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2020: First vaccine for the prevention of COVID-19 to receive conditional marketing authorization from the European Medicines Agency: COMIRNATY® (BNT162b2/Pfizer-BioNTech COVID-19 vaccine)

09/05/2021

Nominated by: Pfizer

Organisations in nomination: Pfizer, BioNTech

   

In March 2020, the WHO declared COVID-19 a pandemic. At “lightspeed,” Pfizer collaborated with BioNTech, a German-based company, to develop an mRNA-based vaccine. The companies moved with urgency, without compromising their high standards for safety, quality, or integrity. Through a rigorous clinical trial programme and extensive discussions with regulators, the vaccine candidate BNT162b2 advanced rapidly.

In November, Pfizer and BioNTech announced that BNT162b2 had been shown to be 95% effective against COVID-19 in their Phase 3 trial. This advance could not have happened without the partnership of Pfizer and BioNTech, along with the leadership of Pfizer’s Kathrin Jansen, who herself emigrated from Germany.

BNT162b2 is one of the most significant scientific advancements in the past century, helping both to protect communities from COVID-19 and pave the way for a return to normalcy. Pfizer plans to deliver >2.5 billion doses worldwide in 2021 and next generation vaccine formulations are in development to potentially increase access. Trials in special populations, including pregnant women and young children, have also been initiated.

It is important to recognize this remarkable outcome has far reaching implications for research and development. The vaccine crystalized the scientific potential of mRNA technology, which Pfizer is now expanding into other areas in hopes of preventing and treating other serious, life-threatening diseases.

References:

  • About the landmark Pfizer trial
  • PFIZER AND BIONTECH CONCLUDE PHASE 3 STUDY OF COVID-19 VACCINE CANDIDATE, MEETING ALL PRIMARY EFFICACY ENDPOINTS
  • Polack P., Fernando et al. New Engl J of Med. Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine. December 31, 2020. 
  • Burger, Ludwig. Reuters. BioNTech-Pfizer raise 2021 vaccine output goal to 2.5 billion doses. March 30, 2021. 
  • STUDIES TO ADDRESS NEW FORMULATIONS
  • STUDIES IN ADDITIONAL POPULATIONS 
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Alexandra Simionca
Alexandra Simionca
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