BNT162b2 mRNA COVID-19 against symptomatic Omicron infection following a mass vaccination campaign in southern Brazil: A prospective test-negative design study
Institution:
1. Internal Medicine Department, Hospital Moinhos de Vento (HMV), Porto Alegre, RS, Brazil;2. Research Unit, Inova Medical, Porto Alegre, RS, Brazil;3. Research Institute, HMV, Porto Alegre, RS, Brazil;4. Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, Ontario, Canada;5. Federal University of Rio Grande do Sul (UFRGS), Brazil;6. Otus Solutions, Porto Alegre, RS, Brazil;7. Faculty of Medicine - Campus Toledo - Federal University of Paraná (UFPR), Brazil;8. Department of Biochemistry and Molecular Biology, Department of Genetics - UFPR, Brazil;9. Department of Health of Toledo, Toledo, PR, Brazil;10. Pfizer, Vaccines Medical and Scientific Affairs – Emerging Markets, Collegeville, PA, USA;11. Orbital Therapeutics, Cambridge, MA, USA
Abstract:
BackgroundEvidence regarding effectiveness of BNT162b2 mRNA COVID-19 vaccine against Omicron in Latin America is limited. We estimated BNT162b2 effectiveness against symptomatic COVID-19 in Brazil when Omicron was predominant.MethodsThis prospective test-negative, case-control study was conducted in Toledo, Brazil, following a mass COVID-19 vaccination with BNT162b2. Patients were included if they were aged ≥12 years, sought care for acute respiratory symptoms in the public health system between November 3, 2021 and June 20, 2022, and were tested for SARS-CoV-2 using RT-PCR. In the primary analysis, we determined the effectiveness of two doses of BNT162b2 against symptomatic COVID-19.ResultsA total of 4,574 were enrolled; of these, 1,758 patients (586 cases and 1,172 controls) were included in the primary analysis. Mean age was 27.7 years, 53.8 % were women, and 90.1 % had a Charlson comorbidity index of zero. Omicron accounted for >97 % of all identified SARS-CoV-2 variants, with BA.1 and BA.2 accounting for 84.3 % and 12.6 %, respectively. Overall adjusted estimate of two-dose vaccine effectiveness against symptomatic COVID-19 was 46.7 % (95 %CI, 19.9 %–64.6 %) after a median time between the second dose and the beginning of COVID-19 symptoms of 94 days (IQR, 60–139 days). Effectiveness waned from 77.7 % at 7–29 days after receipt of a second dose to <30 % (non-significant) after ≥120 days.ConclusionIn a relatively young and healthy Brazilian population, two doses of BNT162b2 provided protection against symptomatic Omicron infection. However, this protection waned significantly over time, underscoring the need for boosting with variant-adapted vaccines in this population prior to waves of disease activity.Trial registration number: ClinicalTrials.gov number, NCT05052307 (https://clinicaltrials.gov/ct2/show/NCT05052307).
