Donors and Drug Makers Offer $500 Million to Control Global Epidemics

http://www.nytimes.com/2017/01/18/health/partnership-epidemic-preparedness.html

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Stung by the lack of vaccines to fight the West African Ebola epidemic, a group of prominent donors announced Wednesday that they had raised almost $500 million for a new partnership to stop epidemics before they spiral out of control.

The partnership, the Coalition for Epidemic Preparedness Innovations, will initially develop and stockpile vaccines against three known viral threats, and also push the development of technology to brew large amounts of vaccine quickly when new threats, like the Zika virus, arise.

With enough money and scientific progress, the strategy could bring a drastic change in the way the world tackles pandemics.

Now the global response often resembles a fire department racing from blaze to blaze. The coalition wants something more like a military campaign, with stores of ammunition and different weapons systems ready to be deployed as soon as a threat emerges.

In theory, health officials could even act pre-emptively — inoculating a population against a dangerous new flu or coronavirus circulating in animals before it infects many people, for example.

“We’ll have to make sure we do better than we did against Ebola,” said Bill Gates, founder of the Bill and Melinda Gates Foundation, one of the largest initial donors. He has often predicted that the catastrophe most likely to kill 10 million people in the near future is a pandemic rather than nuclear war, terrorism, famine or natural disaster.

The other donors, besides the Gates Foundation, include the governments of Japan and Norway, and Britain’s Wellcome Trust. Each is putting up $100 million to $125 million over five years; Germany, India and the European Commission are expected to announce donations soon.

Six major vaccine makers — GlaxoSmithKline, Johnson & Johnson, Merck, Pfizer, Sanofi and Takeda — joined in the coalition as “partners” rather than donors, as did the World Health Organization and Doctors Without Borders.

Marie-Paule Kieny, the W.H.O.’s assistant director-general for innovation, said her agency would help by working with governments to streamline regulations.

Ultimately, the coalition will need billions of dollars to fulfill its ambitious plans. Members made their announcement at the World Economic Forum in Davos, Switzerland, in the hopes that the billionaires and corporate leaders in attendance would take notice and chip in.

The announcement was welcomed by Dr. Anthony S. Fauci, director of the National Institute of Allergy and Infectious Diseases, which designs vaccines but must partner with private industry to produce large amounts.

“I’ve been pushing for a global health emergency fund for years,” he said, “and half a billion dollars is a good start.”

Dr. Stanley A. Plotkin, a longtime vaccine researcher and scientific adviser to the new coalition, said members debated which of 10 diseases to target first and picked three because “taking a vaccine from soup to nuts costs at least half a billion dollars.”

Even if the United States is not now a donor, he said, it already supports vast amounts of vaccine research through its bioterrorism budget, “so I hope they’ll supplement the coalition’s work with theirs.”

New epidemics can be expected to occur regularly and spread quickly thanks to air travel, public health experts warn. Stopping them early will save lives and billions of dollars.

The long-discussed idea was given new impetus by the back-to-back Ebola and Zika epidemics.

Experimental Ebola vaccines that worked in monkeys had existed for years, but had never been tested in humans or stockpiled because vaccine companies had no financial incentive to make them. Ultimately, the 2014 epidemic killed 11,000 West Africans, and isolated cases reached Britain, France, Germany, Spain and the United States.

No experimental vaccine was ready when Zika exploded across the Western Hemisphere, but many research teams found them easy to create in the lab because there were already vaccines against two close viral relatives, yellow fever and dengue.

The coalition’s first $500 million will be spent pursuing two goals: further development of vaccines against Lassa fever, the Nipah virus and Middle East Respiratory Syndrome (MERS); and improving the latest DNA and RNA vaccine technology, which seems like the best hope to make a true “plug and play” vaccine platform.

Those viruses were chosen, said Dr. Penny M. Heaton, the Gates Foundation’s director of vaccine development, because many experts consider them the biggest threats for which experimental vaccines are already in the works.

Lassa, like Ebola, causes hemorrhagic fevers; rodents — notably the African soft-furred rat — transmit it through urine and feces.

Nipah causes deadly encephalitis and pneumonia; it circulates in Asian fruit bats and is also caught from pigs that eat fruit gnawed by bats. Outbreaks usually begin among hog farmers or people who drink date-palm sap fouled with bat urine.

MERS is a coronavirus related to SARS that also causes acute, deadly pneumonia. It originates in bats and circulates among camels, and can prompt large hospital outbreaks, especially when patients are crowded together and staff members do not wear protective masks.

The coalition will pick two experimental vaccines against each virus and pay vaccine companies to prove they work in monkeys, are safe for humans and induce what are thought to be protective levels of antibodies in humans.

After that, modest amounts will be stockpiled — ideally within five years.

Scientists obviously cannot test vaccines by giving healthy humans lethal doses of incurable diseases. So the ultimate test will be to see if the stockpiled version stops the next outbreak that occurs in nature.

Bringing a new vaccine to market can take 20 years and cost up to $1 billion, and candidates usually disappear in the “valley of death” — the many expensive steps required between showing that a lab-brewed concoction protects mice or monkeys, and rolling out a factory-line version proven safe to inject into millions of humans.

The coalition aims to move candidates far enough across that valley so they can stop an outbreak and see if full-fledged production is justified.

RNA and DNA technology involves injecting a virus’s genes to provoke the immune system to make both antibodies and white blood cells primed to attack the virus.

But RNA and DNA can break down, or fail to penetrate cell membranes or to trigger protein-coding. So various “platforms” are being tried, such as folding them into larger shapes or chemically gluing them onto microscopic beads.

Once the technical issues are solved, the method will have great promise. Large amounts of vaccine could be made much faster than, for example, growing vaccine in fertilized chicken eggs.

Thorny legal issues, however, remain — including who will hold patents on innovations developed with coalition funds and who will be held legally liable if anyone dies or is harmed during vaccine trials.

“We have not sorted out all the intellectual property problems yet, but I’m confident we can,” said Dr. Jeremy Farrar, director of the Wellcome Trust.

Any fund recipient would have to guarantee that its vaccines would be priced for poor countries as well as rich ones, he said.

On the liability issue, Dr. Farrar added, the coalition likes an American model — the National Vaccine Injury Compensation Program, under which vaccine makers cannot be sued but must contribute to a fund that compensates anyone hurt by a vaccine.

Andrew P. Witty, chairman of GlaxoSmithKline, or GSK, who joined the Davos announcement, said the industry preferred protection like that of the United States’ 2005 Public Readiness and Emergency Preparedness Act, which exempts vaccine makers from all liability — except for willful misconduct — once the secretary of health and human services declares a public health emergency.

The United Nations or W.H.O. will have to help protect the industry, Mr. Witty said.

His company is willing to devote a slice of one of its research facilities to the coalition’s goals and to conduct up to $50 million worth of research on a nonprofit basis.

GSK will do so, Mr. Witty said, “first, because it’s the right thing to do when the world is up against it, and, second, because it prevents disruption of our business.”

The world’s vaccine companies have no factories sitting idle for emergencies, he said, “so when a crisis hits, as the biggest company, we get the first call — and we have to stop doing other stuff.”

With assurances that good manufacturing processes would be followed, he said, GSK could be willing during an epidemic to let vaccine companies in India or Brazil, for example, use the company’s patented techniques to make vaccines.