The return on investment in global health is tremendous, and the biggest bang for the buck comes from vaccines. Vaccines are among the most successful and cost-effective health investments in history.
—SETH BERKLEY, MD
It’s hard to overstate the impact of vaccines on our history and on our lives.
The term “vaccine” hearkens back to the work of Edward Jenner, who referred to cowpox, the disease to which he exposed patients to immunize them from smallpox, as Variolae vaccinae, Latin for “smallpox of the cow.” With the success and popularity of this means of inoculation against one of history’s great killers, all such methods became known as vaccination.
But while we rightly consider Jenner the father of vaccination, the basic concept probably goes back a thousand years. Recognizing that scratching or cutting the skin and inserting a small amount of smallpox pus could confer immunity, Chinese healers in the tenth century employed a practice known as variolation. An alternate method was to let the pus dry into a powder and then blow it up the nose. Though these practices did keep many recipients from getting full-blown smallpox, they were not without significant risk; they could cause the disease—sometimes fatally—as well as transmit other dangerous microorganisms, including syphilis bacteria, into the scratched or cut skin or through inhalation into the lungs. But as the best means of inoculation available until Jenner’s time, they were adopted by many cultures.
Jenner’s inoculation method changed everything and ushered in the modern era of vaccines. The benefits were recognized at different times in different nations. In some, skeptics physically attacked vaccinators as charlatans or worse.
In 1777, General George Washington mandated smallpox inoculation for every member of the Continental Army. In 1806, with Jenner’s method in wide use, President Thomas Jefferson publicly endorsed vaccination. “Medecine [sic] has never before produced any single improvement of such utility,” he declared. Seven years later, the US Vaccine Agency was established under President James Madison, who instructed the US Post Office to carry smallpox vaccine without charge. In 1885 Louis Pasteur announced his vaccine for rabies, a disease that had carried a 100 percent fatality rate. Jefferson’s observation was now difficult to deny.
So compelling was the case for the early vaccines that in 1905, the Supreme Court ruled in Jacobson v Massachusetts that the benefit of compulsory smallpox vaccination to public health took precedence over an individual’s personal agency to refuse.
From around that time, scientific discoveries in infectious disease etiology, antitoxins, and means of transmission ushered in the great age of vaccine innovation. One glance at the CDC tables comparing annual morbidity and mortality in the United States in the twentieth century and in 2014 from a group of common infectious diseases presents a striking picture.
The annual number of twentieth-century US pertussis—whooping cough—cases averaged 200,752 before vaccine was available. In 2014 the number was 32,971: an 84 percent decrease. By the same time measures, measles went from an average of 530,217 cases per year to 668 by 2014: a 99 percent decrease from before vaccine was used in children. In 1964, in the last great US outbreak of rubella, a disease that can be devastating to the unborn children of affected pregnant women, 2,100 babies died and another 20,000 were born with severe, lifelong disabilities. Today cases of mumps and rubella have decreased by a similar 99 percent. Tetanus, with an extremely high mortality rate, went down 96 percent. And polio, diphtheria, and smallpox all went to zero cases.
At the turn of the twentieth century, the US infant mortality rate—the rate of deaths among children in the first year of life—was 20 percent, in some cities as high as 30 percent. Of those fortunate 70 to 80 percent who survived, another 20 percent died before reaching their fifth birthday. Later in the century, similar deaths in children were greatly reduced due to vaccination and improvements in basic sanitation.
From 1900 to 1904, an average of 48,164 cases and 1,528 deaths caused by smallpox were reported each year in the United States. Outbreaks occurred periodically after 1905 and then ended in 1929. Sporadic cases continued until 1949. The absence of smallpox cases in the United States for the past sixty-seven years is one of the most remarkable public health achievements of all time, considering the death, disfigurement, and suffering the virus caused for centuries.
In 1954, Jonas Salk, a virologist at the University of Pittsburgh School of Medicine and developer of the first polio vaccine, became an international hero to the generations of parents who worried every summer when their children went to a playground, swimming pool, or movie theater—anywhere people congregated and the poliovirus silently lurked. They were haunted by images of row after row of iron-lung respirators and boys and girls in leg braces and wheelchairs. Now there was a prospect of those images disappearing from the modern world.
On April 12, 1955, in what became one of the most famous quotes of the decade, legendary broadcast journalist Edward R. Murrow asked Salk on the live CBS program See It Now, “Who owns the patent on this vaccine?”
With matter-of-fact modesty and a shy smile, Salk replied, “Well, the people, I would say. There is no patent. Could you patent the sun?”
That was it—the apotheosis from man to immortal. Jonas Salk was every parent’s selfless deliverer from fear.
Salk’s archrival, Dr. Albert Sabin of the Cincinnati Children’s Hospital Medical Center, later developed a vaccine based on live attenuated virus—a virus that has been changed so it doesn’t cause disease but still grows in humans or animals—which could be administered on a sugar cube rather than injected into the arm. Both vaccines were highly effective in their mutual objective of protecting humans from polio.
Even without a patent, the vaccines were economically viable, which encouraged a number of companies to get into the polio vaccine business and reaffirmed Jefferson’s observation that vaccines were there for the good of all.
And that, in turn, created a vital and continuous manufacturing demand. The vaccine business flourished. Five major pharmaceutical companies produced Salk’s vaccine. Between 1955 and 1962, 400 million doses were administered in the United States alone. Just about everyone was inoculated against smallpox and polio.
Over the course of the 1960s and 1970s, children in the United States and other developed world countries began receiving a standard lineup of immunizations before they started school. These included diphtheria, tetanus, and pertussis (DTP), and later measles, mumps, and rubella (MMR) and chicken pox. Most school districts required proof of immunization before parents could enroll their kids. Vaccination against deadly rabies was standard procedure for anyone bitten by a suspect animal that couldn’t be caught and examined or that was captured and found to have rabies. Newly recruited soldiers and sailors lined up for vaccinations against anything the military feared they might face, including yearly influenza shots. There was an ongoing need for vaccines, and pharmaceutical companies were eager to participate in a lucrative business model that supported public health on a mass scale.
These staggering advances are all due to vaccines. It is no exaggeration to say that vaccine remains, along with basic sanitation, the sharpest and most effective arrow in our public health quiver. How we aim that arrow will determine our future.
So successful was the effort to curtail or eradicate the range of childhood diseases that the public started taking their absence for granted. This, among other things, has given rise to an antivaccine movement, whose members are wary of vaccines, particularly childhood vaccines, believing that they may cause autism, or even the diseases they are supposed to prevent. There is no scientific evidence to support these charges, but that doesn’t stop a good many sophisticated, educated people from backing away from vaccines that were once considered miraculous. Ironically, this resistance recalls the dawn of vaccines, when smallpox vaccinators were harassed and attacked by suspicious opponents. But they, at least, had the excuse of lack of established knowledge.
Today’s opponents have no such defense. Measles, for example, which is usually self-limiting but can become very serious in some individuals (in the immunocompromised, the fatality rate can be as high as 30 percent), was eliminated from the United States by the year 2000. But it has returned, caused by infected children from other countries that still have measles traveling to the United States and exposing our unvaccinated children. And that transmission can happen easily, as when an infected guest visited Disneyland in California in 2015. The outbreak sickened 147 people in the United States, including 131 in California. Whether this was due to the complacent belief that the disease was a thing of the past or misplaced fear of the highly effective vaccine doesn’t matter. The result was needless sickness—some of it quite severe—widespread fear, and economic costs.
It isn’t just complacency and the antivaccine crowd that challenge vaccine development. The basic economics have changed.
Today, the pharmaceutical business model for routine immunizations and travel-related protection, such as against yellow fever and typhoid, still holds, even though fewer manufacturers remain in the business and bulk purchasers such as the government and insurance companies have brought prices and profit margins way down on certain vaccines. In 2002, Wyeth pharmaceutical company stopped producing DTP and flu vaccines. The move had negligible effect on company profits but created rationing for both vaccines in the following year.
But now we have new and different vaccine needs and the business model has become more complicated. Pharmaceutical manufacturers are noting that vaccine production is no longer where the major action is. In 2014, the worldwide pharmaceutical industry was estimated to have more than $1 trillion in annual revenues. Just the five leading drugs around the world generated more than $49 billion in sales. This included three autoimmune drugs—Humira ($12.54 billion), Remicade ($9.24 billion), and Enbrel ($8.54 billion); Solvaldi, for hepatitis C ($10.28 billion); and Lantus, a drug for diabetes ($8.54 billion). Overall, the ten biggest-selling pharmaceutical products in 2014 generated combined sales of $83 billion.
In contrast, in 2014, the top five vaccine manufacturers in the world had combined sales of $23.4 billion, a mere 2 to 3 percent of the trillion-dollar drug market.
Let’s get one thing straight about vaccines: It’s not like in the disease outbreak thriller novels and movies. A bunch of scientists in a lab don’t suddenly find the magic formula, bottle it up, and have a medical flying squad race to the scene and inject it into the arms of the stricken, who, miraculously, recover in a matter of seconds or minutes. For one thing, vaccines are almost always for prevention rather than treatment. For another, once you’ve got the proof-of-concept “formula” that appears to work in the lab and then in animal models, you’ve got a long way to go before you can even submit the vaccine for FDA approval and then create and ramp up production facilities, not to mention figuring out how to pay for all of this.
Vaccines are not like other kinds of drugs, and comparatively speaking, they are hard to make. The production of the Lipitor you take for your cholesterol, the Metformin you take for diabetes, the Prozac you take for depression, or the Viagra you take for erectile dysfunction—all maintenance drugs of one kind or another—can be likened to building a Chevrolet on a General Motors assembly line. Production of a vaccine, on the other hand—particularly a new vaccine—is more like growing lettuce in a field in California. By the time the Chevy gets to your garage or the lettuce gets to your table, each is going to be pretty much what you expected. But the process for manufacturing the car is a lot more predictable, repeatable, and scalable than the process for growing lettuce, which is subject to weather, ground conditions, drought or flood, insects, and any plant-based diseases that happen to be circulating in the area.
What we’re talking about is the difference between a chemical agent and an essentially biologic agent; that is, chemical synthesis versus biological growth. For decades our vaccines have grown in cell cultures, in eggs, or on the skin of animals such as calves. This is a time-consuming process with a number of difficult-to-control manufacturing variables. And most of the vaccine production for influenza requires a whole lot of chickens laying a whole lot of eggs. The more modern cell culture technology, in which a seed virus is introduced into an existing cell line and grown in capacity in a fermenter, is faster and more efficient, but it’s still a biologic process.
Just as a vaccine is different from a maintenance drug in terms of manufacturing and makeup, it is fundamentally different from an economic perspective. A pharmaceutical company can count on a regular and predictable market for the maintenance drugs its customers will take every day, often for the rest of their lives. For the major noncommunicable illnesses like cancer, manufacturers know they will have a steady market because the diseases are not going away anytime soon, and they can charge a lot of money for their drugs as long as their patent monopoly lasts.
In contrast, the need for a particular vaccine is unsteady and unpredictable. By the time you need one that is already licensed, it is often too late to ramp up production. During the 2009–10 H1N1 flu pandemic, the number of cases of the second, critical wave peaked in the United States in October 2009. The number of doses of vaccine shipped peaked at the end of January 2010, by which time the number of cases had dropped sixfold. Even then, the number of doses shipped in the United States was less than 125 million. This was far short of the number needed to vaccinate every American, particularly given that children required two doses.
To be dispensed in the United States, vaccines have to go through the same sorts of FDA-mandated clinical trials as other pharmaceuticals. As vaccine development progresses, there are various internal tests, and then animal testing. Then there are three phases of human trials. Phase I tests safety. Phase II tests various dosage levels for safety and effectiveness. Phase III tests the actual effectiveness of the drug or vaccine on a large enough cohort of human subjects to allow for variations in response, factoring in considerations such as how the vaccine affects children, teens, persons over sixty-five, persons with an immunocompromising condition, pregnant women, and so on.
Generally, Phase III trials are double-blind, meaning that neither the subject nor the administrator knows which subjects are given the actual drug and which are given a placebo. At the end of the trial, that information is revealed and the outcomes are compared. Sometimes the trials are stopped early when an independent monitoring board determines that during the trial, the vaccine has clearly demonstrated it is or is not working, or there are patient safety issues emerging. Phase III trials can get extremely expensive, and pharmaceutical companies don’t like to undertake them unless they think they have a pretty strong prospect of obtaining FDA approval. Today a pharmaceutical company can expect that getting a new vaccine licensed will take more than a decade of work and a billion dollars of investment.
Pharmaceutical executives know that the process from the beginning of Phase III through its results, submission to the FDA’s Office of Vaccines Research and Review, and that office’s complete review and evaluation literally can take years. We call this Phase III evaluation “the valley of death”: the point at which substantial research, development, testing, and licensing costs are piling up but no revenue is being generated.
To understand this phenomenon, let’s back up a couple of steps. Vaccine development often starts with grants and contracts from the NIH and science- and health-oriented foundations, as well as “angel” investors. Much of the research originates from the academic sphere. This initial development step, if successful, can get the vaccine to the prototype stage and through Phase II trials. But then the product enters the valley of death. Now the prospect of huge expenses comes into focus and the researcher-developer has to make some fundamental decisions.
What are the chances the vaccine will make it through Phase III trials and prove itself effective and without serious side effects? What are the chances the vaccine will find a large and steady market if it does successfully make it through Phase III trials and wins FDA approval? How much will manufacturing facilities cost? What about the added time and expense of having to go through other countries’ regulatory procedures? How do you decide to allocate research and development dollars, including those for Phase III trials for diseases that might best be considered “potential global calamities waiting to happen” but might not reveal themselves for years or even decades to come? The West African experience with Ebola and the Americas’ experience with Zika virus infections are two examples of this challenge.
This makes sense. Corporations cannot ignore economic realities. They have to demonstrate to their boards that they are acting rationally from a business perspective. While we all applaud corporate social responsibility, we cannot expect it to be a business model. As Dr. Rajeev Venkayya, president of the Global Vaccine Business Unit of Takeda Pharmaceutical Company and former director of Global Health Delivery for the Bill & Melinda Gates Foundation, told a conference at the National Academy of Medicine, “Pharmaceutical companies want to do the right thing, but they don’t like risk or tolerate it well.”
Philanthropic funding still plays a role in the research and development of vaccines and their subsequent purchase, as was modeled by the March of Dimes and the polio campaign. The Bill & Melinda Gates Foundation is partnering with academic research groups, pharmaceutical companies, and product development partnerships to try to develop a vaccine for HIV/AIDS and a more effective one for malaria, two of the biggest infectious killers in Africa. And there are other examples.
But as Bill Gates said to us when Mark and I met with him in his Seattle-area office, “People invest in high-probability scenarios: the markets that are there. And these low-probability things that maybe you should buy an insurance policy for by investing in capacity up front, don’t get done. Society allocates resources primarily in this capitalistic way. The irony is that there’s really no reward for being the one who anticipates the challenge.”
Every time there is a new, serious viral outbreak, such as Ebola in 2012 and Zika in 2016, there is a public outcry, a demand to know why a vaccine wasn’t available to combat this latest threat. Next a public health official predicts a vaccine will be available in x number of months. These predictions almost always turn out to be wrong. And even if they’re right, there are problems in getting the vaccine production scaled up to meet the size and location of the threat, or the virus has receded to where it came from and there is no longer a demand for prevention or treatment. Here is Bill Gates again:
Unfortunately, the message from the private sector has been quite negative, like H1N1 [the 2009 epidemic influenza strain]: A lot of vaccine was procured because people thought it would spread. Then, after it was all over, they sort of persecuted the WHO people and claimed GSK [GlaxoSmithKline] sold this stuff and they should have known the thing would end and it was a waste of money. That was bad. Even with Ebola, these guys—Merck, GSK, and J & J [Johnson & Johnson]—all spent a bunch of money and it’s not clear they won’t have wasted their money. They’re not break-even at this stage for the things they went and did, even though at the time everyone was saying, “Of course you’ll get paid. Just go and do all this stuff.” So it does attenuate the responsiveness.
This model will never work or serve our worldwide needs. Yet if we don’t change the model, the outcome will not change, either.
Let’s consider one example. Each year, starting around September, we’re all admonished to get our influenza vaccinations. And yet, each year, we all hear from someone, “I got the vaccine last time and I still got the flu!” A couple of years ago, it happened to me: Even though I got the shot, I still wound up in bed for a week with influenza.
The fact is, influenza vaccine is one of our least effective vaccines, and the only one that has to be changed every year. That is partly because influenza strains shift so easily that public health officials have to make an educated guess about which strain or strains will be predominant in a given year, and they have to do it many months in advance by observing what is going on in the other hemisphere of the world. We follow what is happening with influenza virus strains in the Southern Hemisphere when it is their fall (our spring) to predict which influenza viruses will likely be with us the next winter. Some years that educated guess is more accurate than others.
So is it worth getting the vaccination each year? I give that a qualified yes. It might or might not prevent you from getting flu. But even if it is only 30 to 60 percent effective, it sure beats zero protection.
What we really need is a game-changing influenza vaccine that will target the conserved—or unchanging—features of the influenza viruses that are more likely to cause human influenza pandemics and subsequently seasonal influenza in the following years.
How difficult would such a game-changing influenza vaccine be to achieve? The simple truth is that we don’t know, because we’ve never gotten a prototype into, let alone through, the valley of death.
We need a new paradigm—a new business model that pairs public money with private pharmaceutical company partnerships and foundation support and guidance.
What might that look like?
Going back to our war analogy, when the Department of Defense decides it needs a new weapon system, it puts out general specifications and solicits bids, but it doesn’t expect the large defense contractors to develop that weapon, test it, and then hope the government wants to buy it in quantities sufficient to make it profitable. Instead, bids are evaluated and a contractor or consortium of contractors is selected. If we’re serious about having vaccines for a wide range of potentially destructive or antibiotic-resistant infectious diseases, we need to strongly consider the government’s involvement—not just in initial research and development, but also in actually bringing the vaccine to market.
We’d like to see the paradigm shift throughout the world, but the United States, as is so often the case, will have to lead. We surely welcome the countries of the European Union, China, and even India to provide science and policy leadership as well as financial resources. But we can’t wait for an international consensus; the infectious bugs are now gaining on us at breakneck speed. The US government must increase its support of the development of vaccines that will address our Crisis Agenda, and coordination among government, academia, and industry will be needed to ensure that the vaccines with clear potential make it across the valley of death.
The US government has tried to make a real difference in the critical vaccine arena. Foreign and terrorist threats reliably get official attention. Following 9/11 and during the subsequent anthrax attack, Health and Human Services secretary Tommy Thompson asked me to serve as a special adviser to him and the highly competent and seasoned team of bioterrorism and public health experts he had assembled. He had become aware of my experience in these areas of concern after reading my book Living Terrors, as well as through my numerous calls and meetings with his senior staff in the days following 9/11. I subsequently spent more than three years as a special adviser to the secretary’s office on a part-time basis while still serving as the director of CIDRAP. To my pleasant surprise, I quickly learned that Secretary Thompson understood, as did few other senior government officials, the critical importance of public health preparedness.
One of the efforts I was involved with was called Project BioShield. It was the brainchild of Stewart Simonson—one of the secretary’s closest advisers and the first assistant secretary for public health emergency preparedness—and Major General Philip K. Russell, MD—former head of the US Army Medical Research and Materiel Command and an expert on vaccine development. In addition, the late D. A. Henderson; Anthony (Tony) Fauci, MD, director of the NIH’s National Institute of Allergy and Infectious Diseases (NIAID), who came up with the name; the late John LaMontagne, PhD, deputy director of NIAID; William Raub, PhD, former acting director of the NIH and then science adviser to Secretary Thompson; and Kerry Weems, a career executive at the Department of Health and Human Services (HHS), made up the team that brought BioShield to reality. As a result of their visionary and groundbreaking work, Congress appropriated $5.6 billion in fiscal year 2004 to the Project BioShield Special Reserve Fund to support the goal of acquiring chemical, biological, radiological, and nuclear (CBRN) medical countermeasures over a ten-year period. The hope was that having such a large, precommitted government fund would incentivize the pharmaceutical industry to invest its resources in multiyear countermeasure projects.
By guaranteeing the market, the fund attracted a number of smaller to midsize pharmaceutical companies to participate in countermeasure product development, including new vaccines. Unfortunately the $5.6 billion fund was not adequate to entice larger companies, which have unique expertise in vaccine production, to get involved in this work. Nonetheless, a number of countermeasure products, particularly related to terrorism response, were secured. This fund has run its ten-year course (2004–14) and exhausted the advance commitment support. It now requires an annual appropriation from Congress, which is always fraught with uncertainty and therefore is a deterrent to companies that understandably want to commit only to multiyear projects.
Throughout the often shaky relationship between government, the public health establishment, and the pharmaceutical industry, you will continually hear laments about the severe difficulty of obtaining ongoing budgetary commitments on anything that cannot be labeled defense spending or Homeland Security spending. Defense funders are used to requests for multiyear budgets. You can’t develop and build a weapon system in a year. But almost everything we do in public health and medical countermeasures also takes longer than one fiscal year or one funding cycle. When it comes to funding, the single most common aspirational word we hear is “sustainability.”
In 2006, Congress established the Biomedical Advanced Research and Development Authority (BARDA). It is intended to provide an integrated, systematic approach to the development and purchase of the necessary vaccines, drugs, therapies, and diagnostic tools for public health medical emergencies. Project BioShield is now part of BARDA. Its annual appropriated budget must now cover the development of all CBRN measures. In 2016, the budget was approximately $1.8 billion, with no dedicated funds for emerging infectious diseases, including vaccines or drug treatments. And the need to go to Congress and ask for new money every year has all but killed the possibility of major long-term projects, such as the development of game-changing influenza vaccines.
While I respect the efforts of the BARDA staff, the way they have to do business is just not sufficient for what we need to obtain the vaccines for worldwide pandemics or epidemics of critical regional importance. Far too often BARDA is pressured by key members of Congress to prioritize the development and procurement of certain countermeasures when those countermeasures are made by companies in their districts or states. While such influence is not always obvious to the public, one need look no further than BARDA’s decisions regarding the procurement of anthrax vaccine to realize the power of one company’s lobbying efforts in Congress and in turn, BARDA. In addition, I believe that far too often, when BARDA senior staff members have been called before Congress to testify on the status of their programs, they have provided a “glass half-full perspective” when, in fact, the glass was damn near dry. This surely has been the case with pandemic influenza preparedness. The current federal government effort to secure needed new vaccines may not be a recipe for disaster, but it is certainly a recipe for getting little done in advance of a crisis, as recent history has proven.
Lately, others outside the US government have realized that increasing threats from emerging infections demand improved global preparedness. Three independent initiatives led by the WHO, the Norwegian Institute of Public Health, and the Foundation for Vaccine Research have come up with lists of “Priority Pathogens” for top funding. A pathogen’s position on this list is based on its likelihood of occurrence, its potential impact on global health, and the reasonable chances of coming up with a safe and effective vaccine.
The Foundation for Vaccine Research proposed a global vaccine fund with an initial capitalization of $2 billion to take on the first of the forty-seven diseases with no vaccine or only partially effective ones. The fund would be intended to move vaccine prototypes for Crisis Agenda diseases such as MERS, Ebola, and Zika from the laboratory and through the valley of death so that they would be ready and available when outbreaks occur. Citing the fact that there are now only four major manufacturers that focus on vaccine development—GlaxoSmithKline, Merck, Pfizer, and Sanofi Pasteur—the authors called for seed money to come from governments, foundations, the pharmaceutical industry itself, and nontraditional but related sources, such as the insurance and travel industries. To justify the funding, they note that due to the lack of a proven Ebola vaccine, the 2013–15 crisis cost upward of $8 billion. However, there was no economic incentive for bringing an Ebola vaccine to market because the target population in Africa couldn’t afford it.
Lawrence Summers, Charles W. Eliot Professor and president emeritus of Harvard University, as well as former secretary of the Treasury, was quick to tell us, “I would not dream of calling myself an expert in this field.” That may be, but his analyses and perspectives on public health are consistently insightful. Delivering the keynote address for the release of the Global Health Risk Framework Commission report The Neglected Dimension of Global Security: A Framework to Counter Infectious Disease Crises, he said:
With respect to vaccines in general and with respect to the capacity to develop vaccines as rapidly as possible in the wake of an emergency, it is essential that we invest more. This is the quintessential problem for which we cannot rely on the private sector. No one would permit, nor should anyone want, to profit immensely from having the scarce vaccine or antibody at the moment of pandemic. Therefore, the private sector will not be able to capture even a small fraction of the social benefit from a valuable preventative.
The Foundation for Vaccine Research, the WHO, and the Norwegian Institute efforts are highly commendable and a great first step. But who will pay for this major new international effort? How much will they pay, and for how long? Who will decide which vaccines are rushed to the head of the line for investment? Who will be responsible for the oversight of both the public and private sector partners? The list of questions goes on.
While hope is not a strategy, I am hopeful that there is a new and frankly exciting development in the vaccine world. As a result of the ongoing conversations among leaders involved in the three above-noted organizations, major foundations, the World Economic Forum, major vaccine manufacturers, and the US government, a new organization is emerging: the Coalition for Epidemic Preparedness Innovations (CEPI).
I have participated in two of CEPI’s four working groups, and having seen it from the inside, I am optimistic that the vision described on the CEPI website for this yet emerging coalition is potentially game changing: “Epidemic outbreaks of infectious diseases will be managed at an early stage to prevent them becoming public health emergencies that result in loss of life, undermine social and economic development and emerge into humanitarian crises.”
Taking an end-to-end approach from initial vaccine development to application, CEPI will focus on essential gaps in the process due to market failure. The initial focus will be to move new vaccines through the entire procedure, from preclinical to proof of principle in humans and to the creation of platforms that can be used for rapid vaccine development against unknown pathogens. How we will find the sustained funds to make this effort a reality is a huge unanswered question. Still, I believe this group does represent the best chance we have ever had for creating a sustainable international response for realizing a viable and dependable pipeline for critical vaccines, and we should all pay close attention to CEPI’s progress. Our lives could one day depend on it.