Waning of BNT162b2 Vaccine Protection against SARS-CoV-2 Infection in Qatar
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Abstract
BACKGROUND: Waning of vaccine protection against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection or coronavirus disease 2019 (Covid-19) is a concern. The persistence of BNT162b2 (Pfizer-BioNTech) vaccine effectiveness against infection and disease in Qatar, where the B.1.351 (or beta) and B.1.617.2 (or delta) variants have dominated incidence and polymerase-chain-reaction testing is done on a mass scale, is unclear. METHODS: We used a matched test-negative, case-control study design to estimate vaccine effectiveness against any SARS-CoV-2 infection and against any severe, critical, or fatal case of Covid-19, from January 1 to September 5, 2021. RESULTS: Estimated BNT162b2 effectiveness against any SARS-CoV-2 infection was negligible in the first 2 weeks after the first dose. It increased to 36.8% (95% confidence interval [CI], 33.2 to 40.2) in the third week after the first dose and reached its peak at 77.5% (95% CI, 76.4 to 78.6) in the first month after the second dose. Effectiveness declined gradually thereafter, with the decline accelerating after the fourth month to reach approximately 20% in months 5 through 7 after the second dose. Effectiveness against symptomatic infection was higher than effectiveness against asymptomatic infection but waned similarly. Variant-specific effectiveness waned in the same pattern. Effectiveness against any severe, critical, or fatal case of Covid-19 increased rapidly to 66.1% (95% CI, 56.8 to 73.5) by the third week after the first dose and reached 96% or higher in the first 2 months after the second dose; effectiveness persisted at approximately this level for 6 months. CONCLUSIONS: BNT162b2-induced protection against SARS-CoV-2 infection appeared to wane rapidly following its peak after the second dose, but protection against hospitalization and death persisted at a robust level for 6 months after the second dose. (Funded by Weill Cornell Medicine-Qatar and others.).
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Third-dose effectiveness may be declining faster than that of the second dose.
“However, it seems that effectiveness could be declining faster than that of the second dose6,19.”
From Waning effectiveness of the third dose of the BNT162b2 mRNA COVID-19 vaccine (2022) · cites this paper as [6]
The Results section reports that effectiveness against infection declined after the second dose, accelerating after the fourth month. It does not assess effectiveness after a third dose or compare the rates of decline, so it cannot support the claim that third-dose effectiveness may decline faster. (LLM, conf=0.85)
Experimental — accuracy not yet measuredAdditional vaccine effectiveness studies revealed waning of vaccine-induced protection over time.
“However, as vaccination campaigns progressed, additional vaccine effectiveness (VE) studies revealed waning of the vaccine-induced protection over time [8-13]”
Matching on sex, age, nationality, and calendar week was previously shown to adequately control for differences in SARS-CoV-2 exposure risk in Qatar.
“Matching according to these factors was previously shown to provide adequate control of differences in the risk of SARS-CoV-2 exposure in studies of different designs, all of which involved control groups, such as test-negative, case–control studies.”
From Effects of Previous Infection and Vaccination on Symptomatic Omicron Infections (2022) · cites this paper as [12]
The inclusion and exclusion criteria were implemented to allow immunity to build after vaccination and to reduce several potential biases.
“These inclusion and exclusion criteria were implemented to allow for build-up of immunity after vaccination4,14 and to minimize different types of potential bias, as informed by earlier analyses in the same population.”
From Effects of Previous Infection and Vaccination on Symptomatic Omicron Infections (2022) · cites this paper as [12]
Matching was not possible for coexisting conditions, but matching on sex, age, and nationality provided demonstrable control of bias in earlier studies.
“Although matching was performed according to sex, age, and nationality, matching was not possible for other factors, such as coexisting conditions. However, matching according to these factors provided demonstrable control of bias in our earlier studies.11,12,15,21,22”
From Effects of Previous Infection and Vaccination on Symptomatic Omicron Infections (2022) · cites this paper as [12]
With the mass scale of PCR testing in Qatar, the likelihood of bias is perhaps minimized.
“Moreover, with the mass scale of PCR testing in Qatar,12 the likelihood of bias is perhaps minimized.”
From Effects of Previous Infection and Vaccination on Symptomatic Omicron Infections (2022) · cites this paper as [12]
Extensive sensitivity and additional analyses were conducted to investigate potential bias in earlier studies using similar methods, and these analyses showed consistent findings.
“Extensive sensitivity and additional analyses were conducted to investigate effects of potential bias in our earlier studies that used similar methods. These included different adjustments and controls in the analysis and different study inclusion and exclusion criteria to investigate whether effectiveness estimates could have been biased.12,22 These analyses showed consistent findings.2,3,12,17,2”
From Effects of Previous Infection and Vaccination on Symptomatic Omicron Infections (2022) · cites this paper as [12]
The bias may have also arisen because the reference group of unvaccinated individuals included mainly children or young persons, and therefore may not be representative of the wider population.
“With the high vaccine coverage among adults in Qatar (>85%)13, this bias may have also risen because the reference group of unvaccinated individuals included mainly children or young persons; therefore, it may not be representative of the wider population.”
From Duration of mRNA vaccine protection against SARS-CoV-2 Omicron BA.1 and BA.2 subvariants in Qatar (2022) · cites this paper as [13]
The findings support the durability of mRNA vaccine protection against COVID-19 hospitalization and death for at least several months after receiving the second dose.
“These findings support the durability of vaccine protection against COVID-19 hospitalization and death for at least several months after receiving the second dose,13,14,23”
From Duration of mRNA vaccine protection against SARS-CoV-2 Omicron BA.1 and BA.2 subvariants in Qatar (2022) · cites this paper as [13]
Bias due to depletion of the susceptible population may lead to underestimation of vaccine effectiveness, even in the test-negative, case-control study design.
“Bias due to depletion of the susceptible population may lead to underestimation of vaccine effectiveness34, even in the test-negative, case–control, study design, which is less prone to effect of this bias13.”
From Duration of mRNA vaccine protection against SARS-CoV-2 Omicron BA.1 and BA.2 subvariants in Qatar (2022) · cites this paper as [13]
Matching by sex, age, and nationality provided demonstrable control of bias in studies of different epidemiologic designs that used control groups in Qatar.
“However, matching by these factors provided demonstrable control of bias in studies of different epidemiologic designs and that used control groups in Qatar13,14,35–37.”
From Duration of mRNA vaccine protection against SARS-CoV-2 Omicron BA.1 and BA.2 subvariants in Qatar (2022) · cites this paper as [13]
With the mass scale of PCR testing in Qatar, the likelihood of bias is perhaps minimized.
“Moreover, with the mass scale of PCR testing in Qatar13, the likelihood of bias is perhaps minimized.”
From Duration of mRNA vaccine protection against SARS-CoV-2 Omicron BA.1 and BA.2 subvariants in Qatar (2022) · cites this paper as [13]
Inclusion and exclusion criteria were implemented to minimize different types of potential bias based on earlier analyses in the same population.
“These inclusion and exclusion criteria were implemented to minimize different types of potential bias based on earlier analyses in the same population13,14.”
From Duration of mRNA vaccine protection against SARS-CoV-2 Omicron BA.1 and BA.2 subvariants in Qatar (2022) · cites this paper as [13]
Sustained vaccine effectiveness against severe disease has been shown for previous doses also.
“Sustained vaccine effectiveness against severe disease has been shown for previous doses also.20 34”
The rationale for excluding negative tests for cases was to avoid a potential bias stemming from repeated tests, indicating different healthcare seeking behaviour and potentially a lower pre-test risk of infection.
“The rationale was to avoid a potential bias stemming from repeated tests, indicating different healthcare seeking behaviour and potentially a lower pre-test risk of infection.20”
Protection from previous doses against severe disease has been shown to wane more slowly than protection against infection.
“Protection from previous doses against severe disease has been shown to wane more slowly than protection against infection.20 34”
Two immunizations with BNT might be markedly less effective against the Omicron variant than against the Delta variant.
“These results suggest that two immunizations with BNT, which can provide more than 90% protection from severe disease upon infection with the Delta variant (Chemaitelly et al., 2021), might be markedly less effective against the Omicron variant.”
From The Omicron variant is highly resistant against antibody-mediated neutralization: Implications for control of the COVID-19 pandemic (2022) · cites this paper as Chemaitelly et al., 2021
Two immunizations with BNT can provide more than 90% protection from severe disease upon infection with the Delta variant.
“which can provide more than 90% protection from severe disease upon infection with the Delta variant (Chemaitelly et al., 2021)”
From The Omicron variant is highly resistant against antibody-mediated neutralization: Implications for control of the COVID-19 pandemic (2022) · cites this paper as Chemaitelly et al., 2021
The protective effect of BNT162b2 against SARS-CoV-2 infection peaks after the second dose and then quickly declines, with the humoral immune response sharply decreasing.
“Studies have shown that the protective effect of BNT162b2 against SARS-CoV-2 infection peaks after the second dose and then quickly declines, with the humoral immune response sharply decreasing.388–391”
From Advances in COVID-19 mRNA vaccine development (2022) · cites this paper as [388]
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COVID-19 vaccine effectiveness against the omicron (BA.2) variant in England
Kirsebom, F. C. M., Andrews, N., Stowe, J., Toffa, S., Sachdeva, R., Gallagher, E., Groves, N., O'Connell, A.-M., Chand, M., Ramsay, M., et al. (2022) · The Lancet Infectious Diseases · doi:10.1016/s1473-3099(22)00309-7 · Cited by 182 · see citing works
Gazit, S., Shlezinger, R., Perez, G., Lotan, R., Peretz, A., Ben-Tov, A., Herzel, E., Alapi, H., Cohen, D., Muhsen, K., et al. (2022) · Clinical Infectious Diseases · doi:10.1093/cid/ciac262 · Cited by 283 · see citing works
Waning effectiveness of the third dose of the BNT162b2 mRNA COVID-19 vaccine
Patalon, T., Saciuk, Y., Peretz, A., Perez, G., Lurie, Y., Maor, Y., & Gazit, S. (2022) · Nature Communications · doi:10.1038/s41467-022-30884-6 · Cited by 143 · see citing works
Waning Effectiveness of the Third Dose of the BNT162b2 mRNA COVID-19 Vaccine
Patalon, T., Saciuk, Y., Peretz, A., Perez, G., Lurie, Y., Maor, Y., & Gazit, S. (2022) · doi:10.1101/2022.02.25.22271494 · Cited by 143 · see citing works
Neutralising antibodies predict protection from severe COVID-19
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Coronavirus Disease 2019 Disease Severity in Children Infected With the Omicron Variant
Butt, A. A., Dargham, S. R., Loka, S., Shaik, R. M., Chemaitelly, H., Tang, P., Hasan, M. R., Coyle, P. V., Yassine, H. M., Al-Khatib, H. A., et al. (2022) · Clinical Infectious Diseases · doi:10.1093/cid/ciac275 · Cited by 129 · see citing works
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Waning mRNA-1273 Vaccine Effectiveness against SARS-CoV-2 Infection in Qatar
Abu-Raddad, L. J., Chemaitelly, H., & Bertollini, R. (2022) · New England Journal of Medicine · doi:10.1056/nejmc2119432 · Cited by 114 · see citing works
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Effectiveness of mRNA-1273 and BNT162b2 Vaccines in Qatar
Abu-Raddad, L. J., Chemaitelly, H., & Bertollini, R. (2022) · New England Journal of Medicine · doi:10.1056/nejmc2117933 · Cited by 79 · see citing works
Self-citationWaning COVID-19 Vaccine Effectiveness for BNT162b2 and CoronaVac in Malaysia: An Observational Study
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- Authors
- Chemaitelly, H., Tang, P., Hasan, M. R., AlMukdad, S., Yassine, H. M., Benslimane, F. M., Al Khatib, H. A., Coyle, P., Ayoub, H. H., Al Kanaani, Z., Al Kuwari, E., Jeremijenko, A., Kaleeckal, A. H., Latif, A. N., Shaik, R. M., Abdul Rahim, H. F., Nasrallah, G. K., Al Kuwari, M. G., Al Romaihi, H. E., Butt, A. A., Al-Thani, M. H., Al Khal, A., Bertollini, R., & Abu-Raddad, L. J.
- Affiliations
- Cornell University (US)
- From the Infectious Disease Epidemiology Group (H.C., S.A., L.J.A.-R.) and the World Health Organization Collaborating Center for Disease Epidemiology Analytics on HIV/AIDS, Sexually Transmitted Infections, and Viral Hepatitis (H.C., S.A., L.J.A.-R.), Weill Cornell Medicine–Qatar, Cornell University, Qatar Foundation–Education City, the Department of Pathology, Sidra Medicine (P.T., M.R.H.), the Biomedical Research Center, Member of QU Health (H.M.Y., F.M.B., H.A.A.K., P.C., G.K.N.), the Departments of Biomedical Science (H.M.Y., F.M.B., H.A.A.K., G.K.N.) and Public Health (H.F.A.R., L.J.A.-R.), College of Health Sciences, and the Mathematics Program, Department of Mathematics, Statistics, and Physics, College of Arts and Sciences (H.H.A.), Qatar University, Hamad Medical Corporation (P.C., Z.A.K., E.A.K., A.J., A.H.K., A.N.L., R.M.S., A.A.B., A.A.K.), Primary Health Care Corporation (M.G.A.K.), and the Ministry of Public Health (H.E.A.R., M.H.A.-T., R.B.) — all in Doha, Qatar; Wellcome–Wolfson Institute f...
- Corresponding author
- Abu-Raddad, Laith J.
- ORCID
- Venue
- New England Journal of Medicine
- Publisher
- Massachusetts Medical Society
- Published
- 2021-12-09
- Volume
- 385
- Issue
- 24
- Pages
- e83-e83
- ISSN
- 0028-4793 (ISSN-L)
- 1533-4406
- PMC
- PMC8522799
- OpenAlex
- W3203602168
- Cited by
- 831
- References
- 14
- Citations by year
- 2026: 30 · 2025: 52 · 2024: 86 · 2023: 171 · 2022: 412 · 2021: 78 · 2013: 1
- FWCI
- 59.78
- Type
- journal article
- Language
- en
- Open access
- green
- doi.org
- Locations
- New England Journal of Medicine (publishedVersion)
- medRxiv (acceptedVersion)
- PubMed Central (publishedVersion)
- PubMed (publishedVersion)
- LSHTM Research Online (London School of Hygiene and Tropical Medicine) (acceptedVersion)
- Qatar University QSpace (Qatar University) (submittedVersion)
- Funders
- Biomedical Research Program and the Biostatistics, Epidemiology, and Biomathematics Research Core at Weill Cornell Medicine–Qatar
- Ministry of Public Health, Hamad Medical Corporation, and the Qatar Genome Programme
- Topics
- Health Sciences › Medicine › Infectious Diseases › SARS-CoV-2 and COVID-19 Research
- Physical Sciences › Mathematics › Modeling and Simulation › COVID-19 epidemiological studies
- Social Sciences › Health › Vaccine Coverage and Hesitancy
- Keywords
- BNT162b2, COVID-19 pandemic, SARS-CoV-2, waning vaccine effectiveness, vaccine protection, B.1.351 variant, symptomatic infection, asymptomatic infection, severe COVID-19 outcomes, hospitalization, mortality, Qatar
- MeSH terms
- Immunogenicity, Vaccine, COVID-19, COVID-19 Vaccines, Vaccine Efficacy, BNT162 Vaccine, 2019-nCoV Vaccine mRNA-1273, Breakthrough Infections, Adult, Aged, Female, Humans, Immunization, Secondary, Male, Middle Aged, Qatar, Time Factors, Case-Control Studies, Young Adult
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