The Centers for Disease Control and Prevention’s outside vaccine advisers voted unanimously Thursday to expand their recommendations for Moderna’s COVID-19 vaccine to virtually all ages of children, adding the first alternative to Pfizer’s shots for millions of adolescents and school-age kids.
On Friday, CDC Director Dr. Rochelle Walensky endorsed the panel’s updated recommendations, officially clearing the shots for use. This comes just days after thefrom both Moderna and Pfizer-BioNTech for preschoolers, toddlers, and infants as young as 6 months old.
“Today, we have expanded the options available to families by recommending a second safe and effective vaccine for children ages 6 through 17 years,” Walensky said in a statement.
Moderna’s pediatric shots will join a vaccination effort that has slowed to a near-standstill in children 5 years and older.
In the more than seven months since the FDA and CDC first signed off on Pfizer’s shots for children down to age 5, more than a third of those ages 12 to 17 years old remain unvaccinated. More than two-thirds of children ages 5 to 11 are unvaccinated.
Surveys fielded by the CDC suggest parents’ vaccine hesitancy may be growing. Around a third of parents say their child, 5 years and older, “probably or definitely will not get vaccinated” through the end of May. That’s up from around one in five last fall.
CDC data suggests children are generally at the lowest risk of severe COVID-19 of any age group and that the majority of kids have already.
However, hospitalization rates during the Omicron wave in children 5 and older were worse than those seen during flu seasons.
Data presented to the CDC’s advisers also suggests vaccination may blunt the.
Clearing the Moderna shots for older kids could ease some logistical challenges for vaccinators. The shots can be stored at traditional freezer temperatures and do not need to be diluted. Doctors already offering Moderna’s vaccine for young children and adults may also prefer to stick to one brand for all age groups.
“I think a lot of providers are probably going to carry one vaccine or the other, and not both. And that’s because of the concerns about wastage, but also, these vaccines are very different in their dosages and age groups, and just to avoid vaccine administration errors,” Molly Howell of the Association of Immunization Managers told the CDC panel last week.
On the other hand, adding the new vaccine could also raise the risk of errors for busy doctors, officials acknowledged to the committee. Multiple advisers on the committee also voiced frustration over an error on some of the labels for Moderna’s vaccine and a myriad of similarly colored vials that some dubbed a “nightmare.” Some of Pfizer’s vials for younger children also had an error on their label.
“We do definitely hear the feedback. I think this has kind of arisen with the speed with which these have come forward,” Moderna’s Rituparna Das told the advisers.
Doses and the risk of myocarditis
Moderna’s request to vaccinate adolescents and teens had been stalled for months before the FDA, despite swifter approvals from regulators overseas.
Federal health officials had said they were concerned Moderna’s 100 microgram dose might pose a higher risk than from Pfizer’s vaccine of rare heart inflammation side effects, known as myocarditis and pericarditis. However, FDA officials said earlier this month that U.S. safety surveillance data has not turned up “a significantly higher” risk from Moderna’s doses at the full 100 micrograms, compared to Pfizer’s vaccine in young adults.
Moderna uses the same ingredients for all of their authorized shots, an FDA spokesperson said, but it’s bottled in different dosage amounts for different age groups.
There are 25 micrograms of mRNA in each of Moderna’s primary series doses for children up to 5 years old; 50 micrograms up to 11 years old; and 100 micrograms for everyone else 12 years and older.
In a statement last week, the FDA said data from safety surveillance of both mRNA vaccines “continue to strengthen the evidence” that myocarditis remains uncommon and that patients usually recover quickly with no long-term impact on their lives.
Like with Pfizer’s vaccine, CDC officials told their outside advisers on Thursday that they plan to recommend that adolescent and young adult males can wait as much as eight weeks after their second Moderna dose to cut their myocarditis risk even further.
So far, the FDA has not authorized a booster dose from Moderna in this age group. However, federal health officials said they expect a third dose could be greenlighted in time for these children.
“We would expect to be addressing this gap in booster dose recommendations over the summer and into early fall,” the FDA’s Doran Fink told the panel.