ACIP Evidence to Recommendations for Use of Moderna COVID-19 Vaccine in Children Ages 6–11 years and Adolescents Ages 12–17 years under an Emergency Use Authorization

About

The Evidence to Recommendations (EtR) frameworks describe information considered in moving from evidence to ACIP vaccine recommendations.

Summary

Question: Should vaccination with Moderna COVID-19 vaccine (2-doses, 50 mcg, IM) be recommended for children ages 6–11 years, under an Emergency Use Authorization?

Should vaccination with Moderna COVID-19 vaccine (2-doses, 100 mcg, IM) be recommended for adolescents ages 12–17 years, under an Emergency Use Authorization?

Population: People ages 6–17 years

Intervention: Moderna COVID-19 vaccine mRNA-1273

Comparison: No vaccine

Outcomes:

  • Symptomatic laboratory-confirmed COVID-19
  • Hospitalization due to COVID-19
  • Multisystem Inflammatory Syndrome in Children (MIS-C)
  • SARS-CoV-2 seroconversion to non-spike protein
  • Asymptomatic SARS-CoV-2 infection
  • Serious adverse events
  • Reactogenicity grade ≥3

Background

The emergence of SARS-CoV-2, the virus that causes coronavirus disease 2019 (COVID-19), in late 2019 has led to a global pandemic with dramatic societal and economic impact on individual persons and communities. In the United States, more than 85 million cases and more than 1,000,000 COVID-19-associated deaths have been reported as of June 16, 2022. Persons of all ages are at risk for infection and severe disease. While children <18 years of age infected with SARS-CoV-2 are less likely to develop severe illness compared with adults, children and adolescents are still at risk of developing severe illness and complications from COVID-19 and contribute to transmission in households and communities. A disproportionate burden of COVID-19 infections and deaths occur among racial and ethnic minority communities, including among children and adolescents. Non-Hispanic Black, Hispanic/Latino and American Indian/Alaska Native persons have experienced higher rates of disease, hospitalization and death compared with non-Hispanic Whites. This is likely related to inequities in social determinants of health that put racial and ethnic minority groups at increased risk for COVID-19, including income disparities, reduced access to healthcare, or higher rates of comorbid conditions.

On June 17, 2022, the Food and Drug Administration (FDA) authorized an Emergency Use Authorization (EUA) for a 2-dose Moderna COVID-19 vaccine primary series for administration to individuals ages 6 through 17 years for prevention of COVID-19. The FDA also authorized a 3rd primary series dose to individuals ages 6 through 17 years with certain kinds of immunocompromise. Following FDA’s regulatory action, CDC expanded eligibly of COVID-19 vaccines to individuals ages 6 through 17 years on June 23, 2022.

Additional background information supporting the ACIP recommendation on the use of Moderna COVID-19 vaccine for individuals ages 6 through 17 years can be found in the relevant publication of the recommendation referenced on the ACIP website.

Problem

Criteria Work Group Judgements Evidence Additional Information
Is the problem of public health importance? Yes Incidence:

As of June 14, 2022, there were more than 85 million total recorded cases of COVID-19 in the United States.1 Additionally, as of June 12, 2022, over 5.1 million cases occurred among children ages 5 – 11 years and more than 5.6 million cases occurred among adolescents ages 12 – 17 years.2 Furthermore, in relation to the rates of COVID-19 cases by vaccination status and age group, as of April 2022, unvaccinated individuals ages 5 years and older had a 2.0X greater risk of testing positive for COVID-19, compared to children and adolescents vaccinated with at least a primary series.3

Hospitalization:

There was an increase in hospitalizations among both children and adolescents during the peak of the Omicron surge, leading to the highest hospitalization rate for these age groups to date during the pandemic.4 However, it is known that vaccination prevents hospitalization. The monthly COVID-19-associated hospitalization rates by vaccination status illustrates that adolescents ages 12 – 17 years who were vaccinated with a primary series or with a primary series and one or more booster dose, had lower hospitalization rates than those who were unvaccinated. Although children ages 5 – 11 years have lower hospitalization rates overall than adolescents, the same pattern can be seen after they became eligible for vaccination in late 2021.5 It is important to note that the benefits of vaccination are more pronounced when the disease burden is high. We can predict that with future COVID-19 surges, the unvaccinated will continue to bear the burden of disease.

To further put the burden of COVID-19 illness in context, among children 5 – 11 years, COVID-19 hospitalization rates from October 2020 – September 2021 were lower than influenza hospitalization rates during the 2017 – 2018 through 2019 – 2020 (or pre-pandemic) influenza seasons. However, in this age group, preliminary COVID-19 hospitalization rates during October 2021 – April 2022 (which includes the Omicron surge) were as high as or higher than influenza hospitalization rates for all included influenza seasons. Nevertheless, among adolescents 12 – 17 years, the cumulative rates of COVID-19 hospitalizations in both years are much higher than influenza hospitalization rates during all flu seasons.6

Mortality:

As of May 11, 2022, there were 189 COVID-19 related deaths reported to the National Center for Health Statistics (NCHS) among children ages 5 – 11 years, which made up 2.5% of all deaths among children in this age group. Furthermore, there were 443 COVID-19 related deaths reported to NCHS among adolescents ages 12 – 17 years, which made up 2.4% of all deaths among adolescents in this age group.7

 Percentage of children and adolescents who received at least one dose of the COVID-19 vaccine over time:
In regard to the percentage of children and adolescents who received at least one dose of the COVID-19 vaccine, 36.2% of children ages 5 – 11 years and 69.7% of adolescents ages 12 – 17 years have received at least one dose of the COVID-19 vaccine from December 14, 2020 to June 16, 2022. All things considered, 18 million children ages 5 – 11 years and 7.5 million adolescents ages 12 – 17 years remain unvaccinated.8

Benefits and Harms

Criteria Work Group Judgements Evidence Additional Information
How substantial are the desirable anticipated effects? Large Children ages 6 – 11 years:

Risk of symptomatic COVID-19 was reduced among persons ages 6 – 11 years receiving two doses of the Moderna COVID-19 vaccine compared to placebo, which was further supported by evidence from immunobridging (GRADE Tables 3a and 3b).  Additionally, risk of asymptomatic SARS-CoV-2 infection was lower in the vaccine group compared with the placebo group (GRADE Table 3c).

The phase 2/3 randomized controlled trial (RCT) for the Moderna COVID-19 vaccine demonstrated efficacy of the 2-dose regimen against symptomatic, laboratory-confirmed, COVID-19.1,2 The efficacy among participants ages 6 – 11 years with or without evidence of prior infection was 80.6% (95% Confidence Interval [CI]: 18.8%, 95.3%). Efficacy was assessed a median of 51 days after receipt of a second dose.

Immunobridging data comparing geometric mean antibody titers (GMT) in children ages 6—11 years to adults ages 18 – 25 years, for whom clinical efficacy was previously established, were provided in support of efficacy. In participants ages 6 – 11 years, the immune response to vaccine was noninferior to that observed in those ages 18 – 25 years, with a GMR of 1.2 (95% CI: 1.1, 1.4).

Asymptomatic SAR-CoV-2 infection was defined as absence of symptoms and at least 1 of the following among participants who were PCR negative at baseline: 1) Binding antibody level against SARS-CoV-2 nucleocapsid protein negative at Day 1 that becomes positive post-baseline or 2) positive RT-PCR test post-baseline at scheduled or unscheduled visit. Note that antibody levels were taken only on a subset (n=510) in this trial.

Among children ages 6 – 11 years, the vaccine efficacy (VE) against asymptomatic infection was 71.0% (95% CI: 28.8%, 88.1%).

Adolescents ages 12 – 17 years:

Risk of symptomatic COVID-19 was reduced among persons ages 12 – 17 years receiving two doses of the Moderna COVID-19 vaccine compared to placebo, which was further supported by evidence from immunobridging (GRADE Tables 3a and 3b).  Risk of asymptomatic SARS-CoV-2 infection was not statistically different between the vaccine and placebo groups (Grade Table 3c).

The phase 2/3 randomized controlled trial (RCT) for the Moderna COVID-19 vaccine demonstrated efficacy of the 2-dose regimen against symptomatic, laboratory-confirmed, COVID-19.1,3 The efficacy among participants ages 12 – 17 years without evidence of prior infection was 89.2% (95% Confidence Interval [CI]: 49.9%, 97.6%). Efficacy was assessed a median of 53 days after receipt of a second dose.

Immunobridging data comparing geometric mean antibody titers (GMT) in adolescents ages 12—17 years to adults ages 18 – 25 years, for whom clinical efficacy was previously established, were provided in support of efficacy. In adolescents ages 12—17 years, the immune response to vaccine was noninferior to that observed in those ages 18 – 25 years, with a GMR of 1.1 (95% CI: 0.9, 1.2).

Asymptomatic SAR-CoV-2 infection was defined as absence of symptoms and at least 1 of the following among participants who were PCR negative at baseline: 1) Binding antibody level against SARS-CoV-2 nucleocapsid protein negative at Day 1 that becomes positive post-baseline or 2) positive RT-PCR test post-baseline at scheduled or unscheduled visit.

Among children ages 12 – 17 years, the vaccine efficacy (VE) against asymptomatic infection was 36.1% (95% CI:-22.0%, 66.5%).

How substantial are the undesirable anticipated effects? Small Children ages 6 – 11 years:

Risk of serious adverse events was low and equally common in the vaccine and placebo groups. Grade 3 reactogenicity was increased among persons receiving 2 doses of the Moderna COVID-19 vaccine compared to placebo (GRADE table 3d and 3e).

Solicited injection-site reactions and systemic events within 7 days after vaccination were frequent and mostly mild to moderate. Systemic reactions were generally more frequent and severe after dose 2 compared with dose 1. Median onset of systemic reactions was 1 to 2 days post-vaccine receipt and they resolved in a median duration of 1 to 2 days.

Severe adverse reactions (grade ≥3, defined as interfering with daily activity) occurred more commonly after the vaccine (17.1%) compared with placebo (3.3%). The most common grade 3 local symptom reported by vaccine recipients was pain at the injection site (2.7%). The most commonly reported systemic reactions of grade 3 or higher after dose 2 were fatigue (6.4%) and headache (4.0%) among vaccine recipients. Generally, grade ≥3 reactions were more commonly reported after the second dose than after the first dose.

Adverse events classified as serious were reported at similar rates among recipients of vaccine and placebo, overall (0.2% vs. 0.2%) and by system organ class; they represented medical events that occur in the pediatric population at a frequency similar to that observed in the study. No specific safety concerns were identified.

Adolescents ages 12 – 17 years:

Risk of serious adverse events was low but more common in the vaccine compared with the placebo group. Grade 3 reactogenicity was increased among persons receiving 2 doses of the Moderna COVID-19 vaccine compared to placebo (GRADE table 3d and 3e).

Solicited injection-site reactions and systemic events within 7 days after vaccination were frequent and mostly mild to moderate. Systemic reactions were generally more frequent and severe after dose 2 compared with dose 1. Median onset of systemic reactions was 1 to 2 days post-vaccine receipt and they resolved in a median duration of 1 to 2 days.

Severe adverse reactions (grade ≥3, defined as interfering with daily activity) occurred more commonly after the vaccine (25.3%) compared with placebo (4.8%). The most common grade 3 local symptom reported by vaccine recipients was pain at the injection site (5.4% after dose 1; 5.1% after dose 2). The most commonly reported systemic reactions of grade 3 or higher after dose 2 were fatigue (7.6%) and new or worsening muscle pain (5.2%) among vaccine recipients. Generally, grade ≥3 reactions were more commonly reported after the second dose than after the first dose.

Adverse events classified as serious were reported more commonly among recipients of vaccine than placebo, overall (0.24% vs. 0.16%) and by system organ class; they represented medical events that occur in the adolescent population at a frequency similar to that observed in the study. No specific safety concerns were identified.

Safety data showed an acceptable safety profile.

Post-marketing surveillance will be critical to detect any rare serious adverse events, which were not identified in the clinical trial.

Myocarditis in young children:

Before the COVID-19 pandemic, peaks in myocarditis hospitalizations were seen in infants (many cases can represent cardiomyopathy with genetic component) and adolescents (typically viral in etiology). In children, the annual incidence of myocarditis was 0.8 per 100,000 (66% were male and the median length of stay [LOS] was 6.1 days). However, in adolescents ages 15 – 18 years, the annual incidence was 1.8 per 100,000 in 2015 – 2016.4

Vaccine-associated myocarditis in children and adolescents:

Myocarditis/pericarditis, in particular in the first week following Dose 2, is a known risk associated with the Moderna COVID-19 vaccine, with the highest reported rate in males 18 – 24 years in routine pharmacovigilance/safety surveillance by the CDC and FDA1. There were no confirmed cases of myocarditis or pericarditis among participants 6 – 17 years in Moderna clinical studies2,3.

Do the desirable effects outweigh the undesirable effects? Favors intervention The Work Group decided that the desirable effects of the Moderna COVID-19 vaccine outweigh the undesirable effects.
What is the overall certainty of this evidence for the critical outcomes? Children ages 6 – 11 years:

For the critical outcomes, the certainty of evidence was Moderate for prevention of symptomatic COVID-19 assessed using direct efficacy, Moderate for symptomatic COVID-19 assessed using immunobridging, and Very Low for serious adverse events. For important outcomes, the certainty of evidence was Low for asymptomatic SARS-CoV-2 infection and High for reactogenicity.

Adolescents ages 12 – 17 years:

For the critical outcomes, the certainty of evidence was Moderate for prevention of symptomatic COVID-19 assessed using direct efficacy, Moderate for symptomatic COVID-19 assessed using immunobridging, and Very Low for serious adverse events. For important outcomes, the certainty of evidence was Low for asymptomatic SARS-CoV-2 infection and High for reactogenicity.

Values

Criteria Work Group Judgements Evidence Additional Information
Does the target population feel that the desirable effects are large relative to undesirable effects? Varies
To assess attitudes and intentions related to the COVID-19 vaccine during the pandemic, adolescents ages 13 – 18 years and parents of adolescents ages 13 – 18 years were surveyed using national research panels on three occasions or “waves”: wave 1 (August – September 2020) – before the COVID-19 vaccine was available, wave 2 (February – March 2021) – after it was available for adults, and wave 3 (June 2021) – after it was available for ages 12 years and older. Parent survey responses regarding the importance of routine vaccines and the COVID-19 vaccine (with ratings of extremely or very important) were assessed. COVID-19 vaccine and influenza vaccines were rated similarly by parents. Overall, parents reported a relatively high importance of getting the COVID-19 vaccine, although it was less than the importance reported for other routinely recommended vaccines.1
Parents’ willingness to have their teen get the COVID-19 vaccine and routine vaccines together were also assessed. The CDC and the American Academy of Pediatrics support giving other recommended childhood and adolescent immunizations at the same time as COVID-19 vaccines, particularly for children and teens who are behind on their immunizations. Seventy percent (70%) of parents were willing to vaccinate their teen with other vaccines at the same time as the COVID-19 vaccine.1
A survey by the Kaiser Family Foundation (KFF) conducted April 13 – 26, 2022, among a nationally representative random digit dial telephone sample of 1,889 adults ages 18 and older, found that most parents of adolescents ages 12 – 17 years say their child has been vaccinated (56%, which has been fairly steady since January).2
Results from another KFF survey, which was conducted February 9 – 21, 2022, among a nationally representative random digit dial telephone sample of 1,502 adults ages 18 and older, reported that among parents of children ages 5 – 11 years, who have been eligible for vaccination since October, about four in ten (39%) say their child has been vaccinated.3
Reflecting vaccine intentions among parents of children from different age groups, parents of adolescents express the most confidence in the safety of the vaccines for their children. Over half of parents say they are confident in the safety of COVID-19 vaccines for children ages 12 – 17 years (57%), many of whom have already been vaccinated.3
Additionally, adolescents were surveyed to gain a better perspective of potential factors that would increase vaccination intent. Potential factors of vaccine upsurge among adolescents encompass more information about safety (22%) and efficacy (18%), preventing the spread of COVID-19 to family and friends (17%) and resumption of or increase in social activities (16%) and traveling (15%).4
Is there important uncertainty about or variability in how much people value the main outcomes? Probably Important uncertainty or variability
Parents were asked of their willingness to have their teen get a COVID-19 vaccine and routine vaccines they may need at the same time. For those who selected no or not sure, a follow-up question was posed allowing parents to select any of the following reasons that explain their answer or provide a comment. The most common reasons for not doing so were that the teen was already up to date on vaccinations (62%) and concerns regarding safety with concomitant vaccination (38%).1
A survey by the Kaiser Family Foundation (KFF) conducted April 13 – 26, 2022, reported that about three in ten (31%) parents of adolescents say they will “definitely not” get their teen vaccinated and 4% say they will only do so if they are required.2
A large share of parents of children ages 5 – 11 years say they will either only get their child vaccinated if they are required for school (12%) or say their child will definitely not get the COVID-19 vaccine (32%).3
Reflecting vaccine intentions among parents of children from different age groups, fewer parents (46%) are confident in the safety of the vaccines for children ages 5 – 11 years, whereas 54% of parents say they are not confident in the safety of the vaccines for children ages 5 – 11 years.3

Acceptability

Criteria Work Group Judgements Evidence Additional Information
Is the intervention acceptable to key stakeholders? Yes
Pediatricians are the top trusted source for information about the COVID-19 vaccines for children among parents across community types, with around three-quarters of each group saying they trust their child’s pediatricians a great deal or a fair amount. While majorities of urban and suburban parents also trust their local health department and the CDC, rural parents are somewhat less trusting of some of these sources (50% trust their local public health department and 45% trust the CDC). Fewer parents say they trust their child’s school or daycare or other parents they know for reliable information on the COVID-19 vaccine for children.1
Moreover, around half of all parents across community types say their child’s school has provided them with information on how to get a COVID-19 vaccine for their child. However, smaller shares of rural parents say their child’s school has encouraged them to get their child vaccinated (36%) compared to parents in urban areas (50%). This difference may play an important role in vaccine uptake for children across communities, as parents whose children’s schools encouraged vaccination are more likely than those whose schools did not encourage vaccination to say their child was vaccinated for COVID-19.1
Jurisdictional immunization programs on implementation planning to administer COVID-19 vaccines to children entail a variety of strategies including:
  • Multi-pronged approach – Using a combination of the three below approaches, often staged over time.
  • Existing provider network – Reaching adolescents through an existing provider network, including mass vaccination and public health sites.
  • Pediatric providers and PCPs – Emphasis on reaching populations through activation of new pediatric providers and family doctors.
  • School-based clinics – Preparing school-based clinics and events to reach populations through temporary points of dispensing.2

As it pertains to parent-reported place of COVID-19 vaccination among children and adolescents from August 2021 – May 2022, based on results from the National Immunization Survey-Child COVID-19 Module, medical place and pharmacy were the highest reported places of COVID-19 vaccination among children ages 5 – 11 years and adolescents ages 12 – 17 years.3

Feasibility

Criteria Work Group Judgements Evidence Additional Information
Is the intervention feasible to implement? Yes The Moderna COVID-19 vaccine product (50 mcg) for children ages 6 – 11 years:
  • Ships at -20°C
  • Same cap color as product for children ages 6 months through 5 years (blue)
  • Different color border (purple)
  • Different concentration than adult primary series (25 µg/0.25mL)
  • Product labeled as “Booster dose, 18 years and older” authorized for use
  • Does not require diluent

The Moderna COVID-19 vaccine product (100 mcg) for adolescents ages 12 – 17 years:

  • Ships at -20°C
  • Red cap, light blue border
  • Same as product approved for adults
  • 0.5mL volume for primary series in individuals ≥12 years
  • 0.25mL volume for booster dose in adults ≥18 years
  • No new national drug code (NDC)
  • Does not require diluent1

Parents and their children can find a COVID-19 vaccine by:

  • Searching vaccines.gov online
  • Texting their ZIP code to 438829
  • Calling 1-800-232-0233 to find locations near them

Resource Use

Criteria Work Group Judgements Evidence Additional Information
Is the intervention a reasonable and efficient allocation of resources? Yes Studies in adults have shown COVID-19 related healthcare costs in the United States could be billions or trillions of dollars.1,2 Given this, COVID-19 vaccines overall are likely cost-saving.3,4,5 In a study conducted by Pfizer, they estimated that Pfizer-BioNTech COVID-19 vaccine use in individuals ages ≥12 years in 2021 averted 9 million symptomatic cases, almost 700,000 hospitalizations and over 110,00 deaths resulting in $30.4 billion direct healthcare cost savings.6 At this time, vaccines will be available at no cost to the recipient. Cost-effectiveness is not a primary driver for decision making during a pandemic but will be reassessed in the future.

Equity

Criteria Work Group Judgements Evidence Additional Information
What would be the impact of the intervention on health equity? Probably no impact
Looking at vaccination coverage and parental vaccination intent for children between the ages of 5 – 17 years, older children were significantly more likely to be vaccinated than younger children; and multiracial and Hispanic children were more likely to be vaccinated than Black or White children.1
In relation to the monthly percent of children ages 5 – 11 years with at least 1 COVID-19 vaccine dose, by race and ethnicity, other or multiple races had the highest percentage of children with at least 1 COVID-19 vaccine dose. Whereas, Black children had the lowest percentage, with 71.8% remaining unvaccinated as of April 30, 2022. As it pertains to adolescents ages 12 – 17 years, Hispanics had the highest percentage of adolescents with at least 1 COVID-19 vaccine dose. However, Black adolescents had the lowest percentage, with 40.2% remaining unvaccinated as of April 30, 2022.2
With respect to the monthly percent of children and adolescents ages 5 – 17 years with ≥1 COVID-19 vaccine dose by metropolitan statistical area, disparities are identified in vaccination coverage between those who reside in urban and suburban areas as compared with those who reside in rural areas. Potential drivers of this disparity consist of rural parents reporting lesser intent to vaccinate their children, lower vaccine safety confidence, and more than half of rural parents stating that getting their children vaccinated against COVID-19 would be a bigger risk to their children than COVID-19 infection.2
Communication resources for vaccine providers and partners include:
  • Website on vaccinating children with disabilities3
  • Updated quick conversation guide for talking with families4
  • Medscape commentary on routine pediatric and COVID-19 vaccination
  • Customizable materials that align with key messages
  • Updated information for schools to include content for childcare partners

Communication resources for parents and caregivers include:

Redesigned websites consisting of

COVID-19 Vaccines for Children and Teens

Frequently Asked Questions about COVID-19 Vaccination in Children

6 Things to Know About COVID-19 Vaccination for Children and Teens

  • short videos in development

New website content for COVID-19 Vaccination for Children with Disabilities

Culturally and linguistically appropriate materials including printable fact sheets , which are available in Amharic, Arabic, Chinese, English, French, Korean, Portuguese, Spanish and Vietnamese

Resources to promote the COVID-19 vaccine for children and teens involve:

  • Social Media Graphics and Posters: Age appropriate COVID-19 vaccine educational posters and social media graphics to use in exam rooms, waiting rooms, classrooms and on social media channels
  • Videos: View, share or embed videos on websites, use as PSAs, and post on social media
  • Fact sheets – Coming Soon: COVID-19 Vaccines for Children and Teens – What Parents and Caregivers Need to Know and COVID-19 Vaccination for Children and Teens (Information for families with lower health literacy)5

Work Group Interpretation Summary

The Work Group discussed each age group for the Moderna COVID-19 vaccine primary series compared to no vaccine. Two vaccine options may allow parents and providers a choice. The Moderna COVID-19 vaccine primary series in older children and adolescents met the non-inferiority endpoints, provide protection against symptomatic COVID-19 disease, and are expected to provide higher protection against severe disease. An interval of 8 weeks between dose 1 and dose 2 would likely improve both safety and effectiveness of the Moderna COVID-19 vaccine in older children and adolescents.

Since the beginning of the COVID-19 pandemic, among U.S. children ages 5–17 years, there have been over 10 million cases, over 45,000 hospitalizations and over 600 deaths. COVID-19 can cause severe disease and death among children, including children without underlying medical conditions. Future surges will continue to impact children, with unvaccinated children remaining at higher risk of severe outcomes. As with all other age groups, priority is vaccination of unvaccinated individuals. There are currently 25 million unvaccinated children and adolescents ages 5–11 and 12–17 years. Overall, the benefits outweigh risks for mRNA COVID-19 vaccines in all ages and receipt of a primary series continues to be the safest way to prevent serious COVID-19.

For more information, the Interim Clinical Considerations guidance for use of the Moderna COVID-19 vaccine primary series in children ages 6–11 years and adolescents ages 12–17 years is linked here: Interim Clinical Considerations for Use of COVID-19 Vaccines | CDC

Balance of consequences (Moderna COVID-19 vaccine in children ages 6–11 years, 2-doses, 50µg)

Desirable consequences clearly outweigh undesirable consequences in most settings

Is there sufficient information to move forward with a recommendation? Yes

Balance of consequences (Moderna COVID-19 vaccine in adolescents ages 12–17 years, 2-doses, 100µg)

Desirable consequences clearly outweigh undesirable consequences in most settings

Is there sufficient information to move forward with a recommendation? Yes

Policy options for ACIP consideration

ACIP recommends the intervention

Draft recommendation (text)

On June 23, 2022, ACIP voted (15-0) in favor of recommending:

A two-dose Moderna COVID-19 vaccine series (50µg) for children ages 6 – 11 years, under the EUA issued by FDA

On June 23, 2022, ACIP voted (15-0) in favor of recommending:

A two-dose Moderna COVID-19 vaccine series (100µg) for adolescents ages 12 – 17 years, under the EUA issued by FDA

Final deliberation and decision by ACIP

Final ACIP recommendation

ACIP recommends the intervention.

The Moderna COVID-19 vaccine is recommended for individuals ages 6 through 17 years of age under an Emergency Use Authorization.

References

Problem

  1. COVID Data Tracker, https://covid.cdc.gov/covid-data-tracker/#trends_dailytrendscases. Accessed 6/21/2022
  2. COVID Data Tracker, https://covid.cdc.gov/covid-data-tracker/#demographicsovertime. Accessed 6/16/2022
  3. CDC COVID Data Tracker. https://covid.cdc.gov/covid-data-tracker/#rates-by-vaccine-status Accessed May 20, 2022
  4. COVID-NET, https://gis.cdc.gov/grasp/COVIDNet/COVID19_3.html, accessed 6/20/22
  5. CDC COVID Data Tracker: COVID-NET Hospitalizations by Vaccination Status. Accessed June 20, 2022
  6. Delahoy MJ, Ujamaa D, Taylor CA, et al. Comparison of influenza and COVID-19-associated hospitalizations among children < 18 years old in the United States-FluSurv-NET (October-April 2017-2021) and COVID-NET (October 2020-September 2021). Clin Infect Dis. 2022 May 20:ciac388. doi: 10.1093/cid/ciac388.
  7. https://data.cdc.gov/NCHS/Provisional-COVID-19-Deaths-Counts-by-Age-in-Years/3apk-4u4f/data. Accessed 5/14/22
  8. CDC COVID Data Tracker. https://covid.cdc.gov/covid-data-tracker/#vaccination-demographics-trends Accessed June 20, 2022

Benefits and harms

  1. Food and Drug Administration. Moderna COVID-19 vaccine. https://www.fda.gov/media/159189/download
  2. Grading of Recommendations, Assessment, Development, and Evaluation (GRADE): Moderna 6-11 years
  3. Grading of Recommendations, Assessment, Development, and Evaluation (GRADE): Moderna 12-17 years
  4. Vasudeva et al. Am J Cardiology 2021 https://www.sciencedirect.com/science/article/pii/S0002914921002617

Values

  1. Middleman, A. B., et al. (2022). "Vaccine Hesitancy in the Time of COVID-19: Attitudes and Intentions of Teens and Parents Regarding the COVID-19 Vaccine." Vaccines 10(1): 4. https://doi.org/10.3390/vaccines10010004
  2. KFF COVID-19 Vaccine Monitor: April 2022. https://www.kff.org/coronavirus-covid-19/dashboard/kff-covid-19-vaccine-monitor-dashboard/#parents. Accessed May 4, 2022
  3. KFF COVID-19 Vaccine Monitor: February 2022. https://www.kff.org/coronavirus-covid-19/dashboard/kff-covid-19-vaccine-monitor-dashboard/#parents. Accessed May 4, 2022
  4. Scherer AM, Gedlinske AM, Parker AM, et al. Acceptability of Adolescent COVID-19 Vaccination Among Adolescents and Parents of Adolescents — United States, April 15–23, 2021. MMWR Morb Mortal Wkly Rep 2021;70:997–1003. DOI: http://dx.doi.org/10.15585/mmwr.mm7028e1

Acceptability

  1. KFF COVID-19 Vaccine Monitor: Winter Update on Parents' Views (November 8-23, 2021). https://www.kff.org/coronavirus-covid-19/poll-finding/kff-covid-19-vaccine-monitor-vaccine-attitudes-rural-suburban-urban/ Accessed March 7, 2022
  2. Jurisdiction data call survey – 05/03/21-05/06/21. n=46
  3. CDC unpublished data

Feasibility

  1. CDC. Updated Pediatric COVID-19 Vaccination Operational Planning Guide – Information for the COVID-19 Vaccine for Children 6 Months through 4 Years Old and/or COVID-19 Vaccine for Children 6 Months through 5 Years Old [9 pages]. Accessed June 1, 2022

Resource Use

  1. Bartsch et al https://www.healthaffairs.org/doi/full/10.1377/hlthaff.2020.00426
  2. Cutler and Summers. JAMA https://jamanetwork.com/journals/jama/fullarticle/2771764
  3. Bartsch et al. JID https://academic.oup.com/jid/article/224/6/938/6267841?login=true
  4. Kohli et al. Vaccine https://www.sciencedirect.com/science/article/pii/S0264410X2031690X
  5. Li et al. Int JID https://www.sciencedirect.com/science/article/pii/S1201971222001680
  6. Di Fusco et al Full article: Public health impact of the Pfizer-BioNTech COVID-19 vaccine (BNT162b2) in the first year of rollout in the United States (tandfonline.com)

Equity

  1. CDC COVID Data Tracker. Trends in COVID-19 Vaccine Confidence in the US. https://covid.cdc.gov/covid-data-tracker/#vaccine-confidence. Accessed May 20, 2022
  2. Estimates produced by NORC at the University of Chicago using CDC's National Immunization Survey-Adult COVID-19 Module (NIS-ACM). COVID-19 Vaccination Coverage and Vaccine Confidence Among Children | CDC. Accessed June 2, 2022.
  3. CDC. Vaccinating Children with Disabilities Against COVID-19 | CDC. Accessed June 21, 2022
  4. CDC. 6 Things to Know about COVID-19 Vaccination for Children.
  5. CDC. Vaccines and Immunizations. Accessed June 21, 2022

View the complete list of EtR Frameworks‎

List of Evidence to Recommendations Framework Tables
Print
Content Source:
National Center for Immunization and Respiratory Diseases (NCIRD)