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ACIP Evidence to Recommendations for Use of Pfizer-BioNTech COVID-19 Vaccine						Print
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										**Question:**Should vaccination with the Pfizer-BioNTech COVID-19 vaccine be recommended for people 16 years of age and older?
**Population**: Persons 16 years of age and older
**Intervention**: Pfizer-BioNTech COVID-19 vaccine (30 μg, 2 doses 21 days apart)
**Comparison**: No COVID-19 vaccine
**Outcomes**:
Symptomatic laboratory-confirmed COVID-19
Hospitalization due to COVID-19
Death due to COVID-19
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 38 million cases and more than 600,000 COVID-19-associated deaths have been reported as of August 27, 2021. 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 (Hispanic) and American Indian/American Native persons have experienced higher rates of disease, hospitalization and death compared with non-Hispanic White persons. 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 vaccines to prevent COVID-19 received Food and Drug Administration (FDA) Emergency Use Authorizations (EUA): Pfizer-BioNTech on December 11, 2020 for persons aged 16 years and older, Moderna on December 18, 2020 for adults aged 18 years and older, and Janssen on February 27, 2021 for adults aged 18 years and older. On August 23, 2021, the FDA approved a Biologics License Application (BLA) for use of the Pfizer-BioNTech COVID-19 vaccine in persons aged 16 years and older.
Additional background information supporting the 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 has important associated morbidity and mortality.
**Incidence:**
As of August 27, 2021, there were 38,709,295 COVID-19 cases reported in the United States for an incidence of 11,929 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 August 21, 2021 was 625.3 per 100,000 population. Among those hospitalized, 23% required care in an intensive care unit and 10% died.2,3
COVID-19-associatiated hospitalization rates were 13-24 times higher in unvaccinated adults compared to fully vaccinated adults.4
**Mortality:**
As of August 27, 2021, there were 634,157 COVID-19-associated deaths reported in the United States.1
**ICU Capacity:**
As of August 29, 2021, 23 states had over 80% intensive care unit (ICU) beds occupied.5**Vaccination:**
As of August 28, 2021, more than 200 million doses of COVID-19 vaccine had been administered in the United States.6 However, 38% of people ≥16 years of age were not fully vaccinated. Vaccination coverage varies by geography and age. Older adults ≥16 had a higher proportion of individuals receiving ≥1 dose (94% in 65-74 years) compared to younger person 12-15 (49%).7
**Variants of Concern:**
As of August 28, 2021, the Delta variant is the dominant circulating variant in the United States and is more than twice as contagious as previous variants.8Benefits and Harms
Benefits and Harms
Criteria
Work Group Judgements
Evidence
Additional InformationHow substantial are the desirable anticipated effects?
Large
Risk of symptomatic COVID-19, hospitalization due to COVID-19, and deaths due to COVID-19 were reduced among persons receiving two doses of the Pfizer-BioNTech COVID-19 vaccine rather than placebo or no vaccine (GRADE Tables 3a, 3b, and 3c).
The phase II/III randomized controlled trial (RCT) for the Pfizer-BioNTech COVID-19 vaccine demonstrated efficacy of the 2-dose regimen up to 6 months after vaccination.1,2 The overall efficacy* against symptomatic, laboratory-confirmed COVID-19§ was 91.1% (95% Confidence Interval [CI]: 88.8%, 93.1%).  Similar efficacy was observed in subgroup analyses by age group and those with underlying medical conditions.
Thirty-one RCT participants were hospitalized with COVID-19; all were in the placebo group.1 Vaccine efficacy against hospitalization due to COVID-19 was 100% (95% CI: 87.6%, 100%). For deaths due to COVID-19, 1 occurred in the vaccine group and 6 occurred in the placebo group. Vaccine efficacy against death was 83% (95% CI: -39%, 98%).  A body of evidence from vaccine effectiveness studies showed robust effectiveness against symptomatic COVID-19 and associated hospitalizations and deaths, consistent with the RCT data, with pooled effectiveness estimates against all outcomes of 90% or higher. A small body of observational evidence indicated that vaccination is also effective against asymptomatic SARS-CoV-2 infection, although the magnitude of the effect was inconsistent among studies.  (GRADE Table 3d).
The Phase II/III randomized controlled trial was conducted in six countries and data cutoff was March 13, 2021. Twenty-six observational vaccine effectiveness studies provided data that informed benefits specified in the PICO question, and two vaccine safety surveillance provided data on harms. The evidence profile included data on benefits and harms based on hundreds of thousands of vaccinated persons.How substantial are the undesirable anticipated effects?
Small
The Phase II/III RCT data indicated that risk of serious adverse events was low and similar between the vaccine and placebo groups (GRADE Table 3e). Data from two vaccine safety surveillance systems, the Vaccine Adverse Event Reporting System and the Vaccine Safety Dataline, demonstrated anaphylaxis and myocarditis/myopericarditis were rare, but associated with vaccination. Grade ≥3**  reactogenicity was increased among persons receiving ≥1 dose of the Pfizer-BioNTech COVID-19 vaccine rather than placebo (GRADE Table 3f).
Adverse events classified as serious§§ were reported in the same proportion among recipients of vaccine and placebo (1.2% each)
Severe reactions (grade ≥3) in the 7 days post vaccination occurred more commonly with the vaccine (10.6%) compared with placebo (2.3%) based on the Phase II/III trial data.
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 felt 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 1-2 (high to 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 moderate for prevention of death due to COVID-19, very low for prevention of asymptomatic 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 51 national surveys among U.S. adults conducted between December 2020 and August 2021, for the scenario that a vaccine would be or had been approved in the United States, acceptability was moderate overall. The proportion intending to receive the COVID-19 vaccine ranged across the surveys between 47%-84%.1 Acceptance over time has been relatively stable after COVID-19 vaccines became available in December. Surveys in July and August 2021 reported acceptance from 64-77%.1Common concerns or factors associated with vaccine hesitancy included vaccine side effects, belief that vaccines are too new, and belief that vaccination is not necessary.2,3When unvaccinated people were asked what would make them more likely to get vaccinated, 31% said they would be more likely to get vaccinated after a vaccine had full FDA approval.2
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.Is there important uncertainty about or variability in how much people value the main outcomes?
Probably important uncertainty or variability
In a recent survey 64-77% of respondents said they were already vaccinated or would likely get vaccinated, and of those who are not vaccinated, 20% said they would only get vaccinated if required, and 36% said they would definitely not get vaccinated.4Vaccination intentions also varied by race or ethnicity and socioeconomic status of respondents.5,6,7,8,9,10,11,12
The Work Group determined that whereas there might be variability and uncertainty in how all populations value the vaccine, for most populations, the desirable effects probably outweigh the undesirable effects.Acceptability
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. COVID-19 vaccination has been implemented in a variety of situations, including state and local health departments, healthcare sites and hospitals, mass vaccination clinics, Long Term Care Facilities, and retail pharmacies. As of August 29, 2021, more than 207 million doses have been administered.1
Vaccination with the Pfizer-BioNTech COVID-19 vaccine was already highly acceptable to stakeholders under FDA EUA and ACIP interim recommendation, and vaccination may be more acceptable to stakeholders under full FDA approval and a standard ACIP recommendation.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 over $10 billion to Operation Warp Speed for the provision of vaccines.4
An effective vaccine combined with a successful vaccination program would be expected to reduce costs associated with COVID-19 disease outcomes and other COVID-19 mitigation activities. Several published modeling studies have found that COVID-19 vaccinations are likely to be of a reasonable economic value and may also be cost-saving under many circumstances.5-8Another recent study estimated that in June and July 2021, COVID-19 hospitalizations among unvaccinated adults cost the U.S. healthcare system over $2 billion.9
The Work Group concluded that cost-effectiveness may not be a primary driver for decision-making on this policy question.
The Work Group concluded that use of all vaccines with acceptable vaccine efficacy is required during a pandemic because it will save lives and resources.Equity
Equity
Criteria
Work Group Judgements
Evidence
Additional InformationWhat would be the impact of the intervention on health  equity?
Varies/
Don’t know
Several groups were identified that might be disadvantaged in relation to COVID-19 disease burden or receipt of the Pfizer-BioNTech COVID-19 vaccine. The Work Group considered that some of these same groups might also experience disproportionate barriers in relation to standard recommendation for the Pfizer-BioNTech COVID-19 vaccine.
As of August 14, 2021, cumulative COVID-19 associated hospitalizations in the United States illustrated that rates (per 100,000 population) were higher among American Indian/Alaska Native, Black, and Hispanic populations compared to White and Asian/Pacific Islander populations.10
Further analysis showed that Hispanic or Latino, Black, American Indian or Alaska Native (AI/AN), and Native Hawaiian or Other Pacific Islander (NH/PI) populations in the United States experienced higher rates of COVID-19 infection and mortality compared with the non-Hispanic White population and greater excess mortality (i.e., the percentage increase in the number of persons who have died relative to the expected number of deaths for a given place and time).11 During the COVID-19 pandemic in 2020, the highest total excess mortality incidence rate among adults aged 25-64 years were among American Indian/Alaska Native populations, followed by Black, Native Hawaiian or Other Pacific Islander and Hispanic populations respectively.11
As of August 24, 2021, the percentage of people who received at least one dose of the COVID-19 vaccine was highest among American Indian/Alaska Native (51.5%), followed by Native Hawaiian or Other Pacific Islander (41.2%), Asian (39.8%), Hispanic/Latino (38.3%) and White (36.7%).  Black populations had the lowest percentage (30.8%) of people who received at least one dose of the COVID-19 vaccine.12
Unvaccinated adults cite a variety of reasons why they have yet to receive a COVID-19 vaccine. Consistent with previous research, unvaccinated Hispanic and Black adults are more likely than White adults to cite worries about missing work and having to pay for the vaccine as major reasons for not being vaccinated.13 In addition, unvaccinated Hispanic adults are more likely than unvaccinated White adults to say they are too busy, would have difficulty traveling to a vaccination site, or are not sure how or where to get the vaccine.13
Additional analysis of an integrated, county view of vaccination coverage in the United States illustrates that 50-70% of the population ≥12 years of age are fully vaccinated, which consists of 32% of U.S. counties.14
Overall, COVID-19 has resulted in disproportionate hospitalization and mortality in minority populations. Although, equitable uptake of the COVID-19 vaccine has improved over time, we must strive to continue to improve vaccine confidence and vaccine access for all.
Application of the PROGRESS-Plus Framework1,2 assisted in the identification of groups that could be associated with inequities in relation to COVID-19 disease burden or receipt of the Pfizer-BioNTech COVID-19 vaccine.
Groups currently disadvantaged under Emergency Use Authorization (EUA) for the Pfizer-BioNTech COVID-19 vaccine include:
People living in rural/frontier areas3, justice-involved (incarcerated persons)4, those living in congregate settings (long-term care facilities)5 and those experiencing homelessness6
Racial and ethnic minority populations, such as Black, Hispanic/Latino, Alaskan Native/American Indian and non-U.S. born persons7
People living in poverty or with a high social vulnerability3
People with disabilities8 or substance use disorders9
The Work Group had varying opinions on the impact a standard ACIP recommendation for Pfizer-BioNTech COVID-19 vaccine would have on equity and believes it is likely that the impact will vary by community.Feasibility
Feasibility
Criteria
Work Group Judgements
Evidence
Additional InformationIs the intervention feasible to implement?
Yes
There are a variety of barriers that are likely to limit the feasibility of implementing the Pfizer-BioNTech COVID-19 vaccine including:
Complexity of recommendations
Vaccine storage and handling requirements
Financial barriersThe Pfizer-BioNTech COVID-19 vaccine is currently the only COVID-19 vaccine that has an FDA approved Biologics License Application (BLA). Furthermore, the BLA has only been issued for some indications, which may add complexity to current recommendations. For example, the BLA has been issued for individuals ≥16 years, whereas an Emergency Use Authorization (EUA) has been issued for individuals aged 12-15 as well as an additional dose in immunocompromised individuals.
Vaccine storage and handling requirements also influence feasibility. Ultra-cold storage requirements (-90oC to -60oC) impacts where vaccines can be stored. Currently, the maximum ultra-cold freezer storage has been extended from 6 to 9 months, whereas vaccines can be stored for up to 2 weeks in the freezer (-25oC to -15oC) and up to 1 month (31 days) in the refrigerator (2oC to 8oC).1,2 Furthermore, the minimum size of orders are currently 450 doses.1,2
Financial barriers to receiving the Pfizer BioNTech 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 implementation, clinics, outreach and education. Furthermore, financial hardship may arise if vaccine recipients need to take time off to receive the vaccine or experience post-vaccination reactogenicity that prevents them from working.
Vaccine supply in the U.S. is now sufficient for implementation of the intervention. As of August 29, 2021, >209 million doses of Pfizer-BioNTech COVID-19 vaccine have been administered in the U.S., demonstrating that the vaccine is feasible to implement.3
The Work Group determined that the Pfizer-BioNTech COVID-19 vaccine is feasible to implement.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)
The Pfizer-BioNTech COVID-19 vaccine is recommended for people 16 years of age and older under FDA’s Biologics License Application (BLA)*Overall efficacy was calculated at ≥7 days after second dose of vaccine among persons without evidence of prior SARS-CoV-2 infection.
§Moderate to severe/critical COVID-19 is defined as PCR-positive (with or without confirmation at central laboratory) AND ≥1 of: respiratory rate ≥ 20 breaths/min, abnormal SpO2, pneumonia, DVT, shortness of breath/difficulty breathing OR ≥2 of: fever (≥100.4°F [380C]), heart rate ≥90, shaking chills, sore throat, cough, malaise, headache, myalgia, GI symptoms (nausea, vomiting, diarrhea, abdominal pain), olfactory/taste disorder, red/bruised toes.
†Asymptomatic SARS-CoV-2 infection is defined as (1) positive serology (non-spike protein), and (2) no prior SARS-CoV-2 positive PCR or COVID-19 symptoms during the study. Seroconversion to a non-spike protein can distinguish between natural infection and vaccine-induced immunity.
**Grade 3 reactions are defined as: use of a prescription pain reliever or those preventing daily routine activity, fever 102.1-104.00F (39°C–40°C); grade 4 reactions are defined as: requires emergency room visit or hospitalization, fever >1040F (40°C).
§§Serious adverse events defined as any untoward medical occurrence that results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, or results in persistent disability/incapacity.
References
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							Last Reviewed:  September 21, 2021						Source: 	National Center for Immunization and Respiratory Diseases
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