Positive early data shows the vaccines spur the generation of more neutralizing antibodies
The U.S. Food and Drug Administration (FDA) has granted “fast track” status to two promising coronavirus candidates from Pfizer and BioNTech. The two vaccine candidates are called BNT162b1 and BNT162b2, and both are messenger ribonucleic acid (or mRNA) vaccines.
The fast-track status was granted based on preliminary data from phase one and two studies in the U.S. and Germany. The company expects to enroll 30,000 people in its next phase of trials.
If the trials are successful, the companies hope to make 100 million doses by the end of the year and possibly more than 1.2 billion doses 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 of global regulatory affairs at Pfizer.
References:
- https://www.consumeraffairs.com/news/fda-fast-tracks-two-new-vaccine-candidates-071320.html
- https://www.thestreet.com/investing/pfizer-up-on-fda-fast-track-status-for-coronavirus-vaccine