100 Day milestone of Ebola Bundibugyo outbreak must be a “wake up call” for pandemic preparedness, says pharma industry

100 days after the Ebola Bundibugyo outbreak was declared in the Democratic Republic of the Congo, the global pharmaceutical industry has underlined its track record and commitment to tackling health emergencies and urged that the milestone should provide a "wake up call" to re-focus the Pandemic Agreement negotiations.

Within a matter of days after the announcement of the Ebola Bundibugyo outbreak, biotechnology and pharmaceutical companies mobilized alongside governments, Africa CDC, WHO, CEPI, Gavi and other partners to develop new vaccines and therapeutics and explore cross-activity from existing ones for the current Bundibugyo Ebola outbreak.

This rapid response demonstrates the willingness of companies to voluntarily contribute to collective response efforts and the value of years of prior investment in science, platform technologies, partnerships, and preparedness.

Companies, working with experts from WHO and other partners, identified a number of priority candidates for clinical studies for Bundibugyo virus disease, including:

• MSD (known as Merck & Co., Inc. in the US and Canada) is exploring whether the technology underpinning ERVEBO, MSD's vaccine for the Ebola Zaire strain, could be adapted to support development of a Bundibugyo-specific vaccine. Informed by in vitro studies, MSD is also working to assess whether their oral antiviral molnupiravir is effective against the Bundibugyo virus.
• Moderna is advancing research into a novel Bundibugyo-specific mRNA vaccine candidate as part of the outbreak response effort and is among the leading developers that moved vaccine candidates into Phase 1 testing in humans.
• Gileadhas donated and is supporting ongoing clinical trials with two antiviral medicines, obeldesivir and remdesivir. This includes evaluating the potential for preventing the disease following high-risk exposure, and assessing both monotherapy and combination approaches to treat patients infected with Bundibugyo.
• Regeneron is evaluating investigational antibody therapies, including maftivimab, one component of its Ebola triple-antibody therapy Inmazeb.
• Other companies are working on several alternative vaccine and treatment approaches, as well as a range of diagnostic tests.

As products advance in clinical trials, it will be important to focus on practical, tried, and tested approaches to get them to the people who need them. For past Ebola outbreaks, pharmaceutical companies have a well-established track record of working with governments, international organizations, and partners to ensure access to vaccines and therapeutics through a range of mechanisms tailored to outbreak needs, including stockpiles, compassionate use arrangements, donations, and other access pathways. These efforts have consistently been driven by public health needs and the shared objective of responding rapidly and effectively to outbreaks.

The International Federation of Pharmaceutical Manufacturers and Associations (IFPMA), alongside the Biotechnology Innovation Organization (BIO), have underscored that this response is indicative of the industry's track record and commitment to preparing and responding to health emergencies.

However, both associations see the outbreak as a "wake up call" for negotiators discussing the final details of the Pandemic Agreement. Governments continue negotiations on the Pathogen Access and Benefit-Sharing system (PABS). Some of the current proposals under discussion could add complexity and cost to the response to future pandemics, and delay access to critical samples and information that scientific research relies on to develop and deliver medicines and vaccines. They will do nothing to strengthen the R&D pipeline to improve global preparedness and will likely lead to fewer companies working in these crucial areas of public health during the interpandemic period.

IFPMA and BIO have both called for the PABS system to strengthen the conditions that encourage company engagement in pandemic preparedness and response, including ensuring timely and open sharing of pathogens and data, legal certainty for researchers and manufacturers, predictable rules, and partnerships that allow science to move quickly.

David Reddy, Director General, IFPMA, said:

"100 days have now passed since the announcement of the Ebola Bundibugyo outbreak, and it is clearer than ever that pandemic preparedness depends on sustained medical innovation. This relies on strong partnerships, rapid access to pathogens and data, and practical solutions to the real barriers that slow outbreak response - from regulatory readiness and clinical trial capacity to financing, procurement, manufacturing, and delivery. These principles should remain at the centre of the ongoing PABS negotiations, which forms a central part of the WHO Pandemic Agreement."

Phyllis Arthur, Executive Vice President, Chief of Global Health, BIO, said:

"The first 100 days of this outbreak have shown what can be possible when biotech innovators have the tools and certainty they need. It also serves as a warning not to squander the gains made through the investment, innovation, and public-private collaboration that keep us prepared to respond to the next public health emergency. Leaders negotiating the PABS system must build on this progress by establishing conditions that encourage more companies to invest in pandemic preparedness, innovation, and collaboration."

Media Contacts