Informed consent and informed intervention: SARS-CoV-2 vaccinations not just call for disclosure of newly emerging safety data but also for hypothesis generation and testing

Eur J Med Res. 2021 Aug 6;26(1):87. doi: 10.1186/s40001-021-00558-y.

Abstract

Background: COVID-19 infection is a major threat to patients and health care providers around the world. One solution is the vaccination against SARS-CoV-2.

Methods: We performed a comprehensive query of the latest publications on the prevention of viral infections including the recent vaccination program and its side effects.

Results: The situation is evolving rapidly and there is no reasonable alternative to population-scale vaccination programs as currently enrolled.

Conclusion: Therefore, regulatory authorities should consider supplementing their conventional mandate of post-approval pharmacovigilance, which is based on the collection, assessment, and regulatory response to emerging safety findings.

Publication types

  • Letter

MeSH terms

  • COVID-19 / immunology
  • COVID-19 / prevention & control*
  • COVID-19 / virology
  • COVID-19 Vaccines / administration & dosage*
  • Disclosure
  • Humans
  • Informed Consent / standards*
  • Pharmacovigilance*
  • SARS-CoV-2 / immunology*
  • Vaccination / standards*

Substances

  • COVID-19 Vaccines