Dr. Reingold welcomed everyone for a discussion of the Moderna COVID-19 Vaccine EUA for 6-17 year-olds.
Moderna COVID-19 Vaccine EUA for 6-17 Year Olds: Workgroup Discussion
Arthur Reingold, MD, Chair
Dr. Reingold and then Dr. Lee summarized the June 23 ACIP meeting. The data presented show that in this age group the Moderna COVID-19 vaccine is safe and effective, the benefits outweigh the risks, the efficacy against symptomatic infection is quite good, and the safety profile is also very good.
Dr. Lee reported more details on the ACIP meeting, sharing that:
- Children 5-17 years are at risk of severe COVID-19 illness.
- 10.3 million cases among this age group have occurred in the US to date, resulting in 45,000 hospitalizations and over 600 deaths from COVID-19.
- The CDC presented the most comprehensive data Dr. Lee has seen so far concerning post-COVID complications in children. Post-COVID-19 complications occur in children and adolescents more frequently in those who have had severe illness, although they are also seen after mild or asymptomatic infections.
- There is a risk of myocarditis/pericarditis after both mRNA vaccines. This risk is highest in those 12 years of age and older and in males especially after the second dose; these risks appear to be much lower in 5-11 year-olds after either the first or second dose, there is a very weak signal for 5-11 year-old boys. We will have to monitor myocarditis/pericarditis following COVID-19 vaccine in infants and children under 5 years. There is no evidence of an increased risk of myocarditis in girls.
- Using comparable data between Pfizer and Moderna for those 18 years of age and older, it does appear that there is a trend toward a higher risk of myocarditis following receipt of the Moderna COVID-19 vaccine compared to the Pfizer COVID-19 vaccine.
- Compared to no vaccination, the Moderna COVID-19 vaccine is safe and effective. The committee did not compare the COVID-19 vaccines from Moderna and Pfizer or make a preferential recommendation.
- The Workgroup spent most of its time on implementation issues of multiple pediatric vaccine formulation, as there are so many complexities with the different colors of caps and vial labels, and with outdated or otherwise incorrect information about dosing and storage on the labels. Dr. Lee noted that there will need to be a lot of attention and focus to minimize vaccine administration errors in young children.
Dr. Brooks added that the discussion regarding long COVID showed that children are less likely to have long COVID if they have a moderate case of COVID-19, are not hospitalized, or do not need oxygen. It was not clear whether children who are vaccinated who have COVID-19 have less risk of long COVID. Dr. Brooks suggested including language in the statement that long COVID is less likely in those that have less severe COVID-19 disease.
He noted that the VSD reported no myocarditis signal in the youngest children, but a positive signal for 12-17 year-olds.
Dr. Brooks also shared information about how many children remain unvaccinated against COVID-19:
- 72% of African-American children 5-11 years of age and 40% of African-American children 12-17 years of age are unvaccinated
- Overall, 65% of children 5-11 years of age and 30% of those 12-17 years of age are unvaccinated
- This is 75 million children ages 12-17 and 18 million children ages 5-11 who are unvaccinated.
Discussion on Vaccine Intervals
Dr. Lee noted that the Canadian evidence about using an 8-week interval between the first and second dose of the COVID-19 vaccine for reducing the risk of myocarditis is compelling. The suggested interval for Moderna is 4-8 weeks. She believes that the shorter interval may be appropriate for those who are immunocompromised or need to travel, but for those who can wait it may be preferable for both immune response and safety to wait the 8-week interval.
Dr. Klein agreed that the data are compelling and suggested including this in the link to the clinical considerations language. She might analyze the data further.
Dr. Reingold reinforced that waiting longer between vaccine doses, in the absence of urgency, may reduce the risk of myocarditis as supported by a Canadian paper expected to be released June 24. The group deliberated about whether and how to include this information in its statement.
Another important reason to consider giving preference to the longer interval is that it appears to increase efficacy through enhanced immunogenicity and possibly durability of protection.
Dr. Picker noted that all the data shared were during the pre-Omicron era and therefore might be less relevant now.
Several members noted that surveys are showing increasing parental concern about the safety of the COVID-19 vaccines and are concerned that highlighting the very rare safety risks might
contribute to unwarranted fears and vaccine hesitancy. Noting myocarditis in the statement, given the very low risk, raised some concerns, but there is also a desire to be transparent. The statement could note that the risk of myocarditis from COVID-19 is 6 times higher than the risk associated with vaccination.
The group also discussed what to do if an 11–17 year-old gets SARS-CoV-2 infection or COVID-19 between vaccine doses. Dr. Lee shared that the CDC clinical considerations suggest postponing the second dose to 3 months, given the immune response maturation after infection and the natural protection this offers.
Dr. Maldonado shared that the AAP statement published on June 18 recommends following the CDC guidance. She feels that giving pediatricians latitude is helpful. Stanford and the AAP are putting together infographics to try to clarify the Moderna and Pfizer schedules. There are four different sized vials for different age groups, three different caps, and two different labels. The AAP is talking to the FDA about changing bottles and simplifying recommendations for how to use the vials for various pediatric age groups. The AAP is also planning to issue a separate infographic on immunocompromised children.
Dr. Picker noted that the workgroup hadn’t reviewed specific data regarding the benefits of a 4-week vs. 8-week interval between vaccine doses, which may be worth doing. This could be the topic for a future statement.
Michele Roberts added that there could be reasons to use a shorter interval, based on community COVID-19 rates or to ensure full protection before school starts, among other considerations.
Ultimately, the group agreed not to recommend a specific interval but instead to note the various considerations, giving latitude so that pediatricians can make decisions based on clinical and implementation considerations. This will be equivalent to the group’s Pfizer COVID-19 vaccine recommendations, which did not specify the interval between doses.
Timing of Western States Statement and Next Steps
Arthur Reingold, MD, Chair
Bobbie Wunsch, Pacific Health Consulting Group
Dr. Reingold and Bobbie will share a draft statement by June 24 and finalize a statement for the states by Monday June 27.