The world's leading international coalition on vaccines and immunizations announced Wednesday that it will invest in a promising Ebola virus vaccine that has demonstrated 100 percent effectiveness in human trials.
The announcement, which came during the World Economic Forum in Davos, Switzerland, marks the first time that the public-private vaccine consortium Gavi -- which includes governments, philanthropic organizations and pharmaceutical companies -- has invested in a vaccine that isn't licensed or available yet.
"They made an exception here, with the encouragement that this vaccine continue in evaluation and be submitted for licensure next year," said Michael Osterholm, director of the Center for Infectious Disease Research and Policy at the University of Minnesota, who was not involved in Gavi's decision.
Gavi, which stands for the Global Alliance for Vaccines and Immunization, pledged $5 million to buy Merck & Co.’s version of a live vaccine for the Zaire strain of the Ebola virus, once it becomes licensed by the end of 2017. When the vaccine hits the market, this $5 million will be subtracted from the first “bill" Gavi receives when it begins stockpiling the vaccine.
A spokesperson for Gavi confirmed to The Huffington Post that this is, indeed, the first time the coalition has agreed to purchase a vaccine before it's licensed -- but pointed out that Gavi is not buying doses of an unlicensed vaccine, only committing funds to its purchase ahead of the licensing.
Indeed, part of the agreement includes a provision for Merck to stockpile 300,000 doses right now in case another outbreak strikes before the drug is completely vetted. Gavi won't be able to purchase the emergency stockpile until the vaccine is licensed, because the coalition only buys vaccines that have been licensed by a regulatory authority (like the U.S. Food and Drug Administration) and then prequalified and recommended by the World Health Organization, the gold standard for vaccines.
Wednesday's announcement signals three important changes in our global approach to disease prevention:
1. We are acknowledging that the future includes the Ebola virus.
Because Ebola can hide in bodily fluids for months after a person is cured, there will always be a risk that the virus can flare up again in small pockets. Last week, around the same time the WHO declared the Ebola outbreak over in West Africa, lab workers in Sierra Leone confirmed that a woman who had recently died tested positive for the disease.
"We have every reason to believe Ebola is going to re-emerge again in Africa,” said Osterholm, who also is the co-chair of an international research group that monitors Ebola vaccine development.
Gavi’s deal with Merck includes a promise from the pharmaceutical giant to provide the licensed vaccine at an affordable price for the poorest countries, as well as a commitment to stockpile 300,000 doses of the unlicensed vaccine by May 2016 in case of emergency.
"This vaccine will clearly be used," Osterholm said. "Ebola is going to be with us forever, so this is a very important step forward."
2. We're supporting pharmaceutical companies that invest in research for rare diseases.
When the Ebola virus began ravaging West Africa in 2014, the question came up: If we'd known about the virus since 1976, why had we never come up with an effective treatment or vaccine for it?
There were fewer than 2,000 cases of Ebola in the decades before the epidemic, meaning that -- as one U.S. doctor put it -- there was simply “no market” for such countermeasures. And with a limited global budget for vaccine development, governments and scientists had to prioritize research on diseases that they knew were poised to wreak the most havoc on the greatest number of lives.
"When there’s a crisis, everybody kind of gears up and runs into the crisis to help. But what happens in the end if you don’t come up with a product?" Michael Osterholm, director of the Center for Infectious Disease Research and Policy
But now that Ebola has proven it can spread like wildfire through a population, sickening more than 28,600 people and killing more than 11,300 in the 2014-2015 outbreak, drug companies are rushing to put out the flames with accelerated and expensive research and trials on vaccines -- and the world should support that, Osterholm says.
"When there’s a crisis, everybody kind of gears up and runs into the crisis to help,” he said. “But what happens in the end if you don’t come up with a product? How many times do you have to do that before you say to yourself, 'Well, maybe next time we’re not going to run into the crisis'?”
In truth, Gavi is pledging a relatively small amount of money compared to the cost of developing and testing a vaccine. Still, the pledge -- and the promise of more purchases once this vaccine is licensed -- may prove to be an important way of keeping pharmaceutical companies engaged in solutions.
“While we all in the public health community appreciate the vaccine manufacturers stepping up, putting their own money into this and risking it on these vaccines, we have to make sure they’re held whole going forward,” Osterholm said.
3. Merck's vaccine, in particular, really seems to work.
Merck’s VSV-ZEBOV Ebola vaccine is still being tested in people, but it’s the only vaccine that has published any preliminary data from a randomized phase III trial, which is the final research phase before a drug hits the market.
The study is still ongoing, but the researchers have already published exciting news: Merck’s VSV-ZEBOV seems to be 100 percent effective in protecting people from the disease.
In a study of 7,651 people in Guinea, researchers described two groups: those who got the vaccine immediately and those who waited to get one. Among the people who got their shots immediately, there were zero cases of Ebola 10 days after the vaccines were administered, while the people who had to wait to get their shots ended up with 16 cases.
These are exciting results, but it’s important to note that we still don’t know how long the protection lasts, or what the long-term health effects of the vaccine might be. We also don’t know how many doses are needed for the vaccine to work best. That’s why the trials still need to be completed -- not just for Merck’s product, but for all the other vaccines that are still in development, said Osterholm.
Rob Kelly, a spokesman for Gavi, said there are a number of things to consider when choosing the best Ebola vaccine, including storage concerns. Merck’s version, for instance, needs to be kept at very cold temperatures, which presents an extra logistical wrinkle.
"We’re neutral on which manufacturer’s vaccines we buy," as long as the vaccines are licensed and prequalified, Kelly said. "In the longer term, when hopefully multiple Ebola vaccines will be licensed, prequalified and recommended, it’s entirely possible we will purchase from a range of suppliers."
Osterholm likewise said the fight against Ebola won't necessarily be limited to one kind of vaccine.
"There may be other vaccine candidates that offer unique features also, and we wouldn’t want to lose those,” Osterholm said. "This shouldn’t be a winner take all."
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