Pfizer and BioNTech Granted FDA Fast Track Designation for COVID-19 vaccines
Pfizer and BioNTech were granted fast track designation by the FDA for two of the companies’ four vaccine candidates against the coronavirus.
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Staff or Guest writer for The Dog of Wall Street.
2020-07-13 17:37

Two experimental coronavirus vaccines jointly developed by German biotech firm BioNTech and U.S. pharmaceutical giant Pfizer have received ‘fast track’ designation from the FDA. BNT162b1 and BNT162b2 are the two most advanced vaccine candidates in the BNT162 program currently being evaluated in ongoing Phase 1/2 clinical studies in the United States and Germany.

“The FDA’s decision to grant these two COVID-19 vaccine candidates Fast Track designation signifies an important milestone in the efforts to develop a safe and effective vaccine against SARS-CoV-2,” said Peter Honig, Senior Vice President, Global Regulatory Affairs, Pfizer. “We look forward to continue working closely with the FDA throughout the clinical development of this program, Project Lightspeed, to evaluate the safety and efficacy of these vaccine candidates.”

Subject to regulatory approval, the companies are expecting to start a Phase 2b/3 trial as soon as later this month and are anticipating enrolling up to 30,000 subjects. If the ongoing studies are successful, and the vaccine candidate receives regulatory approval, the companies currently expect to manufacture up to 100 million doses by the end of 2020 and potentially more than 1.2 billion doses by the end of 2021.

 


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Published On
2020-07-13 17:37

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Staff or Guest writer for The Dog of Wall Street.

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Last updated 2020-11-25


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