As anti-Ebola vaccines and treatments finally undergo fast-track testing, public health advocates say that governments’ repeated failure to create global norms for coordinating and financing medical advances is a major reason behind the struggle to produce medicine fast enough to end the scourge quickly.
Medical officials fighting Ebola in West Africa say the development of new drugs and vaccines to treat and prevent infection are crucial, among other tactics, to controlling the current epidemic, which has killed more than 8,000 people and infected more than 20,000, primarily in Guinea, Liberia and Sierra Leone, since the outbreak was detected in March 2014.
Gavi, the public-private partnership that aims to expand access to vaccines in the developing world, pledged up to $300 million to buy vaccines for the affected countries once the World Health Organization recommends a drug.
Progress, however, in making vaccines and treatments has so far been uneven. One top vaccine candidate, cAd3-EBO, developed by the National Institute of Allergy and Infectious Diseases in the United States and the British pharmaceutical company GlaxoSmithKline, was well tolerated by participants in the first phase of US trials, but its second phase of testing has been pushed back until February after a World Health Organization meeting of national regulatory authorities said they needed more information about the vaccine from GlaxoSmithKline.
Trials for another promising vaccine, rVSV-EBOV, originated by the Canadian Public Health Agency and recently licensed to the American drug maker Merck & Company, were temporarily suspended in December after volunteers at Geneva University Hospital complained of joint pains. Trials resumed in early January, and results are expected to be ready in March.
Johnson & Johnson, another American-based pharmaceutical company, also introduced the first testing phase of its own vaccine in January, but it does not expect to finish clinical trials before the summer.
These drug companies and others working on potential vaccines against Ebola regularly participate in World Health Organization meetings on treatments and intervention. All 34 members of the agency’s board are government officials from its member states, which include Britain, Japan and the US, where many of the drug companies testing vaccines are based.
Meanwhile, a leveling off or slowdown in the rate of new infections of Ebola in West Africa has brought concern that testing the new drugs’ effectiveness will be disrupted.
Doctors Without Borders (or MSF, as it is called, using the French acronym for Médecins Sans Frontières), has started its own drug program, giving Ebola-positive patients at its treatment center in Guéckédou in Guinea (where the first Ebola patient in the West African outbreak was detected), the option to participate in an experimental trial of favipiravir. The drug, an antiviral, is produced by the Japanese company Toyama/FujiFilm.
The trials by MSF, which are being done by the French medical research institute Inserm, started in mid-December. Conclusive results are not expected until the spring.
MSF also began trials with Oxford University researchers in January to test the antiviral drug brincidofovir at the MSF treatment center in Monrovia, Liberia’s capital. Neither of these two drugs has been studied in humans against Ebola, but if they prove to be safe and effective in people, MSF said, they will be made available to patients in the next round of trials.
In addition, MSF may conduct clinical testing of blood plasma therapies at its treatment center in Conakry, Guinea’s capital, with the Antwerp Institute of Tropical Medicine.
These latest accelerated developments have resulted from increased financial commitments and intensified coordination and consultations among public and private parties. The push began after the World Health Organization announced on Aug. 8 that the Ebola crisis was an international public health emergency, nearly five months after the first outbreak was detected in Guinea. The UN agency has also been heavily criticized for its seemingly laggard response in handling the outbreak.
Biotechnology analysts at Credit Suisse have said that investors’ doubts about financial gains from Ebola vaccines and treatments have been the main obstacle to more aggressive research initiatives. Moreover, big pharmaceutical companies had little financial incentive to find remedies for a smattering of West African countries. Yet as fears rose that the current outbreak in West Africa could spread throughout the rest of the continent and infections could widen in North America and Europe and head to Asia, many governments’ renewed their interest in Ebola eradication.
An MSF campaign that advocates for more access to lifesaving drugs has said that even when there is a profit incentive behind medical innovation, the resulting diagnostics, vaccines and treatments are often priced too high for people in developing countries.
According to the WHO, current tests to diagnose Ebola infection cost about $100 per person and rely heavily on laboratory support and technical expertise that are difficult to find in West Africa. Storage requirements for the two leading anti-Ebola vaccine candidates, rVSV-EBOV and cAd3-EBO, which must be kept very cold, have also been an important technical challenge.
“The current innovation systems for medicines isn’t functional,” Judit Rius, the manager and legal adviser for MSF Access, the campaign, told PassBlue.
Rius said that though the World Health Organization has taken a more active and prescriptive role to address the failures of medical research and development systems in recent years, governments worldwide have not responded adequately to calls for change.
A 2012 report by a WHO independent consulting group recommended establishing a convention for global norms in medical innovations, which MSF welcomed. The recommendations would have created mechanisms to determine international medical needs and priorities, secure financing and monitor and coordinate research and development efforts.
“Unfortunately, very little has been done to move these recommendations from paper to action, and that’s really in the hands of UN member states,” Rius said. “WHO has a huge role to play, but WHO member states have to show leadership and take steps to implement these recommendations.”
Rius said that government programs to provide economic incentives for research and development can promote medical innovation, but such programs have fallen short of expectations. “Governments can play a more important role, like the US is doing, by creating incentives,” she said. “The challenge is that these incentives should be well designed.”
In the last several months, MSF Access has urged US lawmakers to tighten loopholes in a Federal Drug Administration program that aims to promote medical innovations for neglected diseases. The Priority Review Voucher program, which now includes Ebola on its list of eligible diseases, provides companies a fast-track approval process of drugs in their portfolio for certain diseases. The companies can also sell their voucher to other companies.
MSF said the vouchers have clear commercial value for drug makers, but there are no safeguards to ensure that companies are actually investing in research or that patients and treatment providers have affordable access to the drugs being produced.