Breakthroughs Blog: NIH

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.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.

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. US science leaders, including Dr. Lawrence Corey of the Fred Hutchinson Cancer Research Center, Dr. John Mascola and Dr. Anthony Fauci of the National Institute of Allergy and Infectious Diseases, and Dr. Francis Collins, director of the National Institutes of Health, penned an article in Science Magazine, emphasizing that “the global need for vaccine and the wide geographic diversity of the pandemic require more than one effective vaccine approach,” and that unprecedented collaboration among industry, government, and academia will be essential to meet this need. The authors were encouraged that several different vaccine platforms are moving toward clinical evaluation, citing their different characteristics, such as safety, manufacturing flexibility, and cold chain requirements, that could make them suitable for meeting global needs. They cited the Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) partnership as allowing for discussions and consensus on clinical trial design, data sharing, and close public-private collaboration. The authors emphasized that “the ability to manufacture hundreds of millions to billions of doses of vaccine requires the vaccine-manufacturing capacity of the entire world” and that “there is an immediate need to fund the necessary biomanufacturing infrastructure, including the fill/finish steps that provide vialed vaccine products for distribution.”At least 16,000 people, mostly young adults, have signed onto a registry saying they would be willing to be infected with COVID-19 in clinical trials to help accelerate vaccine development. Typically, bioethicists consider it unethical to do human-challenge studies with deadly pathogens that have no approved treatment or cure because of safety risks to patients. The conventional method is vaccinating volunteers during ongoing outbreaks and tracking them for months to monitor infection rates. If human-challenge trials could happen for COVID-19, it could potentially accelerate vaccine development by several months. Researchers note, however, that launching human challenge trials take several months, and that planning should begin now if that’s a route scientists are willing to consider. Requests for human challenge studies must be approved by national regulatory and/or scientific agencies, and not all requests are granted.The Coalition for Epidemic Preparedness Innovations (CEPI), in its single largest investment to date, is providing US$384 million to advance Novavax’s NVX-CoV2373 SARS-CoV-2 vaccine candidate. Novavax will use the funding to further clinical development and expand large-scale manufacturing capacity for the candidate in multiple countries. Novavax plans to be capable of producing 100 million doses by the end of 2020 and potentially 1 billion by the end of 2021.