ACIP Evidence to Recommendations for Use of Pfizer-BioNTech COVID-19 Vaccine under an Emergency Use Authorization

At a glance

  • Pfizer-BioNTech COVID-19 vaccine is recommended for prevention of coronavirus disease (COVID-19) for persons 12-15 years of age in the U.S. under an Emergency Use Authorization.

Summary

Question: Should Pfizer-BioNTech COVID-19 vaccine be recommended for persons 12-15 years of age in the U.S. under an Emergency Use Authorization?

Population: Persons 12-15 years of age

Intervention: Pfizer-BioNTech COVID-19 vaccine (30 μg, 2 doses 21 days apart)

Comparison: No Pfizer-BioNTech COVID-19 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 32.6 million cases and approximately 580,000 COVID-19-associated deaths have been reported as of May 12, 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, 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 adolescents. 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 May 10, 2021, the Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA) for Pfizer-BioNTech COVID-19 vaccine in persons aged 12-15 years for prevention of COVID-19. The vaccine was safe and highly effective in a randomized controlled clinical trial that included 2,264 participants randomized 1:1 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

Criteria Work Group Judgements Evidence Additional Information
Is 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 May 10, 2021, there were 1,606,199 SARS-CoV-2 infections reported among adolescents 12-17 years of age in the United States.1
During April 2021, children 12-17 years comprised 9% of total SARS-CoV-2 infections reported in the United States1.
Hospitalization:
COVID-19 Associated Hospitalization Network (COVID-NET), a population-based surveillance system, reports a cumulative hospitalization rate among adolescents aged 12-17 years of 53.1 per 100,000 population as of May 1, 2021, indicating over 13,000 SARS-CoV-2 associated hospitalizations for this age group.2
Multisystem Inflammatory Syndrome in Children (MIS-C): MIS-C is a serious hyperinflammatory condition occurring 2-6 weeks after acute SARS-CoV-2 infection. The condition often requires intensive care and can be fatal.3 As of March 29, 2021, 3,185 cases of MIS-C have been reported to CDC, with a median age of 9 years; 21% of cases occurred in adolescents 12-17 years.4
Mortality:
As of May 10, 2021, there were 127 COVID-19-associated deaths among children and adolescents 12-17 years of age, which was 1.3% of all reported deaths among this age group.5
 Consideration of Disparities:
Adolescents with certain medical conditions such as obesity, diabetes, or medical complexity are at increased risk for severe illness from COVID-19.6 Approximately 50%-60% of adolescents 12-17 years hospitalized with COVID-19 have an underlying condition.2,7
Additionally, 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.5, 8, 9

Benefits and Harms

Criteria Work Group Judgements Evidence Additional Information
How substantial are the desirable anticipated effects? Large
Risk of symptomatic COVID-19 was reduced among persons aged 12-15 years who received two doses of the Pfizer-BioNTech COVID-19 vaccine rather than placebo (GRADE table 4).
The clinical trial for the Pfizer-BioNTech COVID-19 vaccine demonstrated very high efficacy of the 2-dose regimen against symptomatic, laboratory-confirmed COVID-19.1,2 The overall efficacy* was 100% (95% Confidence Interval [CI]: 75.3%, 100%).
Immunobridging data comparing geometric mean antibody titers (GMT) in 12-15-year-olds to those in 16-25 year-olds, for whom clinical efficacy was previously established, were provided in support of efficacy. The geometric mean ratio (GMR) for antibodies in 12–15-year-olds compared to 16–25-year-olds was 1.76 (95% CI:1.47, 2.10), and met the noninferiority criteria. Efficacy was assessed a median of 2 months after receipt of the second dose.
 Direct evidence of efficacy against severe outcomes is not expected from early results from phase 3 studies. Vaccine efficacy in preventing hospitalizations and MIS-C may be inferred from observed high efficacy against symptomatic COVID-19.
How substantial are the undesirable anticipated effects? Small
Risk of serious adverse events was low but slightly more common in the vaccine than the placebo group. Grade 3 reactogenicity was increased among persons receiving 2 doses of the Pfizer-BioNTech COVID-19 vaccine rather than placebo (GRADE table 4).
Solicited injection-site reactions and systemic events within 7 days after vaccination were frequent and mostly mild to moderate. Injection-site reactions were reported by 91% of participants; the most frequent symptom was pain. The most common solicited systemic reactions were fatigue (78%), headache (76%), chills (49%), muscle pain (42%), fever (24%), and joint pain (20%). Systemic reactions were generally more frequent and severe after dose 2 compared with dose 1. Median onset of systemic reactions was 1 to 4 days post-vaccine receipt and they resolved in a median duration of 1 to 2 days. Among reported unsolicited adverse events, lymphadenopathy occurred more frequently in the vaccine group than the placebo group and is plausibly related to vaccination.
Severe adverse reactions (grade ≥3, defined as interfering with daily activity) occurred more commonly with the vaccine (10.7%) compared with placebo (1.9%). The most common grade 3 symptoms reported by vaccine recipients were fatigue (3.5%), fever (3.0%), headache (2.7%), chills (2.1%), and injection site pain (1.5%). Generally, grade ≥3 reactions were more commonly reported after the second dose than after the first dose.
Adverse events classified as serious† were reported in more recipients of vaccine than placebo, overall (0.4% vs. 0.2%) and by system organ class; they represented medical events that occur in the general population at a frequency similar to that observed in the study. No specific safety concerns were identified.
 Safety data showed an acceptable safety profile.1,2
Post-marketing surveillance will be critical to detect any rare serious adverse events which were not identified in the clinical trial.
Do the desirable effects outweigh the undesirable effects? Favors intervention The Work Group decided 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)
Safety of the intervention is Level 4 (Very Low)		 For the critical outcomes, the certainty of evidence was High for prevention of symptomatic COVID-19, and Very Low for serious adverse events. For important outcomes the certainty of evidence was 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? Probably yes
In 32 national surveys among U.S. adults conducted between December 2020 and April 2021, acceptability was moderate overall. The proportion intending to receive the COVID-19 vaccine ranged between 47%-84% across the surveys.1
In surveys focusing on parent intent to get their children vaccinated, the proportion reporting positive intentions ranged from 46%-60%.2,3,4,5,6,7,8 Reasons for not intending to vaccinate their children included concerns about safety of the vaccine, concerns about speed of vaccine development, not trusting the vaccine or information about the vaccine, and not having enough information.3
Parents reported similar or slightly lower intent to vaccinate their children compared to intent to vaccinate themselves.7,8
A survey of parents and adolescents conducted in April 2021 reported that 52% of adolescents definitely or probably intended to be vaccinated (CDC unpublished data).
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 parents or adolescents in the U.S. Information available on adolescent intent to be vaccinated was limited to one survey. Most surveys used convenience sampling, had limited representation of minority populations (and 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 gender, race or ethnicity and socioeconomic status of respondents.4,6,7,8 Mothers were less willing to vaccinate their children than fathers, and younger mothers were less willing to vaccinate their children than older mothers.4,7 Intent to vaccinate children by race is similar to overall intent to get vaccinated in adults by race. Intent to vaccinate their children was lowest among Black respondents, highest among Asian respondents, and greater with higher socioeconomic status.6,8

Acceptability

Criteria Work Group Judgements Evidence Additional Information
Is the intervention acceptable to key stakehold-ers? Yes
Pandemic vaccination response planning requires collaboration among a wide range of public- and private-sector partners.  A survey of jurisdictional immunization programs indicate that they plan to use existing provider networks, pediatric providers, and school-located clinics to implement COVID-19 vaccine to adolescents (CDC unpublished data).
In a survey of family physicians, pediatricians, and general internal medicine physicians conducted from October to December 2020, physicians reported being willing to administer COVID-19 vaccine in their practices, with only 2%-3% reporting they were “not at all willing”.1 Physicians reported the largest perceived barrier to vaccinating was parent/patient concern about safety of COVID-19 vaccine.

Resource Use

Criteria Work Group Judgements Evidence Additional Information
Is the intervention a reasonable and efficient allocation of resources? Yes
The work group reviewed estimates of economic costs related to COVID-19 vaccinations, disease outcomes, and disease mitigation activities.
Relative to other vaccines, the costs of vaccine doses are likely to be low for traditional payer systems such as private insurance, Medicare and Medicaid because the U.S. Government has committed to providing free COVID-19 vaccines.1 While COVID-19 vaccines may be provided by the U.S. government, the costs of vaccine administration may be incurred by traditional payer systems. Vaccine administration fees range from $16.94 to $28.39 per dose in some Medicare programs2 and average $27.86 per dose in the private sector.3 Outside the traditional health care sector, the US government has committed $10 billion for the provision of vaccines.4
An effective vaccine combined with a successful vaccination program could potentially offset portions of the estimated costs associated with COVID-19 disease outcomes and other COVID-19 mitigation activities. If 20% of the U.S. population were to become infected with SARS-CoV-2, the direct medical costs could be $163 billion.5 Health-related costs (including premature deaths, long-term health impairment, and mental health impairment) have been estimated at $8.5 trillion and lost economic productivity has been estimated at $7.6 trillion.6
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 were available at the time of this decision. It is also likely that a precise estimate of cost-effectiveness and economic impact of vaccination would depend on a number of factors that remain unknown, such as: duration of protection; vaccination coverage levels; and implementation costs associated with a large vaccination program.
Vaccinations occurring prior to an increase in incidence are likely to avert more infections and deaths than vaccinations that occur during or after an increase in incidence.7

Equity

Criteria Work Group Judgements Evidence Additional Information
What would be the impact of the intervention on health equity? Probably increased
Among adolescents several groups were identified as being at increased risk for disproportionate COVID-19 morbidity and mortality.
Analysis of demographic and social vulnerability data for COVID-19 vaccination coverage among U.S. adults indicated areas of potential concern for ensuring equitable COVID-19 vaccine access among adolescents. As of May 5, 2021, a smaller percentage of Black and Hispanic persons were fully or partially vaccinated relative to their percentage of the U.S. population.1 During the first 2.5 months of the U.S. vaccination program, counties with high social vulnerability had lower COVID-19 vaccination coverage than those with low social vulnerability; disparities in vaccination coverage were observed in most states.2
Pfizer-BioNTech has submitted data to FDA supporting the stability of their COVID-19 vaccine when stored for up to one month (31 days) at 2°-8°C (standard refrigerator temperature). This alternative to storage in an ultra-low temperature freezer, coupled with the anticipated availability of smaller vaccine dose packs and plans for local redistribution, should allow for expanded access to the Pfizer-BioNTech vaccine and provide vaccination centers greater flexibility. The requirement for a 2-dose series will make follow-up challenging for some underserved groups such as those who are homeless, live in rural locations, are justice-involved, disabled, or have no/limited access to healthcare.
Application of the PROGRESS-Plus Framework3,4 assisted in the identification of factors that could be associated with inequities in COVID-19 incidence, morbidity, mortality, or access to COVID-19 vaccination.
CDC case-based surveillance data and other studies of adolescent age groups have reported racial and ethnic disparities in COVID-19 infections and deaths. Non-Hispanic Black, Hispanic/Latino and American Indian (AI)/American Native (AN) persons have experienced higher rates of COVID-19-related disease, hospitalization, and death compared with non-Hispanic Whites.5-7 For example, an analysis of population-based surveillance data during March-July 2020 among children and adolescents aged 5-17 years, found that cumulative COVID-19-associated hospitalization rates among Hispanic and Black children were approximately seven and four times higher, respectively, the rate in White children.7 Although Hispanic, Black, and AI/AN persons represent 41% of the U.S. population aged <21 years, these groups accounted for approximately 75% of deaths in persons aged <21 years during February 12-July 31, 2020.6

Among adults, people working in subsets of essential industries; people living in poverty or with high social vulnerability; people residing in rural areas and in congregate settings such as corrections/detention facilities, homeless shelters, and group homes; people with disabilities; and people with substance abuse disorders, are disproportionately affected by COVID-19 morbidity and mortality.8 Adolescent-specific data are not available for most of these groups. However, the Work Group supported the view that evidence for adults is likely broadly generalizable to adolescents. Unfair differences in COVID-19 disease burden for many adolescents, similar to adults, often stem from multiple factors that compound health inequity.9,10 Many of the social inequities that contribute to disproportionate COVID-associated morbidity and mortality in parents or other adults would be expected to extend to adolescents in a shared household.6,11

Many of these same groups (e.g., racial/ethnic minority groups,12 adolescents experiencing homelessness,13 adolescents with substance use,14 adolescents with disabilities,15 and sexual and gender minorities16) also face barriers to routine care, that may lead to disparities in access to COVID-19 vaccines.

The judgment of a plurality of Work Group members was that the Pfizer-BioNTech COVID-19 vaccine would probably increase health equity. Nearly an equal number thought the Pfizer-BioNTech COVID-19 vaccine would increase equity. The judgements of the remaining Work Group members were nearly equally distributed among the five other judgment options. The range of judgments reflected concerns about current cold chain requirements for the Pfizer-BioNTech COVID-19 vaccine and current large minimum order sizes which could reduce access to adolescents who bear a disproportionate burden of COVID-19-related disease. The differing judgements also indicated concerns about observed disparities in COVID-19 vaccine coverage.
To help ensure that inequities are reduced whenever possible and are not increased, the Work Group noted the critical importance of focused outreach and education tailored to adolescents, particularly those who experience inequities in the social determinants of health; identification and resolution of barriers to vaccination; and active follow-up to ensure completion of a 2-dose vaccination series. Although Pfizer-BioNTech COVID-19 vaccine will be provided at no cost, personal and parental/guardian investments in time and travel to obtain vaccine may be a barrier for some adolescents disproportionally affected by COVID-19.

Feasibility

Criteria Work Group Judgements Evidence Additional Information
Is 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 vaccine to adolescents aged 16-17 years. Building on lessons learned from implementation of adult vaccination can improve implementation for adolescents.
Remaining implementation challenges include current cold-chain storage requirements and packaging sizes, which may limit the availability of Pfizer-BioNTech COVID-19 vaccine, particularly to primary care providers and rural or other hard-to-reach areas. As of May 2021, the Pfizer-BioNTech COVID-19 vaccine will be the only vaccine available to adolescents 12-17 years of age, which may require allocation and prioritization for adolescents.
Other challenges for program implementation include that vaccination requires a two-dose series and that states may have varying requirements for consent/assent.
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.

Balance 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 (text)

Pfizer-BioNTech COVID-19 vaccine is recommended for prevention of coronavirus disease (COVID-19) for persons 12-15 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 12-15 years of age in the U.S. population under the FDA’s Emergency Use Authorization.

*Overall efficacy was calculated at >7 days after the second dose among persons without evidence of prior SARS-CoV-2 infection

† 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:

  1. COVID Data Tracker. Atlanta, GA: US Department of Health and Human Services, CDC; 2020. https://covid.cdc.gov/covid-data-tracker. Accessed: May 10, 2021
  2. COVID-NET A Weekly Summary of U.S. COVID-19 Hospitalization Data, Preliminary Cumulative Rates. Atlanta, GA: US Department of Health and Human Services, CDC; 2020. https://gis.cdc.gov/grasp/COVIDNet/COVID19_3.html. Accessed: May 8, 2021.
  3. Feldstein LR, Tenforde MW, Friedman KG, et al. Characteristics and Outcomes of US Children and Adolescents with Multisystem Inflammatory Syndrome in Children (MIS-C) Compared with Severe Acute COVID-19. JAMA. 2021;325(11):1074-1087. DOI:10.1001/jama.2021.2091
  4. Health Department-Reported Cases of Multisystem Inflammatory Syndrome in Children (MIS-C) in the United States. Atlanta, GA: US Department of Health and Human Services, CDC; 2020. Accessed: May 14, 2021.
  5. COVID-19 Death Data and Resources. Atlanta, GA: US Department of Health and Human Services, CDC; 2020. www.cdc.gov/nchs/nvss/covid-19.htm. Accessed: May 8, 2021.
  6. People with Certain Medical Conditions. Atlanta, GA: US Department of Health and Human Services, CDC; 2020. . Accessed: May 8, 2021.
  7. Preston LE, Chevinsky JR, Kompaniyets L, et al. Characteristics and Disease Severity of US Children and Adolescents Diagnosed With COVID-19. JAMA Netw Open. 2021;4(4):e215298. Published 2021 Apr 1. DOI:10.1001/jamanetworkopen.2021.5298
  8. Van Dyke ME, Mendoza MCB, Li W, et al. Racial and Ethnic Disparities in COVID-19 Incidence by Age, Sex, and Period Among Persons Aged <25 Years – 16 U.S. Jurisdictions, January 1-December 31, 2020. MMWR Morb Mortal Wkly Rep. 2021;70(11):382-388. Published 2021 Mar 19. DOI:10.15585/mmwr.mm7011e1
  9. Bixler D, Miller AD, Mattison CP, et al. SARS-CoV-2–Associated Deaths Among Persons Aged <21 Years — United States, February 12–July 31, 2020. MMWR Morb Mortal Wkly Rep 2020;69:1324–1329. DOI:15585/mmwr.mm6937e4

Benefits and harms:

  1. Food and Drug Administration. Pfizer-BioNTech COVID-19 vaccine. https://www.fda.gov/media/144412/download. Accessed May 10, 2021.
  2. GRADE.

Values:

  1. Oliver SE. Evidence to recommendation framework. Presentation to ACIP. May 12, 2021.
  2. Axios/Ipsos poll. April 6, 2021. https://www.axios.com/adults-say-yes-to-the-vaccine-for-themselves-not-their-kids-a59af424-c312-4bcb-b4b2-94f3b88ec3ac.html
  3. Axios/Ipsos poll. April 19, 2021. Axios/Ipsos Poll – Wave 44 Topline and Methodology.
  4. Calarco, J. M.and E. M. Anderson. "I'm Not Gonna Put That on My Kids": Gendered Opposition to New Public Health Initiatives. SocArXiv, 18 Mar. 2021, doi:10.31235/osf.io/tv8zw.
  5. March 2, 2021. https://www.webmd.com/vaccines/covid-19-vaccine/news/20210302/webmd-survey-many-parents-back-kid-teacher-covid-shots
  6. National Parents Union Survey. January 2021. https://mercuryllc.app.box.com/s/ndrxnws68jcp04mvg057pmcjdk3nmwhq
  7. Simonson M, Baum M, Lazer D, et al. The COVID States Project #45: Vaccine hesitancy and resistance among parents. OSF Preprints, 19 Mar. 2021. https://doi.org/10.31219/osf.io/e95bc
  8. Parents Together. March 31, 2021. https://parents-together.org/wp-content/uploads/2021/03/PT-Brief_-Parental-Attitudes-about-COVID-19-Vaccine.pdf

Acceptability:

  1. Kempe A, et al. Primary Care Physicians' Willingness and Capacity to Contribute to COVID-19 Vaccine Delivery. Unpublished.

Resource use:

  1. Centers for Medicare & Medicaid Services. https://www.cms.gov/covidvax-provider. Accessed December 2, 2020.
  2. Source: https://www.cms.gov/newsroom/press-releases/trump-administration-acts-ensure-coverage-life-saving-covid-19-vaccines-therapeutics
  3. Tsai Y, Zhou F, Lindley MC. Insurance reimbursements for routinely recommended adult vaccines in the private sector" Am J Prev Med 2019;57:180-190. DOI: 10.1016/j.amepre.2019.03.011.
  4. Source: https://www.hhs.gov/about/news/2020/05/15/trump-administration-announces-framework-and-leadership-for-operation-warp-speed.html
  5. Bartsch SM, Ferguson MC, McKinnell JA. The potential health care costs and resource use associated with COVID-19 in the United States. Health Aff. 2020:39:927-35. DOI: 10.1377/hlthaff.2020.00426.
  6. Cutler DM and Summers LH. 2020. The COVID-19 pandemic and the $16 trillion virus. JAMA. 2020;324:1495-6. DOI: 10.1001/jama.2020.19759.
  7. Biggerstaff M. Modeling strategies for the initial allocation of SARS-CoV-2 vaccines. Presentation to ACIP. October 30, 2020.

Equity:

  1. COVID Data Tracker. Atlanta, GA: US Department of Health and Human Services, CDC; 2020. https://covid.cdc.gov/covid-data-tracker. Accessed: May 10, 2021
  2. COVID-NET A Weekly Summary of U.S. COVID-19 Hospitalization Data, Preliminary Cumulative Rates. Atlanta, GA: US Department of Health and Human Services, CDC; 2020. https://gis.cdc.gov/grasp/COVIDNet/COVID19_3.html. Accessed: May 8, 2021.
  3. Feldstein LR, Tenforde MW, Friedman KG, et al. Characteristics and Outcomes of US Children and Adolescents with Multisystem Inflammatory Syndrome in Children (MIS-C) Compared with Severe Acute COVID-19. JAMA. 2021;325(11):1074-1087. DOI:10.1001/jama.2021.2091
  4. Health Department-Reported Cases of Multisystem Inflammatory Syndrome in Children (MIS-C) in the United States. Atlanta, GA: US Department of Health and Human Services, CDC; 2020. Accessed: May 14, 2021.
  5. COVID-19 Death Data and Resources. Atlanta, GA: US Department of Health and Human Services, CDC; 2020. Accessed: May 8, 2021.
  6. Bixler D, Miller AD, Mattison CP, et al. SARS-CoV-2–associated deaths among persons aged <21 Years — United States, February 12–July 31, 2020. MMWR Morb Mortal Wkly Rep 2020;69:1324–1329. DOI: https://dx.doi.org/10.15585/mmwr.mm6937e4.
  7. Kim L, Whitaker M, O'Halloran A, et al. Hospitalization rates and characteristics of children aged <18 years hospitalized with laboratory-confirmed COVID-19 — COVID-NET, 14 states, March 1–July 25, 2020. MMWR Morb Mortal Wkly Rep 2020;69:1081–1088. DOI: https://dx.doi.org/10.15585/mmwr.mm6932e3.
  8. Advisory Committee on Immunization Practices. ACIP Evidence to Recommendations for Use of Janssen COVID-19 vaccine under an Emergency Use Authorization.
  9. Ismail SJ, Tunis MC, Zhao L, et al. Navigating inequities: a roadmap out of the pandemic. BMJ Global Health 2021;6:e004087. doi:10.1136/bmjgh-2020-004087.
  10. COVID-19 racial and ethnic health disparities.
  11. Center KE, Da Silva J, Hernandez AL, et al. Multidisciplinary community-based investigation of a COVID-19 outbreak among Marshallese and Hispanic/Latino communities — Benton and Washington counties, Arkansas, March–June 2020. MMWR Morb Mortal Wkly Rep 2020;69:1807–1811. DOI: https://dx.doi.org/10.15585/mmwr.mm6948a2.
  12. Racism and health.
  13. White BM, Newman SD. Access to primary care services among the homeless: a synthesis of the literature using the equity of access to medical care framework. J Prim Care Community Health.2015;6:77-87. doi:10.1177/2150131914556122
  14. Paquette CE, Syvertsen JL,Polliniae RA. Stigma at every turn: health services experiences among people who inject drugs. Int J Drug Policy 2018;57:104-10. org/10.1016/j.drugpo.2018.04.004.
  15. Peterson-Besse JJ, Walsh ES, Horner-Johnson W, et al. Barriers to health care among people with disabilities who are members of underserved racial/ethnic groups: a scoping review of the literature. Med Care. 2014; 52:S51-S63. doi: 10.1097/MLR.0000000000000195.
  16. Kates J, Ranji U, Beamesderfer A, et al. Health and access to care and coverage for lesbian, gay, bisexual, and transgender individuals in the U.S. Issue Brief updated May 2018. KFF. https://www.kff.org/racial-equity-and-health-policy/issue-brief/health-and-access-to-care-and-coverage-for-lesbian-gay-bisexual-and-transgender-individuals-in-the-u-s/.

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