Sunday, April 21, 2019 09:08:28 PM
Gloria Pallares :
There are dozens of deadly diseases with the potential to become international health threats, including Ebola, avian influenza, and Zika. Yet there is uncertainty about when and where deadly epidemics will emerge, meaning there is little financial incentive for pharmaceutical companies to bring vaccines to the market.
Enter public-private partnerships. The 2014-2016 Ebola outbreak in West Africa, which claimed more than 11,000 lives and took several billion dollars to contain, rallied international organizations and countries around the need to align efforts - among themselves and with the private sector - to prepare for future health emergencies.
The deployment of an Ebola vaccine to control an outbreak in the Democratic Republic of the Congo in May, for example, was the result of a deal between Gavi, the Vaccine Alliance and U.S. pharmaceutical company MSD. It was the first time a vaccine could be used as an integral part of the response to an outbreak of the virus.
The Coalition for Epidemic Preparedness Innovations, launched in 2017 with initial funding of nearly $500 million, is also engaging the industry to accelerate the development of vaccines for Lassa fever, Nipah virus disease, and Middle-East Respiratory Syndrome.
CEPI's targets stem from a World Health Organization research and development blueprint list of priority pathogens that may cause epidemics, but have no vaccines to slow their spread. This list, which aims to cut the time needed to develop candidate products from years to months, is another outcome of the first Ebola wake-up call.
Following the Ebola outbreak in DRC's Equateur province, Devex spoke to Gavi, CEPI, WHO, and Médecins Sans Frontières to discuss how lessons learned from this emergency can inform preparedness against other lethal infectious diseases, and what role PPPs are playing in getting the world ready for the next big epidemic. The Ebola vaccine illustrates the role of PPPs in helping tackle global epidemics. Between its discovery in 1976 and the beginning of the epidemic in West Africa, the virus infected about 2,400 people and killed less than 1,600. By 2014, there were 10 vaccines and drugs in the pipeline, but none of them was ready for rollout.
"Before 2013, Ebola outbreaks had been sporadic, and only affected a small number of people in isolated communities in poor African countries," Deputy Chief Executive Director of Gavi Anuradha Gupta told Devex. "Despite the severity of the disease, there was little incentive for pharmaceutical companies to bring [a vaccine] to market."
In 2016, Gavi responded by committing an initial $5 million toward the procurement of MSD's Ebola vaccine once it is commercially available. This will require licensing by international regulatory authorities such as the European Medicines Agency and the U.S. Food and Drug Administration, and prequalified and recommended by WHO. As part of the deal, MSD agreed to ensure that a stockpile of 300,000 doses of the investigational vaccine was continuously available in case there was an outbreak before the product was licensed. This includes 100,000 doses that can be shipped within five calendar days.
Efforts to contain the latest Ebola outbreak in DRC have been given a vital boost with the availability of five experimental medicines, WHO experts told Devex, though none have yet been officially licensed.
"We created a guaranteed market and a clear incentive for the company to take the vaccine through licensure," said Gupta. "The deal also meant that, when Ebola broke out in the DRC earlier this year, there was a supply of thousands of doses to meet the demand."
Around 3,300 people received the vaccine from May-July through a "ring vaccination" approach targeting front-line responders, contacts of infected individuals, and contacts of contacts. The same method had been used to control smallpox.
The DRC government had to approve the deployment of the investigational vaccine under compassionate-use regulations and as part of a clinical protocol. Then, the United Nations Children Fund, WHO, and MSF supported the implementation, while WHO, Gavi, the United Kingdom Department for International Development and others funded operational costs.
"Merck donated the doses and worked with WHO to ship them when needed. Until licensure, there is no commercial value and no money changes hands between Gavi and Merck when it comes to using doses from the stockpile," clarified Gupta.
"The vaccine is an important additional tool in managing Ebola outbreaks and a major milestone for global public health that has brought hope to the affected community," WHO spokesperson Tarik Jarasevic told Devex. "However, it does not replace the vital role of good community mobilization, surveillance, contact tracing, and infection prevention and control."
Asked about PPPs' role in the fight against epidemics, WHO referred to a 2017 report that notes they are "the most visible manifestation of the power of collaboration to promote R&D for diseases that predominantly affect the poor."
In that spirit, the governments of Norway and India, the U.K. Wellcome Trust, the Bill & Melinda Gates Foundation, and the World Economic Forum launched CEPI in 2017, following a series of expert consultations convened by WHO.
Speaking to Devex, CEPI CEO Richard Hatchett noted vaccine development takes a long time and is costly and complicated, while epidemics are unpredictable and demand for vaccines is episodic. On top of that, vaccines such as the one for Ebola expire after a couple of years.
"As a result, you have a situation which is often referred to as a 'market failure,' but in reality, the market is doing precisely what markets do in terms of supply and demand. What that means, though, is there is no provision for the collective need when there is an outbreak."
CEPI's coalition of public and private partners was created to bridge that gap: "Our funding and support change the return on investment calculus for private sector partners, so they do not need to rely exclusively on commercial sales to repay the full cost of [vaccine] development," explained Hatchett.
The organization's strategies include working with companies as it builds a portfolio of vaccine candidates, and supporting cross-cutting R&D preparedness against pathogens that may cause future epidemics, but are still unknown to cause human disease. The alliance is also working with industry partners on issues of access, research, and manufacturing. The coalition hopes this model can share the risks, costs, and benefits of the process across partners.
"Ebola proved that we can develop vaccines quickly, even in extremely challenging conditions, but we cannot continue to rely on ad-hoc partnerships and the goodwill of a handful of companies," reads a statement on CEPI's website. "We need a sustainable model for epidemic vaccine development."
Miriam Alía, MSF vaccination and outbreak response adviser, recognized the role of PPPs in helping bring critical vaccines to the market, but called on manufacturers to keep prices as close as possible to production costs. Particularly, given prior public and philanthropic investments in R&D.
Following the attacks of Sept. 11, 2001, for example, the U.S. funded biodefense research related to Ebola, as did Canada's Department of National Defense, which invested $7 million in developing a vaccine. In Aug. 2014, Canada donated the vaccine for use in Africa and allowed MSD to manufacture it.
"Prices should not be so high so as to limit access to vaccines during an outbreak," said Alía, who is a delegate to the International Coordinating Group on Vaccine Provision powered by MSF, WHO, UNICEF, and the International Federation of the Red Cross and ICG is expected to manage the global stockpile of the Ebola vaccine once it is licensed, so that emergency supplies are adequately allocated to countries during outbreaks.
Gavi finances ICG's stockpiles of meningitis, yellow fever, and cholera vaccines for its eligible countries, and Gupta told Devex they will also "fund 100 percent of the Ebola vaccine for Gavi-supported countries."
For MSF's Alía, an important next step would be to make the vaccine easier to use in the field. The product must be currently kept at -60 to -80 degree Celsius, so implementers have to rely on specialized fridges to transport supplies to remote areas of DRC.
Another possibility could be having stockpiles in some high-risk countries. "The DRC is at risk of periodical Ebola outbreaks, so having protocols and in-country supplies could accelerate the response and greatly increase its effectiveness," Alía said.
Taking a broader look at epidemic preparedness, CEPI's Hatchett noted that preparing for clinical trials during outbreaks would take a "tremendous" amount of planning. "Many of the countries at risk do not have strong clinical trial infrastructures, so much of the capacity we will need still needs to be built," Hatchett said.
This June, there were outbreaks of six of the pathogens on WHO's priority list, he pointed out, including Ebola, Rift Valley fever, and Zika.
"Familiarity can invite complacency, but vaccine development requires sustained commitment of people and resources, so once we decide to develop one, we are in for the long haul," he added.
Hatchett believes one of the main challenges is maintaining public attention to the threat of global epidemics: "Now we need to keep this issue at the top of people's agenda, so we can prepare for, and not just react, during future outbreaks," he said.
(Gloria Pallares is a journalist reporting on sustainable development, global health and humanitarian aid from Africa and Europe).
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