By Amber Hsiao
Originally published in the2x2project.org
While U.S. policymakers struggle with efforts to stymie the resurgence of measles globally—in recent months cropping up at seemingly innocuous places like Disneyland—other countries are faced with a beast of a different nature. In the United States, we are fortunate to be armed with a large supply of vaccines that have all but eliminated the most frequent killers of children under the age of 5, including smallpox, tetanus, and measles. In the developing world, however, there’s still a long way to go.
Consider measles: a viral respiratory infection, measles killed more children than any other vaccine-preventable disease in 2003. Of the more than 500,000 deaths, the majority occurred in developing countries where mortality from measles is particularly high. Poor hygiene, crowded conditions, and a host of other dire situations cause children’s immune systems to suffer, leaving them more susceptible to diarrhea, pneumonia, and malnutrition. Even if a child survives infection, he or she may suffer from other life-altering health conditions, such as blindness or brain damage.
According to the Bill & Melinda Gates Foundation, about 1.5 million children die each year—one every 20 seconds—from vaccine-preventable diseases. Globally, one in five children does not have full protection from even basic vaccines. And over 70 percent of unvaccinated children live in countries with very large populations and very weak health systems for delivering these much-needed vaccines, which are some of the most cost-effective public health interventions around.
While medicines and technologies for their delivery are often available, lack of effective vaccination programs are the result of various factors including political will, lack of trained health workers, supply shortages, unreliable transportation, and the lack of storage facilities for vaccines.
A HISTORICAL LOOK
It may be decades before many countries experience changes that will overcome these health system deficiencies. In introductory epidemiology courses, public health students often learn about the epidemiological transition that occurs as non-communicable diseases replace communicable diseases as countries develop. More recently however, the World Health Organization’s (WHO) global burden of disease study has shown that in actuality, there are now many poor countries that are experiencing a “triple burden of communicable disease, non-communicable disease, and socio-behavioural illness.”
In contrast, the epidemiological transition moving from infectious diseases to chronic diseases happened after World War II for many developed countries in which the prevalence of communicable diseases has been considerably lower. Given that wartime support for research and development (R&D) increased drastically, U.S. government programs focused on finding cures for infectious diseases such as measles. A number of companies worked under the oversight of the War Production Board, churning out a wide range of miracle antibiotics, including penicillin, first mass-produced by Merck starting in 1942. Other antibiotics were also developed during this golden era of pharmaceuticals: streptomycin (Merck), chlortetracycline (Lederle), chloramphenicol (Parke-Davis), erythromycin (Abbott and Lilly), and tetracycline (Pfizer). With mass-produced antibiotics finally on the U.S. market, curing previously-deadly diseases, pharmaceutical companies were able to shift slowly over to drugs that didn’t just provide a quick cure, but instead sustained life as well as longer-term use of their products.
During the next five decades there was a flurry of activity—major innovations addressing a number of chronic diseases; strengthened regulations and requirements for clinical trials in response to the thalidomide tragedy that caused thousands of birth defects in children; significant advances in laboratory sciences, including the development of new instruments that would aid in drug discovery; and computational and combinatorial chemistry, genomics, and biotechnology, which revolutionized technologies that could target specific genes and microbes more precisely.
By 1980, the Supreme Court decided that patents were allowed for genetically manipulated organisms. Companies that received federal research funding were also allowed to secure patents as a result of the Bayh-Dole Act. Following Genentech, the first biotechnology company to go public, thousands of biotech companies were also founded. Around the same time was the rise of disease-based activists who mobilized and rallied for their own causes, criticizing pharmaceutical companies for catering only to chronic diseases that affected the middle-aged and elderly. In response, the Orphan Drug Act of 1983 was established to provide incentives for R&D for drugs to treat diseases that affect a limited number of patients.
By the early 21st century, pharmaceutical companies had become powerful, yet polarizing, players in the healthcare market. At times intensely criticized for profiting off the sick, pharmaceutical companies are now faced with the challenge of intense competition in a highly saturated market that makes it difficult to balance both public and private interests. Often what makes headlines are stories of Big Pharma behaving badly, or the high profits they reap, or the frequency with which they bankrupt very sick Americans. WHO Director General Margaret Chan even recently lambasted Big Pharma for delaying the development of an Ebola vaccine.
But just how challenging is it to balance the bottom line alongside so many stakeholder interests?
THE REAL COSTS OF DEVELOPMENT
Bottom line costs for drug development vary widely depending on the source and how you account for expenses. Some figures account only for drugs that are approved for sale on the market. For example, the Tufts Center for the Study of Drug Development (CSDD) cites the average cost of developing a new prescription medicine at $2.6 billion over a decades-long period. Another source adjusts this figure by combining all drugs in development, regardless of whether they reach the market, finding that the average cost for R&D ranges anywhere from $3.7 billion to $12 billion per drug. But no matter how you look at it, the costs are significant, especially when less than one in 10 human clinical trials actually succeeds.
“Product development costs have gone up astronomically in the last 10 years. The cost has doubled for drugs and biologics collectively, and a doubling of costs in 10 years is really quite serious,” explained Ronald Evens, adjunct research professor at the Tufts CSDD and adjunct clinical professor at the University of the Pacific School of Pharmacy.
"Very few organizations can undertake the arduous, risky, expensive process of drug R&D. There is a common misconception that NIH research is responsible for most drug breakthroughs." —Michael Rosenblatt, Merck & Co.
Part of this cost is due to several new requirements as authorized by the Food and Drug Administration (FDA). For example, data requirements for studies, such as number of patients and number of tests per study, have grown dramatically. Also, the FDA Amendments Act of 2007 authorized a significant new requirement for product approvals. Companies must now submit Risk Evaluation and Mitigation Strategies, or REMS, that assess the risks and benefits of a new drug, with a plan of action in case of adverse events.
“The government is asking you to estimate what may happen with side effects after product approval and during standard usage, how you’re going to collect data on this, and a plan on how you’re going to deal with it,” Evens said. “It may not sound like a big deal, but it means you have to develop the paperwork, concept, and systems before approval and required for approval. These additional requirements have added on to the product development costs.”
According to a recent piece in the Harvard Business Review by Michael Rosenblatt, executive vice president and chief medical officer at Merck & Co., “[o]nly 20 percent of approved medicines generate revenues that exceed average R&D investment.”
“Very few organizations can undertake the arduous, risky, expensive process of drug R&D. There is a common misconception that [the National Institutes of Health’s (NIH)] research is responsible for most drug breakthroughs. In reality, the pharmaceutical industry’s investment in R&D (more than $50 billion in 2012) far exceeds the NIH’s total budget (about $20 billion in 2012),” Rosenblatt wrote. He continues to explain that the NIH’s research sometimes generates leads for what direction to head toward, but “industry’s enormous investment is what translates those basic advances into actual treatments for patients.”
As many of the top blockbuster drugs have come off patent in recent years (on average, 12 years of protection), pharmaceutical companies are strategizing new ways to boost revenues to stay afloat. Blockbuster drugs like Lipitor (a cholesterol-lowering medication) and Plavix (prevents blood clots after recent heart attack or stroke) have for years brought in high revenues for their respective companies. Lipitor, the best selling drug to date, brought in $13.7 billion in sales at its peak in 2006. In the year of its patent expiration in November 2011, Lipitor brought in nearly $7.5 billion in sales for Pfizer. To give this some additional context, Pfizer reported $67.4 billion in revenues and $10 billion in profits in 2011, making it one of the top 10 most profitable companies that year, up there with companies including Wal-Mart ($444.2 billion), Apple ($103.3 billion), and Microsoft ($73.4 billion).
Pfizer’s 2012 Annual Report reads, “[t]he majority of our revenues come from the manufacture and sale of biopharmaceutical products. The biopharmaceutical industry is highly competitive and we face a number of industry-specific challenges, which can significantly impact our results. These factors including, among others: the loss or expiration of intellectual property rights, the regulatory environment and pipeline productivity, pricing and access pressures, and increasing competition among branded products.”
Since Pfizer’s Lipitor patent expiration, Pfizer has struggled to keep its revenues up. It also attempted to enter the generics market by pulling out all the stops and selling its own authorized generic version before the rapid decline in sales in its market share.
Bristol-Myers Squibb, the company who sold Plavix in partnership with Sanofi-Aventis, faced similar stings. Plavix revenues accounted for over a third of the company’s revenue in 2011. According to the New York Times, Plavix generated $42.8 billion in sales for the company before it went off patent in May 2012.
While the timeline and costs for development are somewhat similar comparing vaccines and pharmaceutical drugs, the payoff isn’t quite the same. Take, for example, the top five best selling drugs of all time as of 2013 (starting from the top): Lipitor, Plavix, Humira, Advair, and Enbrel.
What do all these drugs have in common? Lipitor and Plavix fall into the treatment for heart disease category, while Advair is used for asthma and chronic obstructive pulmonary disease, often associated with emphysema and bronchitis. The last two are Humira (fights autoimmune diseases and disorders) and Enbrel (alleviates pain from arthritic and other autoimmune disorders).
Not surprisingly, these top five drugs mostly fall into the category of drugs that treat chronic and degenerative diseases, such as heart disease, that affect those living in developed countries. The next 15 drugs on the list are similar: antipsychotic and mood disorder drugs, acid production regulators, and cancer-related drugs. These “risk-reducing” drugs, such as Enbrel, prevent further damage and deterioration to the body, while at the same time lengthening life. “Lifestyle” drugs, such as Viagra, have also cropped up that are meant to enhance life.
Two of the top five in particular highlight one of the major shifts in the industry in past years: both Humira and Enbrel are biologics. Biologics are medications made from live cell cultures that begin in the microscopic living factory of Chinese hamster ovary cells, making them far more complex to manufacture than chemical drugs. The benefit of this to the industry is that this makes it potentially more difficult for another company to come up with a generic equivalent once they’re off patent. Vaccines make up a small percent of biologics.
“All big pharmaceutical companies around the world are moving toward biologics significantly,” Evens said. “As much as 25 to 75 percent of R&D is in biologics at many companies now. There have been some major, major changes as some companies (such as Roche) have transformed themselves from years past. There’s been some real evolution in the focus of the research because of lost patents. How do you replace that?”
With the increased focus on biologics, the biotechnology world has become a major driver of innovation, looking to new antibodies, proteins, and peptides as potential targets for pharmaceutical development. Public-private partnerships (PPP) and alliances between pharmaceutical and biotech companies are also becoming more common.
For example, in 2009 GlaxoSmithKline (GSK) formed a PPP with Brazil’s Foundation Oswaldo Cruz (Fiocruz) to transfer manufacturing technologies for a sophisticated pediatric vaccine to prevent meningitis and pneumonia. Arthur Daemmrich, associate professor at the University of Kansas Medical Center, wrote of the PPP in a Harvard Business School case study, “Analysts considered vaccine sales in developing countries with significant unmet medical needs as critical to the company’s future, especially when considering forecasts for prescription drugs sales to level or even decline in Europe and North America.”
More partnerships and additional investment in diseases affecting developing countries would be ideal, “but epidemics don’t happen on timelines that are easily amenable to interventions by the pharmaceutical industry, considering the decade-plus timeline between research and a drug that is safe and effective for wide-scale human use,” said Daemmrich, who has written extensively on the history of the development of the pharmaceutical industry. “Basic public health measures and investment in healthcare infrastructure would be far more effective.”
While the development of a new class of biologic drugs may be on the rise, there may be hints that pharmaceutical companies are also looking for new emerging markets that may share the same target audience as the global health and development community.
EMERGING MARKETS AND UNMET NEEDS IN DEVELOPING COUNTRIES
According to the WHO, vaccines only comprised two-thirds of 1 percent of the global pharmaceutical market in 2010, though the industry has experienced spectacular growth. From 2000 to 2014, the market nearly tripled from $5 billion to $24 billion. Five multinational corporations account for 80 percent of the market in sales: GSK, Sanofi Pasteur, Pfizer, Merck, and Novartis.
“There is vaccine market growth. GSK, Pfizer, and Merck have had vaccines for a long time,” Evens said. “A few companies are dabbling in entering vaccine development, so there is some increase in activity. Prevnar (protects against pneumococcal infection) and Gardasil (protects against human papillomavirus, or HPV) have both been very beneficial for patients and healthcare, and are highly profitable, so that has attracted some new players. Some new technologies are being developed to improve vaccine effectiveness, such as mammalian culture systems.”
Little has been published on vaccine development, however, compared to pharmaceuticals or biologics more generally. One of the few review papers on the topic by Canadian researchers found that “[c]linical phases are different in the resources required: biopharmaceutical trials are much smaller, requiring only 3,000 to 5,000 participants, while vaccine clinical trials require between 10,000 and 100,000 participants.”
While the exact R&D costs for vaccines are unknown, we do know that the developing world makes up 80 percent of the world’s population but only takes up 20 percent of the annual volume of vaccines sold in the global market.
“Generally, vaccine development varies from anywhere between eight to 16 years,” explained Sushant Sahastrabuddhe, head of the enteric and diarrheal disease program at the International Vaccine Institute (IVI) in Seoul, South Korea. “The vaccine development timeline is generally a bit longer because they are developed for healthy people. Proving safety in healthy children and infants takes more time for approval.”
In the United States, several processes for vaccine approvals are similar to that of other pharmaceuticals, according to Evens, with the exception of childhood vaccines, such as biological quality testing, preclinical testing, and the three clinical trials phases.
“Especially in the United States, there is a reluctance to participate in clinical trials because they are healthy children,” Evens explained. “So the trials are often done in developing countries where the need is higher, more patients are available, and many patients are not inoculated for even some common communicable diseases.”
Nevertheless, more than 120 new vaccine products are in the development pipeline, and roughly half of these are of importance for developing countries. Vaccines for malaria are currently being pursued actively by many companies, though Evens says that there will not likely be any major effort to pursue new vaccines because of the difficulty to testing proof of concept.
In drug development, animal models are often used to test proof of concept and to run experimental trials during clinical trials. Vaccines, however, mimic natural infections that trigger the body to produce antibodies to kill the virus. For example, the malaria parasite has been difficult to develop a vaccine against. Even though scientists have already mapped the genome of both the parasite (Plasmodium) and the mosquito vector, it could take decades to determine the specific genes to effectively target with a vaccine. Further, such a vaccine if available could not be tested on animals because they are not affected by the types of Plasmodium that affect humans. Viral diseases like Ebola are even harder to develop vaccines for because they evolve quickly.
Companies that are already in the vaccines sector are more likely to refine their existing successful vaccines by increasing the serotypes targeted to make them better for protecting patients.
While the exact R&D costs for vaccines are unknown, we do know that the developing world makes up 80 percent of the world’s population but only takes up 20 percent of the annual volume of vaccines sold in the global market.
But more recent trends are promising. The WHO notes that there is a “[m]ajor focus on new vaccine development for industrialized country markets.” In particular, the growth of vaccine marketing has been noted in Mexico, Brazil, Turkey, Indonesia, China, and India. Manufacturers have also been established in China, India, South Korea, and Brazil.
Many U.S.-based pharmaceutical companies have drug assistance programs meant to assist U.S. patients who cannot afford medicines. Moreover, many also donate medicines to those in need in low-income countries, abiding by the WHO’s guidelines for medicine donations that specify guidelines for donations during large-scale emergencies.
GSK, for example, donated to the WHO over 24 million doses of their pandemic vaccine during the 2009 to 2010 H1N1 influenza pandemic for use in developing countries. The company emphasizes in its public policy positions that they “do not believe that long-term donations and/or donations for the treatment of chronic diseases are a sustainable solution to the healthcare challenges faced by many countries.” Nonetheless, GSK, along with Merck, are part of a long-term donation program through the Global Programme to Eliminate Lymphatic Filariasis (commonly known as elephantiasis). Both companies have pledged to donate albendazole tablets for as long as it takes to eliminate the disfiguring disease.
Merck’s MECTIZAN(R) Donation Program for the treatment of onchocerciasis, or river blindness, has also been in place since 1987, making it the longest-running disease-specific donation program to control disease.
Nevertheless, pharmaceutical companies are often demonized for not being altruistic enough, or at all. U.S. tax policies have also been criticized for encouraging drug companies to donate products rather than dispose of unwanted drugs properly. During the mid 90s, recipient countries reported that many drug donations were expired and inadequately labeled. In response to these reports, the WHO Guidelines for Drug Donations was prepared in 1996 (the most recent edition published in 2011). Though not a set of international regulations, they do provide core principles to improve the quality and appropriateness of donations.
INTERNATIONAL SUPPORT FOR PUBLIC GOODS:
DEVELOPING THE PIPELINE AND SUPPLY
In a recent article in The Atlantic, editor Bourree Lam wrote, “It’s absurd to think profits could have ever been the sole motivation of vaccine production.” Pharmaceutical companies may be some of the most profitable industries now, but the public also stands to gain substantially in social and economic productivity, even if the gains may vary dramatically from country to country.
“We must remember that drug companies have stockholders and must be profitable to exist,” Evens said. “Profitability around the world, where many third world countries cannot afford the new expensive medications, often does not exist and poses a major challenge to worldwide healthcare. There is low likelihood of that happening in some parts of the world. The good thing is that there is the Gates Foundation, in conjunction with some pharma companies as well as some WHO initiatives that are able to funnel money into vaccine development [for developing countries]. Furthermore, even with the typical financial incentives, some good new vaccine product development is underway for malaria and dengue fever in late-stage clinical development.”
In the past two decades, major initiatives have taken place globally that have amassed resources and created global alliances to help address this unmet need. In November 1999, the Gates Foundation contributed $750 million over five years to the Global Alliance for Vaccines and Immunizations (GAVI) to establish the Global Fund for Children’s Vaccines. As a global vaccine alliance of public-private stakeholders in the field of immunization, GAVI officially launched in early 2000 to leverage the WHO’s technical expertise, UNICEF’s purchasing power, and the massive R&D capacity and market knowledge of the vaccine industry around the world.
By guaranteeing a minimum international standard of quality, WHO prequalification allows vaccines to then be purchased by GAVI, UNICEF, and governments who work with the WHO to procure vaccines.
Around the same time, investments in R&D for neglected diseases increased as product development partnerships (PDPs) emerged as a way for organizations to address gaps in vaccine development. By forging alliances across sectors and experts, development assistance in the health sector increased from $5.5 billion in 1990 to $21.8 billion in 2007.
“A lot of these PDPs—mostly based in the U.S. and Europe—are not-for-profits funded by donors that include the Bill & Melinda Gates Foundation,” explained Deborah Hong, head of the communications and advocacy unit at IVI. “[PDPs] are a very diverse group; they are private-public partnerships designed to bring vaccines and drugs to the market for the poor.”
In addition to strengthening R&D, these PDPs are meant to address the lack of commercial incentive to invest in R&D in the first place for vaccines that could benefit developing countries. Donors tend to make investments in diseases that have a very clear high mortality rate.
At a PDP like IVI, a very simplified breakdown of the R&D process looks something like this: Once an antigen is discovered in the lab, it’s made into a viable vaccine (approximately two years of work). Preclinical studies are then conducted in animals, including mice, rabbits, guinea pigs, and chimps. If the vaccine passes the safety tests, humans clinical trials begin, which on average take anywhere between eight to 10 years.
The clinical trials are sometimes the trickiest part. Depending on the country in which the trial takes place, two or more different agencies in charge of regulatory and ethical oversight may be involved. IVI in particular ensures that any country they work in has an Institutional Review Board (IRB). This means that if they are working in six different sites (as IVI has done previously), there are seven IRBs to pass, including their own.
“The IRBs requirements sometimes vary,” said Sahastrabuddhe of IVI. “Some countries are more concerned about blood draws from children, while some are more interested in the scientific rationale. You can imagine, there’s only one protocol [for running the clinical trial], so we get many comments from each IRB.”
Once clinical trials are successfully completed, the product is licensed for manufacturing, abiding by the WHO’s prequalification program.
“The prequalification program is similar to what the FDA does for the United States,” explained Hayatee Hasan, WHO technical officer for the immunization, vaccines, and biological unit. “The U.S. only needs to think about the domestic market, whereas the WHO has to think about the same vaccine being used in Chad, Cambodia, in various countries. This ensures that all people of the world have access to the full range of quality vaccines.”
By guaranteeing a minimum international standard of quality, WHO prequalification allows vaccines to then be purchased by GAVI, UNICEF, and governments who work with the WHO to procure vaccines.
As the name implies, a PDP like IVI then partners with local manufacturers to produce the drug. In the manufacturing phase, IVI creates a technology transfer plan. Scientists from the manufacturer’s side are invited to go to IVI where they train for approximately four weeks, after which they return to their own facilities in their home countries for two to three months to set up production. Scientists from IVI remain at the manufacturing site for an additional three to six months to ensure there aren’t any additional issues during production.
While IVI works with governments closely to fund R&D, clinical trials, and licensing, adoption of vaccines by countries also can vary. Ultimately, the decision to adopt, introduce, and implement a new vaccine program in a country depends on the government.
“One of the reasons for a country not to adopt a vaccine is because they don’t think they have the infrastructure currently to deliver another vaccine,” Sahastrabuddhe said. “Politicians are also generally risk averse. Vaccination itself can be tricky. For example, if one clinic within a country isn’t adequate and causes a couple deaths after administering the HPV vaccine, but a medical expert says it wasn’t due to the vaccine itself, the public perception may still be that the vaccine caused the death. Politicians and scientists don’t always speak on the same platform.”
Once licensed, the manufacturer is free to set whatever price it wants for individuals who pay out of pocket. For the public market, manufacturers can only mark up the price a certain percentage above the manufacturing cost. The capped selling price for the vaccine ensures that is it is affordable for countries that want to purchase the vaccines, according to Sahastrabuddhe.
GAVI also has a system of tiered pricing that offers vaccines at fixed lower prices depending on a country’s needs. If a country is very poor, GAVI might support purchase of the vaccine 100 percent initially, and then eventually transition to a co-pay system until the country is able to pay the full cost. For example, as part of a deal between GAVI, Merck, and GSK, a dose of the HPV vaccine was made available to developing countries for $4.50 per dose (compared to $100 in developed countries).
THE FUTURE OF VACCINES
While many PDPs tend to focus on only one disease (e.g., HIV, malaria), IVI works on developing a range of vaccines to target cholera, typhoid, and dengue, among others. IVI—an independent organization since 1999—was originally established through the United Nations Development Programme and the WHO in 1997 to discover, develop, and deliver safe, effective, and affordable vaccines for developing nations. Because it receives a large portion of its operating budget from the South Korean government, IVI has a relatively diversified funding base that allows it to tackle more than one disease at a time.
More recently, however, funding for PDPs has been decreasing while R&D costs have increased, according to Hong. And when funds are allocated, they are often project-specific awards that are restrictive and make it somewhat difficult for an organization like IVI to work on multiple projects as needed.
“Because of the current global financial climate, funders, particularly those from the public sector, are under pressure to demonstrate that government investments are having impact in a time frame that does not lend itself to longer product development timelines,” Hong said. “Donors are less eager to fund technologies in a portfolio that are still in the early phases of research—before proof of concept—making it more difficult to pursue promising science that may hold more risk but have potential for longer-term impact, because they don’t have the flexibility to transfer funds to promising projects.”
Nevertheless, there appears to be glimmers of hope in the field based on the actions of pharma, biotech, and major global players in the past few years. The severe acute respiratory syndrome (SARS) scare of 2003 and more recent ongoing Ebola outbreak tragedy highlight just how porous geographical borders are. Populations that were previously more isolated are now, more than ever, susceptible to new diseases and outbreaks, especially in countries with fragile health systems.
“I think for some diseases, there may be some interest by pharmaceutical companies, tempered by the fact that [the disease] is going to be a concern for developed countries. A good example is Ebola.” —Deborah Hong, International Vaccine Institute
Global travel will only increase. But perhaps the emergence of these global threats provides some impetus for companies to pursue strategies that will help strengthen global health networks.
“There is certainly some shift. Sanofi (the maker of the dengue vaccine) just cleared Phase III clinical trials. There is a lot of anticipation that this vaccine will be available in the near future,” Hong said. “And this vaccine is a bit of a game changer because up until now there wasn’t much interest in dengue, as it was a disease associated with low- and middle-income countries.”
At least five other dengue vaccine candidates are currently in development by various companies. Cases of dengue, a mosquito-borne disease that had been eliminated in the United States for decades, began to appear between 2009 and 2010 in Florida.
“Because dengue is becoming a problem in the U.S., and with talk of climate change, there is concern that the mosquito vector may be coming to the U.S.,” Hong said. “I think for some diseases, there may be some interest by pharmaceutical companies, tempered by the fact that [the disease] is going to be a concern for developed countries. A good example is Ebola.”
IVI has also been actively involved in the development of a number of vaccines. One of their major initiatives currently is to garner greater global support for the prevention and control of cholera, a rapidly-dehydrating diarrheal disease common in developing countries. The WHO issued a position paper on cholera vaccines in early 2010 that strongly urged that oral cholera vaccines be used in conjunction with traditional strategies to improve water and sanitation. The oral cholera vaccine received WHO approval for global use in 2011, though demand was relatively low.
According to a 2012 IVI report, “An Investment Case for the Accelerated Introduction of Oral Cholera Vaccines,” Vietnam was one of the only countries at the time that provided cholera vaccination to the public sector.
“For a very long time, many people felt that the only way to address cholera was to improve sanitation and hygiene—basically it was thought of as a disease of poverty,” Hong said. “I heard cholera used to be a problem in Korea about a century ago, but as the country became developed, with proper sanitation, hygiene, and sewage, cholera was no longer a problem. That’s obviously a very effective way of eliminating cholera. But investing in resources for water and sanitation requires huge political will. This is a challenge for many developing countries; therefore, short-term and medium-term interventions are needed.”
Hong explained that the change in attitude in use of the cholera vaccine was in part because of Doctors Without Borders demonstrated that the vaccine did in fact work during an outbreak of cholera in Guinea in 2012. This has led to a change in tide about prevention and control plans. A stockpile for the oral cholera vaccine has also now been established, supported by GAVI.
“We have come a long way in oral cholera delivery, but there are still a lot of people who don’t know much about the vaccine,” Hong said. “The next big initiative is to be engaged in access issues, uptake, and generating evidence that it does in fact work in the real-world public health setting.”
Globalization will continue to drive the global disease landscape. Though there may always be a misalignment of private and public interests, there is promise as access and use of vaccines worldwide increase.
Even as vaccine critics in the United States turn defensive over measles, at the very least, it has revived debates—and perhaps injected a modicum of scientific understanding—into the rhetoric surrounding anti-vaccine movements. How we approach prevention, control, and treatment measures will largely determine our success in stemming future epidemics.
Edited by Dana March