Potential Ebola Vaccine Raises Questions About Funding, Packaging and More

While concerns about contracting Ebola within the United States seem to have abated, the disease continues to ravage several nations in West Africa, with the death toll now reaching nearly 5,000. To combat this serious outbreak, a number of pharmaceutical companies are rushing to develop vaccines for the virus, hoping to be able to deliver millions of doses by next year. However, drugmakers have more than clinical trials to worry about: the cost of funding the venture, as well as ensuring that vials can be filled, packaged and transported without compromising the medication’s sterility, could serve as serious obstacles as the death toll continues to rise.

On November 6, Facebook launched a fundraising campaign asking users of the social media site to donate money, shortly after CEO Mark Zuckerberg announced a $25 million personal donation to Centers for Disease Control Foundation. On November 10, Google followed this initiative by promising to match every dollar donated with two of its own, on top of a $10 million contribution from the company itself and a $15 million pledge from CEO Larry Page. However, in spite of an estimate from the United Nations which predicts that as much as $1 billion will be needed to fight the epidemic, at least one health industry expert has predicted that cost will not be as much of an issue as the implementation itself.

A vaccine is now considered a vital part of slowing the epidemic, with the World Health Organization planning to begin efficacy trials in West Africa in December, a month earlier than expected. But as necessary as this may be, these deadlines have also put additional pressure on all parties to speed up development, production and distribution. In a high-level meeting in Geneva in late October, a number of pharmaceutical executives, health experts and government officials debated a number of issues, including the planned clinical trials and biosafety.

Currently, two potential vaccines from GlaxoSmithKline and NewLink Genetics are in human safety trials, while another from Johnson and Johnson will begin testing in January. Five more vaccines are expected to begin testing in the first few months of 2015. So far, all companies have invested a significant amount of time and money in these projects, and have also pledged to offer their successful product at affordable prices. However, companies are still faced with the obstacles of finding a sterile method of filling and packaging vials, meeting quality standards, building a supply chain in Africa, and maintaining storage temperatures of minus 80 degrees Celsius at all times.

Packaging is a common concern for all medical devices and medications: a flexible sterile package like an IV Bag, for example, needs to be inspected during its product life cycle to ensure sterility. However, because the Ebola vaccines will use genetically modified organisms, the vials must be filled using biosafety level 2 (BSL2) facilities. Unfortunately, few companies possess these operations, and those that do, such as GSK, Sanofi, Merck and Novartis, might find the demands of packaging the vaccine too extensive, as they will also be producing vaccines for measles, mumps, rubella and rotavirus.

Reports from inside the industry suggest that companies are now discussing working together to meet production quotas. Some businesses have also met with regulators to discuss lightening BSL2 requirements for Ebola vaccines, as well as accelerating the quality assurance process. However, these changes could be worrying, given past lapses in biosafety. Comparatively, some organizations have considered running quality checks in parallel, rather than sequentially, which would take greater organization but might yield faster results.

Once these issues are resolved, a system will also need to be implemented to procure and deliver the millions of vaccines to West Africans. The Norwegian Institute of Public Health estimates that anywhere from 10 million to 27 million doses will be required, creating the need for a specialized refrigeration system to keep the doses sterile and effective. This number of doses will only increase if Ebola spreads to neighboring countries. With these practicalities being discussed, one can only wonder how many West Africans might be affected should an effective solution fail to arise.

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