Waning Effectiveness of the Third Dose of the BNT162b2 mRNA COVID-19 Vaccine

Patalon, Tal; Saciuk, Yaki; Peretz, Asaf; Perez, Galit; Lurie, Yoav; Maor, Yasmin; Gazit, Sivan

doi:10.1101/2022.02.25.22271494

PreprintCited by 143SARS-CoV-2 and COVID-19 ResearchVaccine Coverage and HesitancyCOVID-19 epidemiological studies

Waning Effectiveness of the Third Dose of the BNT162b2 mRNA COVID-19 Vaccine

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Patalon, Tal, Saciuk, Yaki, Peretz, Asaf, Perez, Galit, Lurie, Yoav, Maor, Yasmin, Gazit, Sivan·2022·Nature Communications

DOI 10.1101/2022.02.25.22271494PMC PMC9184525

Preprint — published as 10.1038/s41467-022-30884-6 · Paper page

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Abstract

The duration of protection of the third (booster) dose of the BioNTech/Pfizer BNT162b2 mRNA Coronavirus Disease 2019 vaccine has yet to be sufficiently researched, while global discussions around the necessity and effectiveness of a fourth dose are already underway. By conducting a retrospective study implementing a test-negative case-control design, analyzing 546,924 PCR tests performed throughout January 2022 by 389,265 persons who received three doses of the vaccine, we found that the effectiveness in each month since vaccination decreased significantly. Compared to those vaccinated early, on August 2021, relative protection against infection waned from 53.4% a month after vaccination to 16.5% three months after vaccination. These results suggest that there is a significant waning of vaccine effectiveness against the Omicron variant of the third dose of the BNT162b2 vaccine within a few months after administration and should prompt policy discussion as to additional booster doses and vaccine development.

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Consistent findings were reached, indicating rapid waning of vaccine protection against symptomatic Omicron infection, consistent with findings of other studies for effectiveness against Omicron infection (with no BA.1/BA.2 subvariant specified).
“Notwithstanding these limitations, consistent findings were reached, indicating rapid waning of vaccine protection against symptomatic Omicron infection that are consistent with findings of other studies for effectiveness against Omicron infection (with no BA.1/BA.2 subvariant specified)42–48.”
From Duration of mRNA vaccine protection against SARS-CoV-2 Omicron BA.1 and BA.2 subvariants in Qatar (2022) · cites this paper as [45]
Compared with the previously demonstrated waning pattern of relative vaccine effectiveness of three doses versus two doses in real world settings, the relative effectiveness of the fourth dose against infection appears to wane sooner, just as waning after the third dose was sooner than after the second dose.
“Nonetheless, compared with the previously demonstrated waning pattern of the relative vaccine effectiveness of three doses versus two doses in real world settings (which begins around three months after inoculation), the relative effectiveness of the fourth dose against infection appears to wane sooner, just as waning after the third dose was sooner than after the second dose.11 26”
From Short term, relative effectiveness of four doses versus three doses of BNT162b2 vaccine in people aged 60 years and older in Israel: retrospective, test negative, case-control study (2022) · cites this paper as [11]
The waning of vaccine effectiveness against SARS-CoV-2 infection is consistent with previous observations of the second and third doses of the BNT162b2 vaccine.
“The waning of vaccine effectiveness against SARS-CoV-2 infection is consistent with previous observations of the second and third doses of the BNT162b2b vaccine.10 11”
From Short term, relative effectiveness of four doses versus three doses of BNT162b2 vaccine in people aged 60 years and older in Israel: retrospective, test negative, case-control study (2022) · cites this paper as [11]
The eligible yet unvaccinated population in a massively campaigned environment such as Israel is plausibly different in health related behaviour, which could introduce a bias in rendering it the reference group.
“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”
From Short term, relative effectiveness of four doses versus three doses of BNT162b2 vaccine in people aged 60 years and older in Israel: retrospective, test negative, case-control study (2022) · cites this paper as [11]
Previous covid-19 studies implementing a test negative design yielded comparable results to cohort studies on this population, while presenting diminished bias in short term outcomes of vaccine effectiveness.
“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.”
From Short term, relative effectiveness of four doses versus three doses of BNT162b2 vaccine in people aged 60 years and older in Israel: retrospective, test negative, case-control study (2022) · cites this paper as [11]

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Mizrahi B, Lotan R, Kalkstein N, et al. Correlation of SARS-CoV-2-breakthrough infections to time-from-vaccine. Nat Commun. 2021;12(1):1-5.

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Vaccinating against a Novel Pathogen: A Critical Review of COVID-19 Vaccine Effectiveness Evidence
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Real-World COVID-19 Vaccine Protection Rates against Infection in the Delta and Omicron Eras
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A live attenuated SARS-CoV-2 vaccine constructed by dual inactivation of NSP16 and ORF3a
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Exploring a COVID‐19 Endemic Scenario: High‐Resolution Agent‐Based Modeling of Multiple Variants
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Efficacy of the Second COVID-19 Vaccine Booster Dose in the Elderly
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Immunogenicity and SARS-CoV-2 Infection following the Fourth BNT162b2 Booster Dose among Health Care Workers
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Decoding the paradox: Understanding Elevated Hospitalization and Reduced Mortality in SARS-CoV-2 Variants
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Protection against Omicron BA.1/BA.2 severe disease 0–7 months after BNT162b2 booster
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An analysis of the waning effect of COVID-19 vaccinations
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COVID-19 Vaccine Effectiveness of Booster Doses Against Delta and Omicron Variants Over Follow-up Times Using Longitudinal Meta-analysis
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Evaluation of Strategies for Transitioning to Annual SARS-CoV-2 Vaccination Campaigns in the United States
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Assessing the impact of vaccination and medical resource allocation on infectious disease outbreak management: a case study of COVID-19 in Taiyuan City
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As the virus evolves, so too must we: a drug developer’s perspective
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The nuts and bolts of recombination in the generation of SARS-CoV-2 variants; from XA to XBB
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Antibody Response against Circulating Omicron Variants 8 Months after the Third Dose of mRNA Vaccine
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Association between BNT162b2 vaccination and health-related quality of life up to 18 months post-SARS-CoV-2 infection in Israel
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Cost effectiveness analysis comparing varying booster intervals of vaccination policies to address COVID-19 situation in Thailand, 2023
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Evolutionary dynamics of voluntary vaccination for imperfect multi-efficacy vaccines
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Fourth dose of BNT162b2 vaccine for patients with autoimmune rheumatic diseases in a nationwide setting
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The pattern from the first three rounds of vaccination: declining vaccination rates
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Evaluating the Adverse Events Associated with Three Doses of the COVID-19 Vaccination in Adults in the Western Region of Saudi Arabia: A Cross-Sectional Study
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Receiving three doses of inactivated or mRNA COVID-19 vaccines was associated with lower odds of long COVID symptoms among people with a history of SARS-CoV-2 infection in Hong Kong, China: a cross-sectional survey study
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Immunocompromise and durability of BNT162b2 vaccine against severe outcomes due to omicron and delta variants
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Effectiveness of BNT162b2 mRNA vaccine third doses and previous infection in protecting against SARS-CoV-2 infections during the Delta and Omicron variant waves; the UK SIREN cohort study September 2021 to February 2022
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Effectiveness of Messenger RNA–based Vaccines During the Emergence of the Severe Acute Respiratory Syndrome Coronavirus 2 Omicron Variant
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Authors: Patalon, T., Saciuk, Y., Peretz, A., Perez, G., Lurie, Y., Maor, Y., & Gazit, S.
Affiliations: Maccabi Healthcare Services (IL)
Shaare Zedek Medical Center (IL)
Corresponding author: Patalon, Tal
ORCID: Patalon, Tal
Saciuk, Yaki
Peretz, Asaf
Lurie, Yoav
Gazit, Sivan
Venue: Nature Communications
Publisher: openRxiv
Published: 2022-02-26
Volume: 13
Issue: 1
Pages: 3203-3203
ISSN: 2041-1723 (ISSN-L)
DOI: 10.1101/2022.02.25.22271494
PMC: PMC9184525
OpenAlex: W4281648214
Cited by: 143
References: 23
Citations by year: 2026: 4 · 2025: 15 · 2024: 25 · 2023: 56 · 2022: 43
FWCI: 16.99
Type: journal article
Language: en
Open access: gold
doi.org
Licence: cc-by
Locations: Nature Communications (publishedVersion, cc-by)
medRxiv (acceptedVersion)
PubMed Central (publishedVersion, cc-by)
PubMed (publishedVersion)
RePEc: Research Papers in Economics (submittedVersion)
DOAJ (DOAJ: Directory of Open Access Journals) (submittedVersion)
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 vaccines, booster vaccination, waning vaccine effectiveness, Omicron variant, COVID-19 pandemic, test-negative case-control, PCR testing, duration of protection
MeSH terms: COVID-19, SARS-CoV-2, COVID-19 Vaccines, BNT162 Vaccine, Humans, Retrospective Studies, RNA, Messenger

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Waning Effectiveness of the Third Dose of the BNT162b2 mRNA COVID-19 Vaccine

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