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Regulatory approval pathway for COVID-19 vaccine in USA, Europe and India

Jaipratap Narasimhan1, Saba Maanvizhi1

  • 1Department of Pharmaceutics, Sri Ramachandra Faculty of Pharmacy, SRIHER (DU), Porur, Chennai, India.

Annals of Medicine and Surgery (2012)
|April 28, 2023
PubMed

Insights

The study compares standard vaccine approval with emergency use applications for COVID-19 vaccines. It highlights the expedited process and simultaneous trials required for emergency authorization.

Area of Science:

  • Vaccinology
  • Regulatory Science
  • Infectious Diseases

Background:

  • The COVID-19 pandemic necessitated rapid vaccine development.
  • Initial treatments like monoclonal antibodies showed limitations in providing a lasting cure.
  • Vaccine development emerged as a key strategy to build resistance against the coronavirus.

Purpose of the Study:

  • To compare the standard biological license application process with the emergency use application for vaccines.
  • To elucidate the regulatory pathway for COVID-19 vaccine approval.

Main Methods:

  • Comparative analysis of regulatory approval processes.
  • Review of clinical trial phases (II, III, and IV) and peer review requirements.
  • Examination of market data presentation for adverse event tracking.

Main Results:

  • Emergency Use Application (EUA) allows market release after Phase II trials.
  • EUA requires simultaneous conduct of Phase III and IV trials alongside post-market surveillance.
  • Regulatory bodies prioritize high efficacy and low adverse event risk for EUA approval.

Conclusions:

  • The emergency use application streamlines vaccine approval during public health crises.
  • Simultaneous trials and continuous monitoring are critical components of the EUA process.
  • Understanding these regulatory differences is crucial for evaluating vaccine accessibility and safety.

Keywords:
COVID-19adverse eventsemergency use applicationvaccine

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