News

Statement from Jamie Bay Nishi, Director, Global Health Technologies Coalition (GHTC), on the passage of the Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2019 (PAHPAI), which reauthorizes the Biomedical Advanced Research and Development Authority (BARDA)WASHINGTON, DC—The passage of PAHPAI is an important action by Congress to strengthen our nation’s preparedness against global disease threats. We applaud Congress for recognizing that protecting our nation’s health requires deploying BARDA’s unique capabilities to combat all hazards—not only chemical, biological, radiological and nuclear threats, but naturally occurring health threats as well. The legislation’s authorization of Strategic Initiatives to develop countermeasures against emerging infectious diseases, pandemic influenza, and antimicrobial-resistant pathogens is a welcome step forward in fortifying our nation’s public health defenses.Now, Congress must match this authorization with strong investments in BARDA so the agency can deliver innovations against the full spectrum of health threats we face. Most of BARDA’s work on emerging infectious diseases has been funded piecemeal through emergency appropriations for Zika and Ebola, funding now nearly depleted—even as the Ebola outbreak escalates. This funding by crisis approach is inadequate. It undermines our ability to prepare for future threats. The House of Representatives’ proposed fiscal year (FY) 2020 appropriation provides a modest increase for BARDA, which is welcome. But a larger investment is needed for BARDA to fully and equitably fund the breadth of disease threats within its mandate and capitalize on recent scientific advances to generate innovations that could dramatically boost our capacity to neutralize potentially catastrophic outbreaks.BARDA’s reinforced authority to pursue Strategic Initiatives against naturally occurring threats can provide a significant contribution to our nation’s defenses. But this authority is of limited value without sufficient funding. We urge Congress to provide BARDA with a budget that is aligned with its mandate—and its unique capacity to deliver new tools to fight back against intensifying threats like Ebola; unexpected emergencies like Zika; and smoldering problems, like the steady, ominous rise in drug-resistant infections, and the near certainty of a future fight against a deadly strain of pandemic influenza.  Diseases punish the unprepared. We need a research infrastructure primed for a rapid response. That requires a strong, reliable investment in BARDA distributed across a diverse and promising research portfolio.CONTACT: Sally Bohrer, sbohrer@burness.com, +1 301-280-5742

GHTC submitted written testimony to the Senate appropriations subcommittees with jurisdiction over the US Agency for International Development and Department of State and the Department of Health and Human Services and its sub-agencies urging these subcommittees to sustain and protect global health R&D funding in the fiscal year 2020 (FY20) budget.

Interested in more global health innovation news? Every week GHTC scours media reports worldwide to deliver essential global health R&D news and content to your inbox. Sign-up now to receive our weekly R&D News Roundup email. An experimental drug, remdesivir, was shown to protect monkeys against infection with Nipah virus—an emerging pandemic threat for which there is no approved vaccine or cure. The only current treatment is a still experimental monoclonal antibody that was tested during an outbreak in India last year. Remdesivir is also being tested against the Ebola virus in the current outbreak in the Democratic Republic of Congo and has shown some effectiveness against Lassa fever, MERS coronavirus, and respiratory syncytial virus in other studies. In the new study performed by the National Institute of Allergy and Infectious Diseases (NIAID) and the Centers for Disease Control and Prevention, eight African green monkeys were given lethal doses of Nipah virus. The four monkeys who received intravenous remdesivir within 24 hours of infection and daily infusions for 12 days survived, while the four that did not died within eight days. If remdesivir wins approval, “it will give us an extra treatment that could be used relatively quickly,” said Emmie de Wit, a virologist at NIAID, noting that “the average person who reaches a hospital dies within two days, so it’s hard to protect them once they’re infected.” The next step is to test how long after infection the drug can be given and still cure the animals. Women make up just over half of the 35 million people living with HIV worldwide but are underrepresented in clinical trials of potential HIV treatments, cures, and vaccines. A 2016 study performed by amfAR, the Foundation for AIDS Research, found that women represented a mean of only 11 percent of HIV cure trials, 19 percent of antiretroviral drug trials, and 38 percent of vaccine studies. Despite the well-known differences in how the immune systems of men and women respond to the HIV infection and how women respond to some drug treatments, clinical trials continue to rely heavily on the participation of gay men in particular. Further complicating women’s participation in clinical trials is the US Food and Drug Administration’s (FDA) strict rules for including women of childbearing age, leaving most researchers to opt for the easy way out and just enroll men, collecting data from women only after the drug is on the market. As scientists continue to pursue cures for HIV in light of reports of the second patient cured of the infection, researchers must reckon with the longstanding obstacle of the lack of women in clinical trials. The FDA has authorized the first diagnostic test to detect Zika antibodies in human blood to be marketed in the United States. The diagnostic, known as ZIKV Detect 2.0 IgM Capture ELISA, detects the proteins produced by the body’s immune system when it tests for the Zika virus in blood. Though 18 other active tests to detect Zika exist, they have only been allowed under emergency use. This newly approved diagnostic test will only be usable by those with clinical signs and symptoms of Zika or on those who have traveled to regions with active Zika transmissions. FDA Acting Commissioner Ned Sharples noted that the marketing authorization of this Zika diagnostic demonstrates “FDA’s work to protect the public health in emergency response situations.”