An announcement today was major news about a COVID-19 vaccine. Another of the vaccines that had advanced to early stage human clinical trials had its development halted by the FDA.
Inovio Pharmaceuticals DNA coronavirus vaccine had completed an early stage human safety trial, but its further human trial was put on hold by the FDA today. Inovio’s approach involves using the genetic material from the virus to make viral proteins in human cells. They hope this protein will then induce an immune response that can protect an individual from COVID-19.
Unlike other vaccines, which are injected, Inovio uses an electrical current to get the viral DNA into cells. It is a complex process that causes virus DNA enter deep into cells. This technique has yet to produce an approved vaccine despite the company’s 18 years in business. Inovio did not disclose what the FDA’s concerns were except they involved this delivery system and not their prior clinical trial.
Inovio has received funding for its Covid-19 vaccine program from the Bill and Melinda Gates Foundation and the Oslo-based Coalition for Epidemic Preparedness Innovations. It has also received $71 million from the Department of Defense to scale up manufacturing of the device for delivering the vaccine.
The clinical trial issues identified by the FDA have stopped the trials of both the Inovio and AstraZeneca vaccines and points out the need for the government to fund multiple candidates for a COVID-19 vaccine. While these early vaccine problems relate to safety (with AstraZeneca) and technology (with Inovio), there will likely be other vaccines that are safe but don’t achieve effective prevention of COVID-19, therefore many vaccine candidates are necessary.
While the FDA did not question the early stage human trial that Inovio had conducted, analysts were not impressed with the results. Company management also was described as vague in its comments about the data The concerns raised in early July when the results were announced focused on the ability of the vaccine to induce immunity to the COVID-19 virus.
Inovio’s stock which has risen and fallen substantially over the years based on recurrent pandemics of infectious disease, could be ameliorated by an effective vaccine. The stock is up 400% this year due to COVID-19 and saw a similar, although muted, rise with Ebola outbreaks. It was down over 25% with today’s news.