UNLABELLED: In the coronavirus disease 2019 (COVID-19) pandemic, vaccinations were essential in preventing COVID-19 infections and related mortality in older adults. The objectives of this study were to evaluate the effectiveness and safety of the COVID-19 vaccines in older adults. We systematically searched the electronic bibliographic databases of PubMed, Web of Science, Embase, Cochrane Library, ClinicalTrials.gov, Research Square, and OpenGrey, as well as other sources of gray literature, for studies published between January 1, 2020, and October 1, 2022. We retrieved 22 randomized controlled trials (RCTs), with a total of 3,404,696 older adults (aged over 60 years) participating, that were included in the meta-analysis. No significant publication bias was found. In the cumulative meta-analysis, we found that the COVID-19 vaccines were effective in preventing severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection (OR = 0.38, 95% CI = 0.23-0.65, p = 0.0004) and in reducing the number of COVID-19-related deaths (OR = 0.16, 95% CI = 0.10-0.25, p < 0.00001) in elderly people. Antibody seroconversion (AS) and geometric mean titer (GMT) levels significantly increased in vaccinated older adults [OR = 24.42, 95% CI = 19.29-30.92; standardized mean difference (SMD) = 0.92, 95% CI = 0.64-1.20, respectively]. However, local and systemic adverse events after COVID-19 vaccine administration were found in older adults (OR = 2.57, 95% CI = 1.83-3.62, p < 0.00001). Although vaccination might induce certain adverse reactions in the elderly population, the available evidence showed that the COVID-19 vaccines are effective and tolerated, as shown by the decrease in COVID-19-related deaths in older adults. It needs to be made abundantly clear to elderly people that the advantages of vaccination far outweigh any potential risks. Therefore, COVID-19 vaccination should be considered as the recommended strategy for the control of this disease by preventing SARS-CoV-2 infection and related deaths in older adults. More RCTs are needed to increase the certainty of the evidence and to verify our conclusions.

  • Adults
  • Older adults
  • Vaccine/vaccination
  • COVID-19
  • Efficacy/effectiveness
  • Safety