FDA Halts Another Coronavirus Vaccine Trial
By T. Chakraborty, Ph.D.
COVID-19, caused by SARS-CoV-2, has brought the world to its knees. As of September 28th, the World Health Organization (WHO) has reported that this deadly virus has affected approximately 33 million people and claimed 1 million lives. As major biopharmaceutical companies advance further in clinical trials, some others have faced significant roadblocks. The U.S. Food and Drug Administration (FDA) announced on September 28th that it is pausing Inovio Pharmaceuticals Inc.’s plans to start a late-stage trial of its coronavirus vaccine as the FDA seeks further information about the vaccine itself.
Impact of the FDA Decision
Inovio confirmed that the delay by the FDA’s clinical hold wasn’t due to any side effects in the participants. Instead, the hold up was due to the delivery details of their vaccine, which injects individuals with synthetic DNA. The DNA vaccine codes for antibodies that can trigger an immune response against the SARS-CoV-2 virus. The delay means that the planned Phase 2/3 trials for Inovio’s experimental vaccine will not start until November. This has given rival biopharma companies, AstraZeneca and Moderna, already in the final Phase of their clinical trials, with an edge in the vaccine race. After the FDA raised concerns and halted the trials, Inovio’s shares dropped drastically by approximately 25%
Inovio further added that it intends to respond to FDA’s queries in October, following which the FDA would have 30 days to decide whether or not the trial should proceed. Piper Sandler analyst Christopher Raymond said, “It’s not guaranteed that Inovio will have the all-clear from FDA to start the trial once it hears back from the agency in November.”
Inovio has never brought a vaccine to the marketplace before, but its current COVID-19 candidate could change that. The vaccine designed using Inovio’s proprietary DNA platform needs to be administered to the patients using a device called Cellectra, responsible for sending out an electrical pulse to open pores in a cell so the synthetic DNA can enter.
Previously, the company reported in June that Inovio’s DNA-based vaccine had shown promising preliminary results in a small cohort of patients. This helped the company secure $71 million in funding from the U.S. Department of Defense to scale up manufacturing of Cellectra, which the FDA now has questions about, from the Bill and Melinda Gates Foundation and the Oslo-based Coalition for Epidemic Preparedness Innovations. While announcing its funding this summer, the company announced that it potentially would expand production beyond its San Diego plant through independent contract manufacturers of the vaccine, which now looks to be in hot water.
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