ACIP Evidence to Recommendations (EtR) for Use of Bivalent COVID-19 Vaccine Booster Doses under an Emergency Use Authorization

About

The Evidence to Recommendations (EtR) frameworks describe information considered in moving from evidence to ACIP vaccine recommendations.

Summary

Question: Does ACIP support the use of updated (bivalent) COVID-19 vaccine booster doses, for those individuals in age groups currently recommended to receive a COVID-19 vaccine booster?

Population:

Individuals in age groups currently recommended to receive a COVID-19 vaccine booster who have completed a primary vaccination or have received the most recent booster dose with any authorized or approved monovalent COVID-19 vaccine at least two months ago

Intervention:

  • A single dose of bivalent Pfizer-BioNTech COVID-19 vaccine for individuals ages 5 years and older at least 2 months after receipt of a primary series or prior monovalent booster dose
  • A single dose of bivalent Moderna COVID-19 vaccine for individuals ages 6 years and older at least 2 months after receipt of a primary series or prior monovalent booster dose

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 94 million cases and more than 1 million COVID-19-associated deaths have been reported as of August 29, 2022.1 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/Alaska 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.

Four COVID-19 vaccines are currently approved under a Biologics License Application or authorized under an Emergency Use Authorization (EUA) by the Food and Drug Administration (FDA) and recommended for primary vaccination by the Advisory Committee on Immunization Practices (ACIP): 1) the 2-or 3-dose monovalent mRNA Pfizer-BioNTech/Comirnaty COVID-19 vaccine; 2) the 2-or 3-dose monovalent mRNA Moderna/Spikevax COVID-19 vaccine; 3) the single-dose adenovirus vector-based Janssen (Johnson & Johnson) COVID-19 vaccine, and 4) the 2-dose, adjuvanted protein subunit-based Novavax COVID-19 vaccine.

During September – October 2021, the FDA amended the COVID-19 vaccine EUAs to allow for booster doses of Pfizer-BioNTech, Moderna, or Janssen COVID-19 vaccines in persons who completed primary vaccination with these vaccines, as well as use of each of the available COVID-19 vaccines as a heterologous (or "mix and match") booster dose in eligible individuals following completion of primary vaccination with a different COVID-19 vaccine. Previous data on the use of COVID-19 vaccine booster doses is linked here: EtR for Use of COVID-19 Vaccine Booster Doses | CDC.

Furthermore, on March 29, 2022, the FDA amended the COVID-19 vaccine EUAs to authorize a second booster dose of either the Pfizer-BioNTech or the Moderna COVID-19 vaccine for individuals 50 years of age and older as well as certain immunocompromised individuals 12 years of age and older at least 4 months after receipt of a first booster dose of any authorized or approved COVID-19 vaccine.

Additionally, on August 31, 2022, the FDA amended the Emergency Use Authorization (EUA) of the Moderna COVID-19 vaccine and the Pfizer-BioNTech COVID-19 vaccine to authorize bivalent formulations of the vaccines for use as a single booster dose at least two months following primary or booster vaccination. Following FDA's regulatory action, CDC updated its COVID-19 vaccination guidance on September 1, 2022, for use of updated COVID-19 boosters from Pfizer-BioNTech for people ages 12 years and older and from Moderna for people ages 18 years and older to better protect against the most recently circulating COVID-19 variant.

Once more, on October 12, 2022, the FDA amended the Emergency Use Authorization (EUA) of the Moderna COVID-19 vaccine and the Pfizer-BioNTech COVID-19 vaccine to authorize bivalent formulations of the vaccines for use as a single booster dose in younger age groups. The bivalent booster is authorized for administration at least 2 months following completion of primary or booster vaccination in children down to 6 years of age for the Moderna COVID-19 vaccine and down to 5 years of age for the Pfizer-BioNTech COVID-19 vaccine. Subsequent to FDA's regulatory action, CDC expanded the use of updated (bivalent) COVID-19 vaccines to children ages 5 through 11 years.

Additional background information supporting the interim ACIP recommendation on the use of updated (bivalent) COVID-19 vaccine booster doses can be found in the relevant publication of the recommendation referenced on the ACIP website.

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1https://covid.cdc.gov/covid-data-tracker/#trends_dailycases

Problem

Criteria Work Group Judgements Evidence Additional Information
Is the problem of public health importance? Yes Incidence:
As of August 29, 2022, there were 94,110,810 COVID-19 cases reported in the United States.1
Hospitalization:
Hospitalization rates peaked for all age groups during last year’s winter Omicron wave and since April 2022, hospitalization rates in older age groups have increased relative to other age groups.2
In June 2022, unvaccinated adults ages ≥18 years had 4.6X higher COVID-19-associated hospitalization rates compared to those vaccinated with at least one booster dose.3
Mortality:
In June 2022, unvaccinated people ages ≥5 years had 8X higher COVID-19-associated death rates compared to those with at least one booster dose. This was a decrease from ~20X during January – March 2022.4 Additionally, people ages 50 years and older with ≥2 booster doses had 14X lower risk of dying from COVID-19, compared to unvaccinated people and 3X lower risk of dying from COVID-19 than people with one booster dose.5
 Vaccination:
Considering trends in the cumulative percentage of the US population vaccinated with a primary series by age group, persons aged 65 or older have the highest coverage at 92%. This coverage decreases as age decreases with the lowest coverage among persons ages 5-11 years at 30%.
With regard to trends in coverage for first boosters by age group, the highest coverage is again among those ages 65 years or older (69%) with the lowest coverage among persons ages 5-11 (13%).
Pertaining to trends in coverage for second boosters by age group, once again, the highest coverage is among those ages 65 years or older (41%).6

Benefits and Harms

Criteria Work Group Judgements Evidence Additional Information
How substantial are the desirable anticipated effects? Moderate Because data on prevention of symptomatic COVID-19 and immunogenicity on an updated bivalent (ancestral + BA.4/5) booster dose was not yet available, benefits were inferred through immunogenicity from clinical trials using an ancestral + BA.1 bivalent booster dose. Among persons ages ≥18 years, 28 days post Moderna bivalent booster dose, geometric mean ratios of neutralization titers were 1.2-fold higher for ancestral SARS-CoV-2 antibodies and 18-fold higher for Omicron SARS-CoV-2 antibodies compared with receipt of a Moderna monovalent booster dose, regardless of prior infection, meeting superiority criteria.1 With regards to Pfizer-BioNTech bivalent booster, among persons ages >55 years, 1 month post bivalent booster dose, geometric mean ratios of neutralization titers were equivalent for ancestral SARS-CoV-2 antibodies and 1.6-fold higher for Omicron SARS-CoV-2 antibodies compared with receipt of a Pfizer-BioNTech monovalent booster dose, meeting non-inferiority criteria against ancestral strain and superiority criteria against Omicron.2 Additional immunogenicity data for monovalent vaccination were provided in support of a Moderna COVID-19 booster dose in children ages 6-11 years and adolescents ages 12-17 years. Among persons ages 6-11 years and 12-17 years, 28 days post Moderna monovalent booster dose, geometric mean ratios of neutralization titers were 4.2-fold higher and 5.1-fold higher respectively for ancestral SARS-CoV-2 antibodies compared with titers seen 28 days after receipt of a Moderna primary series in young adults ages 18-25 years.3 COVID-19 Scenario Modeling Hub Round 14 and Round 15 were planning scenarios projecting COVID-19 burden through mid-2023 under different booster policies.4  Round 14 showed that regardless of presence of a new variant, flulike vaccine uptake in individuals ages ≥18 years would lead to a > 20% reduction in hospitalizations and >15% reduction in deaths versus a recommendation for individuals ages ≥50 years only. Round 15 demonstrated that absent a new variant, boosters to individuals ages ≥18 years could prevent 137,000 more September hospitalizations and 9,700 more deaths compared to boosters in November.
How substantial are the undesirable anticipated effects? Small In clinical trials for mRNA COVID-19 bivalent booster doses, rates of local or systemic adverse events were similar or less frequent after a bivalent booster as a 4th dose than after the 2nd dose of primary series vaccination or monovalent booster as a 3rd dose. No serious adverse events (SAEs) related to the vaccine were reported for mRNA booster doses.1,2
Risk of myocarditis/pericarditis has been identified after COVID-19 vaccines, though risk after a bivalent booster dose is unknown. The risk following the primary series and monovalent booster is rare and primarily observed in adolescent and young adult males. Review of safety data, including myocarditis risk after bivalent booster dose, will continue.
Do the desirable effects outweigh the undesirable effects? Favors intervention The Work Group concluded that the desirable effects of a COVID-19 bivalent booster vaccine dose outweigh the undesirable effects for the populations under consideration.

Values

Criteria Work Group Judgements Evidence Additional Information
Does the target population feel that the desirable effects are large relative to undesirable effects? Moderate In an ongoing survey designed by the CDC and University of Iowa/RAND Corporation to assess attitudes and intentions for COVID boosters for Fall 2022 among fully vaccinated U.S. adults, 72% of respondents “definitely” or “probably” will get an updated booster that protects against Omicron variants.1 Preventing the spread to others and change in case severity were the most selected facilitators to getting an updated booster. Additionally, 63% of respondents were “extremely” or “somewhat” willing to get an annual flu shot and updated COVID booster at the same visit this Fall.1 The data collection period began August 30, 2022; and is currently ongoing. The participation rates for eligible respondents included 109 vaccinated and boosted and 42 vaccinated and not boosted respondents.1
Is there important uncertainty about or variability in how much people value the main outcomes? Probably important uncertainty or variability In relation to attitudes and intentions for COVID boosters for Fall 2022 among fully vaccinated U.S. adults, belief that previous doses provided enough protection (33.3%) and doubts about an updated vaccine’s efficacy (31.3%) were the top deterrents for being unsure or not intending to get an updated booster.1

Acceptability

Criteria Work Group Judgements Evidence Additional Information
Is the intervention acceptable to key stakeholders? Probably yes As of August 2022, the U.S. COVID-19 vaccination program has met several  milestones including the delivery of over 800 million doses in 88 weeks, over 606 million doses administered in 87 weeks, about 90% of the population ages 18 years and older who have received at least one dose, about 90% of the population ages 65 years and older who are fully vaccinated with 71% boosted and over 223 million people who are fully vaccinated.1
There is a broad network of COVID-19 vaccine providers including approximately 38,000 critical pharmacy providers, nearly 1,500 federal partners and roughly 48,000 jurisdictional providers.

Feasibility

Criteria Work Group Judgements Evidence Additional Information
Is the intervention feasible to implement? Probably yes In relation to trends in completed primary series and first boosters for persons ages 5 – 49 years in the United States, for most individuals ages 5 – 49 years, it has been 6 months or more since their last COVID-19 vaccine dose. Regarding trends in completed series, first, and second boosters for persons ages 50 years and older, while many people have received a 2nd booster in the past 6 months, comparatively few have received a dose in the past 8 weeks. Furthermore, on September 2, 2022, the total number of persons eligible (which includes those who have completed a primary series but not received a COVID-19 vaccine dose in the past 2 months) is roughly 209 million, while the number ineligible (which includes those who have had a vaccine dose in the past 2 months) is less than 5 million.1
As it pertains to jurisdictional planning and considerations, the U.S. Government has purchased approximately 171 million bivalent mRNA COVID-19 vaccine booster doses for the fall and beyond. There will be a sufficient but finite supply of updated (bivalent) COVID-19 vaccines, which should be directed to providers with expected demand among eligible patients. Considerations for selecting sites to receive the initial doses include:
  • Location and access to a range of populations and ensuring that distribution to these groups is equitable to the extent possible
  • Ability to reach eligible persons at highest risk for severe COVID-19 (e.g., older adults, long-term care facility residents, people with certain medical conditions)
  • Ability to handle 100-dose & 300-dose product configurations
  • Ability to administer both Pfizer-BioNTech and Moderna bivalent vaccines to meet anticipated community demand
  • Ability to efficiently vaccinate within 12 hours once a vial is opened
  • Ability to manage inventory to ensure availability of primary series doses, in addition to bivalent booster doses, in their local area when feasible
  • Overall readiness (e.g., staffing, scheduling capabilities)
Considering implementation for bivalent COVID-19 vaccine booster doses, the bivalent vaccines will have the same storage and handling parameters as the monovalent vaccine products. However, both manufacturers’ bivalent vaccines have a grey label border, but different injection volume. The Pfizer-BioNTech vaccine labels for both the monovalent and bivalent vials will have an identical grey cap and grey label border presentation. The Moderna bivalent vaccine will be distinct from the adult monovalent dose (i.e., red cap and light blue label border), but may look similar to the monovalent product for ages 6 – 11 years (i.e., dark blue cap and grey label border).2

Resource Use

Criteria Work Group Judgements Evidence Additional Information
Is the intervention a reasonable and efficient allocation of resources? Probably yes The Commonwealth Fund estimated that an early fall vaccination campaign could avert between $63 billion and $109 billion in medical costs, depending on level of booster coverage achieved, with the majority of savings resulting from averted hospitalizations, particularly in the ICU. Vaccine doses and administration costs would rise between $3.2 billion and $7.4 billion compared with the baseline scenario where vaccination rates remain at the current pace. A booster coverage mirroring the 2020–2021 influenza campaign, translates to $1,241 in savings per dose. In moving from the lower coverage target to the higher, savings of $706 per dose would be realized.1 The cost savings generated as a result of an early fall vaccination campaign were calculated by multiplying the total number of averted health outcomes and the average unit cost of health outcomes due to COVID-19 illness. Costs of health outcomes were stratified into outpatient visits for symptomatic infection, hospitalizations and/or intensive care for severe illness, emergency medical services (EMS) calls, and emergency department visits. Only direct medical costs were considered, not indirect costs.1 See Study Methods for further details.

Health Equity Questions and Evidence Reviewed

CDC is committed to COVID-19 vaccine equity, which is when everyone has fair and just access to COVID-19 vaccination.1 The Evidence to Recommendations Framework (EtR), through which ACIP considers all evidence regarding the potential use of a vaccine to guide its recommendations, includes an Equity Domain. However, the impact of the intervention on health equity was not clear through the current EtRs to date. Therefore, processes were put in place to restructure the Equity domain of the Evidence to Recommendations Framework.

In April – August 2022, a subset of the COVID-19 ACIP Work Group engaged in a critical review of the Equity Domain and gathered extensive input and feedback on strategies to adjust the domain through the following mechanisms: a thorough review of use of the Equity domain (April 2022), a one-time consultation with health equity experts (May 2022), an iterative review of possible adjustment strategies with experts (June – August 2022), presentation to leadership and membership of the National Medical Association and presentation to the Structural & Social Determinants of Health Workgroup of the Office of Minority Health and Health Equity (August 2022). Through this process, it became clear that consideration of equity is integral to every aspect of production, study, authorization, and recommendation of COVID-19 vaccines.

The need for a systematic, reliable, and action-oriented review of evidence toward enhanced equity was also made clear: structural problems require structural solutions. Adjustment of structure is required for meaningful change; and adjustment of the EtR Framework to enable systematic and reliable review of evidence toward actionable recommendations to enhance equity may facilitate meaningful change. Therefore, we proposed a change to restructure the Equity Domain as a consideration across each EtR Domain. We recommend the systematic, reliable inclusion of data to speak to the Equity considerations in each domain, both to demonstrate the data and encourage actions needed to enhance equity as relevant to each domain. Therefore, we will remove the voting question on Equity and enhance attention to equity across all domains. We do not recommend voting on these Equity questions, but rather using them to ensure consideration of equity through every step of the process of production, study, authorization, and recommendation of COVID-19 vaccines. For that reason, while the Work Group reviewed data to support the recommendation, they did not determine their judgement for any of the Equity Domain Questions. This newly proposed structure will be depicted in this Evidence to Recommendations (EtR) Framework.

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1 https://archive.cdc.gov/#/details?url=https://www.cdc.gov/coronavirus/2019-ncov/community/health-equity/vaccine-equity.html

Evidence to Recommendations (EtR) Domain Domain Equity Question Evidence Reviewed
Public Health Problem Does the problem impact all populations equally? In the recent Omicron surge, COVID-19 case rates were higher among large metro classifications, while death rates were higher in rural populations.7
People of racial and ethnic minority groups have been disproportionately burdened by COVID-19 illness, hospitalization, and death. 8,9,10
Benefits and Harms Are the desirable and undesirable anticipated effects demonstrated across all populations equally? The demographic makeup of the Moderna clinical trial consisted of a smaller percentage of Hispanic and Latino participants than the makeup of the United States, according to US census data. Likewise, the trial was comprised of a larger proportion of White participants than the US population.5,6,7
Similarly, the Pfizer-BioNTech trial had less racial and ethnic diversity than the U.S. population. Additionally, since the trial was conducted in persons older than 55 years, the median age of trial participants was much higher than that of the US population.8
For trial results by race/ethnicity, the Moderna trial demonstrated that Omicron B.1 and original strain neutralizing antibodies after a 4th dose were comparable across racial groups.5,6 In the Pfizer-BioNTech trial, subgroups of participants >55 years of age in the safety population had generally similar adverse event profiles from study vaccination to 1-month post-dose, across various vaccine groups when evaluated by subgroups of sex, race, and ethnicity and overall, there were no clinically meaningful differences between subgroups for neutralizing GMTs for the Omicron variant and the original strain.8 However, it should be noted that in both trials, subgroups of race and ethnicity  included a limited number of participants, and their results should be interpreted with caution.
Values Is there important variability in how patients or populations value the outcome? Booster uptake has remained relatively steady, with those groups with higher initial vaccine uptake also more likely to have received their booster dose. This means that older adults (76%), college graduates (67%), and those with higher incomes (62%) remain most likely to be vaccinated and boosted.2 There is a notable difference in “vaccinated” vs “boosted” status among adults of Hispanic/Latino ethnicity, however – despite a high vaccine uptake (83%), about a third (33%) of Hispanic/Latino adults who say they’re fully vaccinated have not received a booster dose.2
When those who are vaccinated for COVID-19 but have not received a booster dose are asked about reasons for not getting a booster, 57% say they feel they have enough protection from their initial vaccination or a prior infection of COVID-19, 52% say they just don’t want to get it, and 48% say they don’t think the boosters are effective, since some vaccinated people are still getting infected. Additionally, vaccinated Hispanic adults without a COVID-19 booster are more likely to report they had bad side effects from a previous dose of the vaccine (36%) than White (21%) or Black adults (14%) and are also more likely than their counterparts to say they are worried about missing work.2
Acceptability Is the intervention equally acceptable across all populations? Regarding the percentage of the population with a completed COVID-19 vaccine primary series by race/ethnicity over time, Asian (62.5%), American Indian/Alaska Native (61.8%) and Native Hawaiian or Other Pacific Islander populations (61.6%) have the highest percentage among those who are fully vaccinated or have completed a primary series. Whereas Black populations (43.1%) have the lowest vaccination rate. As it pertains to booster vaccination trends by race and ethnicity, Multiracial and Asian populations (68.8% and 67.9%, respectively) have the highest percentage among those who have received their first booster dose; and second booster dose receipt is highest among Multiracial populations (42.8%) relative to other racial and ethnic groups.2
There have also been disparities by population for those who have completed a primary series and received a first booster dose by county urbanicity, with those in large central metropolitan areas having a higher vaccination rate than those in rural populations.3
Vaccination rates also vary by both race and ethnicity and disability status. Vaccination rates for those assessed as having different abilities with vision, hearing, mobility, or cognition have lower vaccination rates and this varies by race and ethnicity as well.4
Provider’s recommendation remains very important to COVID-19 vaccine acceptability, and this importance appears highest among adults who are Black (79%), over age 65, retired, or with incomes under $30,000 (56%, respectively). This indicates the potential for healthcare providers to increase the acceptability of the updated (bivalent) COVID-19 boosters through their communication with their patients.5
Feasibility Is the intervention equally feasible to implement across all populations? CDC COVID Data Tracker’s Demographic Characteristics of People Receiving COVID-19 Vaccinations in the United States demonstrates persistent racial and ethnic disparities in receipt of first booster doses among those eligible. Previously reviewed survey data demonstrated that about a third of adults of Hispanic/Latino ethnicity who had completed a primary series had not received a booster. Per CDC COVID Data Tracker, of those ages 12 years and older who are eligible for a first booster, 58.2% of those of Hispanic/Latino ethnicity had not received it. In fact, more than half of those eligible among American Indian/Alaskan Native Non-Hispanic populations (52.4%), Black Non-Hispanic populations (55.4%), Native Hawaiian/Pacific Islander populations (50.6%) have also not received their first booster.3
Resource Use Is the intervention a reasonable and efficient allocation of resources across all populations? Cost-effectiveness data are not yet available for most demographic subgroups, but some information is available for older adults. A study evaluated the cost-effectiveness of the first booster dose of the Pfizer-BioNTech COVID-19 vaccine administered 6 months after the second dose among adults ≥65 years from a healthcare system perspective. Compared with 2 doses of COVID-19 vaccine without a booster, the booster strategy in 100,000 older adults would result in a net monetary benefit of $3.4 million and a gain 3.7 quality-adjusted life-years over 180 days.2 While cost-effectiveness of the boosters is highly sensitive to the population incidence of COVID-19 and vaccine effectiveness, offering the COVID-19 boosters to adults age ≥65 years in the United States is likely to be cost-effective.2

Work Group Interpretation Summary

The Work Group had broad policy discussions around the use of updated (bivalent) COVID-19 vaccines for all people of age groups currently recommended for booster doses. Based on current FDA authorizations, current recommendations would be Pfizer-BioNTech COVID-19 vaccine, bivalent for individuals ages 12 and older and Moderna COVID-19 vaccine, for individuals ages 18 and older. Additional authorizations for other ages and vaccines may follow.

The current population recommended for these boosters is very heterogenous. Many in the United States had Omicron over the past 9 months. Individuals recommended for the bivalent COVID-19 booster doses previously received primary series only, one booster dose and two booster doses for those ages 50 years and older. The balance of benefits and risks for individuals may vary by age, previous receipt of booster, or recent SARS-CoV-2 infection. There are uncertainties around the incremental benefits for some individuals, including those with recent infection or recent vaccine receipt.

COVID-19 vaccines are recommended, even for those with prior infection, as rate of reinfections increased during the Omicron period. Bivalent COVID-19 vaccines in the setting of prior SARS-CoV-2 infection ("hybrid immunity") resulted in highest antibody titers. These high and diverse titers may result in longer duration of protection and decreased need for frequent COVID-19 vaccine booster doses. Studies have shown that increased time between infection and vaccination may result in an improved immune response to vaccination.1 Those with recent SARS-CoV-2 infection may consider delaying a vaccine dose by 3 months from symptom onset or positive test.

Time since most recent COVID-19 vaccine dose may be more important than cumulative number of doses. There will be a time of transition as recommendations may move from counting dose number to optimal timing of vaccination campaigns. Vaccine recommendations that are simple and easy to communicate are important. If SARS-CoV-2 becomes a seasonal virus, an annual vaccine program could be an effective strategy for the future.

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1 www.cdc.gov/acip/media/pdfs/2024/09/11-COVID-Moulia-508.pdf

Implementation and Considerations for Equity

There are many social, geographic, economic, and environmental factors that create challenges to vaccination access and acceptance, and that often affects racial and ethnic minority groups.1

A few key activities for readiness and response for equitable access to updated (bivalent) COVID-19 vaccine booster doses entail:

Supply and ordering readiness

  • Determine which provider locations will receive initial vaccine supply, balancing equitable access with vaccination capacity and consideration of initial demand

Provider readiness

  • Ensure providers are enrolled to reach key populations; identify providers who are not yet COVID-19 vaccination providers and facilitate their enrollment, especially providers who can fill a geographic gap in access and providers who care for people who are at increased risk for developing severe outcomes
  • Ensure providers are aware of resources to help support coadministration of COVID-19 vaccines and other vaccines, including influenza vaccines, during a visit
  • Encourage providers who are not able to offer COVID-19 vaccination to refer their patients to nearby vaccination providers2

Communication

  • Create a communication plan that outlines strategies, audiences, and products that will be used to promote COVID-19 vaccination of unvaccinated key populations and populations recommended for bivalent booster vaccination
  • Understand existing data, attitudes, and perceptions regarding COVID-19 vaccination (including co-administration with influenza vaccine) in terms of demand, provider types, and locations where vaccination would be preferred
    • Share these data with local jurisdictions and partners to help shape messages
  • Develop communication products for providers, pharmacies, and the public that align with federal messaging and ensure communication materials are culturally and linguistically appropriate
  • Leverage partnerships to help mobilize providers and promote COVID-19 bivalent booster vaccination messaging
  • Engage and educate partners and trusted messengers (e.g., healthcare professionals, community leaders, faith leaders and faith-based organizations) as soon as possible

Balance of consequences

Desirable consequences probably and/or 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)

On September 1, 2022, ACIP voted (13-1) in favor of recommending:

A single dose of bivalent Pfizer-BioNTech COVID-19 vaccine for individuals ages 12 years and older at least 2 months after receipt of a primary series or prior monovalent booster dose, under the EUA issued by FDA

ACIP repeals its previous recommendations for administration of monovalent Pfizer-BioNTech COVID-19 vaccine boosters for persons ages 12 years and older

On September 1, 2022, ACIP voted (13-1) in favor of recommending:

A single dose of bivalent Moderna COVID-19 vaccine for individuals ages 18 years and older at least 2 months after receipt of a primary series or prior monovalent booster dose, under the EUA issued by FDA

ACIP repeals its previous recommendations for administration of monovalent Moderna COVID-19 vaccine boosters for persons ages 18 years and older

Final deliberation and decision by ACIP

Final ACIP recommendation

ACIP recommends the intervention.

Updated COVID-19 boosters from Pfizer-BioNTech for people ages 12 years and older and from Moderna for people ages 18 years and older is recommended under an Emergency Use Authorization.

References

Problem:

  1. CDC COVID Data Tracker. https://covid.cdc.gov/covid-data-tracker/#trends_dailycases Accessed August 30, 2022
  2. COVID-NET. https://gis.cdc.gov/grasp/COVIDNet/COVID19_3.html Accessed August 26, 2022
  3. CDC COVID Data Tracker. https://covid.cdc.gov/covid-data-tracker/#covidnet-hospitalizations-vaccination Accessed August 3, 2022
  4. CDC COVID Data Tracker. https://covid.cdc.gov/covid-data-tracker/#rates-by-vaccine-status Accessed August 24, 2022
  5. CDC COVID Data Tracker. https://covid.cdc.gov/covid-data-tracker/#rates-by-vaccinbooine-status Accessed August 24, 2022
  6. Source: CDC Immunization Data Lake. Accessed 8/22/22
  7. CDC COVID Data Tracker. Trends in COVID-19 Cases and Deaths in the United States, by County-level Population Factors. https://covid.cdc.gov/covid-data-tracker/#pop-factors_7daynewcases Accessed August 25, 2022
  8. CDC COVID Data Tracker. COVID-19 Weekly Cases and Deaths per 100,000 Population by Age, Race/Ethnicity, and Sex. https://covid.cdc.gov/covid-data-tracker/#demographicsovertime Accessed August 25, 2022
  9. CDC COVID Data Tracker. COVID-NET Laboratory-confirmed COVID-19 hospitalizations. https://covid.cdc.gov/covid-data-tracker/#covidnet-hospitalization-network Accessed August 25, 2022
  10. Source: https://data.cdc.gov/NCHS/Provisional-Weekly-Deaths-by-Region-Race-Age/tpcp-uiv5 (National Vital Statistics System provisional death certificate data)

Benefits and Harms:

  1. Food and Drug Administration (FDA). FDA briefing document Moderna COVID-19 Vaccine, Bivalent (Original and Omicron BA.4/BA.5). https://www.fda.gov/media/161554/download
  2. Food and Drug Administration (FDA). FDA briefing document Pfizer-BioNTech COVID-19 vaccine, Bivalent (Original and Omicron BA.4/BA.5). https://www.fda.gov/media/161595/download
  3. Food and Drug Administration (FDA). FDA briefing document Moderna COVID-19 Vaccine, Bivalent (Original and Omicron BA.4/BA.5), for 6 years through 17 years of age. https://www.fda.gov/media/162515/download
  4. COVID-19 Scenario Modeling Hub. https://covid19scenariomodelinghub.org/
  5. ACIP Presentation. Moderna COVID-19 Bivalent vaccine (Original and Omicron BA.4/BA.5). www.cdc.gov/acip/media/pdfs/2024/09/06-COVID-Miller-508.pdfAccessed September 1, 2022
  6. A Bivalent Omicron-containing Booster Vaccine Against Covid-19 (medrxiv.org)
  7. U.S. Census Bureau QuickFacts: United States
  8. Pfizer-BioNTech Bivalent booster clinical trial. Unpublished data from manufacturer.

Values:

  1. CDC and University of Iowa/RAND survey, August 2022, unpublished
  2. KFF COVID-19 Vaccine Monitor: July 2022. https://www.kff.org/coronavirus-covid-19/poll-finding/kff-covid-19-vaccine-monitor-july-2022/ Accessed August 9, 2022

Acceptability:

  1. Source: Data pulled from CDC COVID Data Tracker as of 08/17/22
  2. CDC COVID Data Tracker. Trends in Demographic Characteristics of People Receiving COVID-19 Vaccinations in the United States. https://covid.cdc.gov/covid-data-tracker/#vaccination-demographics-trends Accessed August 31, 2022
  3. CDC COVID Data Tracker. COVID-19 Vaccination Equity. https://covid.cdc.gov/covid-data-tracker/#vaccination-equity Accessed August 31, 2022
  4. CDC COVID Data Tracker. COVID-19 Vaccination among People with Disabilities. https://covid.cdc.gov/covid-data-tracker/#vaccinations-disability-status Accessed August 25, 2022
  5. Institute for Healthcare Policy and Innovation. University of Michigan. August 9, 2022. Most older adults are ready to roll up sleeves this fall for updated COVID-19 boosters, U-M poll shows. https://ihpi.umich.edu/news/most-older-adults-ready-roll-sleeves-fall-updated-covid-19-boosters-u-m-poll-shows Accessed August 24, 2022

Feasibility:

  1. Source: CDC IZDL; Accessed 8/22/22
  2. CDC Fall Vaccination Operational Planning Guide – Information for the Fall Vaccine Campaign, Including Upcoming Bivalent COVID-19 Vaccine Booster Doses. www.cdc.gov/vaccines/covid-19/downloads/CDC-Fall-Vaccination-Operational-Planning-Guide.pdf Accessed August 19, 2022
  3. CDC COVID Data Tracker. Demographic Characteristics of People Receiving COVID-19 Vaccinations in the United States. https://covid.cdc.gov/covid-data-tracker/#vaccination-demographic Accessed August 27, 2022

Resource Use:

  1. Abhishek Pandey et al., "How Many Lives Could a Fall COVID-19 Booster Campaign Save in the United States?" To the Point (blog), Commonwealth Fund, July 26, 2022. https://doi.org/10.26099/rc8x-dx51
  2. Li, R., et al. (2022). "Cost-effectiveness analysis of BNT162b2 COVID-19 booster vaccination in the United States." International Journal of Infectious Diseases 119: 87-94. https://doi.org/10.1016/j.ijid.2022.03.029

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Content Source:
National Center for Immunization and Respiratory Diseases (NCIRD)