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Newserector
2020-04-26

Countries, companies are risking billions in coronavirus vaccine race

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They are quickly monitoring vaccine testing and regulatory review without any guarantee that they will be effective. They are building and retooling vaccine plants with slim chances of approval. They place orders for vaccines which are unlikely to be produced in the end.

It is the new paradigm of pandemics, focused on speed and fraught with risk.

"The crisis in the world is so great that each of us will now have to take the maximum risk to put an end to this disease," said Paul Stoffels, Johnson & Johnson's Chief Scientific Officer, who has partnered with the U.S. government to invest $1 billion to accelerate the development and production of his still-unproven vaccine. "If it fails," Stoffels said to Reuters, "it's going to be bad." Historically, only 6% of vaccine candidates end up marketing it, often after a long process that doesn't make big investments until testing shows that a product is likely to work. But in the face of a virus that has infected 2,7 million people, killed more than 192,000 and devastated the global economy, the traditional rules of drug and vaccine development are being thrown aside. The goal with COVID-19 is to have a vaccine identified, tested and available in just 12 to 18 months, on a scale of hundreds of millions of doses.

Drug companies and their financing governments and investors are boosting their "at-risk" expenditure in unprecedented ways. The overriding consensus among more than 30 drug company executives, government health officials and pandemic response experts interviewed by Reuters is that the risks are necessary not only to ensure that a new coronavirus vaccine is rapidly developed, but that it is ready to be distributed as soon as it is approved.

Investments from governments, global health groups and philanthropies were primarily targeted at the most promising of the more than 100 vaccine candidates worldwide in development. But only a handful of those have advanced to human trials, the true safety and effectiveness indicator-and the stage where most vaccines are washing out.

Even very few of the more encouraging prospects are likely to succeed. More than one will work; it's possible that none will.

There are some likely benefits for companies in the race: It is a proving ground for vaccine technologies and an opportunity to burn up reputations and boost shares. While some large companies, including Johnson & Johnson and GlaxoSmithKline Plc, have said they are planning to make the vaccine available at cost-at least at first-if seasonal vaccination is needed and countries invest in stockpiles, they may be making profits down the road.

But finding a workable vaccine does little good without being able to produce it and distribute it. This now means the construction of production plants.

"We want to make investments on the front, at risk, even before we know the vaccines are working, so that they can (immediately) be produced at tens or hundreds of millions of doses," said Richard Hatchett, a physician who managed the U.S. pandemic flu policy under former President George W. Bush and returned to advise the Obama White House during the swine flu pandemic in 2009.

Hatchett now heads the Coalition for Innovation in Epidemic Preparedness (CEPI), a vaccine-development consortium supported by private donors as well as the United Kingdom, Canada, Belgium, Norway, Switzerland, Germany and the Netherlands. The organization has raised more than $915 million of the $2 billion it anticipates spending on speeding up testing and building specialized production plants for at least three candidates for coronavirus vaccines.

In the United States, the Biomedical Advanced Research and Development Authority (BARDA), a federal agency funding disease-fighting technology, has announced nearly $1 billion in investment to support the development of coronavirus vaccines and the scale-up of manufacturing to promising candidates.

One underlying fear, shared by everybody interviewed by Reuters, is that there won't be enough to go around even if a vaccine proves effective.

Having worldwide reserves ready to inoculate critical populations immediately-health care workers, the elderly, people made vulnerable by medical conditions-would stamp out pandemic economies faster and reignite, Hatchett said. The alternative, he said, is a replay of past pandemics, including the 2009 H1N1 influenza outbreak, with the vaccines being hoarded by rich nations.

If that happens, pandemic experts warn that hot spots from infection will continue to pop up, each with the potential to create a new wave of disease.

FULL SPEED AHEAD There are no historical parallels to the scale of a coronavirus vaccine breed. CEPI identified at least 115 vaccine initiatives underway worldwide. And the race shatters standards of speed and safety in the development of drugs and vaccines.

Some developers run safety and efficacy tests in tandem rather than sequentially, as is typical of traditional testing protocols, and short-cut them. Others work simultaneously with regulators in multiple countries in search of the fastest route to market.

The resulting uncertainty makes it particularly risky for a given candidate to invest in manufacturing facilities, since various types of vaccines may require very distinct production lines.

Many of the candidates that attract the most investment rely on proven vaccine approaches being adapted with regulatory and manufacturing acumen by big pharma companies. Some funders are playing games on smaller biotech companies and academic laboratories, which may have promising technologies but little to no experience obtaining approval and scale production of a drug or vaccine.

BARDA, The Americans R&D agency, with some $5 billion to spend, is among the largest vaccine funders. The agency plans to invest in five candidates for the vaccine, focusing mostly on projects by experienced drug manufacturers.

"Each one comes with a lot of previous experience," said Rick Bright, who was the director of BARDA until this month. "They all know how to scale up." BARDA is pouring almost $500 million into a J&J effort on one of its biggest bets.

J&J's candidate for the coronavirus vaccine uses a cold virus, rendered harmless, to deliver genes derived from the spiky, crown-shaped proteins on the new coronavirus surface, prompting an immune response.

The same technology is used by J&J to develop vaccines for other viruses including Ebola. While none have completed testing and won full U.S. approval, so far trials have produced data in tens of thousands of people showing the basic approach is safe, which could speed up regulatory approval for the new coronavirus vaccine. But it's far from being a sure bet: animal test data will give the first hint of the effectiveness of the vaccine this summer, and human trials will start in September.

"We'll know if it protects humans by the end of the year," said Stoffels, the chief science officer at J&J.

In China, CanSino Biologics Inc. has similar vaccine technology to the one that J&J uses. CanSino is further along with its testing, having announced this month that its candidate had cleared initial human safety tests and was set to move forward to the next stage.

Based on its approved Flublok flu shot, Sanofi SA, the world's largest vaccine maker, has attracted BARDA money for yet another proven approach. Instead of the traditional chicken eggs, Sanofi uses insect cells to grow the genetically modified virus proteins used to spur an immune response.

Not all attention-getting vaccine projects have a Big Pharma pedigree.

Moderna Inc, a biotech company based in Cambridge, Massachusetts, was the first to begin human trials in the United States when it began testing its vaccine last month. Joining the U.S. National health institutes, the company received seed money from CEPI, and this month, BARDA kicked in $483 million to support the development of the vaccine and help scale up manufacturing. That includes hiring 150 skilled workers around the clock to eventually produce a vaccine.

Moderna's vaccine uses genetic material called messenger RNA (mRNA) to instruct the body's cells to make specific proteins of the coronavirus which then produce an immune response.

No vaccine with mRNA has ever been approved for public use, but the technology is attracting interest, partly because it makes it easier to design and produce a vaccine in vast quantities.

"Millions of doses are the end game," Tal Zaks, chief medical officer of Moderna, told Reuters. The company hopes that an approved vaccine will be available to healthcare workers as early as March 2021, and possibly before that. German vaccine manufacturers CureVac and BioNTech SE, who are partnering with Pfizer Inc, are preparing to start studies with similar mRNA-based candidates. So is Translate Bio Inc. based in Massachusetts, Lexington, working with Sanofi.

EXTRAORDINARY SHORTCUTS Even in human tests for vaccine hopefuls, there will be months before there is any conclusive evidence of safety and efficacy-something that the funders are keenly aware of.

The rush prompted scientists to consider shortcuts which were previously unthinkable.

Vaccines would normally need to go through clinical trials involving thousands of people before widespread inoculation is permitted. But after testing a prospective vaccine in a smaller group to ensure that it is not toxic, Swiss researchers are trying to "immunize a lot of the Swiss population over the next six months and then produce for a world market," said this week Dr. Martin Bachmann, head of immunology at Inselspital, Bern University Hospital.

A spokesman for Swissmedic, the drug regulator in the country, said it was in contact with Bachmann's group and would not allow trials until the agency is assured of addressing safety risks.

The Swiss vaccine uses virus-like particles to provoke an immune response, an approach that is considered theoretically safer since it does not directly expose people to the actual coronavirus. It's only been tested in mice until now.

Dr. Gregory Poland, a vaccine researcher at the Mayo Clinic in Rochester, Minnesota, is one of those concerned about the risks of injecting a large group of people with a vaccine that has been tested in humans only minimally.

"I don't see how that's possible," he told Reuters, referring to the plan of Inselspital.

LESSONS DO INCLUDED?

The COVID-19 war is haunted by lessons learned a decade ago from the fight against another virus.

The H1N1 swine flu virus emerged in the United States and Mexico in the spring of 2009, and spread throughout the world. Within weeks it was declared the first pandemic since 1968 by the World Health Organization(WHO).

According to Hatchett and numerous official reports, wealthier governments that had provisional contracts with vaccine makers immediately exercised them, "effectively monopolizing the global supply of vaccines." The US alone ordered 250 million doses, and all had vaccines in Australia, Brazil, France, Italy, New Zealand, Norway, Switzerland and Britain.

Slideshow (3 Images) Those countries, under pressure from the WHO, ultimately committed to share 10 percent of their stock with poorer nations. But only about 77 million doses were shipped – far less than needed – due to production and distribution snarls, and only after the disease had peaked in many regions.

If an effective vaccine for the new coronavirus develops, a replay is possible, pandemic preparedness experts say. None of the global health authorities consulted by Reuters believe sufficient supplies will be in place to meet the immediate demand. Governments are going to be under tremendous pressure to immunize their own citizens and restore life to normal, so hoarding is still a serious risk.

Ronald St. John, a physician who has held government posts in the United States and Canada on infectious disease control, expects a similar vaccine scenario.

"In terms of the production, there will be a lot of self-interest," he said.

BARDA gives explicit preference to vaccine projects that promise US production capacity.

"We are asking the American taxpayer to give a lot" to the vaccine effort, so ensuring U.S. access to any successful vaccine is important, "said Bright, the recent chief of BARDA.

But he added that BARDA is also encouraging the companies it supports to build manufacturing capacity outside the United States, "so we can have a global supply all at once." Many governments are pouring money into vaccine initiatives with expectations that if a viable vaccine emerges they will be first in line.

Arcturus Therapeutics Holdings Inc, a San Diego biotech company, is receiving up to $10 million from the Singapore government in partnership with the Duke-National University of Singapore Medical School to develop its mRNA-based coronavirus vaccine candidate. Singapore gets first access if the vaccine is approved, Arcturus CEO Joseph Payne said. Everything after that, he said, goes to "whoever pays for it." "Arcturus is not responsible for the ethics of distribution-governments are-but they need to pay for it in order for governments to get the vaccine," Payne said. "The country that will win is the country that stocks multiple vaccines at risk." This week, the company raised $80.5 million from a public offering on a common stock.

The government is backing several coronavirus vaccine projects in China, a major global vaccine producer, raising the prospect that it will first inoculate its 1.4 billion people. Sinovac Biotech Ltd. is already testing vaccine candidates in humans and awaiting initial data for one government-backed effort.

Sinovac got 60 million yuan ($8.4 million) in low-rate lines of credit through a discount loan program supported by the central bank of China. Government officials quickly made the company's land available to build production plants, including a factory intended to produce up to 100 million doses of its coronavirus vaccine a year.

Sinovac would not discuss how much money is invested in the public sphere. The government agencies concerned have declined requests for comment.

The World Health Organization announced on Friday a "landmark collaboration" across the international community to raise $8 billion to accelerate the development of the coronavirus vaccine and ensure equitable access to any successful vaccine worldwide. Countries across Europe, Asia, Africa, the Middle East and the Americas have announced their participation, but the US and China, two of the world's largest pharmaceutical forces, have not.

"There will be no official U.S. participation," a U.S. mission spokesman in Geneva told Reuters, adding that the U.S. supports "global cooperation to develop a vaccine." According to a member of the White House coronavirus task force who spoke to Reute, broader questions about U.S. policy on international vaccine distribution are still under consideration within the Trump administration The official noted U.S. State Department, and U.S. The International Development Agency is spending nearly $500 million on helping internationally with the COVID-19 response.

A spokeswoman for the WHO said Friday's announcement was the beginning of a global collaboration and "we'd welcome more countries coming on board."

People involved in the global vaccine race have told Reuters that the biggest incentive for countries to promise to share vaccines for coronavirus may be the uncertainty about which ones will work.

Since no country can be sure that the candidates it supports will be successful, sharing commitments with other nations can help ensure that they will have an initial supply to inoculate health care workers and other critical populations.

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