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

Question: Should Pfizer-BioNTech COVID-19 vaccine be recommended for persons 16 years of age and older in the U.S. under an Emergency Use Authorization?

Population: Persons 16 years of age and older

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

Comparison: No Pfizer-BioNTech COVID-19 vaccine


  • 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 15.4 million cases and approximately 291,500 COVID-19-associated deaths have been reported as of December 10, 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 who put racial and ethnic minority groups at increased risk for COVID-19, including overrepresentation among essential workers that have higher risk of exposure to COVID-19, lower incomes, reduced access to healthcare, or higher rates of comorbid conditions.

On December 11, 2020, the Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA) for Pfizer-BioNTech COVID-19 vaccine in persons aged 16 years and older for prevention of COVID-19. The vaccine was safe and highly effective in a randomized controlled clinical trial that included 43,252 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.


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 has important associated morbidity and mortality.
As of December 10, 2020, there were 15,474,800 COVID-19 cases reported in the United States for an incidence of 4,721 cases per 100,000 population.1
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 5, 2020 was 278.7 per 100,000 population. Among those hospitalized, 32% required care in an intensive care unit and 15% died.2,3
As of December 10, 2020, there were 291,522 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 43% are aged ≥65.3

Among persons who died with COVID-19, 76% had ≥ 1 underlying medical condition and 80% were aged ≥65.12 As of December 10, 2020, approximately 40% 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

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%.17

Benefits and Harms

Benefits and Harms
Criteria Work Group Judgements Evidence Additional Information
How 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 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 95% (95% Confidence Interval [CI]: 90.3%, 97.6%). Consistent high efficacy (≥92%) was observed when participants with evidence of prior SARS-CoV-2 infection were included, across age, sex, race, ethnicity and, among those with one or more of the following conditions: obesity, diabetes, hypertension, and chronic cardiopulmonary disease.
For hospitalization due to COVID-19, 5 events occurred, all in the placebo group. Vaccine effectiveness against hospitalization was 100% (95% CI: -9.9%, 100%). Deaths were also uncommon, 2 in the vaccine group and 4 in the placebo group.
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 Pfizer-BioNTech COVID-19 vaccine rather than placebo (GRADE Table 4).
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 85% of participants; the most frequent symptom was pain. The most common solicited systemic reactions were fatigue (62.9%), headache (55.1%), muscle pain (38.3%), chills (31.9%), joint pain (23.6%), and fever (14.2%). Systemic reactions were generally more frequent and severe in the younger age group (16-55 years) compared with the older age group (>55 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 1 day, which was similar in the younger and older age groups. Among reported unsolicited adverse events, lymphadenopathy occurred much 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 (8.8%) compared with placebo (2.1%). The most common grade 3 symptoms reported by vaccine recipients were fatigue (4.2%), headache (2.4%), muscle pain (1.8%), chills (1.7%), and injection site pain (1.4%). 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 a similar proportion among recipients of vaccine and placebo, overall (0.6% vs. 0.5%) 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.1,2
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) and Level 3 (low)

Safety of the intervention is Level 2 (moderate)

For the critical outcomes, the certainty of evidence was high for prevention of symptomatic COVID-19, low 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 high for reactogenicity.


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 31 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 in November 2020, 71% of respondents believed Pfizer-BioNTech COVID-19 vaccine was effective and 68% believe it was safe given a press release of 90% efficacy.4 In another survey conducted during the same timeframe, intent to receive the vaccine was 60% (up from 51% in September).2
Common desirable effects included protecting self, family, and community from SARS-CoV-2 infection and severe illness, and return to normalcy.1,5 A provider recommendation was positively associated with COVID-19 vaccination intentions.5-7 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.8
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.
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.2,5,6,9,10 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.11


Criteria Work Group Judgements Evidence Additional Information
Is 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. All health department jurisdictions have developed COVID-19 vaccine implementation plans on how to operationalize the vaccination response within their jurisdictions. Chain and independent pharmacies have signed agreements with the federal government to participate in the COVID-19 vaccination program.
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 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 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.7


Criteria Work Group Judgements Evidence Additional Information
What would be the impact of the intervention on health  equity? Reduced
Probably reduced
Probably no impact
Probably increased
Don’t know
Several groups were identified who are disadvantaged in relation to COVID-19 disease burden. The Work Group considered that many of these same groups might also be disadvantaged in relation to access and receipt of the Pfizer-BioNTech COVID-19 vaccine.
The Work Group identified two characteristics of the Pfizer-BioNTech COVID-19 vaccine that have the potential to impact health equity: 1) challenging ultra-cold chain storage, handling, and administration requirements (i.e., access to an ultra-low-temperature freezer, dry ice), and 2) the need for a 2-dose series. Feasibility considerations related to cold chain requirements will limit the number and types of facilities that can receive and use this vaccine. The Work Group noted that equitable distribution of the Pfizer-BioNTech COVID-19 vaccine would be impacted if the vaccine can be accessed principally at large health centers or central distribution sites rather than in local community settings as is typical for vaccines. The requirement for a 2-dose series 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. These two characteristics will likely reduce access of the Pfizer-BioNTech COVID-19 vaccine to 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 Pfizer-BioNTech 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 Pfizer-BioNTech 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 Pfizer-BioNTech COVID-19 vaccine to 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 populations4,5
  • people living in poverty or with high social vulnerability6
  • essential workers: racial and ethnic minority populations are disproportionately represented in subsets of essential industries,7-9 and almost one quarter of essential workers live in low income families7
  • residents in congregate settings such as LTCF,10 prisons,11 homeless shelters,12 and group homes for people with intellectual/ developmental disabilities13
  • people with substance use disorders14
In addition, sexual and gender minorities face social or structural inequities that can lead to health disparities.15
The judgment of a plurality of Work Group members was that the Pfizer-BioNTech COVID-19 vaccine would probably reduce health equity. Their judgment primarily reflected concerns with the ultra-cold chain requirements for the Pfizer-BioNTech COVID-19 vaccine which will likely reduce access of this vaccine to groups who bear an unfair burden of COVID-19-related disease. The judgements of the remaining Work Group members were nearly equally distributed among the six other judgment options.
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 Pfizer-BioNTech 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.


Criteria Work Group Judgements Evidence Additional Information
Is the intervention feasible to implement? Probably yes
Delivery of any adult vaccination can be challenging in the United States. Financial barriers to implementing the Pfizer-BioNTech COVID-19 vaccine are reduced because the vaccine will be provided to the U.S. population free of charge. However, health systems or health departments could incur costs for vaccine implementation and clinics.
Population access to healthcare could be limited in rural or other hard-to-reach areas. The range of providers administering vaccine will be impacted by ultra-cold storage requirements (-80°C to -60°C). Vaccine with ultra-cold requirements cannot be stored in most of providers’ practices. Other challenges for program implementation include specialized handling, large minimum size of orders (975 doses as of Dec 12) which may make the vaccine more suitable for centralized vaccination clinics or through the pharmacy chains, and that vaccination requires a two-dose series (protection after the first dose was not systematically evaluated, uptake of the second dose might be influenced  by adverse events experienced after the first dose and convenient location of vaccine providers).
Innovative solutions have been employed to overcome barriers to implementation. Expanded funding opportunities and pharmacy partnerships, along with packing containers that can maintain ultra-cold temperatures without a freezer, will increase access to vaccine. State and local health department jurisdictions have created detailed microplans in preparation for complex implementation scenarios.1
The manufacturer of the Pfizer-BioNTech COVID-19 vaccine will distribute the vaccine to the point of use sites to ensure maintenance of the ultra-cold chain.

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 16 years of age and older in the U.S. under an 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 principles  and 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 vaccination in the initial phase of the COVID-19 vaccine program (Phase 1a) ( icon). Recommendations for groups beyond Phase 1a will be discussed at future ACIP meetings.

Final deliberation and decision by the ACIP

Final ACIP recommendation

ACIP recommends the intervention.

The Pfizer-BioNTech COVID-19 vaccine is recommended for persons 16 years of age and older 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: a. results in death; b. is life-threatening; c. requires inpatient hospitalization or prolongation of existing hospitalization; d. results in persistent disability/incapacity



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Page last reviewed: December 17, 2020