How the feds missed their chance at a coronavirus vaccine - POLITICO

That was a big missed opportunity. They and other scientists say SARS should have been seen as a coronavirus warning shot, not an isolated outbreak, and it should have triggered federal investments like the billions sunk into flu vaccines a decade or so earlier. They want the federal government to act rapidly now to declare a public health emergency, get a vaccine developed, have it approved by the FDA and ready to slow the Wuhan virus’ march across China and globe.

Based on past experience, though, the chances of all that falling into place fast enough to turn the tide aren’t great, many scientists say.

The NIH is working with a U.S. company Moderna Therapeutics to get a separate promising vaccine prospect into early testing within three months, NIAID director Anthony Fauci said this week. But in the best case scenario, he warned, it will take many months longer to get a vaccine into widespread use.

Fauci at a scientific conference this week acknowledged the need to take the long view of coronavirusus now that the world has experienced three outbreaks in the 21st century — SARS, MERS and now Wuhan.

“Clearly they have pandemic potential, and novel coronaviruses are likely to continue to emerge,” he said. “You know, I’ve been talking about a universal flu vaccine for a long time — maybe we should start talking about a universal coronavirus vaccine. Because this is three in 18 years, I mean that is heavy stuff.”

Hotez and Bottazzi hope that NIH, the Biomedical Advanced Research and Development Authority or others will fund a new round of studies for their vaccine; a public health emergency declaration for the Wuhan threat would facilitate that. The pair had worked swiftly after SARS swept out of a Chinese live game market in 2003 and across the world, killing 800 people and sickening 10 times that number. They developed a vaccine, tested it in animals, got a military lab to create a batch of it — and ran out of money before they could test it on people.

In the intervening years, researchers have gained new scientific tools for vaccine development. And China’s rapid release of genetic data on the virus is hugely important. But that’s not enough.

“The frustrating part is, if the global community was less reactive and more anticipatory we could already have had this vaccine through clinical development and it would be ready to roll in China,” Hotez said.

Michael Osterholm, one of the world’s leading experts on pandemics at the University of Minnesota, said the government needs to start looking at vaccines for civilians “as a security procurement,” just as the military does. Otherwise, mistakes are just repeated.

“Every time we enter into one of these epidemics — SARS, MERS, Lassa fever, Zika … we hear, ‘We’re going to have a vaccine!‘” Osterholm said.

“The only one we have a vaccine for is Ebola,” a virus that, while deadly, poses only a remote risk to U.S. citizens. That vaccine enjoyed steady funding because the Pentagon saw Ebola as a bioterror threat, Osterholm says.

While Hotez and Bottazzi try to wrangle finances for their work, a London-based group called the Coalition for Epidemic Preparedness Innovations, or CEPI, which was created in 2017, has already committed $12.5 million to two U.S.-based startups and an Australian university with promising coronavirus vaccine platforms.

The NIH's partner, Moderna Therapeutics, says it could produce up to 100 million doses of a vaccine. The company can use genetic sequence of the virus that China released to get started on its vaccine, and doesn’t need a sample of the virus itself, said Tal Zaks, the company’s chief medical officer.

The Moderna vaccine works by converting genetic sequences of the virus into RNA which when injected into the body, causes cells to make a protein that stimulates immunity to the disease.

The second company, Inovio Pharmaceuticals, based outside Philadelphia, uses vaccines based on inserting virus sequence into bacterial DNA.

A Queensland University group grows its vaccine in cell cultures, and will take a bit longer to produce enough to test in people.

But while the new technologies are exciting, none have ever been used in a licensed vaccine. And the road from promising science to a safe vaccine for millions is littered with thousands of failures.

Some of the earlier SARS vaccines — though not the one that Hotez and Bottazzi developed — showed some dangerous side effects when tested in animals. In this light, the government can't be entirely faulted for its waning interest in a SARS vaccine, said Stanley Perlman, a coronavirus expert at the University of Iowa.

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"In retrospect, they might have been pursued with more vigor, but at the time it was not an unreasonable decision," Perlman said.

Moderna‘s vaccine is using a “plug and play” platform that has been tested with a variety of other germs on about 1,000 people without unusual side effects, while producing good evidence of immunity, Zaks said.

Drew Weissman, whose University of Pennsylvania lab licensed the technology Moderna is using, says the vaccine causes some local pain and fever because it stimulates a vigorous immune response, but “in theory it should be very safe.”

The Moderna vaccine could get a relatively quick review from the Food and Drug Administration. Normally, the agency requires extensive animal safety data for any new vaccine before allowing human trials, but in a public health emergency it can proceed with small-scale human vaccine testing based on safety data from other vaccines using the same technology. This approach was taken with some experimental Zika vaccines, for example.

If one of the new vaccines showed promise it would still take the resources of a major pharmaceutical company to make it available for global use, Osterholm said.

“We tend to gear up rhetoric around vaccines when an event occurs, then forget about it,” Osterholm said. CEPI is a promising organization for stimulating early vaccine development for emergencies, but it will only provide “20 feet of rope when we’re drowning 50 feet out.”

“Yet each time we have a coronavirus epidemic," he said, "we start making vaccines from scratch.”

No one knows if the Wuhan coronavirus epidemic will die out — as was the case with SARS in 2003. Respiratory viruses tend to be seasonal, favoring the winter months, though of course many recur year after year.

Or in the coming months the Wuhan virus could worsen.

Vaccine work will proceed, Fauci said, in preparation for “the worst case scenario.”

Sarah Owermohle contributed to this report.