COVID-19 Vaccine Uptake and Intentions Following US Food and Drug Administration Approval of the Pfizer-BioNTech COVID-19 Vaccine | Vaccination | JAMA Internal Medicine | JAMA Network
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Table 1.  Characteristics of 516 Unvaccinated Respondents After US Food and Drug Administration Full Approval of the BNT162b2 COVID-19 Vaccine
Characteristics of 516 Unvaccinated Respondents After US Food and Drug Administration Full Approval of the BNT162b2 COVID-19 Vaccine
Table 2.  Demographic Associations With Vaccination Intentions in Response to US Food and Drug Administration Full Approval of the BNT162b2 COVID-19 Vaccine Among 465 Respondentsa
Demographic Associations With Vaccination Intentions in Response to US Food and Drug Administration Full Approval of the BNT162b2 COVID-19 Vaccine Among 465 Respondentsa
1.
Centers for Disease Control and Prevention (CDC). COVID-19 vaccinations in the United States. 2022. Accessed February 3, 2022. https://covid.cdc.gov/covid-data-tracker/#vaccinations_vacc-total-admin-rate-total
2.
Kaiser Family Foundation. KFF COVID-19 Vaccine Monitor—June 2021. 2021. Accessed February 3, 2022. https://www.kff.org/coronavirus-covid-19/poll-finding/kff-covid-19-vaccine-monitor-june-2021/
3.
de Beaumont Foundation. Poll: 1/3 of unvaccinated adults say FDA approval of Pfizer vaccine will address their safety concerns. 2021. Accessed February 3, 2022. https://debeaumont.org/news/2021/poll-1-3-of-unvaccinated-adults-say-fda-approval-of-pfizer-vaccine-will-address-their-safety-concerns/
4.
45 CFR 46. Centers for Disease Control & Prevention. March 10, 2021. Accessed January 6, 2022. https://www.hhs.gov/ohrp/regulations-and-policy/regulations/45-cfr-46/index.html
5.
US Economic Research Service/US Department of Agriculture. Rural-urban commuting area codes. 2020. Accessed February 4, 2022. https://www.ers.usda.gov/data-products/rural-urban-commuting-area-codes.aspx
6.
US Census Bureau. Census regions and divisions of the United States. 2013. Accessed December 28, 2021. https://www2.census.gov/geo/pdfs/maps-data/maps/reference/us_regdiv.pdf
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    Research Letter
    April 11, 2022

    COVID-19 Vaccine Uptake and Intentions Following US Food and Drug Administration Approval of the Pfizer-BioNTech COVID-19 Vaccine

    Author Affiliations
    • 1Department of Internal Medicine, University of Iowa, Iowa City
    • 2RAND Corporation, Pittsburgh, Pennsylvania
    • 3Division of Infectious Diseases, Boston Children’s Hospital and Harvard Medical School, Boston, Massachusetts
    • 4Department of Community and Behavioral Health, University of Iowa, Iowa City
    • 5Department of Epidemiology, University of Iowa, Iowa City
    • 6Centers for Disease Control and Prevention COVID-19 Response, Atlanta, Georgia
    JAMA Intern Med. 2022;182(6):678-680. doi:10.1001/jamainternmed.2022.0761

    Despite the availability of safe and effective COVID-19 vaccines, 25% of American adults remained partially vaccinated or unvaccinated against COVID-19 at the beginning of 2022.1 Lack of a formally approved COVID-19 vaccine was a common reason given for nonvaccination in polls prior to US Food and Drug Administration (FDA) approval of the biologics license application—also called full approval—for the BNT162b2 (Pfizer-BioNTech) COVID-19 vaccine.2,3 Understanding the repercussions for vaccination intentions after FDA full approval is important for informing vaccination interventions and policy in future infectious disease outbreaks. The primary objective of this survey with unvaccinated US adults was to assess vaccination intentions in response to full approval of the BNT162b2 COVID-19 vaccine and any demographic associations with these intentions.

    Methods

    A national, cross-sectional, convenience sample of 535 US adults (aged ≥18 years) who had not received a COVID-19 vaccine dose prior to full approval of the BNT162b2 COVID-19 vaccine (on August 23, 2021) completed our online Qualtrics survey between August 24 and September 9, 2021. We used Dynata’s Consumer Research Panel and quota-based sampling for self-reported gender, age, and race and ethnicity to recruit a sample reflecting national distributions of these demographic characteristics for unvaccinated Americans. Dynata’s sampling algorithm routed potentially eligible panelists to our survey until all quotas were achieved. This activity was reviewed and approved by the University of Iowa Institutional Review Board and the Centers for Disease Control and Prevention (CDC) and complied with applicable federal law and CDC policy.4 We followed portions of the American Association for Public Opinion Research (AAPOR) and Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) reporting guidelines. The primary outcome was stated COVID-19 vaccination intentions in response to FDA approval (response options provided in Table 1). Based on their response, respondents were categorized into 1 of 3 vaccine-intention groups (coded as 3 dummy variables):

    • Acceptant: Getting vaccinated as soon as possible responses

    • Hesitant: Continuing to wait for more safety or efficacy data, or “unsure” responses

    • Resistant: Definitely not getting vaccinated or “only if mandated” responses

    Odds ratios (ORs) from logistic regressions were computed using Stata, version 14.2 (StataCorp LLC), with vaccination groups as dependent measures and gender, age, race and ethnicity, educational level, census region,6 and urbanicity or rurality5 as risk factors. Significance testing was 2-sided; P < .05 indicated statistical significance. Unweighted analyses are reported herein.

    Results

    Among 535 respondents, 19 (3.6%) reported receiving their first COVID-19 vaccine dose after August 23, 2021. Table 1 presents characteristics for the 516 respondents who still had not received a COVID-19 vaccine dose at the time of survey completion. Few respondents (45 [8.7%]) were in the acceptant group; the remaining respondents were split between the hesitant (244 respondents [47.3%]) and resistant (224 [43.5%]) groups. Table 1 presents results for each response option.

    Non-Hispanic Black respondents had significantly increased odds of being acceptant in response to the FDA approval (OR, 2.64; 95% CI, 1.14-6.11; P = .02). Hispanic respondents had significantly increased odds of being hesitant (OR, 2.06; 95% CI, 1.14-3.76; P = .02) and significantly decreased odds of being resistant (OR, 0.52; 95% CI, 0.28-0.87; P = .04) in response to the FDA approval. There were no other significant demographic differences in the odds of being in each vaccination intention category (Table 2). Weighted analyses based on population gender, age, and race and ethnicity produced nearly identical results.

    Discussion

    Lack of full FDA approval for any COVID-19 vaccine was a common rationale provided by unvaccinated Americans.2,3 Our results suggest the full approval of the BNT162b2 COVID-19 vaccine had little immediate impact on vaccination intentions. Unvaccinated Americans who said they were awaiting full FDA approval before being vaccinated may have been providing a socially desirable response, or they may subsequently have “moved the goal post” for the level of vaccine safety and efficacy data needed before vaccinating after FDA approval occurred. Key limitations of this study include nonrepresentation by those without internet access or with limited ability to understand English. This survey study’s finding of the limited impact of full FDA approval of the BNT162b2 COVID-19 vaccine for vaccination intentions should be considered when vaccine-related interventions and policies are developed during future infectious disease outbreaks.

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    Article Information

    Accepted for Publication: February 14, 2022.

    Published Online: April 11, 2022. doi:10.1001/jamainternmed.2022.0761

    Corresponding Author: Aaron M. Scherer, PhD, Department of Internal Medicine, University of Iowa, 200 Hawkins Dr, Iowa City, IA 52242 (aaron-scherer@uiowa.edu).

    Author Contributions: Dr Scherer had full access to all data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis.

    Concept and design: Scherer, Parker, Gidengil, Askelson, Petersen, Lindley.

    Acquisition, analysis, or interpretation of data: Parker, Gidengil, Gedlinske, Petersen.

    Drafting of the manuscript: Scherer, Parker, Gidengil.

    Critical revision of the manuscript for important intellectual content: Parker, Gidengil, Gedlinske, Askelson, Petersen, Lindley.

    Statistical analysis: Scherer, Gedlinske.

    Obtained funding: Scherer, Parker, Gidengil, Askelson.

    Supervision: Scherer, Parker, Petersen.

    Conflict of Interest Disclosures: None reported.

    Funding/Support: This study was supported in part by Cooperative Agreement 1U01IP001144 from the Centers for Disease Control and Prevention (CDC) (Drs Scherer, Parker, Gidengil, Petersen, and Askelson and Ms Gedlinske) and K01 Award 1K01AG065440 from the National Institutes of Health/National Institute on Aging (NIH/NIA) (Dr Scherer).

    Role of the Funder/Sponsor: Per the terms of the cooperative agreement, CDC requested the survey, provided the survey topic, and reviewed and approved the study materials and this manuscript. Additionally, the CDC Project Manager (Ms Lindley) of the cooperative agreement is a coauthor of this article. However, CDC had no role in the conduct of the study; collection, management, analysis, and interpretation of the data; or decision to submit the manuscript for publication. The NIH/NIA had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication.

    References
    1.
    Centers for Disease Control and Prevention (CDC). COVID-19 vaccinations in the United States. 2022. Accessed February 3, 2022. https://covid.cdc.gov/covid-data-tracker/#vaccinations_vacc-total-admin-rate-total
    2.
    Kaiser Family Foundation. KFF COVID-19 Vaccine Monitor—June 2021. 2021. Accessed February 3, 2022. https://www.kff.org/coronavirus-covid-19/poll-finding/kff-covid-19-vaccine-monitor-june-2021/
    3.
    de Beaumont Foundation. Poll: 1/3 of unvaccinated adults say FDA approval of Pfizer vaccine will address their safety concerns. 2021. Accessed February 3, 2022. https://debeaumont.org/news/2021/poll-1-3-of-unvaccinated-adults-say-fda-approval-of-pfizer-vaccine-will-address-their-safety-concerns/
    4.
    45 CFR 46. Centers for Disease Control & Prevention. March 10, 2021. Accessed January 6, 2022. https://www.hhs.gov/ohrp/regulations-and-policy/regulations/45-cfr-46/index.html
    5.
    US Economic Research Service/US Department of Agriculture. Rural-urban commuting area codes. 2020. Accessed February 4, 2022. https://www.ers.usda.gov/data-products/rural-urban-commuting-area-codes.aspx
    6.
    US Census Bureau. Census regions and divisions of the United States. 2013. Accessed December 28, 2021. https://www2.census.gov/geo/pdfs/maps-data/maps/reference/us_regdiv.pdf
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