Pfizer gets fast track FDA approval
2 vaccine candidates get full trials
Two investigational coronavirus vaccine candidates from Pfizer and German company BioNTech received fast track approval from the Food and Drug Administration which will further facilitate the development process for a muchneeded vaccine, the companies announced Monday.
The designation from the FDA was granted based off early data from Phase 1/2 trials that are currently ongoing.
“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.
The two vaccine candidates, called BNT162b1 and BNT162b2, were developed as part of the Project Lightspeed development program that generated a total of four candidates so far.
All of the candidates are messenger ribonucleic acid, or mRNA vaccines. The BNT162 vaccine candidates are undergoing clinical studies and are not currently approved for distribution anywhere in the world.
“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,” said Honig.
The companies expected to launch further trials that would enroll up to 30,000 patients later this month. If the studies are successful, the companies currently expect to manufacture up to 100 million doses by the end of 2020.
Cambridge-based Moderna late last week announced it had struck a partnership with ROVI, a European pharmaceutical company, that will provide vial filling and packaging capacity for its vaccine candidate at a facility in Madrid.
Five U.S. companies that are leading the coronavirus vaccine race will testify before Congress later this month to address concerns over safety and effectiveness in the development of a desperately needed vaccine.
Officials from AstraZeneca, Johnson & Johnson, Merck, Moderna and Pfizer will field questions on July 21 about the vaccine prospects before the House Energy and Commerce Oversight and Investigations Subcommittee.