientists know about the condition in this age group, as the data is observational and limited.
Overall, the company’s data showed that most children received the vaccine without incident.
“In general, most of the side effects reported after Covid vaccines are mild and transient events such as injection site and systemic reactions,” says 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 healthcare providers and supplier organizations to better understand these types of side effects.”
More than 5.1 million cases of Covid-19 have occurred among children ages 5 to 11 during the pandemic, according to a presentation at Dr. Sara Oliver of the CDC.
In April, unvaccinated children between the ages of 5 and 17 had a total two times greater risk of testing positive for Covid-19 than unvaccinated children with the vaccine’s primary series.
There is also an increase in hospital admissions among this age group, especially during the Omicron peak. Among adolescents ages 12 to 17, the cumulative rates of Covid-19 hospitalizations are “significantly higher” than for flu during all previous flu seasons, Oliver, a member of the CDC’s Epidemic Intelligence Service, told the committee. The possibility that children could develop Covid for a long time, even if they had a mild or asymptomatic Covid case, is also a major concern.
Children are the least vaccinated of all age groups in the US. About 65% of children between the ages of 5 and 11 and 30% of adolescents are unvaccinated, the CDC said. The CDC hopes more parents will protect their children with a vaccine.
“We can predict that with future Covid-19 peaks, the unvaccinated people will continue to carry the disease burden,” Oliver said.
Following the ACIP vote, CDC Director Dr. Rochelle Walensky decide whether to sign the ACIP recommendation. Shots can be administered after the CDC passes the recommendation.
For children 6 to 11 years of age, the Moderna vaccine is given as a series of two doses of 50 micrograms per dose.
Adolescents ages 12 to 17 are given the same amount that is given to adults — a series of two doses of 100 micrograms per dose.
Moderna’s vaccine is already available for people aged 6 months to 5 years and 18 years and older.
People aged 6 to 17 were already eligible for vaccination with the Pfizer/BioNTech Covid-19 vaccine.
“There are currently 25 million unvaccinated children and adolescents. We know that the benefits outweigh the risks for the mRNA Covid-19 vaccine across all ages,” Oliver said. “Receiving this primary series remains the safest way to prevent severe Covid-19.”
The CDC did not comment on a booster dose for the Moderna vaccine, as it has not yet been approved by the FDA, but Dr. Doran Fink, the deputy director of the FDA’s clinical division of vaccines and related product applications, said they would. address this gap in the summer.
“We would expect to address this gap in booster doses in the summer,” Fink told the committee.
The agency is collecting more data to determine whether a booster dose is needed.
Some children and adolescents who, depending on their age, have received the Pfizer Covid-19 vaccine are eligible for a booster dose.
Tackling confusing labels
The CDC promised its independent vaccine advisor committee that it would create multiple factsheets and more educational opportunities for vaccine administrators because of what it called a “confusing label situation” with Moderna’s vaccine vials.
To distinguish between bottles, Moderna has used different color caps and a different color border around the label. For example, for the age group 6 months to 5 years receiving a smaller dose of 25 micrograms, the cap is dark blue and the rim is magenta. For children 6 to 11 years of age, who receive a larger dose of 50 micrograms, the vial also has a dark blue cap, but the rim is purple. The same vial is used for booster doses for adults 18 years of age and older. The label on that product also states that it can be used for booster doses.
“We recognize that that label for ages 6 to 11 that says ‘BOOSTERDOSES’ in capital letters is very confusing,” said Dr. Elisha Hall of the CDC, the leading clinical guidelines for Covid-19 emergency response, to the committee on Thursday. “There will be multiple educational and communication materials and efforts to communicate the authorized use of this vial for ages 6 to 11.”
She said the CDC will also offer educational webinars to help providers.
“With all these new products on the market, there may be more potential for vaccine administration errors. Beyond just the number of products, of course, those that are not labeled for the indicated age group. In addition, new pediatric health care providers may be not familiar with Covid-19 vaccines and there are some major 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 color blind are unable 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 recognize that it affects acceptability from a provider’s point of view as it’s a lot of complexity to include in busy practice said ACIP President Dr. Grace Lee, the associate chief medical officer for practice innovation at Lucile Packard Children’s Hospital. “For me, this is pretty overwhelming and I feel like I know Covid pretty well.”
Moderna told the committee they are “actively” working on the design issue.