The vaccine received emergency approval from the US Food and Drug Administration last week.
All 15 members of the CDC’s Advisory Committee on Immunization Practices (ACIP) voted in favor of the statements:
“The two-dose modern COVID-19 vaccine (50 mcg) released by the U.S. FDA is recommended for children ages 6 to 11 years.”
“The two-dose modern COVID-19 vaccine (100 mcg) released by the U.S. FDA is recommended for adolescents 12 to 17 years of age.”
The CDC’s Immunization Practice Advisory Committee endorsed the vaccine after hearing Modera’s appeal to the FDA and the latest safety information.
“Even after the Covid-19 messenger RNA vaccine, there is a risk of myocarditis / pericarditis, and in most cases the symptoms have improved rapidly. Subsequent surveys show that myocarditis is completely cured,” the doctor said. Helen Cape Talbot, associate professor of medicine at Vanderbilt University ACIP during a discussion of the vaccine on Thursday. He added that post-vaccination myocarditis was milder than in patients with myocarditis after Covid-19.
The CDC said the risk of myocarditis could be “higher” with the Modern vaccine than with the Pfizer vaccine, but data are observable and limited because scientists have limitations in what they know about the condition in this age group.
Overall, the company said, most children were vaccinated safely.
“In general, most of the adverse events reported after Covid vaccines are mild and transient events, such as injection site and systemic reactions,” the doctor said. Tom Shimabukuro, deputy director of the CDC H1N1 vaccine working group. “We will continue to monitor the safety of these vaccines, and we will continue to work with partners within the federal government, as well as health care providers and providers, to better understand these types of adverse events.”
More than 5.1 million Covid-19 cases during the pandemic occurred among children aged 5 to 11 years, according to Dr. CDC. Sarah Oliver.
In April, unvaccinated children aged 5 to 17 years were twice as likely to be tested positive for Covid-19 than unvaccinated children with the main series of vaccines.
Among this age group, an increase in receptions was observed, especially during the Omicron wave. Oliver, a member of the CDC’s Epidemiological Surveillance Service, told the committee that the covid-19 hospitalized cumulative rate among adolescents aged 12 to 17 was “significantly higher” than the influenza of all previous seasons. Although children may have mild or asymptomatic Covid disease, the possibility that Covid may develop over a long period of time is also a serious concern.
Children are the least vaccinated of all age groups in the United States. According to the CDC, 65% of children between the ages of 5 and 11 and 30% of adolescents were not vaccinated. The CDC hopes that more parents will protect their children by vaccination.
“We can predict the future outbreak of Covid-19, and those who are not vaccinated will continue to carry the burden of the disease,” Oliver said.
After the ACIP vote, CDC Director Dr. Rochelle Valensky decides to sign the ACIP proposal. Shooting can take place after the CDC accepts the offer.
For children from 6 to 11 years of age, the modern vaccine is administered in a series of two doses of 50 micrograms per dose.
Adolescents between the ages of 12 and 17 receive the same amount as adults – two doses of 100 micrograms per dose.
The Moderna vaccine is available to people 6 months to 5 years of age and 18 years of age and older.
People between the ages of 6 and 17 are eligible to be vaccinated with the Pfizer / BioNTech Covid-19 vaccine.
“There are currently 25 million unvaccinated children and adolescents. We know that the benefits of the mRNA Covid-19 vaccine for all ages outweigh the risks,” Oliver said. “Getting this major series remains the safest way to prevent serious Covid-19.”
The CDC has not yet considered the augmentation issue for the modern vaccine because the FDA has not yet approved it, but Dr. Doran Fink, deputy director of the FDA’s Clinical Division of Vaccines and related products, said they will address this gap in the summer.
Fink told the committee: “We expect to close this gap in the summer with increasing doses.”
The agency is gathering more information to determine the need for a booster dose.
Some children and adolescents who have received the Pfizer Covid-19 vaccine are entitled to an additional dose, depending on their age.
Refer to confusing labels
The CDC has promised its Independent Vaccine Advisory Committee that it will create more fact sheets and more educational opportunities for vaccine administrators, calling it a “confusing etiquette situation” with modern vaccine vials.
To distinguish the vials, Moderna used different colored caps and a different colored border around the label. For children aged six months to 5 years, the dose is 25 micrograms less, for example, dark blue cap and dark red forehead. For children 6 to 11 years of age, they receive a dose greater than 50 micrograms, the cap of the vial is also dark blue, but the forehead is pink. The same vial is used for booster doses for adults over 18 years of age. The label on this product states that it can be used for booster doses.
“We understand that the“ BOOSTER DOSES ”label, written in all capital letters from 6 to 11 years old, is very confusing,” the CDC doctor said. Elisha Hall told the committee on Thursday the clinical guidelines for responding to Covid-19 emergencies. “There will be several educational and communication materials and efforts to communicate the permissible use of this vial for 6 to 11 year olds.”
According to him, the CDC also offers educational webinars to help providers.
“When all these new products come out, there may be more opportunities to make a mistake in administering the vaccine. In addition to the number of products, of course, unlabeled products for this age group. In addition, new pediatric providers may be unfamiliar. There are sharp differences, ”Hall said.
Several members of the vaccine advisory committee have urged Moderna and Pfizer to simplify the design of the Covid-19 vaccine vial. They also expressed concern that administrators of color-blind vaccines could not distinguish vials.
“I appreciate when the CDC needs to combine the types of training and support and implement it, but I understand that it will affect the acceptability from the provider’s point of view, because it is very difficult to implement in busy practice,” ACIP said. Chairman Dr. Grace Lee, Assistant Chief Physician for Practical Innovation at Lucille Packard Children’s Hospital. “It’s very surprising to me and I feel like I know Covid well.”
Moderna told the committee that he was “actively working” on the design.