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Odds of Testing Positive for SARS-CoV-2 Following Receipt of 3 vs 2 Doses of the BNT162b2 mRNA Vaccine
Open accessPublished version of a preprint
Abstract
Importance: With the evidence of waning immunity of the mRNA vaccine BNT162b2 (Pfizer-BioNTech), a nationwide third-dose (booster) vaccination campaign was initiated in Israel during August 2021; other countries have begun to administer a booster shot as well. Objective: To evaluate the initial short-term additional benefit of a 3-dose vs a 2-dose regimen against infection of SARS-CoV-2. Design, Setting, and Participants: This preliminary retrospective case-control study used 2 complementary approaches: a test-negative design and a matched case-control design. Participants were included from the national centralized database of Maccabi Healthcare Services, an Israeli healthcare maintenance organization covering 2.5 million members. Data were collected between March 1, 2020, and October 4, 2021, and analyses focused on the period from August 1, 2021, to October 4, 2021, because the booster dose was widely administered from August 1 onward. Exposures: Either 2 doses or 3 doses of the BNT162b2 vaccine. Main Outcomes and Measures: The reduction in the odds of a positive SARS-CoV-2 polymerase chain reaction (PCR) test at different time intervals following receipt of the booster dose (0-6, 7-13, 14-20, 21-27, and 28-65 days) compared with receiving only 2 doses. Results: The study population included 306 710 members of Maccabi Healthcare Services who were 40 years and older (55% female) and received either 2 or 3 doses of the BNT162b2 vaccine and did not have a positive PCR test result for SARS-CoV-2 prior to the start of the follow-up period. During this period, there were 500 232 PCR tests performed, 227 380 among those who received 2 doses and 272 852 among those who received 3 doses, with 14 989 (6.6%) and 4941 (1.8%) positive test results in each group, respectively. Comparing those who received a booster and those who received 2 doses, there was an estimated odds ratio of 0.14 (95% CI, 0.13-0.15) 28 to 65 days following receipt of the booster (86% reduction in the odds of testing positive for SARS-CoV-2). Conclusion and Relevance: Previous studies have demonstrated that vaccine-derived protection against SARS-CoV-2 wanes over time. In this case-control analysis, we showed an association between receipt of the booster dose and a reduction in the odds of testing positive for SARS-CoV-2, potentially counteracting waning immunity in the short term. Further monitoring of data from this population is needed to determine the duration of immunity following the booster.
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“The 7-day cutoff was chosen based on previous research the BNT162b2 vaccine effectivenesss1,11.”
From Waning effectiveness of the third dose of the BNT162b2 mRNA COVID-19 vaccine (2022) · cites this paper as [11]
Experimental — accuracy not yet measuredThe source backs part of the claim, not all of it — or backs it for a different population, condition or comparison.
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“However, as by the outcome period of January 2022 most of Israel’s population had already received the booster, the reference group of those unvaccinated is admittedly prone to bias, as has been discussed in the previous papers11.”
From Waning effectiveness of the third dose of the BNT162b2 mRNA COVID-19 vaccine (2022) · cites this paper as [11]
Experimental — accuracy not yet measuredThe source backs part of the claim, not all of it — or backs it for a different population, condition or comparison.
In the citing paper
“Studies have demonstrated that the third dose increases immunogenicity against SARS-CoV-2 as reflected by a rapid and broad immune response to the third BNT162b2 dose7,11.”
From Waning effectiveness of the third dose of the BNT162b2 mRNA COVID-19 vaccine (2022) · cites this paper as [11]
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“The test-negative design, which does not assume that a lack of a positive test equals a negative test and somewhat adjusts for testing volume, attempts to better mitigate this bias and is the reason we chose this method for this analysis”
From Waning effectiveness of the third dose of the BNT162b2 mRNA COVID-19 vaccine (2022) · cites this paper as [11]
In the citing paper
“Nonetheless, supporting this design were previous covid-19 studies implementing a test negative design that yielded comparable results to cohort studies on this population,6 11 while presenting diminished bias in the short term outcomes of vaccinee effectiveness.”
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“The lack of pre-defined PCR testing protocols implemented in the study population also presented a challenge. This limitation has been discussed extensively in previous covid-19 observational studies and could lead to potential biases relating to healthcare seeking behaviour.6 11 38 39”
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“A second limitation stems from the varying dominance of different SARS-CoV-2 variants over time. The period after fourth dose vaccination in Israel has been dominated by the omicron variant, which makes assessing the relative effectiveness of the fourth dose against other covid-19 variants difficult—a well recognised limitation of real world analyses during this pandemic.6 36 37”
In the citing paper
“Therefore, apart from potential scarcity of data in comparing to unvaccinated individuals, this eligible yet unvaccinated population in a massively campaigned environment such as Israel is plausibly different in terms health related behaviour, which could introduce a bias in rendering it the reference group,43 as has been pointed out in previous vaccination studies of Israeli populations measuring”
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Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine
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BNT162b2 mRNA Covid-19 Vaccine in a Nationwide Mass Vaccination Setting
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Protection of BNT162b2 Vaccine Booster against Covid-19 in Israel
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Three Doses of an mRNA Covid-19 Vaccine in Solid-Organ Transplant Recipients
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Metadata
- Authors
- Patalon, T., Gazit, S., Pitzer, V. E., Prunas, O., Warren, J. L., & Weinberger, D. M.
- Affiliations
- Maccabi Healthcare Services (IL)
- Yale University (US)
- Corresponding author
- Weinberger, Daniel M.
- ORCID
- Venue
- JAMA Internal Medicine
- Publisher
- American Medical Association (AMA)
- Published
- 2022-02-01
- Volume
- 182
- Issue
- 2
- Pages
- 179
- ISSN
- 2168-6106 (ISSN-L)
- PMC
- PMC8634151
- OpenAlex
- W3216645551
- Cited by
- 141
- References
- 21
- Citations by year
- 2026: 2 · 2025: 1 · 2024: 11 · 2023: 33 · 2022: 83
- FWCI
- 10.93
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- JAMA Internal Medicine (publishedVersion)
- medRxiv (acceptedVersion)
- PubMed Central (publishedVersion)
- PubMed (publishedVersion)
- Funders
- National Institutes of Health (UL1TR001863)
- National Institute of Allergy and Infectious Diseases (R01AI137093)
- National Center for Advancing Translational Sciences
- Topics
- Health Sciences › Medicine › Infectious Diseases › SARS-CoV-2 and COVID-19 Research
- Social Sciences › Health › Vaccine Coverage and Hesitancy
- Physical Sciences › Mathematics › Modeling and Simulation › COVID-19 epidemiological studies
- Keywords
- BNT162b2 mRNA vaccine, COVID-19 booster vaccination, third dose vaccination, COVID-19 pandemic, vaccine waning, test-negative design, matched case-control studies, PCR-confirmed infection, vaccine effectiveness, older adults, Maccabi Healthcare Services, SARS-CoV-2 variants, Omicron variant, Delta variant
- MeSH terms
- COVID-19, SARS-CoV-2, COVID-19 Vaccines, BNT162 Vaccine, Adult, Female, Humans, Male, Retrospective Studies, Time Factors, Incidence, Case-Control Studies, Comparative Effectiveness Research
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