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ACIP Evidence to Recommendations for Use of Pfizer-BioNTech COVID-19 Vaccine under an Emergency Use Authorization						Print
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										**Question:**Should Pfizer-BioNTech COVID-19 vaccine be recommended for persons 5-11 years of age in the U.S. under an Emergency Use Authorization?
Population: Persons 5-11 years of age
Intervention: Pfizer-BioNTech COVID-19 vaccine (10 *μ*g, 2 doses 21 days apart)
Comparison: No Pfizer-BioNTech COVID-19 vaccine
Critical and Important Outcomes:
Symptomatic laboratory-confirmed COVID-19
Hospitalization due to COVID-19
Multisystem Inflammatory Syndrome in Children (MIS-C)
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 46 million cases and approximately 745,000 COVID-19-associated deaths have been reported as of November 2, 2021. 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 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. Non-Hispanic Black, Hispanic/Latino and American Indian/American 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 October 29, 2021, the Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA) for Pfizer-BioNTech COVID-19 vaccine in persons aged 5-11 years for prevention of COVID-19. The vaccine was safe and met non-inferiority criteria for immunobridging compared with young adults ages 16-25 years in a randomized controlled clinical trial that included 2,268 participants randomized 2:1 to receive either vaccine or placebo.
Additional background information supporting the interim ACIP recommendation on the use of Pfizer-BioNTech COVID-19 vaccine can be found in the relevant publication of the recommendation referenced on the ACIP website.Problem
Problem
Criteria
Work Group Judgements
Evidence
Additional InformationIs the problem of public health importance?
Yes
COVID-19 is a major global public health threat that dramatically disrupted all sectors of society worldwide. In the United States, COVID-19 had important associated morbidity and mortality.
**Incidence:**
As of November 2, 2021, there were 46,024,349 cases of COVID-19 reported in the United States.1
As of November 2, 2021, there were >1.9 million SARS-CoV-2 infections reported among children 5-11 years of age in the United States.2
Children aged 5-11 years represent a growing proportion of new COVID-19 cases reported to CDC, accounting for 10.6% of infections for the week of October 10, 2021, although they represent 8.7% of the population.2
**Hospitalization:**
COVID-19 Associated Hospitalization Network (COVID-NET), a population-based surveillance system, reports a cumulative hospitalization rate among children aged 5-11 years of 53.7 per 100,000 population as of October 23, 2021.3
**Multisystem Inflammatory Syndrome in Children (MIS-C):** MIS-C is a serious hyperinflammatory syndrome occurring several weeks after acute SARS-CoV-2 infection. The condition often requires intensive care and can be fatal.4 As of October 4, 2021, CDC had received reports of 5,217 cases of MIS-C; 44% of MIS-C cases have occurred in children aged 5-11 years.5
**Mortality:**
As of October 16, 2021, there were 94 COVID-19-associated deaths among children 5-11 years of age reported to the National Center for Health Statistics.6
Children are at least as likely to be infected with SARS-CoV-2 as adults. There have been over 1.9 million reported cases and a study of residual sera from commercial laboratories in 15 states estimated the seroprevalence in this age group to be 38% as of September 2021. Additionally, children 5–11 years of age are at risk of severe illness from COVID-19. There have been >8,300 hospitalizations to date and cumulative hospitalization rates are similar to pre-pandemic influenza seasons. Severity is comparable among children hospitalized with influenza and COVID-19, with approximately one third of children 5–11 years of age requiring intensive care unit (ICU) admission. MIS-C is most frequent among children 5–11 years of age and other post-COVID conditions have been reported in children.7,8 Moreover, secondary transmission from children can and does occur in household and school settings. COVID-19 in children leads to missed school and other adverse outcomes for themselves and their communities.
COVID-19 associated hospitalizations and deaths are similar to or exceed the pre-vaccine-era burden of other vaccine preventable diseases, such as Hepatitis A9,10, Varicella11, Influenza,12,13, Meningococcal disease14 and Rubella15.
Modeling data from the COVID-19 Scenario Modeling Hub describes different scenarios looking at implementation of vaccination of children 5-11 years with and without new and more transmissible variants. Absent a new and more transmissible variant, childhood vaccination among 5–11-year-olds is expected to accelerate the decline in cases, reducing cumulative incidence nationally by an expected 8% (approximately 600,000 cases) from November 1, 2021 to March 12, 2022.16 In scenarios where a variant that is 50% more transmissible than Delta arises in mid-November 2021, childhood vaccination reduces cases by about 13% (nearly 1.2 million cases) over the same period.16Altogether, vaccination of 5–11-year-olds would dampen, but not eliminate a new variant emergence.16
For the 2020–2021 school year, an estimated total of 19,692 school closures occurred in 50 states, which affected approximately 12 million students. Between August 2 and October 22, 2021, at least 2,350 schools in the United States have faced COVID-19–related closures, with nearly half resulting from COVID-19 cases among students.17
There are numerous indirect impacts of the COVID-19 pandemic on children. Children have experienced worsening of mental and emotional health, widening of already existing education gaps by race/ethnicity, in which both are associated with virtual vs. in person instruction. Children have also experienced decreased physical activity and increased BMI, doubling in hospitalizations for new onset of type-2 diabetes mellitus, decreased health care utilization and routine immunizations, and an overall increase in adverse childhood experiences. Additionally, an estimated 140,000 children have lost a caregiver to COVID-19 with significant disparities by race/ethnicity,18,19,20,21,22,23,24,25.
Consideration of Disparities:
Children with certain medical conditions such as asthma, obesity, developmental delay, and cardiovascular disease are at increased risk for severe illness from COVID-19.26Approximately 32% of children 5–11 years hospitalized with COVID-19 have no underlying medical conditions.3Additionally, a disproportionate burden of SARS-CoV-2 infections, SARS-CoV-2 associated deaths and MIS-C cases have occurred among racial and ethnic minority communities.27,28,29Benefits and Harms
Benefits and Harms
Criteria
Work Group Judgements
Evidence
Additional InformationHow substantial are the desirable anticipated effects?
Large
Data from a Phase 2/3 randomized controlled trial conducted among children (>3,000) aged 5–11 years vaccinated with BNT162b2 illustrated that vaccine efficacy estimated 90.9% (95% CI: 68.3%, 98.3%) for prevention of symptomatic, laboratory confirmed COVID-19.1The geometric mean ratio (GMR) for antibodies in 5–11-year-olds compared with 16–25-year-olds was 1.04 (95% CI:0.93, 1.18), and met the noninferiority criteria.1The estimated benefits for every million Pfizer-BioNTech COVID-19 vaccinations given in children 5–11 years of age using recent incidence includes the prevention of approximately 57,000 COVID-19 cases, 200 hospitalizations, 130 MIS-C cases and between 60-72 ICU admissions.2 Additionally, the estimated benefits using pandemic-average benefits incidence entails the prevention of 18,549 COVID-19 cases, 80 hospitalizations, 42 MIS-C cases and 26 ICU admissions.2
The number of children aged 5-11 years needed to vaccinate to prevent one symptomatic COVID-19 case, hospitalization, and MIS-C case is 9, 2,213, and 3,777 respectively, based on epidemiology for the most recent peak (week ending on 9/11/21).3 Additionally, the number of children needed to vaccinate to prevent one COVID-19 case, hospitalization and MIS-C case based on epidemiology averaged for the pandemic (as of 10/24/21) is 26, 8,187 and 11,226 respectively.3
Overall, the benefits of Pfizer-BioNTech COVID-19 vaccine for children 5-11 years of age include the prevention of COVID-19 cases, likely prevention of hospitalizations, MIS-C and deaths, and post-COVID conditions, possible prevention of transmission and greater confidence in a safer return to school and social interactions.
Clinical trial data demonstrated Pfizer-BioNTech COVID-19 vaccine to be safe, immunogenic, and efficacious in children 5–11 years of age.How substantial are the undesirable anticipated effects?
Small
In relation to the theoretical risk of vaccine-associated myocarditis, identified rates of myocarditis reported previously are based on data from adults and adolescents receiving 30μg dose of Pfizer-BioNTech. The dose in the pediatric (5–11-year-old) age group is 10μg. Although a rare event, vaccine-associated myocarditis is most common in adolescent males aged 12-29 years.
Rates of myocarditis after vaccination in 5-11-year-olds is unknown. No cases occurred during clinical trials (>3,000 children with at least 7 days follow-up). Myocarditis after vaccination in the 5–11-year-old population is likely lower than rates seen in 12–15-year-olds. Underlying epidemiology of myocarditis prior to the COVID-19 pandemic varies greatly between children aged 5-11 and 12–17 years, as it is substantially lower in children 5–11 years of age. Also, doses used in 5–11-year-olds (10 μg) is a third of the dose used in 12-15-year-olds (30 μg).
Overall, the known risks of Pfizer-BioNTech COVID-19 vaccine for children 5–11 years of age include short-term reactogenicity and possible risks include myocarditis or other rare events after mRNA vaccines.
Serious adverse events (SAEs) were uncommon among vaccine and placebo recipients (0.07% vs. 0.1%).1 Furthermore, no SAEs were assessed to be related to vaccination and no deaths occurred.1Severe local reactions or systemic reactions were more common among vaccine than placebo recipients and were reported by 2.7% of vaccine recipients.1Do the desirable effects outweigh the undesirable effects?
Favors intervention (Pfizer-BioNTech COVID-19 vaccine)
Data from the Phase II/III clinical trial indicates approximately 9% of children enrolled were baseline SARS-CoV-2 seropositive. Post vaccination antibodies are higher in children who were baseline seropositive. Additionally, rates of local and systemic reactions, as well as adverse events, were lower in children who were baseline seropositive.
Data from U.S. studies show approximately 38% of children aged 5–11 years have evidence of prior SARS-CoV-2 infection based on seroprevalence estimates. Prior infection can result in protection against infection, but not 100% and likely decreases over time. Children have a greater proportion of asymptomatic infection relative to adults3,4,5,6, as asymptomatic infection can result in lower antibody levels than severe disease.
Delta-wave surges of pediatric COVID-19 hospitalizations occurred even with seroprevalence approximately 38%, suggesting acquired immunity alone is not sufficient to provide broad protection. There are limited data on rates of reinfection in children. Protection against asymptomatic or mild infection is still an important outcome in children. MIS-C typically occurs after asymptomatic or mild infection and post-COVID-sequelae can also occur after mild infection. There are no safety concerns about vaccinating seropositive individuals in the 5–11 age group and adults, as individuals 12–64 years recommended for vaccination have seropositivity >30% with no evidence of any elevated risks, and trial data were reassuring regarding safety and reactogenicity among children who were seropositive at baseline. Vaccine recommendations requiring serologic testing place unnecessary barriers and are very difficult to implement. While there is limited data to estimate the impact of vaccination of seropositive children, risks are minimal and resulting levels of protection are expected to be higher than those for seronegative children.
The balance of benefits and risks varies by incidence of COVID-19, with the largest benefits with higher incidence. Overall, the benefits outweigh the risks for the Pfizer-BioNTech COVID-19 vaccine in children 5–11 years of age.
The benefits outweigh risks, even with high current seropositivity rates. While a substantial proportion of children 5–11 years of age are seropositive, there is an unknown duration of protection for asymptomatic infection in children. Therefore, safety data is reassuring in the seropositive population.
The Work Group concluded that the desirable effects of the Pfizer-BioNTech COVID-19 vaccine outweigh the undesirable effects.What is the overall certainty of this evidence for the critical outcomes?
Effectiveness of the intervention is Level 1 (high certainty)
Safety of the intervention is Level 4 (very low certainty)
The level of certainty for the benefits of Pfizer-BioNTech COVID-19 vaccination among children aged 5–11 years was type 1 (high certainty) for the prevention of symptomatic laboratory-confirmed COVID-19. Regarding potential harms after vaccination, evidence was type 4 (very low certainty) for serious adverse events and type 2 (moderate certainty) for reactogenicity.Values

Values
Criteria
Work Group Judgements
Evidence
Additional InformationDoes the target population feel that the desirable effects are large relative to undesirable effects?
Moderate
Several surveys suggested 34%-57% of parents were willing to have their children vaccinated.1-6 Furthermore, 90% of parents who were ‘very worried’ their child would get COVID-19 reported intent to vaccinate their child, compared to 7% of parents ‘not worried at all.’5 Additionally, 82% of fully vaccinated parents reported intent to vaccinate their child, compared to 1% of parents who are unvaccinated or do not plan to get vaccinated.5Among parents of teens who discussed vaccination with their pediatrician, three-quarters (75%) of those whose pediatrician recommended vaccination say their child received at least one dose.6
Knowledge and attitudes may change with time, and intentions may not reflect uptake. The survey sample populations may not be representative, limiting the generalizability of the results to all children in the U.S. Most surveys used convenience sampling, had limited representation of minority populations, and had low or unknown response rates.
The Work Group determined that the desirable effects clearly outweighed any undesirable effects in most settings.Is there important uncertainty about or variability in how much people value the main outcomes?
Probably important uncertainty or variability
Among parents, intent to vaccinate their children varied by age and race or ethnicity. Positive intent trended with age, with more parents planning to vaccinate their older children.1Furthermore, intent to vaccinate children by race is similar to overall intent to get vaccinated in adults by race, with highest positive intent in non-Hispanic Asian parents and lowest among non-Hispanic Black parents.1In a survey conducted in September 2021 of 1,000 U.S. parents of children aged 5-11, 57% of parents surveyed stated they would “definitely” (35%) or “probably” (22%) get their child vaccinated; however, safety concerns were the predominant reasons selected by parents to explain their pediatric vaccine hesitancy.4 Additionally, 37% of parents reported side effects as the primary reason for not wanting a COVID-19 vaccine for their child.4Acceptability
Acceptability
Criteria
Work Group Judgements
Evidence
Additional InformationIs the intervention acceptable to key stakeholders?
Yes
Pandemic vaccination response planning requires collaboration among a wide range of public-and private-sector partners and most jurisdictions plan to utilize a variety of implementation strategies to vaccinate children 5-11 years. As of October 15, over 70% of Vaccine for Children providers were enrolled as COVID-19 providers. According to an American Academy of Pediatrics (AAP) Pediatrician Life and Career Experience Study (PLACES) survey, 75% of pediatricians in primary care reported that their main work setting is enrolled as a COVID-19 provider with their state and 70% have started giving the vaccine to 12–18-year-old patients.1Furthermore, parents expressed the greatest comfort level with having their children receive a COVID-19 vaccine in their primary care provider’s office and jurisdictions anticipate most children will be vaccinated at their pediatric provider’s office.Resource Use
Resource Use
Criteria
Work Group Judgements
Evidence
Additional InformationIs the intervention a reasonable and efficient allocation of resources?
Yes
The U.S. government has purchased enough vaccines to support vaccination of the pediatric population of children 5-11 years of age.1 These doses are available at no cost to the recipient.
The use of COVID-19 vaccines in as many populations as possible will be important to preventing school closures, given their wide-ranging harmful consequences, particularly to the most vulnerable children and families; and returning to pre-pandemic activities, as a return to pre-pandemic activities will likely have a positive economic impact.
The Work Group concluded that cost-effectiveness may not be a primary driver for decision-making on this policy question. In addition, no published cost-effectiveness analyses with COVID-19 vaccines and children were available at the time of this decision.Equity
Equity
Criteria
Work Group Judgements
Evidence
Additional InformationWhat would be the impact of the intervention on health equity?
Varies
Several groups of children were identified as being at increased risk for disproportionate COVID-19 morbidity and mortality or in access to healthcare.
Additional insight into possible inequities was obtained by examining COVID-19 vaccination coverage among adolescents 4 months after ACIP recommendations for this age group. Based on results from the National Immunization Survey in September 2021, analyzing COVID-19 vaccination receipt and intent among parents of adolescents aged 13-17 years, 9.2% of parents stated they definitely planned to get their adolescent vaccinated but have yet to do so.2 This group represents unactualized vaccinations and are concerning for access or behavioral barriers. This rate is higher than what we see in adults (2.2%). Further analysis by race/ethnicity, shows this is highest among adolescents who are Black/non-Hispanic (nearly 20%).2
Additionally, analyzing differences in coverage and intent by social vulnerability index, poverty level, and rural/suburban/urban areas, shows higher unrealized intent among those with a high social vulnerability index and those with a family income of <$75,000.2
Application of the PROGRESS-Plus Framework1 assisted in the identification of factors that could be associated with inequities in COVID-19 incidence, morbidity, mortality, or access to COVID-19 vaccination.
Nearly 5 months after adolescent vaccine roll out there remains unrealized intent for adolescent COVID-19 vaccinations with the largest among adolescents living in poverty and rural areas. CDC and public health partners must redouble efforts for equitable access for COVID-19 vaccinations and consider strategies to improve access, including vaccinations delivered in schools.
Utilizing a multi-pronged approach for vaccination and incorporating lessons learned from the adolescent vaccine rollout will provide opportunities for increasing equitable access to the Pfizer-BioNTech COVID-19 vaccine. The first prong of the approach entails relying on trusted providers in the medical home. Since May, there have been increasing numbers of Vaccine for Children (VFC) providers enrolled as COVID-19 providers, the minimum order size has decreased from 450 to 100 doses and there has been progress in plans for redistribution at the jurisdiction level, all of which should help to get more vaccines to pediatric health care provider (HCP) offices. Secondly, school-located vaccination (SLV) clinics have the potential to reduce barriers to families to have their children vaccinated. The CDC, US Department of Education and pharmacy partners are working together to increase technical assistance and targeted partnerships to schools. The third prong is through the broad reach of pharmacies, which has been successful in vaccinating adolescents, with more than half of adolescents who have been vaccinated receiving their vaccine through a pharmacy.Feasibility
Feasibility
Criteria
Work Group Judgements
Evidence
Additional InformationIs the intervention feasible to implement?
Yes
Health departments and health systems have made tremendous effort in rapidly implementing a national COVID-19 vaccination program, which already provides vaccines to adolescents aged 16-17 years. Building on lessons learned from implementation of adult vaccination can improve implementation for adolescents.
The goal of the pediatric COVID-19 vaccination implementation program will be to:
Enable access to and availability of vaccine providers where populations are most likely to seek vaccination
Ensure programming to ensure access to the vaccine for vulnerable and underserved pediatric populations
Of note, based on census estimates, there are approximately 28.7 million children 5 – 11 years of age in the United States.1
Importantly, the 5–11-year Pfizer-BioNTech COVID-19 vaccine is a new formulation, different from the adult/adolescent formulation, which may lead to possible administration errors. The pediatric formulation consists of a different vial, different dose, and different volume. The 5–11-year 10μg formulation will come in an orange cap vial with an orange label. The CDC and Pfizer have developed numerous guides and education materials; and provider education is needed. Fortunately, the new formulation can be stored at refrigerator temperature (2-8oC) for up to 10 weeks prior to use. However, there is a 100-dose minimum order size, which could limit the availability of Pfizer-BioNTech COVID-19 vaccine for children.2
Considerations to enable providers to use dose packs effectively include:
Encouraging vaccination clinic days
Encouraging expansion of office hours to increase access to the vaccine
Innovative solutions have been employed to overcome barriers to implementation in the adult population. A multipronged approach to adolescent vaccine including utilizing primary care providers, leveraging the broad pharmacy footprint, and partnerships with school-located vaccination clinics in communities could provide equitable access and rapid vaccination of adolescents prior to the start of the school year in the fall of 2021.
The Community Preventive Services Taskforce recommends a combination of community-based interventions to increase vaccination rates among children including family incentive rewards.3 Additionally, universal interventions to reach the majority of children and targeted interventions more likely to reach nonwhite children have been successful in closing gaps in vaccination coverage.4 Furthermore, in June 2021, CDC awarded $2.25 billion in assistance funding to 108 state and local recipients to support such interventions.5Balance of consequences
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: ACIP and CDC recommendations
Pfizer-BioNTech COVID-19 vaccine is recommended for prevention of coronavirus disease (COVID-19) for persons 5-11 years of age in the U.S. under an Emergency Use Authorization.
Final deliberation and decision by the ACIP
Final ACIP recommendation
ACIP recommends the intervention.
**The Pfizer-BioNTech COVID-19 vaccine is recommended for persons 5-11 years of age in the U.S. population under the FDA’s Emergency Use Authorization.**
* Serious adverse events defined as any untoward medical occurrence that results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, or is a congenital anomaly/birth defect.References
Problem:
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Unpublished data from the CDC, the University of Iowa, and RAND Corporation Survey of Parents, September 2021
Gallup Panel Poll. Available at https://news.gallup.com/poll/354998/covid-vaccine-young-child.aspx. Accessed September 29, 2021
Lopes L, et al. KFF COVID-19 Vaccine Monitor: Vaccination Trends Among Children And COVID-19 In Schools. Available at: https://www.kff.org/coronavirus-covid-19/poll-finding/kff-covid-19-vaccine-monitor-trends-among-children-school/ Accessed: October 1, 2021Acceptability:
AAP News. Survey: Pediatricians expect COVID-19 vaccine hesitancy among parents. October 1, 2021. https://www.aappublications.org/news/2021/10/01/researchupdate100121Resource Use
Pediatric COVID-19 Vaccination Operational Planning Guide. www.cdc.gov/vaccines/covid-19/downloads/Pediatric-Planning-Guide.pdfEquity:
O’Neill J, Tabish H, Welch V, et al.  Applying an equity lens to interventions: using PROGRESS ensures consideration of socially stratifying factors to illuminate inequities in health. J Clin Epi. 2014;67: 56-64; ​ Welch VA, Akl EA, Guyatt G, et al. GRADE equity guidelines 1: considering health equity in GRADE guideline development: introduction and rationale. J Clin Epidemiol. 2017;90:59-67.
Unpublished Data from the CDC, National Immunization Survey, August 29 – September 25, 2021Feasibility:
U.S. Census Bureau, Population Division, 2020 Demographic Analysis
Source: Jurisdiction data call survey – 09/27/21. n=58.
The Community Guide. Increasing Appropriate Vaccination. Source: https://www.thecommunityguide.org/topic/vaccination?page=1.
Hutchins, S. S., et al. (2004). “Elimination of measles and of disparities in measles childhood vaccine coverage among racial and ethnic minority populations in the United States.” The Journal of infectious diseases 189 Suppl 1: S146-152.
CDC. National Initiative to Address COVID-19 Health Disparities Among Populations at High-Risk and Underserved, Including Racial and Ethnic Minority Populations and Rural Communities. Source: www.cdc.gov/publichealthgateway/partnerships/COVID-19-Health-Disparities-OT21-2103.html.Top of Page
							
					
							Last Reviewed:  November 5, 2021						Source: 	National Center for Immunization and Respiratory Diseases
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