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ACIP Evidence to Recommendations for Use of Moderna COVID-19 Vaccine under an Emergency Use Authorization						Print
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										**Question:**Should Moderna COVID-19 vaccine be recommended for persons 18 years of age and older in the U.S. under an Emergency Use Authorization?
Population: Persons 18 years of age and older
Intervention: Moderna COVID-19 vaccine (100 μg, 2 doses 28 days apart)
Comparison: No COVID-19 vaccine
Outcomes:
Symptomatic laboratory-confirmed COVID-19
Hospitalization due to COVID-19
All-cause death
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 16.9 million cases and approximately 309,000 COVID-19-associated deaths have been reported as of December 17, 2020. Persons of all ages are at risk for infection and severe disease. However, the risk for severe illness from COVID-19 is higher in people aged ≥65 years, those living in long-term care facilities, and those with chronic medical conditions. Additionally, there is a disproportionate burden of COVID-19 infections and deaths among racial and ethnic minority communities. 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 overrepresentation among essential workers who have higher risk of exposure to COVID-19, lower incomes, reduced access to healthcare, or higher rates of comorbid conditions.
In the United States, the first vaccine to prevent COVID-19 (Pfizer-BioNTech COVID-19 vaccine) received a Food and Drug Administration (FDA) Emergency Use Authorization (EUA) on December 11, 2020 for persons aged 16 years and older. On December 18, 2020, FDA issued an EUA for Moderna COVID-19 vaccine for prevention of COVID-19 in adults aged 18 years and older. The vaccine was found to be safe and highly effective in a randomized controlled clinical trial that included 30,351 participants randomized 1:1 to receive either vaccine or placebo.
Additional background information supporting the interim ACIP recommendation on the use of Moderna 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 has important associated morbidity and mortality.
Incidence:
As of December 17, 2020, there were 16,987,911 COVID-19 cases reported in the United States for an incidence of 5,183 cases per 100,000 population.1
Hospitalization:
Among sites participating in population-based surveillance for laboratory-confirmed COVID-19-associated hospitalizations, the overall cumulative hospitalization rate between March 1, 2020 and December 12, 2020 was 295.9 per 100,000 population. Among those hospitalized, 32% required care in an intensive care unit and 15% died.2,3
Mortality:
As of December 17, 2020, there were 309,880 COVID-19-associated deaths reported in the United States.1 Estimates of the SARS-CoV-2 infection fatality ratio range from 0.5% to 1.4%.4,5
Long-term disability:
While the natural history and long-term disability from COVID-19 are being studied, data on sequelae of COVID-19 and persistent symptoms in the first weeks and months after recovery are emerging.6 Studies have also reported a clinically significant drop (44%-69%) in the quality of life when investigated up to 8 weeks after hospital discharge.7,8
Consideration of Disparities:
Older adults (aged ≥65 years) and people with certain medical conditions such as obesity, diabetes, or chronic kidney disease are at increased risk for severe illness from COVID-19, including COVID-19-associated hospitalization and death.9-11 Nearly 90% of persons hospitalized for COVID-19 have an underlying condition and 44% are aged ≥65.3Among persons who died with COVID-19, 76% had ≥1 underlying medical condition and 80% were aged ≥65.12 As of December 17, 2020, approximately 38% of COVID-19-associated deaths were among long-term care facility (LTCF) residents and staff; they represented 5.4% of US COVID-19 cases.13
Additionally, a disproportionate burden of SARS-CoV-2 infections and COVID-19-associated deaths occurred among racial and ethnic minority communities.14,15
Seroprevalence:
The herd immunity threshold for SARS-CoV-2 is expected to range between 50% and 65%.16 As of end of September 2020, seroprevalence in the United States was estimated to be <10%.17Benefits and Harms
Benefits and Harms
Criteria
Work Group Judgements
Evidence
Additional InformationHow substantial are the desirable anticipated effects?
Large
Risk of symptomatic COVID-19 and hospitalization due to COVID-19 were reduced among persons receiving two doses of the Moderna COVID-19 vaccine rather than placebo (GRADE Tables 3a and 3b).
The clinical trial for the Moderna COVID-19 vaccine demonstrated very high efficacy of the 2-dose regimen against symptomatic, laboratory-confirmed COVID-19.1,2 The overall efficacy* was 94.1% (95% Confidence Interval [CI]: 89.3%, 96.8%). Consistent high efficacy (≥86%) was observed across age, sex, race, ethnicity, and among those at risk for severe COVID-19.
Nine persons in the placebo group and one in the vaccine group were hospitalized with COVID-19.3 Vaccine efficacy against hospitalization due to COVID-19 was 89% (95% CI: 13%, 89%). Deaths were also uncommon, 6 in the vaccine group and 7 in the placebo group.
Preliminary data suggested a lower risk of asymptomatic SARS-CoV-2 infection following one dose (relative risk 0.37, 95% CI: 0.29, 2.33).4
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 III studies. Vaccine efficacy in preventing hospitalizations and deaths 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 and similar between the vaccine and placebo groups. Grade ≥3 reactogenicity was increased among persons receiving 2 doses of the Moderna COVID-19 vaccine rather than placebo (GRADE Table 3f).
Solicited injection-site reactions and systemic reactions within 7 days after vaccination were frequent and mostly mild to moderate. Injection-site reactions were reported by 92.0% of participants; the most frequent symptoms were pain and axillary swelling or tenderness. The most common solicited systemic reactions were fatigue (68.5%), headache (63.0%), muscle pain (59.6%), joint pain (44.8%), and chills (43.4%). Systemic reactions were generally more frequent in the younger age group (18-64 years) compared with the older age group (≥65 years) and after dose 2 compared with dose 1. The median onset of systemic reactions was 1 to 2 days post-vaccine receipt; reactions resolved after a median duration of 2 days.
Severe adverse reactions (grade ≥3†) occurred more commonly with the vaccine (21.4%) compared with placebo (4.4%). Generally, grade ≥3 reactions were more commonly reported after the second dose than after the first dose and were less prevalent in older than younger participants.
Adverse events classified as serious§ were reported in the same proportion among recipients of vaccine and placebo, overall (1.0%) and by system organ class; they represented medical events that occur in the general population at similar frequency as observed in the study.
No specific safety concerns were identified in subgroup analyses by age, race, ethnicity, medical comorbidities, or prior SARS-CoV-2 infection.
Safety data showed an acceptable safety profile.1,2Post-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 Moderna 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) and Level 2 (moderate)
Safety of the intervention is Level 2 (moderate)
For the critical outcomes, the certainty of evidence was high for prevention of symptomatic COVID-19, moderate for prevention of hospitalizations due to COVID-19, and moderate for serious adverse events. For important outcomes, the certainty of evidence was very low for prevention of all-cause death and prevention of asymptomatic SARS-CoV-2 infection, and high 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?
Probably yes
In 33 national surveys among U.S. adults conducted between March and December 2020, for the scenario that a vaccine would be approved in the United States, acceptability was moderate overall. The proportion intending to receive the COVID-19 vaccine ranged across the surveys between 42%-86%.1,2 Vaccine efficacy (90% or 70%) was associated with preferred choice of vaccine.3 There was a trend towards declining acceptance over time; however, in the latest surveys acceptance was slightly higher. In a national survey conducted in November 2020, intent to receive the vaccine was 60% (up from 51% in September).2Common desirable effects included protecting self, family, and community from SARS-CoV-2 infection and severe illness, and return to normalcy.1,4 A provider recommendation was positively associated with COVID-19 vaccination intentions.4-6 Common concerns or factors associated with vaccine hesitancy included vaccine side effects, uncertainty about vaccine efficacy, and low risk perception of COVID-19 or severe disease. Many respondents reported concerns that COVID-19 vaccine approval was too fast.7
According to preliminary notes-based analysis of focus groups conducted by CDC between June and August 2020 (49, n=239), participants were open to getting a COVID-19 vaccine eventually (CDC unpublished data). They typically reported a desire for more information and taking a “wait and see” approach. Common concerns included the rapid development process, safety, effectiveness, sufficient testing in their group, and both short- and long-term side effects. In the seven sub-groups conducted with nurses (n=48), some were reluctant to get vaccinated, and many did not want to receive a vaccine right away.
In a survey conducted in December 2020, after a first COVID-19 vaccine was authorized and recommended for use in the United States, 40% of participants reported that they would get the vaccine as soon as it is available, 44% would wait “a bit,” while 15% would never get the vaccine.8
Most surveys were conducted prior to a vaccine being available, thus respondents stated intentions for unknown or hypothetical vaccine characteristics. 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 adults in the U.S. Most surveys used convenience sampling, had limited representation of minority and priority populations (such as healthcare workers or essential workers), and low or unknown response rates.
The Work Group determined that whereas there might be uncertainty in how all populations value the vaccine, for most populations, the desirable effects probably outweigh the undesirable effects.Is there important uncertainty about or variability in how much people value the main outcomes?
Important uncertainty or variability
Vaccination intentions varied by race or ethnicity and socioeconomic status of respondents.2,4,5,9,10 Acceptance was lowest among Black respondents, highest among Asian respondents, and greater with higher socioeconomic status. Acceptance was also greater with higher vaccine efficacy and healthcare provider recommendation.
A survey among Black and Latino respondents found that trust in the safety and effectiveness of COVID-19 vaccine were important factors related to vaccination intentions.11Acceptability
Acceptability
Criteria
Work Group Judgements
Evidence
Additional InformationIs the intervention acceptable to key stakehold-ers?
Probably yes
Pandemic vaccination response planning requires collaboration among a wide range of public- and private-sector partners. As of December 19, 2020, all health department jurisdictions are operationalizing their COVID-19 vaccination response within their jurisdictions according to their COVID-19 vaccine implementation plans. Chain and independent pharmacies have signed agreements with the federal government to participate in the COVID-19 vaccination program and are working to launch vaccination in LTCFs.
There were no published U.S. provider knowledge, attitudes, and practices surveys. In a CDC survey of state health officers conducted in October 2020, common concerns about vaccine administration included vaccine hesitancy (53%), vaccine safety (32%), and communications (26%) (CDC unpublished data).  In a CDC vaccine intent survey in September 2020, 63% of healthcare personnel reported that they would be likely to get a COVID-19 vaccine (CDC unpublished data). In a convenience sample survey of nurses (n=12,939) conducted in October 2020, 63% were confident a COVID-19 vaccine will be safe and effective, while 34% would voluntarily receive COVID-19 vaccine if not required.1 According to preliminary notes-based analysis of seven focus groups conducted with nurses by CDC between June and August 2020 (n=48), most supported prioritizing healthcare personnel for vaccine allocation (CDC unpublished data).Resource Use
Resource Use
Criteria
Work Group Judgements
Evidence
Additional InformationIs 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 the vaccine dose 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 U.S. Government has committed $10 billion to Operation Warp Speed 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 gets COVID-19, 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.7Equity
Equity
Criteria
Work Group Judgements
Evidence
Additional InformationWhat would be the impact of the intervention on health equity?
Reduced
Probably reduced
Probably no impact**Probably increased**
Increased
Varies
Don’t know
Several groups were identified who are disadvantaged in relation to COVID-19 disease burden. The Work Group considered that some of these same groups might also be disadvantaged in relation to access and receipt of the Moderna COVID-19 vaccine.
The shipping, storage, handling, and administration requirements for the Moderna COVID-19 vaccine (as detailed in the feasibility domain) will allow for it to be distributed and used in most community settings.
The requirement for a 2-dose series, however, will make follow-up challenging for some disadvantaged groups such as those who are homeless, live in rural locations, or have no/limited access to healthcare. This will likely reduce access of the Moderna COVID-19 vaccine to some groups who bear an unfair burden of COVID-19-related morbidity and mortality.
The Work Group noted that the federal Pharmacy Partnership for COVID-19 Vaccination in Long-term Care Facilities Program offers an opportunity to increase equitable access to the Moderna COVID-19 vaccine by LTCF residents and staff. The Program provides end-to-end management of the COVID-19 vaccination process, including cold chain management and on-site vaccinations.1 Access to the Moderna COVID-19 vaccine by LTCF residents and staff in facilities not enrolled in the Program (e.g., the facility elects not to participate in the Program or cannot participate because it is located in an especially remote area), may be limited.
Some Work Group members noted that healthcare facilities that can administer or provide access to the vaccine offer the potential to increase equitable distribution of the Moderna COVID-19 vaccine to a broad range of healthcare personnel.
Application of the PROGRESS-Plus Framework2,3 assisted in the identification of factors that could be associated with unfair differences in COVID-19 morbidity and mortality.
Groups who might be disadvantaged due to unfair differences in COVID-19 morbidity and mortality include:
racial and ethnic minority populations4
people living in poverty or with high social vulnerability5
essential workers: racial and ethnic minority populations are disproportionately represented in subsets of essential industries,6-8 and almost one quarter of essential workers live in low income families6
residents in congregate settings such as LTCF,9 prisons,10 homeless shelters,11 and group homes for people with intellectual/ developmental disabilities12
people with substance use disorders13In addition, sexual and gender minorities face social or structural inequities that can lead to health disparities.14
The judgment of a narrow plurality of Work Group members was that the Moderna COVID-19 vaccine would probably increase health equity. The view of a quarter of the members was that the vaccine would probably have no impact on equity; no member judged health equity to be reduced. The judgements of the remaining Work Group members were nearly equally distributed among the remaining four judgment options.
Work Group members noted that the storage and handling requirements for the Moderna COVID-19 vaccine offer the opportunity for community-based providers to participate in the COVID-19 vaccination program which in turn would allow the vaccine to be distributed in harder-to-reach communities, such as those living in rural areas. Other Work Group members indicated that the requirements for the Moderna COVID-19 vaccine could still be challenging for independent pharmacies which provide vaccination services in many underserved communities. The wide range of judgments also reflected concerns about differential acceptance of vaccines in general by disadvantaged groups and disparities in access to healthcare services including vaccination.
To help ensure that inequities are reduced whenever possible and are not increased, the Work Group noted the critical importance of: 1) identification of groups disproportionately affected by COVID-19 or who face health inequities; 2) focused outreach and education tailored to specific groups, particularly those who experience inequities in the social determinants of health; 3) identification and resolution of barriers to vaccination; and 4) active follow-up to ensure completion of a 2-dose vaccination series. Although the Moderna COVID-19 vaccine will be provided at no cost, personal investments in time and travel to obtain vaccine may be a barrier for some persons in groups disproportionally affected by COVID-19.
Equity and vaccination program implementation are closely linked. The Work Group emphasized that successful implementation of the COVID-19 vaccination program and confidence in COVID-19 vaccines are pivotal to reducing existing health inequities related to COVID-19 and that federal, state and local jurisdictions require adequate resources to get COVID-19 vaccines to the most affected communities and ensure equitable access.Feasibility
Feasibility
Criteria
Work Group Judgements
Evidence
Additional InformationIs the intervention feasible to implement?
Yes
Delivery of any adult vaccination can be challenging in the United States. Financial barriers to receiving the Moderna COVID-19 vaccine will be reduced because the vaccine is being provided free of charge to the U.S. population. However, health systems or health departments could incur costs for COVID-19 vaccination program planning, implementation, and administration. Access to healthcare could be limited for people who live in rural or other hard-to-reach areas.
Storage and handling requirements for the Moderna COVID-19 vaccine1 should make it feasible to administer the vaccine across a range of providers and community locations:
for shipping and long-term storage, the vaccine must be maintained at standard freezer temperatures of -25°C to -15°C.
the vaccine is stable up to 30 days at refrigerated conditions and can be kept at room temperature conditions for up to 12 hours which facilitates administration via temporary/mobile/off-site clinics.
the vaccine does not require dilution at the vaccination site.
Some limitations were identified, including 1) the minimum order size (100 doses as of December 18, 2020) which might require consolidation of some locations for vaccine administration or administration through pharmacy chains (although it will be suitable for medium-to-smaller centers and transportation to off-site clinics), and 2) the requirement for a two-dose series (protection after the first dose was not systematically evaluated); uptake of the second dose might be influenced by adverse reactions experienced after the first dose and ease of access to a conveniently located vaccine provider.
Innovative solutions have been employed to overcome barriers to implementation. Expanded funding opportunities and pharmacy partnerships will increase access to COVID-19 vaccine. State and local health jurisdictions have created detailed microplans in preparation for complex implementation scenarios.2Balance 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)
Moderna COVID-19 vaccine is recommended for prevention of coronavirus disease (COVID-19) for persons 18 years of age and older in the U.S. under the FDA’s Emergency Use Authorization.
Additional considerations (optional)
Demand for COVID-19 vaccine is expected to exceed supply during the first months of the vaccination program. ACIP considered evidence related to SARS-CoV-2 epidemiology, vaccination program implementation, and ethical principlesand issued an interim recommendation on allocation of the initial doses of COVID-19 vaccine.  ACIP recommended that healthcare personnel and long-term care facility residents be offered vaccine in the initial phase of the COVID-19 vaccination program (Phase 1a) (https://dx.doi.org/10.15585/mmwr.mm6949e1external iconexternal icon). Updates to ACIP interim recommendation for allocating initial supplies of COVID-19 vaccine will be posted on the ACIP website (www.cdc.gov/vaccines/hcp/acip-recs/vacc-specific/covid-19.html).Final deliberation and decision by the ACIP
Final ACIP recommendation
ACIP recommends the intervention.
**The Moderna COVID-19 vaccine is recommended for persons 18 years of age and older in the U.S. population under the FDA’s Emergency Use Authorization.***Overall efficacy was calculated at ≥14 days after the second dose among persons without evidence of prior SARS-CoV-2 infection.
†Grade 3 reactions are defined as: use of a prescription pain reliever or those preventing daily activity, fever 102.1-104.00F; grade 4 reactions are defined as: requires emergency room visit or hospitalization, fever >1040F.
§Serious adverse events defined as any untoward medical occurrence that: a. results in death; b. is life-threatening; c. requires inpatient hospitalization or prolongation of existing hospitalization; d. results in persistent disability/incapacity.
References
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COVID-19 Vaccination Program Interim Playbook for Jurisdiction Operations. Version October 29, 2020: www.cdc.gov/vaccines/imz-managers/downloads/COVID-19-Vaccination-Program-Interim_Playbook.pdf.Top of Page
							
					
							Last Reviewed:  December 20, 2020						Source: 	National Center for Immunization and Respiratory Diseases
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