How fast can biotech come up with a vaccine for the latest outbreak?

The deadly outbreak of a novel coronavirus has sparked a race among biotech companies, each claiming that its technology can quickly whip up a vaccine to quell a potential crisis. But history suggests the road ahead will be long, unpredictable, and expensive.

Moderna Therapeutics and Inovio Pharmaceuticals are among the companies turning their focus to the emerging virus, called 2019-nCoV. Each has received millions in funding from the Coalition for Epidemic Preparedness Innovations, a global organization that has set an audacious goal: to have a vaccine ready for human testing, a process that traditionally takes years, in just 16 weeks.

“The challenges those efforts face are not insignificant,” said Mark Feinberg, president and CEO of the International AIDS Vaccine Initiative.

He would know. Feinberg was the chief scientific officer of Merck’s vaccine division during the last Ebola outbreak, when the company deployed a vaccine now approved as Ervebo. Preparing the vaccine for human study was a lengthy, cross-border process full of scientific serendipity. And proving its efficacy rested on unpredictable pieces falling into place, including the length of the outbreak. 

It was difficult enough for Merck, a multinational company with a $220 billion market cap. Replicating it on a biotech budget is another matter altogether.

“It’s hard to align engaging in this sort of work with the financial realities of a small biotech company,” Feinberg said. “It may sound like an attractive target, but the prospects and the amount of work involved will necessarily take them away from their core business and the interest of their investors in getting a return on their investment.”

Moderna, which has already run clinical trials on six vaccines of its own, believes it’s up to the task. 

The company’s technology involves creating synthetic messenger RNA that can compel the body to manufacture specific proteins. For vaccines, that means encoding mRNA to produce antibodies that protect against infection. With CEPI’s funding, Moderna is working with the National Institutes of Health to design such a vaccine for 2019-nCoV. Once it’s ready for human testing, NIH will run the clinical trials.

Dr. Tal Zaks, Moderna’s chief medical officer, committed to getting that done on CEPI’s 16-week timeline. And the company will be able to manufacture the eventual vaccine in a matter of a few months, Zaks said. That should cover clinical trials, he said, but if the vaccine ends up working — and the 2019-nCoV outbreak drags on — the company would have to rely on someone else to churn out the massive number of doses required to halt the virus.

“I don’t kid myself,” Zaks said. “We’re not Sanofi or GSK in terms of global infrastructure and ability to deliver to a global population.”

Inovio’s approach relies on injecting synthetic DNA that codes for protective antibodies, technology developed at the lab of David Weiner of the Wistar Institute in Philadelphia. Like Moderna’s mRNA approach, Inovio’s method doesn’t require administering a live virus and thus should be safer than traditional vaccines. And it promises to be much faster, Weiner said, citing experience.

In 2015, as the Zika virus raged in South America, Weiner and Inovio went from zero to having a ready-for-testing vaccine in about seven months. “And that is still considered the fastest,” Weiner said.

But that work, later published in the New England Journal of Medicine, never resulted in an approved vaccine, through no fault of Inovio’s. The Zika outbreak dissipated in 2016, sapping the need for a vaccine and making it virtually impossible to run the large-scale trials necessary to prove one’s worth. Good news for the world can be bad news for vaccine development.

The same thing could happen with 2019-nCoV, an outbreak in its infancy. If global health authorities successfully contain the virus, Moderna, Inovio, and the handful of other companies on 2019-nCoV’s case will have no patient population to work with. Or, if one of the candidate vaccines succeeds, global organizations like CEPI might pull their support for other efforts. 

There are countless ways vaccine development can go awry in an outbreak, Feinberg said, and what made Merck’s success in Ebola so exemplary is that so many stars aligned to bring it from basic research to clinical trials and finally to regulatory approval. 

“Response to this coronavirus will put some of the new partnerships and mechanisms to the test,” Feinberg said. “Will there actually be a need for a vaccine? Or will the outbreak wane? Will there be partners who will stay with you to support the work that’s necessary to bring a vaccine to licensure?”