Letter to BARDA on Ebola Bundibugyo Therapeutics
Gary L. Disbrow
Director
Biomedical Advanced Research and Development Authority (BARDA)
U.S. Department of Health and Human Services
CC:
John Knox, Principal Deputy Assistant Secretary for Preparedness and Response (ASPR)
Robert Kennedy, Jr., Secretary, Department of Health and Human Services
Jay Bhattacharya, Acting Director, Centers for Disease Control and Prevention, Director, National Institutes of Health
Marco Rubio, Secretary of State
Dear Dr. Disbrow,
As U.S. organizations concerned with equitable access to health products and global health security, we write to urge the U.S. Government to coordinate with the World Health Organization, Africa CDC, affected-country governments, medical humanitarian organizations, and international and civil society actors to make doses of MBP134 and any other requested investigational therapeutics in its possession available for use in clinical trials and compassionate use programs for the Ebola Bundibugyo response. We also call on the U.S. Government to publicly commit to help ensure that the people most affected by Ebola outbreaks have ongoing access to treatments post-trial and in the future if treatments are approved.
The U.S. cannot afford to wait. The rapid availability of safe and effective medical countermeasures, including therapeutics, diagnostics, and vaccines, is a critical part of countering epidemic spread. The current Ebola outbreak is already the third largest on record, with 801 confirmed cases and 180 deaths, and could grow to rival the largest based on U.S. CDC projections. Given the certainty of future outbreaks and risk of international spread, it is in the U.S. national interest to bolster global health security by ensuring medical countermeasures are available in affected countries.
The current outbreak is caused by a less common strain of Ebola, for which there are no approved therapeutics, vaccines, or rapid tests. There are, however, promising candidates that, if approved, could aid the global response in current or future outbreaks.
MBP134, an experimental monoclonal antibody cocktail made from antibodies isolated from a survivor of the 2014 Ebola virus outbreak in West Africa, is considered a potential pan-ebolavirus therapeutic, with animal studies showing protection against Bundibugyo virus, Ebola virus, and Sudan virus. The treatment is one of four candidates prioritized for clinical trials during the current Bundibugyo outbreak. Reports state that preparations are underway to test MBP134’s efficacy against Ebola Bundibugyo.
MBP134’s manufacturer, Mapp Biopharmaceutical, recently commented that it “has enough doses of MBP134 for a trial,” and that BARDA owns these doses. The U.S. Government has confirmed that it is making the investigational therapy available to Americans with high-risk exposures to Ebola. But it has not publicly clarified how many doses it holds, whether it will provide doses for use in trials and compassionate use programs in affected countries, or the extent of its collaboration with stakeholders who will play a critical role in ensuring a trial is conducted effectively.
In addition to supporting clinical trials of candidate therapeutics, ongoing supply of appropriate therapeutics must be readily available to help stop outbreaks where they emerge.
Advanced planning lays the foundation for rapid and effective outbreak response. The U.S. Government and other funders have recognized this in part through their investments in research and development for countermeasures against ebolaviruses, including the virus that is causing the current outbreak. The U.S. Government has provided support to at least three of the four therapeutics recommended for potential use in clinical trials (MBP134, Gilead’s remdesivir, and Regeneron’s Inmazeb). BARDA has committed at least $241 million to Mapp Biopharmaceutical for the advanced development of MBP134,[1] with an aim to achieve FDA licensure for use against Sudan virus by 2028. Additionally, the Department of Defense and National Institutes of Health provided key support in the discovery of MBP134.[2]
Critically, however, medical countermeasures will only be effective at stopping outbreaks if they are available to those most affected, including patients who contribute their participation and data to clinical trials. To that end, the U.S. Government can take decisive action to embed access assurances in R&D collaborations, including clinical trial agreements, as is already U.S. practice in certain NIH and ASPR agreements. Such conditions in R&D agreements should provide for adequate, timely, affordable, and equitable global access to products and ongoing research collaboration, including through protections against abrupt suspension of clinical trials; continued post-trial access for trial participants and at-risk communities; transparency in trial costs and outcomes; product registration obligations, including in trial-host countries and endemic countries; access to products for comparative studies; licensing and technology transfer to support geographically-diverse manufacturing; retention of rights; affordable pricing based on transparent economic variables; and publication of terms that support access.[3]
Taking these steps to enable access to investigational and approved medical countermeasures is crucial to help stop outbreaks at their source and protect vulnerable communities most affected by outbreaks while protecting the U.S. from disease threats.
We request your written response regarding the steps BARDA and other relevant agencies are taking to make candidate therapeutics available, engage and coordinate with stakeholders, and plan for future access to U.S. Government-supported medical products. We would also like to schedule a meeting to discuss these matters.
Thank you for your attention.
Sincerely,
Public Citizen
Health Global Access Project
AVAC
Congregation of Our Lady of Charity of the Good Shepherd, U.S. Region
Doctors for America
Evangelical Lutheran Church in America
National Advocacy Center of the Sisters of the Good Shepherd
NETWORK Lobby for Catholic Social Justice
Treatment Action Group
Universities Allied for Essential Medicines
[1] Based on publicly available information related to contracts 75A50118C00024 and 75A50122C00061 (additional BARDA awards exist but were excluded due to a lack of information about the amount of funding related specifically to MBP134).
[2] Exact funding that supported the research that led to MBP134 could not be isolated as funding was part of broader awards. For example, an $11 million US Defense Threat Reduction Agency (DTRA) contract (HDTRA113C0018) to Mapp and a multi-million dollar NIH grant (U19AI109762) to a consortium studying Ebola that included scientists from the US Army Medical Research Institute of Infectious Diseases and other government agencies supported work that led to the discovery of the antibodies in MBP134.
[3] See here for additional access considerations for R&D initiatives, including clinical trials and pathogen sharing.