U.S. drug producer Pfizer and German biotech group BioNTech announced that a late-phase clinical test has started on a COVID-19 drug candidate that the companies hope to deliver to the market by end of the year.
The vaccine trial will include 30,000 subjects between the ages of 18 and 85 at 120 locations across the world, including areas that have been hit hard by the global health crisis. If successful, the two companies will proceed to apply for a regulatory permit for the candidate drug by October.
In a statement, BioNTech chief executive Ugur Sahin disclosed that the decision to initiate the large-scale test reflects their main objective of producing a highly effective drug that they can bring to the market as soon as possible, while they continue to study other potential treatments as part of a differentiated coronavirus vaccine portfolio.
The two biotech giants are looking to supply around 100 million doses by the end of the year and up to 1.3 billion doses by the end of 2021. Shares of BioNTech climbed over 2 percent and settled at 85.38 while shares of Pfizer increased over 3 percent and closed 39.02 during extended sessions on Tuesday.
After a thorough evaluation of pre-clinical and clinical data from Phase I and II clinical tests and following consultations with the U.S. Food and Drug Administration's Center for Biologics Evaluation and Research and other international regulators, Pfizer and BioNTech have moved to further push forward with their BNT162b2 drug candidate at a 30-µg dose in a two-dose administration.
BNT162b2, which was recently granted an FDA Fast Track Designation, encodes an optimized SARS-CoV-2 full-length Spike (S) Glycoprotein, which is the target of pathogen neutralizing anti-bodies. According to the two companies, several measures have been implemented for the important milestone and they are grateful to all those who worked hard with them for the advanced trial.
Johnson & Johnson is scheduled to begin clinical trials on its potential drug next week. For its part, AstraZeneca, in collaboration with scientists at the University of Oxford, announced they are scouting for enrollees for their ongoing final-phase test of a vaccine in the U.K., South Africa, and Brazil.
If the drug in development proves to be a success, the U.S. government will give BioNTech and Pfizer $1.95 billion to for an initial order of 100 million doses, as part of its Operation Warp Speed to fast-track the development of COVID-19 treatments.
BioNTech and Pfizer are among many global firms scrambling to develop a treatment to combat the highly-contagious disease which has already sickened over 16 million people globally and claimed the lives of around 650,029 as of Monday, data compiled by Johns Hopkins University showed.