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. 2022 Sep 16;40(39):5675-5682.
doi: 10.1016/j.vaccine.2022.08.032. Epub 2022 Aug 24.

Evaluation of BNT162b2 vaccine effectiveness in Malaysia: test negative case-control study

Audrey Huili Lim  1 , Norazida Ab Rahman  2 , Su Miin Ong  2 , Jubaida Paraja  3 , Rahmah Rashid  4 , Ishvinder Singh Parmar  3 , Siti Nadiah Dahlan  4 , Zhi Shan Sujata Tan  4 , Ismuni Bohari  4 , Kalaiarasu M Peariasamy  2 , Sheamini Sivasampu  2
Affiliations

Evaluation of BNT162b2 vaccine effectiveness in Malaysia: test negative case-control study

Audrey Huili Lim et al. Vaccine. .

Abstract

There is a notable lack of vaccine effectiveness studies using test-negative case-controlled approach in low- and middle-income countries which have different logistic, demographic and socio-economic conditions from high-income countries. We aimed to estimate the effectiveness of BNT162b2 vaccine against COVID-19 infection over time, intensive care unit admission, severe or critical disease and death due to COVID-19. This study was conducted in the resident population of Labuan aged ≥18 years who had been tested for SARS-CoV-2 by Reverse-Transcriptase Polymerase Chain Reaction between 1 March 2021 and 31 October 2021. We used a test-negative case-control design where 2644 pairs of cases and controls were matched by age, sex, testing date, nationality and testing reason. Analysis was stratified by age group to estimate age effect (<60 years and ≥60 years). Of 22217 individuals tested by Reverse-Transcriptase Polymerase Chain Reaction, 5100 were positive for SARS-CoV-2 and aged 18 years and above. Overall vaccine effectiveness ≥ 14 days after the second dose was 65.2% (95% CI: 59.8-69.9%) against COVID-19 infection, 92.5% (95% CI: 72.3-98.8%) against intensive care unit admission, and 96.5% (95% CI: 82.3-99.8%) against COVID-19 deaths. Among infected individuals, vaccine effectiveness was 79.2% (95% CI: 42.3-94.1%) in preventing severe or critical disease due to COVID-19. Vaccine effectiveness for ≥60 years was 72.3% (95% CI: 53.4-83.9%) in fully vaccinated individuals, higher than 64.8% (95% CI: 49.3-59.1%) for those <60 years. Two doses of BNT162b2 were highly effective against COVID-19 infection, severe or critical disease, intensive care unit admission and death due to COVID-19. This study addresses a gap in literature on BNT162b2 vaccine effectiveness in low- and middle-income populations and demonstrates the feasibility of such a study design in a resource limited setting while supporting evidence of waning immunity.

Keywords: BNT162b2; COVID-19; Case control; LMIC; Test-negative; Vaccine effectiveness.

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Conflict of interest statement

Declaration of Competing Interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.

Figures

Fig. 1
Fig. 1
Flowcharts describing the population selection process to assess vaccine effectiveness.
Fig. 2
Fig. 2
Vaccine effectiveness against COVID-19 infection over time.
See this image and copyright information in PMC

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