Breakthroughs Blog: DoD

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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. The US Department of Defense is providing US$71 million for increased production of Inovio Pharmaceutical’s Cellectra devices—small, hand-held tools that are used to deliver Inovio’s vaccine candidate, INO-4800, directly to the skin without the use of needles. The device works by using a small electrical pulse that enables the DNA-based virus to pass into the recipient’s skin. Cellectra operates on AA batteries, and it is designed to "function reliably in challenging environments and can be stockpiled in large quantities without maintenance.” The vaccine, INO-4800, is expected to remain effective for up to one year in room-temperature storage. These durable qualities could make this vaccine system effective for low-resource settings. Inovio expects to begin a phase 2/3 trial in July. On Wednesday, the University of Oxford launched the first clinical trial in Africa of a COVID-19 vaccine. The vaccine being evaluated, AZD1222, was invented at the University of Oxford and is being developed in partnership with AstraZeneca. The trial is being conducted in South Africa, which has 120,000 of the continent’s 340,000 total cases. It represents a key moment for a continent that has so far been elbowed out of the global competition for medical supplies during the pandemic. Africa Centers for Disease Control and Prevention Chief John Nkengasong said, “unless we act now, Africa is at risk of being left behind on the global vaccine.” Others noted that several African countries have clinical trial capacities to contribute to global research and development. The University of Oxford is also running trials of AZD1222 in Brazil and Britain.Remdesivir, the first drug to demonstrate a benefit for treating COVID-19, has so far been delivered intravenously but will now be evaluated in an inhalable form in clinical trials. The inhalable version will be delivered via a nebulizer, a tool commonly available in the United States. Scientists at Gilead, remdesivir’s sponsor, hope that the availability of nebulizers will make it easier to use remdesivir at earlier stages of infection, such as when a patient tests positive but is presymptomatic. While delivering remdesivir as an inhalant may help overcome some of the limitations of intravenous delivery, it may also present other issues. Some physicians are worried that using a nebulizer could enable the spread of viral particles, and at improper doses, remdesivir can be toxic.

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.The Department of Defense Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense (JPEO-CBRND) and the Biomedical Advanced Research and Development Authority (BARDA) will partner with SiO2, an advanced materials science company, to introduce a novel technology for packaging COVID-19 vaccines and other pharmaceuticals. JPEO-CBRND and BARDA will provide US$143 million in funding to scale production of the company’s new technology that includes a plastic container with a microscopic glass coating. The product is thermal stable (range of -196 C to 121 C), highly durable (able to withstand 1,500 pounds of direct force), and precision molded, making it more dimensionally consistent than glass vials.The vaccine candidate, mRNA-1273, developed by the National Institute of Allergy and Infectious Diseases in partnership with Moderna, will begin phase 3 clinical testing by July, followed in August by Oxford University/AstraZeneca’s vaccine, and in September by Johnson & Johnson’s vaccine. All three companies are backed by the US government as part of Operation Warp Speed, and each is testing new technology.On Monday, an official from the World Health Organization (WHO) suggested that spread of COVID-19 by people who are asymptomatic is “very rare,” but clarified on Tuesday that scientists are actually unsure how frequently asymptomatic spread occurs. The initial comments caused a stir among public health experts, some labelling the comment as miscommunication. Underlying the confusion is that the term “asymptomatic” can mean either people who are presymptomatic or people who develop a full infection without showing symptoms. There is some evidence that fully asymptomatic cases may not be very contagious, while other studies show that patients may be most contagious when they are presymptomatic. Either way, experts note, individuals without symptoms should still be taking precautions.

Faces of Innovation—a new GHTC project that features scientists on the front lines of research and development on new global health tools and technologies—profiles Dr. Heinz Weidenthaler, who we met at the American Society of Tropical Medicine and Hygiene (ASTMH) Annual Conference, who developed a smallpox and monkeypox vaccine with Bavarian Nordic.My name: Heinz Weidenthaler, MDWhere I work: Bavarian Nordic, which is headquartered in Denmark and has offices in Morrisville, North CarolinaI’m funded by: Biomedical Advanced Research and Development Authority, National Institutes of Health, Department of Defense, Centers for Disease Control and PreventionMy research: I am a medical doctor by training working for a company called Bavarian Nordic…We have done quite an extensive program in developing a smallpox and monkeypox vaccine with support of several federal agencies of the US, mostly BARDA, who has funded most of our clinical trials and helped us really tremendously throughout the development of this product. There were other contributions, NIH NIAID [National Institutes of Health National Institute of Allergy and Infectious Diseases] provided support in specifically running several of the clinical trials that finally led to licensure of the product. The Department of Defense was incredibly helpful in running the key pivotal phase III trial, via USAMRIID [US Army Medical Research Institute of Infectious Diseases]. We also have a collaboration with CDC [Centers for Disease Control and Prevention], who is using our product in a study right now in the Democratic Republic of Congo [DRC].It is intended to be a safer alternative smallpox vaccine, which means it can protect the public, of course, both in America, but also on a global basis. Smallpox is a global threat, not a national threat at a given country…We received US licensure not only for smallpox, but also for monkeypox. There the global impact really comes in because the current epidemiology of monkeypox is endemic in several African countries like the DRC and Nigeria. This is something that, there will be an impact as soon as it is able to be deployed there. This is running right now with the CDC study in DRC, that could really save lives by preventing infections in these areas.Motivation: I’m a medical doctor by training and joined the pharma/biotech industry quite a while ago, and instead of just working on another blood pressure pill that would be generic a few years later, I think working in the pox virus vaccine sphere really has an impact on saving lives. And doing that with the help of government funding, in terms of a really successful public private partnership here, I think is a tremendous success, and being part of that, and helping in the clinical development of our vaccine is really a motivating thing because it just has an impact of peoples’ lives.Why federal support is critical: Global health is affecting all countries, including the US. Last year, we had these cases from Nigeria, people who were bringing cases of monkeypox, transmitting them to the UK, to Singapore, to Israel. The world is so globally connected, and infectious diseases that are endemic in sub-Saharan African countries can be anywhere in the world 24 hours later. I think this has a really huge impact on being prepared for all scenarios, and is of critical importance for the health of individuals worldwide, including the US.When I’m not in the lab: I take care of my family. I have three kids back home. I try to be there as much as possible, which is not always easy, but I enjoy the time back home with my kids. I try to do some kinds of sports as far as I find the time for that. I play volleyball quite frequently.