Manon Cox was the chief operating officer at Protein Sciences Corp. back in the early 2000s when the SARS crisis broke out. Quickly, the drug-development company received $3 million from the feds to take a swing at making a vaccine.
More than 15 years later, Protein Sciences is still in Meriden but now it’s part of Sanofi, the giant drugmaker based in Paris, France. And suddenly, the Connecticut biotech business, founded in 1983, is vying to make a vaccine for the COVID-19 coronavirus.
The race is on. Protein Sciences is one of just three companies with contracts from a federal drug development agency to craft a shield from the illness that’s sweeping the world. Sweeping with panic, that is, if not widespread infection.
For Protein Sciences, it’s a natural extension of what the 100 or so employees in Meriden already do. With Cox running the show, they invented and developed the world’s first flu vaccine made from recombinant gene technology — derived from ovary cells of a single caterpillar two decades ago — rather than using millions of chicken eggs.
They also worked on emergency vaccines for a microscopic murderer’s row of notorious viruses: the avian flu in 1997, then SARS, then Ebola and Zika, mostly without success because of the nature of these things.
Likewise, with COVID-19, we can’t expect a vaccine anytime soon. “It will take at least a year to a year and a half to have a vaccine we can use,” Dr. Anthony Fauci, the nation’s chief infectious disease official at the National Institutes of Health, told a U.S. Senate committee this week.
No one at the Protein Sciences Meriden location, or at Sanofi in Paris, which has 100,000 employees worldwide, answered my calls and emails. In a press release, the company said its recombinant platform and prior work on emergency viruses gives it a head start toward coronavirus.
They’re in the running, as one person familiar with operations there told me, “but that doesn’t mean it’s going to happen.”
Cox, who lives in East Haven, became the CEO a few years after the SARS effort and left in early 2018, five months after Sanofi bought Protein Sciences for $750 million. From her standpoint, a Protein Sciences COVID-19 vaccine won’t happen — and maybe shouldn’t happen.
“I do believe that we will have a therapy for this coronavirus because there are already many approved drugs for viral infections,” she said. “But a vaccine?”
She paused, and said in the accent of her Netherlands homeland, “I don’t think so.”
I’ve known Cox for 20 years and she’s easily the bluntest-speaking CEO of the hundreds I’ve met and interviewed. She argues there’s no great need for a vaccine for the COVID-19 coronavirus. The illness, she believes, will not prove serious enough to go through the effort and expense.
“I could imagine that it’s good practice, but I can’t imagine it would be necessary for this particular virus,” said Cox, a microbiologist and virologist. “I just absolutely don’t understand what’s causing all this madness at this time. ... They’re acting as if hell is breaking loose.”
Obviously, a lot of people hold a different opinion. South by Southwest, the giant music and technology festival in Austin, Texas, was canceled Friday amid coronavirus fears. Is Cox right, that everyone is freaking out needlessly? Probably a bit so, yes.
But whether it’s needed or not, there are other reasons why emergency vaccines fall short, starting with the timeline.
Protein Sciences, founded in West Hartford as MicroGeneSys, embodies the years-long triumphs and failures that define drug development. The founder started with hopes for a hookworm medication.
Later, MicroGeneSys created the first AIDS vaccine ever to win federal approval for clinical trials, though that drug eventually failed and the company collapsed.
Even scientific success doesn’t guarantee victory in the market. Flublok, the Protein Sciences vaccine that Sanofi now sells worldwide, took 16 years from invention to marketing and never really took off when the company was independent.
The problem with development isn’t making the molecules, though that’s hard. It’s making sure they work safely and effectively. For Ebola, for example, Cox said the FDA wouldn’t allow any shortcuts in testing.
It’s also about politics, culture and the fleeting nature of intense bugs. Take the Protein Sciences SARS vaccine effort, for example. It failed, Cox recalls, because of a combination of those issues.
“We made a protein-based vaccine. The protein was called spike,” she said, because of the pattern it showed — same reason the coronavirus is so named because of the appearance of a crown on its surface.
They did animal testing and developed test systems. But then they saw a possible signal that the drug could worsen the disease. “We never investigated that because the political will, and the virus, faded out.”
That’s the nature of what we hope will be a passing virus, occupying intense focus and fear of bio-Armageddon but only for a short time.
“Here’s the point with money from the government,” Cox said. “Is the political will there to continue to send money? That’s just not the case.”
Last month, the federal drug-development agency — Biomedical Advanced Research and Development Authority, or BARDA, part of Health and Human Services — modified existing contracts at Protein Sciences and at a division of Johnson & Johnson, to work on COVID-19. A third company is looking at a range of options, perhaps including a vaccine.
BARDA has not said the amount of the contracts, but in a blog post, the agency acknowledged the difficulties. “This is the third coronavirus in less than 20 years, and it is time for us to get new medical countermeasures over the finish line.”
Sanofi, in a release, said the company’s work on SARS will help in COVID-19. “Additionally, since there is a licensed vaccine based on this platform this will allow for research and materials to be produced relatively quickly for clinical testing.”
The coronavirus effort builds on years of cooperation between Protein Sciences and BARDA. The company has received hundreds of millions of federal dollars over the years to develop methods of making stockpiles of flu vaccines in the event of a pandemic; and for its core product, Flublok, marketed as the most effective flu vaccine in the world with no allergic risks.
Cox has little faith in Sanofi, she said, having seen some great people leave after the takeover — in which many employees made a hefty payday from stock holdings.
“I basically ran that program and I just honestly think that they don’t have the right people in that company anymore,” she said.
“They certainly have the right folks in the room,” my source familiar with the operations said in response.
That’s a Red Sox-Yankees debate. The bigger picture is that fast-turnaround drug development has a spotty history. And thankfully, virus threats have a history of passing fast.
“If you would give me money I would not help develop a coronavirus vaccine right now because this is going to blow over,” Cox said, “and a year from now nobody is going to want it.”
That’s what makes the world so great. Someone will break through and become the Wright Brothers of coronavirus vaccines. It might as well happen in Connecticut, a state down on its luck but with a pedigree of invention unmatched anyplace.