The vaccine received emergency use authorization 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 on the statements:
“A two-dose (50 mcg) Moderna COVID-19 vaccine is recommended for children ages 6-11, under the EUA issued by the FDA.”
“A two-dose (100 mcg) Moderna COVID-19 vaccine is recommended for adolescents ages 12-17, under EUA issued by the FDA.”
The CDC’s Advisory Committee on Immunization Practices approved the vaccine after hearing details about Moderna’s FDA application and the latest safety data.
“There is a risk of myocarditis/pericarditis after both Covid-19 messenger RNA vaccines, most cases show rapid improvement in symptoms. A follow-up survey suggests most have fully recovered from the myocarditis,” said Dr Helen Keipp Talbot, associate professor of medicine. from Vanderbilt University during the ACIP vaccine discussion on Thursday. She added that post-vaccination myocarditis was generally mild compared to those who developed myocarditis after falling ill with Covid-19.
The CDC said the risk of myocarditis “may be higher” with the Moderna vaccine than with the Pfizer vaccination, but there are limits to what scientists know about the disease in this age group since Data are observational and limited.
Overall, the data presented by the company showed that most children received 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, 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, more than 5.1 million cases of Covid-19 have occurred in children ages 5 to 11, according to a presentation at the CDC’s Dr. Sara Oliver meeting.
In April, unvaccinated children aged 5 to 17 overall had a twice as high risk of testing positive for Covid-19 as unvaccinated children with the primary series of the vaccine.
There has also been an increase in hospitalizations in this age group, particularly during the Omicron surge. Among adolescents aged 12 to 17, cumulative rates of hospitalizations for Covid-19 are “significantly higher” than for influenza in all previous flu seasons, said Oliver, a member of the epidemic intelligence service of the CDC to the committee. The possibility that children could develop long Covid, even if they had mild or asymptomatic Covid, is also a significant concern.
Children are the least vaccinated group of all age groups in the United States. About 65% of children ages 5 to 11 and 30% of teenagers have not been vaccinated, the CDC said. The CDC hopes more parents will protect their children with a vaccination.
“We can predict that with future outbreaks of Covid-19, the unvaccinated will continue to bear the burden of the disease,” Oliver said.
Following ACIP’s vote, CDC Director Dr. Rochelle Walensky will decide whether or not to sign the ACIP recommendation. Injections can be given after the CDC adopts the recommendation.
For children 6 to 11 years old, the Moderna vaccine is given as a series of two doses at 50 micrograms per dose.
Teenagers aged 12 to 17 are given the same amount given to adults – a series of two doses at 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 to be vaccinated with the Pfizer/BioNTech Covid-19 vaccine.
“There are currently 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 first round continues to be the surest way to prevent severe Covid-19.”
The CDC has not addressed the issue of the booster dose for the Moderna vaccine because it is not yet cleared by the FDA, but Dr. Doran Fink, associate director of the clinical division of vaccine and product applications Related FDA said they would fill that gap over the summer.
“We expect to close 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.
Dealing with confusing labels
The CDC has promised its independent vaccine advisory committee that it will create more fact sheets and more training opportunities for vaccine administrators because of what it called a “confusing labeling situation.” with Moderna’s vaccine vials.
To distinguish the bottles, Moderna used different colored caps and used a different colored border around the label. For the six month to 5 year age group receiving a lower dose of 25 micrograms, for example, the cap is dark blue and the border is magenta. For children aged 6 to 11, who will receive a larger dose at 50 micrograms, the bottle also has a dark blue cap, but the border is purple. The same bottle is used for booster doses in adults 18 years of age and older. The label of this product also indicates that it can be used for booster doses.
“We recognize that this label for children ages 6 to 11 that says ‘BOOSTER DOSES’ in all caps is very confusing,” CDC’s Dr. Elisha Hall, clinical guidelines lead for emergency response, told the committee Thursday. Covid-19. “There will be multiple education and communication materials and efforts to communicate the authorized use of this vial for ages 6-11.”
She said the CDC will also offer educational webinars to help providers.
“With all of these new products, there may be more opportunity for vaccine administration errors. Besides the number of products, of course, products that are not labeled for the stated age group. new pediatric providers may not be familiar with Covid-19 vaccines and there are big differences between routine vaccines,” Hall said.
Several members of the vaccine advisory committee have urged Moderna and Pfizer to simplify the design of Covid-19 vaccine vials. They also expressed concern that color blind vaccine administrators will not be able to distinguish between vials.
“I really appreciate that the CDC pulls together the types of training and support when we need to implement it, but just acknowledge that it impacts acceptability from a vendor perspective, because it’s very complex to integrate into busy practice,” ACIP said. Chair Dr. Grace Lee, Associate Chief Physician for Practice Innovation at Lucile Packard Children’s Hospital. “For me, it’s quite overwhelming and I feel like I know Covid pretty well.”
Moderna told the committee that they were “actively working” on the design issue.