Coronavirus Vaccine Gets “Fast Tracked” by US FDA

We’re in desperate need of a vaccine.

All as coronavirus cases rocket well above 13 million around the globe.  Here in the U.S., we’re up to 3.3 million cases, with Florida adding 15,299 cases in a single day.  

·      Brazil is up to 1.86 million cases

·      India is up to 878,254

·      Russia is now up to 732,547

·      Peru is up to 326,326

·      Chile is up to 315,041

Fortunately, we may be closer to a vaccine after the U.S. FDA “fast tracked” a vaccine in development with Pfizer and BioNTech.  

According to BioNTech, two of the company’s four investigational candidates from its BNT162 mRNA-based program being developed to help protect against the virus were “fast tracked.”  

Going forward, Pfizer and BioNTech expect to start the next phase of the vaccine trial later this month with 30,000 subjects.  If successful, the two expect to have 100 million doses of the vaccine by the close of 2020, and more than 1.2 billion by the end of 2021.

“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. 

Fast track status by the US FDA is granted to speed up the review of new drugs and vaccines that show the potential to address unmet medical needs, such as the coronavirus.

At the moment, shares of BioNTech are up nearly $14 on the day.  Pfizer is up $1.35.