Clinical research and the Zika virus
Zika, the latest public health threat, has been hot media buzz for a while now. What began in early 2015 in Brazil has spread to neighboring parts of Latin America, as well as islands in the Pacific. In January 2016, the World Health Organization (WHO) said the virus was likely to spread throughout most of the Americas by the end of the year. Will public awareness and fear of the disease spreading translate into rapid action on the part of clinical research? Probably not.
Cyclical outbreaks tend to drive public interest in clinical research for vaccines, but when it comes to public policy, these outbreaks are slow to motivate action. By the time researchers are able to bring a vaccine out of the lab and into the public, interest has often waned.
Remember the SARS outbreak of 2003? Roughly 8,098 people worldwide became sick and 774 died. In the years since that global panic, only one company has been able to get a viable candidate into a phase I clinical trial. Five other companies are still trying to create a SARS vaccine that can be tested in humans. A commercially available vaccine is still many years away, and public interest has moved on to other concerns, like Zika.
We will likely see the same pattern play out in the search for a Zika vaccine. President Obama has asked Congress for $1.8 billion to battle the Zika virus. Others want to use the money previously set aside for the Ebola crisis, ostensibly because the outbreak of 2014 in West Africa is no longer an imminent threat.
Government leadership is essential to motivate clinical research because they offer the most monetary support. The dominant pharmaceutical players in the $22 billion global vaccines market, such as Sanofi, GlaxoSmithKline, Merck, Pfizer and J&J, are often hesitant to partner with the government if funding isn’t certain.
Looking at other infectious diseases that impact the same region of the world, we should expect the development of a Zika vaccine to take some time. Dengue, a mosquito-borne virus that is a leading cause of illness and death in the tropics and subtropics, was first isolated by scientists over 70 years ago, yet we are only now seeing the first vaccine come to market. Sanofi, after two pivotal phase III trials, one in Southeast Asia and the other in Latin America, received its approval in Mexico, Brazil and the Philippines in 2015 under the brand name Dengvaxia. Sanofi intends to pursue approvals in all relevant countries, and other drug makers are following suit, with a number of candidate vaccines in phases I and II.
Similarly, malaria is on the verge of having its first vaccine made available globally. Primarily mosquito-borne, malaria is one of the most prevalent infectious diseases in the world with over 3.3 billion people living in at-risk areas, primarily in the tropics and subtropics. The malaria parasite was discovered in 1880, but it was only last summer that a malaria candidate vaccine from GSK received positive opinion from European regulators for the prevention of malaria in young children in sub-Saharan Africa. Mosquirix, the commercial name of the vaccine, is expected to be widely available in 2017.
While it could take years before an approved Zika vaccine reaches the market, there is reason to hope that clinical research will yield practical results in a more accelerated time frame. New technologies are changing the way vaccines are made, and recent advances have yielded promising results in similar diseases, like yellow fever, dengue and West Nile. Today, entire viral genomes can be cloned, enabling fast, custom design of organisms for use in vaccines. The future of vaccines will likely by dominated by this sort of genetic engineering.
The first vaccine trials against the Zika virus will likely start this fall, and in the best-case scenario, scientists can proceed to phase II by early 2017. But unless Congress approves the funds, health officials may not have enough money to put together a phase II trial, which would make the entire process longer and increase the risk of public interest being distracted by the next big outbreak of yet another infectious disease.
Matthew Howes is executive vice president, Strategy & Growth for PALIO. A leader in digital strategy, he has provided the fuel for digital businesses visited by over 100 million people every month. Email firstname.lastname@example.org.
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