Real-world effectiveness of BNT162b2 mRNA vaccine: a meta-analysis of large observational studies

Inflammopharmacology. 2021 Aug;29(4):1075-1090. doi: 10.1007/s10787-021-00839-2. Epub 2021 Jul 9.

Abstract

This paper aims to summarize through meta-analyses the overall vaccine effectiveness of the BNT162b2 mRNA vaccine from observational studies. A systematic literature search with no language restriction was performed in electronic databases to identify eligible observational studies which reported the adjusted effectiveness of the BNT162b2 mRNA vaccine to prevent RT-PCR confirmed COVID-19. Meta-analyses with the random-effects model were used to calculate the pooled hazard ratio (HR) and pooled incidence rate ratio (IRR) at 95% confidence intervals, and the vaccine effectiveness was indicated as (pooled HR - 1)/HR or (pooled IRR - 1)/IRR. Nineteen studies were included for this meta-analysis. The meta-analysis revealed significant protective effect against RT-PCR confirmed COVID-19 ≥ 14 days after the first dose, with vaccine effectiveness of 53% (95% confidence interval 32-68%), and ≥ 7 days after the second dose, with vaccine effectiveness of 95% (95% confidence interval: 96-97%). Despite its effectiveness, reporting vaccine safety data by relevant stakeholders should be encouraged as BNT162b2 mRNA is a new vaccine that has not gained full approval. There have been limited data about vaccine effectiveness among immunocompromised patients; thus, the vaccine should be used cautiously in this patient population.

Keywords: BNT162b2; COVID-19; Real world; SARS-CoV-2; Vaccine.

Publication types

  • Meta-Analysis
  • Systematic Review

MeSH terms

  • BNT162 Vaccine
  • COVID-19 / diagnosis
  • COVID-19 / epidemiology
  • COVID-19 / prevention & control*
  • COVID-19 Vaccines / administration & dosage*
  • Humans
  • Observational Studies as Topic / methods*
  • Pragmatic Clinical Trials as Topic / methods*
  • Treatment Outcome

Substances

  • COVID-19 Vaccines
  • BNT162 Vaccine