Coronavirus Vaccine: FDA Fast-Tracks Two Candidates From Pfizer, BioNTech

The race to find an effective coronavirus vaccine took a step forward Monday as the U.S. Food and Drug Administration designated two experimental vaccines as fast-tracked. These designations were given to vaccines in development at the multinational pharmaceutical giant, Pfizer, and the German company, BioNTech.

The fast-track status is intended to help these companies move quickly through the regulatory review process, as it will make their projects eligible for priority review. With this eligibility, the FDA could potentially approve their candidate within six months.

Pfizer and BioNTech are the second and third companies to receive fast-track status. Previously, Moderna was granted this designation in May for its vaccine candidate, which is using similar techniques to Pfizer and BioNTech.

“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,” Peter Honig, Senior Vice President of Global Regulatory Affairs for Pfizer, said in a statement. “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.”

Both companies have reported promising results from recent trials, with 24 volunteers showing higher coronavirus antibody levels than infected patients after only 28 days. They are due to begin much larger trials with 30,000 people taking part, pending approval. These trials could take place as soon as the end of July.

In the wake of this news, shares of Pfizer gained 6%, while U.S.-listed share prices for BioNTech gained 2%.