CDC director approves Moderna’s Covid-19 vaccine for people ages 6 to 17

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CDC director approves Moderna's Covid-19 vaccine for people ages 6 to 17

The recommendation comes after the CDC’s vaccine advisors, the Advisory Committee on Immunization Practices, voted unanimously on Thursday to support the recommendation of the Moderna Covid-19 two-dose vaccine for use in people ages 6 to 17 . The vaccine received emergency approval from the US Food and Drug Administration last week.

“It is critical that we protect our children and young people from the complications of serious COVID-19 illness,” Walensky said in a statement on Friday. “Today we expanded family options by recommending a second safe and effective vaccine for children ages 6 to 17. Vaccinating this age group can give families more confidence that their children and young people participating in childcare, school and other activities are at reduced risk of developing severe COVID-19 disease.”

CDC advisors endorsed the vaccine after hearing details about Moderna’s application to the FDA and the latest safety data.

“Following both messenger RNA Covid-19 vaccines there is a risk of myocarditis/pericarditis, most cases show immediate improvement in symptoms from Vanderbilt University during ACIP’s discussion of the vaccine on Thursday. She added that post-vaccination myocarditis was generally mild compared to those who developed myocarditis after contracting Covid-19.

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The CDC said the risk of myocarditis with the Moderna vaccine “could be higher” than with a Pfizer vaccine, but scientists’ knowledge of the condition in this age group is limited because the data is observational and limited .

Overall, the data provided by the company showed that most children received the vaccine without incident.

“In general, most adverse events reported following Covid vaccines are mild and transient, such as injection site reactions and systemic reactions,” said Dr. Tom Shimabukuro, deputy director of the CDC’s H1N1 vaccine task force. “We will continue to monitor the safety of these vaccines and continue to work with partners both within the federal government and with healthcare providers and provider organizations to better understand these types of adverse events.”

During the pandemic, over 5.1 million Covid-19 cases have occurred in children aged 5 to 11, according to a presentation by Dr. CDC’s Sara Oliver at the meeting.

Overall, in April, unvaccinated children between the ages of 5 and 17 had twice the risk of testing positive for Covid-19 than unvaccinated children with the primary series of the vaccine.

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There was also an increase in hospital admissions in this age group, particularly during the Omicron surge. Among youth ages 12 to 17, cumulative rates of Covid-19 hospitalizations are “significantly higher” than for flu during any previous flu season, 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 of all age groups in the United States. About 65% of children in the 5 to 11 age group and 30% of adolescents have not been vaccinated, the CDC said. The CDC hopes more parents will protect their children with vaccination.

“We can predict in future Covid-19 outbreaks that the unvaccinated will continue to bear the disease burden,” Oliver said.

Vaccine Details

Children aged 6 to 11 years are given the Moderna vaccine as a two-dose series, 50 micrograms per dose.

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Adolescents aged 12 to 17 are given the same amount as 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 could already be vaccinated with the Pfizer/BioNTech Covid-19 vaccine.

“There are currently 25 million unvaccinated children and young people. We know that the benefits outweigh the risks of an mRNA Covid-19 vaccine across all age groups,” Oliver said. “Maintaining this primary series continues to be the surest way to prevent severe Covid-19.”

Moderna Booster

The CDC hasn’t picked up a booster dose issue for the Moderna vaccine because it’s not yet FDA approved, but Dr. Doran Fink, the FDA’s associate clinical division director for vaccines and related product applications, said they would close that gap over the summer.

“We expect to close that gap in booster doses over the course of the summer,” Fink told the committee.

The agency is collecting more data to determine if a booster dose is needed.

Some children and adolescents who received Pfizer’s Covid-19 vaccine may be eligible for a booster shot based on their age.

Dealing with confusing designations

The CDC promised its Independent Vaccine Advisory Committee that it would produce more factsheets and more educational opportunities for vaccine administrators because of a “confusing label situation” with Moderna’s vaccine vials.

To differentiate the vials, Moderna used different colored caps and a different colored border around the label. For example, for the 6 months to 5 years age group, which receives a smaller dose of 25 micrograms, the cap is dark blue and the rim is magenta. For children aged 6 to 11 receiving 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 aged 18 and over. The label on this product also says it can be used for refresher cans.

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“We are aware that this label is very confusing for children aged 6 to 11 with the words ‘BOOSTER DOSES’ in capital letters,” said Dr. The CDC’s Elisha Hall, clinical guidelines lead for the COVID-19 emergency response, addressed the committee on Thursday. “There will be multiple educational and communication materials and efforts to communicate the authorized use of this bottle for children ages 6 to 11.”

She said the CDC will also offer educational webinars to help providers.

“With all these new products, there may be more opportunities for vaccine administration errors. In addition to the number of products, of course, the products that are not labeled for the specified age group. Also, new pediatric providers may be unfamiliar with Covid-19 vaccines and there are some clear differences between routine vaccines,” Hall said.

Several members of the Vaccine Advisory Committee called on Moderna and Pfizer to simplify the design of the Covid-19 vaccine vials. They also raised concerns that color-blind vaccine administrators will not be able to distinguish between the vials.

“I really appreciate that the CDC is assembling the types of training and support when we need to implement it, but I just have to recognize that this hurts adoption from a vendor perspective because it’s very complex to put into business practice to integrate,” said ACIP Chair Dr. Grace Lee, associate chief medical officer for practice innovation at Lucile Packard Children’s Hospital. “It’s pretty overwhelming for me and I feel like I know Covid pretty well.”

Moderna told the committee that they are “actively working on the design issue.”

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