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MEETING OF THE ADVISORY COMMITTEE ON 

IMMUNIZATION PRACTICES (ACIP)

DECEMBER 1, 2020

SUMMARY MINUTES

The Centers for Disease Control and Prevention (CDC) convened an emergency meeting of its Advisory 

Committee on Immunization Practices (ACIP) on December 1, 2020. These summary minutes provide an 

overview of the meeting, which was devoted solely to the topic of coronavirus disease 2019 (COVID-19) 

vaccines. 

The purpose of the meeting was for ACIP to vote on interim guidance for federal, state, and local 

jurisdictions on allocation of the initial doses of COVID-19 vaccine. Dr. José R. Romero (ACIP Chair) 

opened the COVID-19 vaccines session.

Dr. Beth Bell (ACIP Work Group Chair) reviewed the COVID-19 Vaccines Work Group’s (WG) activities 

since the November 23, 2020 ACIP meeting. Dr. Bell noted that two applications for Emergency Use 

Authorization (EUA) for a candidate vaccine had been filed with the Food and Drug Administration 

(FDA): Pfizer/BioNTech announced their submission on November 20, 2020 and Moderna announced 

their submission on November 30, 2020. 

ALLOCATION OF INITIAL SUPPLIES OF COVID-19 VACCINE: PHASE 1a 

Dr. Kathleen Dooling (CDC ACIP WG Co-Lead) presented “Phased Allocation of COVID-19 Vaccines” to 

summarize the information available to inform the policy decision before ACIP, namely: “Should 

healthcare personnel and long-term care facility residents be offered COVID-19 vaccination in Phase 

1a?” 

Three areas of evidence were reviewed: 1) the science related to COVID-19 disease burden and the 

balance of benefits and harms of vaccine in each group; 2) implementation considerations, including 

the values and acceptability of each group, as well as feasibility; and 3) the ethical principles that apply 

to each group, namely maximize benefits and minimize harms, promote justice, mitigate health 

inequities, and the promotion of transparency throughout the policy deliberation process. A summary of 

the data for each population and the Work Group’s considerations supporting vaccination of healthcare 

personnel (HCP) and long-term care facility (LTCF) residents in Phase 1a were presented. 

SUMMARY OF DISCUSSION

Healthcare personnel

• The committee expressed concern that access to COVID-19 vaccine will be difficult for 

community-based HCP who are not employees of hospitals or health care systems. HCP who 
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practice in community settings are likely to provide care to patients early in the course of their 

infection when patients may be most infectious. 

• There was strong agreement that healthcare systems and public health authorities must work 

together to ensure that HCP who are not affiliated with hospitals or health care systems have 

access to COVID-19 vaccines. Outreach into the wider community is critical to reach such HCP.

Long-term care facility residents

• There was strong consensus from the committee that LTCF residents are at high risk for 

infection with SARS-CoV-2 and severe disease and death from COVID-19. Prevention of infection 

in this population may reduce COVID-19 associated hospitalizations and reduce the burden on 

health care systems. 

• The committee noted that the federal Pharmacy Partnership for Long-term Care Program offers

efficiencies in implementation but expressed concern that high patient turnover among some 

residents may impede completion of a 2-dose vaccine series. Multiple visits to a facility and data 

tracking systems will help facilitate vaccine coverage in this population

CLINICAL CONSIDERATIONS FOR POPULATIONS INCLUDED IN PHASE 1a 

Dr. Sara Oliver (CDC ACIP WG Co-Lead) then presented “Clinical Considerations for Populations Included 

in Phase 1a.” Clinical considerations related to sub-prioritization, reactogenicity, and implementation 

were reviewed for HCP and LTCF residents. 

Sub-prioritization of populations will be needed because the number of doses of COVID-19 vaccine will 

be limited during the first months of the national vaccination program. Considerations for subprioritization of HCP may include work that involves direct patient care or handling of infectious 

materials; an inability to telework; work in residential care or long-term care facilities; and known prior 

infection with SARS-CoV-2. 

Reactogenicity, including systemic symptoms, may occur post-vaccination. Limited data regarding 

reactogenicity are available from Phase I/II vaccine clinical trials; there are no reactogenicity data for 

LTCF residents. Vaccination programs for HCP will need to plan for the possibility that some HCP may 

need time away from their duties if they experience systemic symptoms. Staggering vaccination of HCP

who work in similar units or positions may be considered. CDC is developing guidance to assist with 

assessment of systemic symptoms in HCP following COVID-19 vaccination. 

Guidance for use of COVID-19 vaccines in pregnant or breastfeeding women will be developed after 

Phase III clinical trial data and EUA Conditions of Use are available. 

Vaccine-specific EUA fact sheets will be provided to vaccine providers and recipients. Fact sheets will be 

provided to family members or medical proxies of LTCF residents as applicable. Language clarifying the 

lack of data for LTCF residents will be included on CDC’s website. Consent/assent will be obtained from 

LTCF residents or families/medical proxies as is standard practice for administration of other vaccines in 

this population. 
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SUMMARY OF DISCUSSION

Sub-prioritization

• Committee members concurred that sub-prioritization of HCP is challenging in the setting of a 

constrained vaccine supply. In addition to the risk of occupational exposure to SARS-CoV-2, it is 

unclear how to weigh other factors such as age, high-risk medical conditions, equity 

considerations, such as racial/ethnic disparities in COVID-19 morbidity and mortality, and risks 

associated with community transmission. Asking HCP to self-disclose medical conditions could 

result in unintended inequities. 

• ACIP recommendations and CDC guidance must have adequate specificity to be helpful yet allow 

for flexibility to take local considerations into account. Committee members encouraged 

discussion and coordination among CDC and its partners and stakeholders in the development 

of guidance related to sub-prioritization and reactogenicity. 

• It is anticipated that sub-prioritization will be needed for a limited period of time until vaccine 

availability increases. 

Reactogenicity

• The committee emphasized that reactogenicity data currently available are limited, especially 

for older adults, and preclude generalizability to LTCF residents. 

Implementation

• Partnerships between local and state public health authorities and hospitals can facilitate 

decision making around vaccine allocation to HCP and LTCF residents taking into account 

national guidance, the local situation, and considerations related to equitable distribution of 

vaccine. 

• Although measures such as staggering of vaccination in similar units/professions may need to be 

considered for both inpatient and outpatient healthcare settings, the committee also noted that 

the storage, handling, and administration requirements for some vaccines will favor centralized, 

high throughput systems. This will make staggering challenging for both large healthcare 

systems and smaller hospitals. 

• Detailed “gating criteria” will be needed to facilitate moving expeditiously from one Phase to 

the next. 

• There was strong support for CDC’s efforts in the development of communication materials such 

as toolkits for vaccination of HCP and LTCF residents. 

POST-AUTHORIZATION SAFETY MONITORING UPDATE

Dr. Tom Shimabukuro (CDC Vaccine Safety Team Co-Lead) presented “Post-Authorization Safety

Monitoring Update.” Dr. Shimabukuro reviewed the multiple monitoring systems that will be in place for 

safety signal detection and assessment including several new systems to enhance routine vaccine safety 

surveillance. Early data on COVID-19 vaccine safety in HCP will be available primarily through v-safe (a 
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new smartphone based active surveillance system for people who receive COVID-19 vaccine) and 

VAERS. Early data for LTCF residents will be primarily available through VAERS. The National Healthcare 

Safety Network (NHSN) monitoring system will provide aggregated weekly data on the number of 

vaccine doses administered and the occurrence of clinically significant adverse events voluntarily 

reported by 17,000 enrolled LTC facilities. An ACIP COVID-19 Vaccine Safety Technical Sub-Group (VaST)

has been established. Communication materials will be distributed to state health officials, healthcare 

providers, and healthcare systems to increase awareness of the critical importance of safety monitoring 

and the mechanisms for reporting adverse events. 

SUMMARY OF DISCUSSION

• The committee underscored the importance of information materials and clear guidance to 

assist public health partners, stakeholders, and healthcare providers in promoting patient 

participation in v-safe, reporting of adverse events to VAERS, and communicating with partners 

about vaccine safety. 

• Additional outreach and guidance will be needed to increase awareness of safety monitoring 

and reporting mechanisms among healthcare providers who may have limited experience with 

VAERS, as well as providers who serve LTCF resident populations. Rollout of COVID-19 

vaccination programs must be accompanied by robust participation in safety monitoring

systems, with particular attention to LTCF residents. 

• Communication materials should be culturally and linguistically appropriate to enhance patient 

and provider participation in safety monitoring systems. 

THE VOTE: ALLOCATION OF INITIAL SUPPLIES OF COVID-19 VACCINE FOR PHASE 1a 

SUMMARY OF DISCUSSION PRIOR TO THE VOTE

• There was strong consensus for allocation of initial supplies of COVID-19 vaccine to HCP to 

maintain healthcare capacity for care of patients with COVID-19 and other medical conditions. 

• Many committee members expressed support for vaccination of LTCF residents to reduce the 

high burden of morbidity and mortality in this population. 

• Some committee members indicated that their initial hesitation about vaccination of LTCF 

residents had been lessened following the presentation of updated information about enhanced 

safety monitoring procedures and the transparency of consent/assent procedures. The 

insufficiency of non-pharmaceutical measures alone to mitigate transmission in LTCFs and the 

likely variability in LTCF staff uptake of vaccine were additional considerations. 

• A few committee members expressed continued concern about vaccination of LTCF residents

related to the unavailability of vaccine safety and efficacy data for this population, as well as 

what they viewed as an insufficient vaccine safety surveillance network for LTCF residents. To 

reduce transmission in LTCF, educational efforts and promotion of vaccine should be directed to 

LTCF staff. 

• Other members noted that vaccination of LTCF residents may offset opportunities for 

transmission of SARS-CoV-2 if vaccine coverage among LTCF staff is low. Participation in the
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Pharmacy Partnership for Long-term Care Program has the potential to improve uptake of 

vaccine in LTCF staff. 

• Committee members re-iterated the importance of providing clear definitions for HCP and 

LTCFs, as well as clinical guidance related to sub-prioritization, reactogenicity, and 

implementation to accompany publication of the ACIP recommendation for Phase 1a allocation. 

• Clarification was sought and the Work Group Co-Lead confirmed that the ordering of HCP and 

LTCF residents in the text of the interim recommendation does not imply any preferential 

ranking for vaccination implementation. 

THE VOTE

ACIP voted 13-1 in favor of the Phase 1a allocation recommendation as interim guidance. The interim 

recommendation may be updated based on additional safety and efficacy data from Phase III clinical 

trials and the conditions of an FDA EAU. 

SUMMARY OF DISCUSSION AFTER THE VOTE

Committee members cited the following considerations in support of their vote: 

• Consideration of the three pillars of evidence related to science, implementation, and ethical 

principles. 

• Alignment with the ethical principles of maximize benefits and minimize harms; promote justice; 

and mitigate health inequities. 
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• The risk of occupational exposure and the growing number of cases and deaths in HCP; inclusion

of the full diversity of HCP which will help address health inequities; the importance of HCP to

remain healthy to care for patients and maintain strained healthcare systems.

• The disproportionate burden of morbidity and mortality among LTCF residents and the need to

protect a fragile population.

• The efficiency of vaccination of both LTCF residents and staff through the Pharmacy Partnership

for Long-term Care Program.

• The implementation of routine and new systems of surveillance for adverse events and

meticulous assessment of these systems for all populations in Phase 1a, but particularly in LTCF

residents.

• The inclusion of the necessary and appropriate consent/assent procedures for LTCF residents.

• The one vote cast not in favor of the recommendation reflected concerns about the lack of

safety and efficacy data for LTCF residents and the need to test and evaluate vaccines in this

population; there were no reservations regarding allocation of COVID-19 vaccine to HCP.

• The importance of post-recommendation guidance to assist in implementation of the

recommendation.

SUMMARY

• Of the 14 ACIP voting members, 13 voted in favor of the recommendation as interim guidance

and one voted not in favor of the recommendation.

• ACIP will consider vaccine-specific recommendations and additional populations when an FDA

authorized vaccine is available.

Upon reviewing the foregoing version of the December 1, 2020 ACIP meeting summary, Dr. Jose 

Romero certified that to the best of his knowledge, they are accurate and complete. His original, 

signed certification is on file with the Strategic Business Initiatives Unit (SBI) of CDC.

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José R. Romero, MD, FAAP, FIDSA, FPIDS, FAAAS

Chair, Advisory Committee on Immunization Practices 

Certification