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COVID-19 Therapeutics and Vaccines: A Race to Save Lives

Ilona Bebenek1, Roy Bannister2, John Dubinion1

  • 1US Food and Drug Administration, Silver Spring, Maryland 20993, USA.

Toxicological Sciences : an Official Journal of the Society of Toxicology
|November 4, 2021
PubMed

Insights

This review covers the development of COVID-19 treatments like remdesivir, REGEN-COV, and the Pfizer-BioNTech vaccine. These therapies improve survival and recovery for patients with Severe Acute Respiratory Syndrome Coronavirus-2.

Area of Science:

  • Virology
  • Immunology
  • Pharmacology

Background:

  • The COVID-19 pandemic, caused by SARS-CoV-2, necessitated rapid development of medical countermeasures.
  • Global collaboration accelerated therapeutic and vaccine development pathways.

Purpose of the Study:

  • To discuss the development programs for key COVID-19 therapies.
  • To provide U.S. Food and Drug Administration perspectives on approved/authorized products.

Main Methods:

  • Review of development programs for VEKLURY (remdesivir), REGEN-COV (casirivimab and imdevimab), and Comirnaty (Pfizer-BioNTech vaccine).
  • Inclusion of regulatory perspectives from the U.S. FDA.

Main Results:

  • Successful development and emergency use authorization/approval of multiple COVID-19 therapies.
  • Demonstrated benefits include improved survival, reduced hospitalization, and faster recovery.
  • Preventative measures, such as vaccines, are also highlighted.

Conclusions:

  • The rapid development of COVID-19 therapies and vaccines represents a significant public health achievement.
  • Ongoing understanding and regulatory oversight are crucial for managing the pandemic.
Keywords:
COVID-19SARS-CoV-2clinical trialdrug developmentpandemicpublic health emergencyregulatorytoxicology

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