Source: The Hill
Publication Date: October 31, 2016
Two years ago, Americans and Europeans watched in collective horror as a faceless, indiscriminate killer landed in their midst without warning. Fear and widespread anxiety were joined by deep frustration at the apparent unpreparedness to handle a threat of such magnitude. I’m not referring to a terror attack or a natural disaster. And though the killer was faceless, it had a name – Ebola.
Of course, the people of Africa were quite familiar with Ebola hemorrhagic fever. National governments, international organizations, humanitarian aid agencies, including Doctors Without Borders and the International Rescue Committee, and health officials in Guinea, Sierra Leone, Liberia and other affected nations have worked tirelessly to contain the disease, which killed 11,300 people in the region during the 2014 outbreak.
It wasn’t until the first cases were diagnosed in the U.S. and Western Europe that developed countries realized the scourge was no longer confined to developing countries. Thankfully, as so often happens in a global health crisis, leaders in public health and government joined forces to develop the protocols needed to stabilize the outbreak.
Today, the Zika virus represents a new, potentially devastating pandemic throughout Latin America and the southern U.S. (for now). Fortunately, we’ve had warning to prepare for Zika. Unfortunately, the U.S. is still unprepared to effectively fight it.
Centers for Disease Control and Prevention (CDC) Director Tom Frieden told reporters in September that “we are now essentially out of money” and informed policy makers that the U.S. is “about to see a bunch of kids born with microcephaly,” a condition in which babies are born with abnormally small heads and brain defects. Microcephaly is just one of the potentially long-term consequences that may affect babies born with Zika.
Frieden’s remarks came as Congress struggled to reach an agreement on a bill proposing more than $1 billion for studies, diagnostic tests, vaccine and drug research and programs to battle Zika. So far in the U.S. more than 730 pregnant women have been found to carry the virus and at least 18 babies have been born with microcephaly. Nearly 3,000 people in the continental U.S. have been infected; the numbers in Puerto Rico and other U.S. territories, and many countries in Latin America, are considerably higher.
While the Obama Administration has redirected funding from other health priorities as a temporary measure, and it’s not clear whether any work on a vaccine has been delayed, what we do know is that without a plan and resources, the numbers will only continue to grow across the country and around the world.
The response to Ebola and the current stalemate in Congress over Zika funding help illustrate how critical global-scale planning, collaboration and funding are to preventing epidemics.
And they point to the increasingly important role that organizations like the Coalition for Epidemic Preparedness Innovations (CEPI) can play. CEPI is a new public-private alliance dedicated to rapidly creating an arsenal of new vaccines to prevent and contain infectious global health epidemics. The concept is to invest in early development of vaccines in order to dramatically reduce the time it takes to have them ready and prepared before an outbreak occurs.
The Norway-based coalition is spearheaded by the Wellcome Trust, the Bill and Melinda Gates Foundation, the World Economic Forum and the governments of Norway and India.
CEPI will initially focus on vaccines to treat diseases identified by the World Health Organization as priority public health threats. Some of the diseases CEPI is considering to target include Lassa fever, Marburg fever, MERS, SARS, Nipah virus, Rift Valley fever, chikungunya and other emerging diseases for which there are currently no vaccines. By funding the early stages of research and development, CEPI can help bring many vaccine candidates forward for a variety of diseases. This way, instead of predicting what the next epidemic will be, we will be ready for whichever one actually breaks out and can then move to late stage clinical studies and quickly get a product approved.
Despite scientific advancements that have brought us safe and effective treatments for a host of cancers, neurological disorders and other difficult to treat diseases, it seems inconceivable that there are still dangerous infectious diseases for which there are no licensed vaccines. In part, this is due to the long and arduous process of vaccine development.
Pre-clinical and clinical development of a vaccine typically takes 12 to 15 years and requires assessment of the safety and efficacy of the vaccine on thousands of patients. There are unpredictable commercial incentives and pathways to regulatory approval as well. And the rarity and remote location of certain outbreaks also makes it difficult for scientists to study a disease or find enough patients to conduct effective vaccine trials.
These and other factors all have the potential to deter investment, even for firms that are committed to discovering new medicines for the good of all who need them. With that said, it’s not difficult to recognize that there is a misalignment between how industry works to develop vaccines and what public health needs are. The solution to this dilemma begins with collaboration.
We’ve seen that when working alone, industry players face barriers to vaccine development. Ebola and Zika have taught us that devastating epidemics aren’t just a threat to those in far off lands. It’s time to turn those lessons into action, and find innovative ways to be prepared before outbreaks become pandemics.
Nima Farzan is Chief Executive Officer of PaxVax, Inc. and the Biotechnology Innovation Organization (BIO) delegate on the board of the Coalition for Epidemic Preparedness Innovations.