PORTAGE, MI (WKZO AM/FM) — The U.S. Food and Drug Administration (FDA) has announced a Fast Track designation to Pfizer, along with its German partner BioNTech, in developing two possible vaccines for COVID-19.
According to Pfizer, these are the two most advanced vaccine candidates currently being evaluated in ongoing 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.”
Company officials say that the next phase of development could come as soon as the end of July, 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.
