Strict Standards: Only variables should be assigned by reference in /home/noahjames7/public_html/modules/mod_flexi_customcode/tmpl/default.php on line 24

Strict Standards: Non-static method modFlexiCustomCode::parsePHPviaFile() should not be called statically in /home/noahjames7/public_html/modules/mod_flexi_customcode/tmpl/default.php on line 54

Strict Standards: Only variables should be assigned by reference in /home/noahjames7/public_html/components/com_grid/GridBuilder.php on line 29

By the time the World Health Organization declared Ebola a “public health emergency of international concern” last August, the virus had spread to four West African countries and taken nearly 1,000 lives. Over the next year, Ebola would claim over 10,000 more. But this month, the WHO made a very different announcement: Early results from a trial in Guinea indicate that an experimental Ebola vaccine (VSV-EBOV) is highly effective at preventing infection. This is a tremendous victory for the global health community—but that victory could have come so much sooner.

Kendall Hoyt

About

Kendall Hoyt is an assistant professor at Dartmouth Medical School and a former International Security Fellow at Harvard. She analyzes US biodefense strategy and vaccine development policy and has published a book on vaccines and national security.


Outbreaks, like earthquakes, are difficult to predict. But they’re also certain to happen eventually—and too often, outbreaks force governments, researchers, drugmakers, and regulators to play an excruciating game of catch up as they scramble to develop vaccines for new pathogens. Ebola is a priority today, but tomorrow will bring another deadly disease. So governments need to invest in the ability to attack new threats. The capacity to generate vaccines and therapies within months, rather than years, could have spared thousands in the Ebola outbreak. It could save millions in a severe flu pandemic.

To deal with the threat of unpredictable health emergencies—bioterrorism, global epidemics—the US has set aside a small collection of previously developed drugs and vaccines. But stockpiling drugs against a few known pathogens is meager protection against the full spectrum of biological threats. Predicting outbreaks is difficult, and the number of possible disease threats far outstrips the country’s drug and vaccine development resources.

Predictive stockpiling didn’t work for Ebola. An Ebola vaccine actually made the shortlist for the US program in 2003, largely because officials worried about this virus in the hands of a terrorist. But making the list and making medicine are different.

Translating lab research into vaccines is costly (up to $1 billion per bug, according to some estimates) and time consuming (up to 15 years). The journey is especially perilous for emergency medical countermeasures: drugs and vaccines that address low-probability, high-consequence events. These countermeasures don’t have a predictable market, so responsibility for developing them often falls to the government’s Biomedical Advanced Research and Development Authority (BARDA).

Making the shortlist for vaccine stockpiling and making medicine are different.

Thanks to a decade of federal assistance, several Ebola vaccine candidates were in the pipeline in 2014. Even so, the dollars directed toward Ebola were inadequate to develop vaccines that were outbreak ready. Few had made the leap from the lab into human trials. As a consequence, West Africa lost precious months last winter to preliminary safety tests. Ideally, these Phase 1 trials would have been done in advance so candidates could have been tested for efficacy soon after cases began to appear in March 2014.

This is what happened with a disease that was on a short list. What will happen if the next disease is not? In public health emergencies, scientists don’t have the luxury of time. And yet they work within research traditions that assume that they do. With Ebola and other vaccines, developers have taken a one-size-fits-one approach. The push to optimize procedures one vaccine at a time has the unintended consequence of spawning a wide variety of methods to grow, purify, measure, formulate, and test injectable proteins. Often these methods do not translate well across products or developers, driving up costs and development times.

In an outbreak, R&D needs to be able to attack timelines as well as pathogens. Rather than trying to optimize each process in isolation, developers must ask: Can we build generic vaccine scaffolds that require minor modifications for different pathogens? Can we do this in a way that accelerates development times, lowers costs, and facilitates regulatory review?

In an outbreak, R&D needs to be able to attack timelines as well as pathogens.

One group of scientists at Massachusetts General Hospital is responding to these questions with VaxCelerate, a consortium of biotechnology companies and academic research labs. VaxCelerate generates vaccines on demand, using a two-part vaccine platform: a standard delivery vehicle and a specialized “payload” that can be tailored to an emerging disease.

Delivery vehicles, or vectors, often take the form of a harmless bacterium or virus. These can be prepared, tested, and stockpiled in advance. Computer algorithms identify peptides most likely to produce a safe and effective human immune response to the disease of concern. These peptides are loaded into the delivery vehicle to quickly identify pre-clinical candidates.

VaxCelerate’s first vaccine targeted Lassa fever, another African virus that is virtually unknown in the West. Lassa fever infects thousands each year and kills ten percent of those infected. The consortium’s first test produced a pre-clinical vaccine for $1 million in just four months—fifteen times faster and ten times cheaper a typical vaccine project at this stage.

This generic vaccine platform shows that it’s possible to address a range of pathogenic threats while shaving years (and millions of dollars) off of the pre-clinical research phase. And using a standardized platform doesn’t just speed research; it can also simplify industry’s manufacturing process and the FDA’s evaluation requirements.

Platform-based experiments are an important investment in our ability to respond to outbreaks more efficiently in the future.

A handful of other companies are investigating vaccine and drug development platforms that promise similar capabilities. Last fall, Novavax was able to generate an Ebola vaccine candidate for human trials in three months using a nanoparticle vaccine platform. When H7N9 broke out in China in 2013, Novartis was able to generate pre-clinical vaccine candidates in 13 days using a nonviral (lipid) delivery system for mRNA.

These early platform-based results are an important investment in the ability to respond to outbreaks more efficiently in the future. But they are just one link in the chain of capabilities required to generate safe and effective emergency countermeasures. Researchers and regulators must improve technologies and operational efficiency in each phase: detection, diagnostics, discovery, development, manufacturing, clinical trials, and delivery. As speed and efficiency improves in each area, they can form a vaccine “superhighway” to dramatically shorten response times.

Building a superhighway will take years, but the US government has invested in many essential ingredients: a new concept acceleration program and translation teams at the NIH, three new Centers for Innovation in Advanced Development and Manufacturing, a regulatory science initiative within the FDA, and BARDA itself. If they work together, these new programs could reduce the lag time between the moment a new pathogen appears to the moment it gets a safe and effective countermeasure.

The greatest challenge and the greatest benefit will come from integrating new technologies as they mature into a streamlined emergency medical countermeasure development system. When the world faces the next “public health emergency of international concern,” let the development timeline be driven wholly by legitimate scientific challenges and not by operational inefficiency. To accomplish this, medical countermeasure programs must focus not just on innovation but also on the timeliness of innovation. Once this becomes our goal, we will run faster in our race against pathogens.

Go Back to Top. Skip To: Start of Article.
Vaccines Weren’t Ready for Ebola. We Can Do Better

Read more http://feeds.wired.com/c/35185/f/661370/s/4959abd6/sc/15/l/0L0Swired0N0C20A150C0A80Cvaccines0Ewerent0Eready0Eebola0Ecan0Ebetter0C/story01.htm


Strict Standards: Only variables should be assigned by reference in /home/noahjames7/public_html/modules/mod_flexi_customcode/tmpl/default.php on line 24

Strict Standards: Non-static method modFlexiCustomCode::parsePHPviaFile() should not be called statically in /home/noahjames7/public_html/modules/mod_flexi_customcode/tmpl/default.php on line 54

Find out more by searching for it!

Custom Search







Strict Standards: Non-static method modBtFloaterHelper::fetchHead() should not be called statically in /home/noahjames7/public_html/modules/mod_bt_floater/mod_bt_floater.php on line 21