Thursday's unanimous vote by the Centers for Disease Control and Prevention's outside vaccination advisers allowed them to recommend Moderna's COVID-19 vaccine for virtually all children. This is in addition to Pfizer's shot for millions of school-age children.
Friday's endorsement by Dr. Rochelle Walensky, Director of the CDC, was a sign that the updated recommendations were approved by the panel. This officially cleared the shots for use. This endorsement comes days after Moderna and Pfizer BioNTech were recommended for infants and toddlers as young at 6 months.
Walensky stated in a statement that "Today we have increased the options for families by recommending another safe and effective vaccine to children aged 6-17 years."
Moderna's pediatric shots are part of a larger vaccination effort for children aged 5 and over that is nearing a halt.
More than a third (13%) of children between the ages of 12 and 17 have not been vaccinated in the seven months since Pfizer's shot for children below the age 5 was approved by the FDA/CDC. Over two-thirds (33%) of children aged 5-11 are not vaccinated.
The CDC has conducted surveys to find that parents are becoming more resistant to vaccinations. A third of parents believe their child aged 5 or older "probably or certainly will not be vaccinated" by May 31st. This is an increase from the one-in-five who said so last fall.
According to CDC data, children are at lowest risk for severe COVID-19 than any other age group. The majority of cases of COVID-19 have been successfully treated.
The Omicron wave was worse for children aged 5 and over than flu seasons.
The CDC advisers were also given data that suggests that vaccination could reduce the risk of children suffering from long-term COVID symptoms.
The Moderna shots can be cleared for older children to ease logistical problems for vaccinators. You can store the shots at normal freezer temperatures. They do not need to diluted. Moderna's vaccine is available to young children and adults. However, doctors may prefer to use one brand for all age groups.
"I believe that a lot providers will likely carry one or the other vaccine, but not both." This is because of concerns about wastage but also because these vaccines have very different dosages and age groups. Molly Howell, of the Association of Immunization Managers, told the CDC panel last Wednesday.
Officials acknowledged that the addition of the vaccine could increase the chance of errors for busy doctors. Numerous advisers to the committee expressed frustration at the label errors on Moderna's vaccine, as well as a multitude of similar-colored vials. Some called it a "nightmare". A number of Pfizer's vials meant for children younger than 5 years old also had an error in their labels.
"We definitely hear the feedback. "I think this has kinda risen with the speed at which these have come forward," Moderna’s Rituparna Das stated to the advisers.
Moderna's request for vaccinations of adolescents and teenagers was held up by the FDA for several months, despite faster approvals from overseas regulators.
Federal health officials stated that they were concerned Moderna’s 100-microgram dose could pose a greater risk than the Pfizer vaccine for rare heart inflammation side effects. These are known as myocarditis or pericarditis. FDA officials stated earlier this month that U.S. safety monitoring data had not found a "significantly higher" risk from Moderna at 100 micrograms compared to Pfizer vaccine for young adults.
Moderna uses the exact same ingredients in all their approved shots, according to an FDA spokesperson. However, it is bottled in different dosages for different age groups.
Moderna's primary series doses contain 25 micrograms of the mRNA for children under 5 years; 50 micrograms for children aged 11 to 13 years; and 100 micrograms each for adults 12 and older.
FDA released a statement last week stating that data from safety surveillance of both the mRNA vaccines and myocarditis "continues to strengthen the evidence". They also stated that patients often recover quickly without any long-term effects on their lives.
CDC officials said on Thursday that, just like with Pfizer's vaccines, they will recommend that adolescent males wait up to eight weeks after receiving their second Moderna dose. This will reduce their risk of developing myocarditis.
The FDA has so far not approved a booster dose of Moderna for this age group. Federal health officials stated that they believe a third dose of Moderna could be approved in the nick of time.
Doran Fink, FDA's director of public affairs, stated that they would expect to address the gap in booster dose recommendations by the end of the summer and early fall.