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 to the statements:
“Two doses of the Moderna COVID-19 vaccine (50mcg) are recommended for children 6 to 11 years of age, under FDA EUA.”
“Moderna’s COVID-19 vaccine is recommended in two doses (100 mcg) for adolescents aged 12 to 17 years, under EU law from the US Food and Drug Administration.”
The Centers for Disease Control (CDC) Immunization Practices Advisory Committee approved the vaccine after hearing details about Moderna’s application to the Food and Drug Administration and the latest safety data.
Dr. said. Helen Kip Talbot, associate professor of medicine from Vanderbilt University during the ACIP vaccine discussion on Thursday. She added that myocarditis after vaccination was generally mild compared to those who developed myocarditis after Covid-19 disease.
The Centers for Disease Control and Prevention (CDC) said the risk of developing myocarditis “may be higher” with Moderna’s vaccine than with the Pfizer vaccine, but there are limitations to what scientists know about the condition in this age group because the data is observational and limited.
Overall, the data provided by the company showed that most children got the vaccine without incident.
Dr. said. 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 among children between the ages of 5 and 11, according to a presentation at the meeting by Dr. Sarah Oliver.
In April, unvaccinated children aged 5 to 17 were twice as likely to contract Covid-19 than unvaccinated children with the initial vaccine series.
There was also an increase in hospitalizations among this age group, particularly during the Omicron increase. Among teens ages 12 to 17, cumulative rates of Covid-19 hospitalizations are “significantly higher” than influenza during all previous flu seasons, Oliver, a member of the CDC’s Epidemiological Information Service, told the committee. The possibility of children contracting COVID-19 for a long time, even if they have a mild or asymptomatic case, is a major concern.
Children are the least vaccinated of all age groups in the United States. The CDC said about 65% of children in the 5- to 11-year age group and 30% of teens haven’t been vaccinated. The CDC hopes more parents will protect their children with vaccination.
“We can anticipate future Covid-19 spikes, as the unvaccinated will continue to bear the disease burden,” Oliver said.
After the ACIP vote, CDC Director Dr. Rochelle Walinsky will decide whether to accept the ACIP’s recommendation. The shots may be given after the CDC adopts the recommendation.
For children 6 to 11 years of age, Moderna vaccine is given as a series of two doses at 50 micrograms per dose.
Adolescents 12 to 17 years of age receive the same amount as adults – a series of two doses at a rate of 100 micrograms per dose.
The Moderna vaccine is already available to people aged 6 months to 5 years and 18 and older.
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 children and adolescents who are not immunized right now,” Oliver said. “We know that the benefits outweigh the risks of the mRNA Covid-19 vaccine at all ages.” “Receiving this initial series remains the safest way to prevent serious Covid-19.”
The Centers for Disease Control and Prevention has not addressed the issue of a booster dose of the Moderna vaccine, as it is not authorized by the U.S. Food and Drug Administration yet, but Dr. Doran Fink, deputy director of the FDA’s Clinical Division of Vaccines and Related Product Applications, said they will address that gap over the summer.
“We expect to address this gap in anabolic doses during the summer,” Fink told the committee.
The agency is collecting more data to determine if a booster dose is necessary.
Some children and teens, depending on their age, who have received the Pfizer Covid-19 vaccine are eligible for a booster dose.
Handling confusing labels
The CDC promised its Independent Vaccine Advisory Committee that it will create multiple fact sheets and more education opportunities for vaccine administrators due to what it called a “confusing naming situation” with Moderna’s vaccine vials.
To differentiate the flasks, Moderna used different color caps and used different color borders around the label. For the age group of six months to 5 years that get a dose smaller than 25 mcg, for example, the cap is dark blue and the border is purple. For children ages 6 to 11, who will get a larger dose size at 50 mcg, the vial also has a dark blue cap, but the frame is purple. The same vial is used for stimulant doses for adults 18 years of age and older. The label on this product also says that it can be used for booster doses.
Dr. says. Elisha Hall, clinical guidelines driving the Covid-19 emergency response, told the committee Thursday. “There will be many educational and communication materials and efforts to communicate the authorized use of this vial to ages 6-11.”
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 just the number of products, of course, products that are not labeled for the specific age group. Additionally, new pediatric providers may be unfamiliar with Covid-vaccines. 19 And there are some stark differences between routine vaccinations.”
Several members of the Vaccine Advisory Committee have urged Moderna and Pfizer to simplify the design of the Covid-19 vaccine vials. They also expressed concern that color-blind vaccine officials would not be able to distinguish between vials.
“I really appreciate that the CDC puts together the kinds of training and support when we need to implement it, but just realize that this affects acceptability from a provider point of view, because it’s very difficult to integrate into a crowded practice,” ACIP said. Dr. chair. Grace Lee, associate medical director of the innovation practice at Lucille Packard Hospital for Children. “For me, this is very overwhelming and I feel like I know Covid very well.”
Moderna told the committee it was “actively working” on the design issue.