Pfizer and BioNTech announced today that they have received "Fast Track" designations from the US Food and Drug Administration for two of their four Covid-19 vaccine candidates, according to a press release.
“This designation was granted based on preliminary data from Phase 1/2 studies that are currently ongoing in the United States and Germany as well as animal immunogenicity studies,” the release stated.
What this means: Fast Track designation allows for a more efficient development process between companies and regulatory agencies and makes drug developers eligible for accelerated approval with a rolling review process of submitted data.
Companies must request the designation and it is reserved for “any drug being developed to treat or prevent a condition with no current therapy obviously is directed at an unmet need,” according to the FDA’s website.
Next steps: Pfizer and BioNTech’s collaboration on Covid-19 vaccine development, dubbed “Project Lightspeed,” expects to begin phase 2b/3 of its trial later this month. The companies aim to enroll 30,000 participants, according to the press release.
Pending the success of ongoing studies, “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.”
“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.”
“We are pleased to have received Fast Track designation from the FDA for two of our vaccine candidates and look forward to working closely with the FDA, along with our partner Pfizer, to expedite the clinical development path forward,” Özlem Türeci, chief medical officer at BioNTech, said in the statement.