CDC vaccine consultants vote unanimously to recommend Moderna Covid-19 vaccine for 6-17 year olds

The vaccine received emergency use clearance from the 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 modern two-dose COVID-19 vaccine (50 mcg) is recommended for children aged 6 to 11, under the UAE issued by the FDA.”

“A modern two-dose COVID-19 vaccine (100 mcg) is recommended for adolescents aged 12-17, under the UAE issued by the FDA.”

The CDC’s Immunization Practices Advisory Committee approved 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 Covid-19 messenger RNA vaccines, most cases have rapid improvement in symptoms. Follow-up investigation suggests that most cases cured of myocarditis. “said Dr. Helen Keipp Talbot, associate professor of medicine at Vanderbilt University during ACIP’s discussion of the vaccine on Thursday. She added that myocarditis after vaccination was generally mild compared to those who developed myocarditis after getting 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 on what scientists know about the condition in this age group as the data is observational and limited.

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

“In general, most 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 H1N1 Vaccine Task Force at the CDC. “We will continue to monitor the safety of these vaccines and will continue to work with partners, both within the federal government and with health care professionals and supplier organizations to better understand these types of adverse events.”

Over 5.1 million cases of Covid-19 occurred among children between the ages of 5 and 11 during the pandemic, according to a presentation at the meeting by CDC’s Dr Sara Oliver.

In April, unvaccinated children between the ages of 5 and 17 were at twice the risk of testing positive for Covid-19 than children not vaccinated with the primary series of the vaccine.

Vaccinations against Covid-19 for US children under 5 are underway

There has also been an increase in hospitalizations in this age group, particularly during the Omicron wave. Among teens ages 12-17, cumulative hospitalization rates for Covid-19 are “noticeably higher” than those for flu during all previous flu seasons, Oliver, a member of the flu, told the committee. CDC’s Epidemic Intelligence Service. The possibility that children may develop Covid for a long time, even if they have had a mild or asymptomatic case of Covid, is also a significant concern.

Children are the least vaccinated group among all age groups in the United States. About 65 percent of children in the 5 to 11-year-old 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 vaccination.

“We can predict that with future waves of Covid-19, the unvaccinated will continue to bear the brunt of the disease,” said Oliver.

After the ACIP vote, the CDC Director, Dr Rochelle Walensky, will decide whether to approve the ACIP recommendation. Shots can be administered after the CDC has adopted the recommendation.

For children 6 to 11 years old, the Moderna vaccine is given in a series of two doses at 50 micrograms per dose.

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Adolescents 12 to 17 years old are given the same amount that is 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 and ages 18 and up.

People between the ages of 6 and 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 the benefits outweigh the risks to the Covid-19 mRNA vaccine in all ages,” Oliver said. “Receiving this primary series continues to be the surest way to prevent severe Covid-19.”

Modern Booster

The CDC did not address the booster dose issue for the Moderna vaccine, as it is not yet cleared by the FDA, but Dr Doran Fink, FDA’s deputy director of the Clinical Division of Vaccines and Related Products Applications, said he would. fill this gap during the summer.

“We would expect to address this booster dose gap 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 may benefit from a booster dose.

Addressing of garbled labels

The CDC promised its independent committee of vaccine consultants that it would create more fact sheets and more education opportunities for vaccine administrators because of what it called a “label confusing situation” with vaccine vials. Modern.

To distinguish between the vials, Moderna used different colored caps and used a different colored border around the label. For the age group six months to 5 years who receive a smaller dose of 25 micrograms, for example, the cap is dark blue and the rim is magenta. For children 6 to 11 years old, who will receive a dosage greater than 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 years and over. The label on that product also says it can be used for booster doses.

How are Pfizer and Moderna vaccines for young children different?

“We recognize that the 6 to 11 year old label that says ‘BOOSTER DOSES’ in capital letters is very confusing,” CDC’s Dr Elisha Hall, head of clinical guidelines for the Covid-19 emergency response, told the committee on Thursday. . “There will be several educational and communication materials and efforts to communicate the licensed use of this vial for ages 6 to 11.”

He said the CDC will also offer educational webinars to help suppliers.

“With all of these new products coming out, there may be more opportunities for vaccine administration errors. In addition to just the number of products, of course, products that are not labeled for the indicated age group. Also, new pediatric operators may not be familiar with Covid-19 vaccines and there are some stark 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 colorblind vaccine administrators will not be able to differentiate between the vials.

“I really appreciate the CDC putting together the types of training and support when it needs to be implemented, but I just recognize that this has an impact on acceptability from a vendor’s perspective, because that’s a lot of complexity to incorporate into the fast-paced practice.” said ACIP President Dr. Grace Lee, associate medical director for practical 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 that they are “actively working” on the design issue.

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