Breakthroughs Blog: BARDA

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.

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. As part of Operation Warp Speed, the Trump Administration has selected five top COVID-19 vaccine candidates to receive priority government support. The candidates include mRNA-1273 (Moderna and the National Institute of Allergy and Infectious Diseases), AZD-1222 (AstraZeneca and Oxford University), Ad26 SARS-Cov-2 (Johnson & Johnson), and candidates from Merck/IAVI and Pfizer. The Merck/IAVI and Pfizer candidates have not yet received federal funding, but as selected companies, they will receive access to government support to advance their programs. The mRNA-1273 and AZD-1222 candidates are already in phase 2 clinical trials and are expected to reach phase 3 in July. Officials anticipate that each vaccine will be tested on 30,000 individuals in phase 3 trials, some of which may take place outside the United States. An official announcement about the selection of these five companies is expected from Operation Warp Speed in the next few weeks.Convalescent plasma, sourced from patients who have recovered from COVID-19, did not demonstrate significant effectiveness as a treatment in the first randomized clinical trial evaluating its use. The Wuhan-based trial, however, fell short of its target recruitment because of containment of the outbreak and only enrolled 103 of the 200 patients needed to demonstrate a clinically meaningful result. In the same journal, Dr. Arturo Casadevall of the Johns Hopkins School of Public Health said that, though there was no significant improvement, the study gave “potentially hopeful signals” and that convalescent plasma should be tested in combination with antiviral drugs.The World Health Organization (WHO) launched at the end of May the COVID-19 Technology Access Pool, or C-TAP, a global project to share intellectual property and speed the research, development, and deployment of new vaccines, tests, treatments, and other health tools for COVID-19. The voluntary pool was initiated by Costa Rica and is supported mostly by low and middle-income countries and only a few high-income countries. Notably, many countries that are leading the research race for new tools, including the United States, the United Kingdom, France, Germany, and Switzerland, have not supported C-TAP. Meanwhile, some leaders from the pharmaceutical industry have dismissed the project while other groups, such as the Médecins Sans Frontières’ Access Campaign, have given praise.

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. Merck and GHTC member IAVI are joining forces to develop a COVID-19 vaccine candidate based on the rVSV platform, the same one under the hood of the ERVEBO Ebola vaccine approved last year by the Food and Drug Administration. The Biomedical Advanced Research and Development Authority announced it will back the project, making it the fifth COVID-19 vaccine candidate in the agency’s portfolio. The rVSV platform typically takes longer to develop than other methods but can lead to a product that creates a robust immune response from a single dose. IAVI has used the rVSV platform in efforts to develop vaccines against HIV, Lassa fever, and Marburg virus. The vaccine development race could turn into a story of global cooperation or global competition. Unfortunately, the United States and China are increasingly at heads, as both nations’ presidents look to vaccine success at home to soften criticism of their countries’ early response. President Trump has launched Operation Warp Speed to deliver a vaccine for Americans as quickly as possible. Meanwhile, President Xi Jinping hopes a first-to-market Chinese vaccine could boost ambitions for China to be a 21st century world leader in biopharmaceuticals and serve as form of “vaccine diplomacy.” With a global problem, a global solution is needed—but with the time it takes to manufacture vaccines, a waiting line will inevitably form, raising questions of which countries will get vaccines first. “It's set up to be a massive geopolitical battle,” said Ian Bremmer, president of the Eurasia Group, “not just around the discovery of the vaccine, but the manufacturing chain — with billions of doses needed, and the challenges of a global vaccination campaign.” COVID-19 is transforming the biomedical research and development ecosystem and accelerating emerging approaches, including real-time data sharing, drug repurposing, regulatory harmonization, and public-private collaboration, according to the founding partners of a new COVID-19 research consortium. The author points out that long hoped for tools—such as modernized regulatory science, digital medicine technologies, and adaptive clinical trial design—are being used to accelerate approvals of new medicines, diagnostics, and vaccines against COVID-19 and are moving us closer to an imagined future faster than expected.

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.In its largest award to date, the Biomedical Advanced Research and Development Authority announced it will put US$1.2 billion behind the ChAdOx1 vaccine candidate, now known as AZD1222, which was invented at the University of Oxford Jenner Institute and was recently licensed to AstraZeneca for further development. This award will fund phase 3 clinical trials to begin this summer with 30,000 US volunteers and scaled-up manufacturing. The vaccine is currently being tested on 1,000 volunteers in England in phase 1/2 clinical trials. The award is part of Operation Warp Speed, the recently launched US government endeavor to make 300 million doses of a SARS-CoV-2 vaccine available by January 2021. Scientists at the Jenner Institute developed ChAdOx1 with support from US government scientists at Rocky Mountain Laboratories, part of the National Institute for Allergy and Infectious Diseases (NIAID), who performed preclinical efficacy testing with the vaccine on rhesus macaques.Moderna released interim phase 1 clinical trial results for its mRNA-1273 SARS-CoV-2 vaccine candidate, which is backed by NIAID. The results, from a NIAID-led trial, found that eight volunteers developed neutralizing antibodies to COVID-19 after receiving two-dose versions of the candidate vaccine at different dose levels. Those who received two lower doses (25 micrograms) developed antibodies commensurate to people who have recovered from the disease, while those who received two higher doses (100 micrograms) developed antibodies significantly exceeding levels of people who have recovered. It’s not yet clear whether these antibodies provide protection, and some experts have tried to temper enthusiasm around the news, noting that Moderna revealed too little information to conclude whether the candidate holds promise.The Chinese government is working to fast-track promising COVID-19 vaccine projects. It has at least four candidates in clinical development funded mostly by its Ministry of Science and Technology. Fast-tracking candidates, however, may come at a cost. Domestic public confidence in Chinese made vaccines is low and was dragged down in 2018 after a Chinese company falsified production records for a rabies vaccine and sold more than 250,000 doses for infants that didn’t meet medical standards. Still, experts say that the Chinese government sees a vaccine as critical for public health and reigniting a strong economy, If China develops the world’s first vaccine, President Xi Jinping has promised to share the vaccine with the rest of the world. Doing so could help the government deflect global criticism of its early response to the outbreak and provide propaganda in favor of China’s authoritarian political structure over Western models.