Pfizer (NYSE:PFE) and BioNTech (NASDAQ:BNTX) will pass an important milestone in the development of a COVID-19 vaccine today when they submit a request to the Food and Drug Administration for Emergency Use Authorization (EUA) of their vaccine candidate. In a press release this morning, the companies said that they will be ready to start distributing the vaccine within hours after receiving authorization, and it could be ready for use by high-risk populations in the U.S. by the middle to the end of December.
The submission means that the vaccine has met endpoints for safety and efficacy in clinical trials. The results from the phase 3 trials demonstrated a 95% efficacy rate, measured seven days after the second dose, and no serious safety concerns reported in 38,000 trial participants who have been followed for a median of two months after the second dose. The efficacy rate was based on 170 confirmed cases of COVID-19 in the trial participants, who were randomly given the vaccine or a placebo.
The companies expect to produce up to 50 million doses of the vaccine globally this year and up to 1.3 billion doses in 2021. The vaccine candidate, BNT162b2, requires storage below minus 60 degrees Celsius (minus 76 Fahrenheit), and Pfizer said it has established distribution hubs that can store the vaccine for up to six months. It has developed specially designed shippers that can maintain the vaccine at the ultra-low temperatures for up to 15 days and are equipped with GPS-enabled thermal sensors to track the location and temperature of each shipment.
Pfizer and European biotech company BioNTech have already initiated rolling submissions with regulatory agencies around the world, including the European Medicines Agency and those in Australia, Canada, Japan, and the United Kingdom. Today's news puts the company firmly in the lead in the race for a coronavirus vaccine.