(CNN)US Centers for Disease Control and Prevention Vaccine Advisorto support two recommendations on Thursday Voted-Administration of the Moderna Covid-19 vaccine for use in people aged 6 to 17 years.
The vaccine received an emergency use authorization from the US Food and Drug Administration last week.
All 15 members of the CDC's Advisory Committee on Immunization and Implementation (ACIP) voted in favor of the following statement:
"Two-dose Moderna COVID-19 vaccine (50 mcg) is recommended for children 6-11 years old based on FDA-issued EUA."
"FDA-issued EUA Under, a double dose of the Moderna COVID-19 vaccine (100 mcg) is recommended for adolescents aged 12 to 17 years. ”
The CDC Immunization Implementation Advisory Board said. After hearing the details of Moderna's application to the FDA and the latest safety data, we approved the vaccine.
"There is a risk of myocarditis / pericarditis after both messenger RNA Covid-19 vaccines, and in most cases the symptoms improve quickly. Follow-up shows the most complete recovery from myocarditis. It is suggested that we did, "says Dr. Helen Keipp Talbot. , Associate Professor at Vanderbilt University, while ACIP is discussing vaccines on Thursday. She added that post-vaccination myocarditis is generally milder than those who develop myocarditis after becoming ill with Covid-19.
The CDC states that the modelna vaccine "may have a higher risk" of myocarditis than vaccination from Pfizer, but the data are observational and limited.
Overall, the data presented by the company showed that most children were vaccinated without problems.
"In general, most adverse events reported after the Covid vaccine are mild, transient events such as injection sites and systemic reactions," said the Deputy Director of the CDC's H1N1 Vaccine Task Force. One Dr. Tom Shimabukuro said. "We will continue to monitor the safety of these vaccines and continue to work with partners within the federal government and with both healthcare provider and provider organization partners to better understand these types of adverse events.
During the pandemic, more than 5.1 million cases of Covid-19 occurred among children aged 5 to 11 years, according to a presentation at a conference from Dr. Sara Oliver of the CDC. ..
In April, unvaccinated children between the ages of 5 and 17 were twice as likely to test positive for Covid-19 than children who were not vaccinated with the primary series of vaccines. ..
Hospitalizations are increasing in this age group, especially during the Omicron surge. Oliver, a member of the CDC's Epidemic Intelligence Service, told the Commission that among adolescents aged 12 to 17, the cumulative rate of hospitalization for Covid-19 is "significantly higher than for influenza during all previous influenza seasons. ". Even with mild or asymptomatic Covid cases, the possibility of a child developing long Covid is also an important concern.
Children are the least vaccinated group of all age groups in the United States. According to the CDC, about 65% of children between the ages of 5 and 11 and 30% of adolescents are not vaccinated. The CDC wants more parents to protect their children with vaccinations.
"We can predict the future surge in Covid-19, but unvaccinated people will continue to bear the burden of illness," Oliver said.
Following the ACIP vote, CDC Director Dr. Rochelle Walensky decides whether to approve the ACIP recommendation. After the CDC adopts the recommendations, she can manage the shots.
Children aged 6 to 11 years receive the Moderna vaccine in a two-dose series at 50 micrograms per dose.
Adolescents aged 12 to 17 receive the same dose as given to adults. This is a two-dose series of 100 micrograms per dose. The
Moderna vaccine is already available to people aged 6 months to 5 years and 18 years and older.
People aged 6 to 17 were already eligible for the Pfizer / BioNTech Covid-19 vaccine.
"Currently, there are 25 million unvaccinated children and adolescents. We know that the risks outweigh the risks of the mRNA Covid-19 vaccine at all ages," Oliver said. Says. "Receiving this primary series remains the safest way to prevent serious Covid-19."
Moderna Booster
CDC He did not address the issue of booster doses of the Moderna vaccine as it has not yet been approved by the FDA, but Dr. Doran Fink, Deputy Director of the FDA's Vaccine and Related Product Applications Clinical Division, said he would address this gap during the summer.
"We look forward to addressing this gap in booster effects during the summer," Fink told the Commission.
The agency is collecting more data to determine if booster immunization is needed.
Depending on age, some children and adolescents vaccinated with the Pfizer Covid-19 vaccine are eligible for booster immunization.
Dealing with Confusing Labels
The CDC told the Independent Vaccine Advisory Board "The Confusing Label Situation" and Moderna's vaccine vials. To distinguish the
vials, Moderna used different colored caps and different colored borders around the label. For example, for the 6-month to 5-year-old age group with low doses of 25 micrograms, the cap is dark blue and the border is magenta. For children 6-11 years old who get a larger dose size at 50 micrograms, the vial also has a dark blue cap, but the border is purple. The same vial is used for booster immunization for adults 18 years and older. The product label also states that it can be used for booster effects.
"We recognize that it is very confusing to see the" booster effect "in all capital letters on labels between the ages of 6 and 11," said Dr. Elisha Hall of the CDC. The Covid-19 Emergency Response Clinical Guidelines Lead states: Thursday's committee. "From 6 to 11 years old, there are multiple educational and communication materials and efforts to convey the permitted usage of this vial."
She is educated by the CDC to assist providers. He said he would also provide a webinar.
"All of these new products may increase the likelihood of vaccination errors. Of course, not only the number of products, but also the label for the specified age group. Not all products are available. In addition, new pediatric providers may be unfamiliar with the Covid-19 vaccine, and there are some major differences between regular vaccines, "Hall said.
Several members of the Vaccine Advisory Board have urged Moderna and Pfizer to simplify the design of Covid-19 vaccine vials. They also expressed concern that colorblind vaccine managers could not distinguish vials.
"I'm really grateful for putting together the types of training and support when I need to implement CDC, but I hope this impacts acceptability from a provider's perspective. I am aware. I am busy with medical treatment. " ACIP Chair Dr. Grace Lee is Deputy Chief Healthcare Officer for Medical Innovation at Lucille Packard Children's Hospital. "For me, this is very overwhelming and I feel like I'm pretty familiar with Covid."
Moderna told the committee that he was "actively working on design issues." I have. "