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.Seventy-five countries submitted expressions of interests to join the COVID-19 Vaccine Global Access (COVAX) Facility, a new initiative to ensure fair and equitable vaccine distribution around the world. The 75 interested countries would fund vaccine production and distribution through their national budgets, supporting vaccine access among their own populations as well as in 90 lower-income countries through voluntary donations. COVAX would provide a guaranteed share of vaccine doses to cover 20 percent of each country’s population and act as a supplement to any deals individual countries make with vaccine manufacturers. The COVAX Facility is a key part of the Access to COVID-19 Tools (ACT) Accelerator vaccine pillar, which is led by Gavi, the Vaccine Alliance; the Coalition for Epidemic Preparedness Innovations (CEPI); and the World Health Organization (WHO). The initial goal of the initiative is to raise US$2 billion to buy COVID-19 vaccines, according to Gavi. More than 100 COVID-19 vaccine candidates are currently in development around the world.In an open letter to National Institutes of Health (NIH) Director Francis Collins, more than 100 scientists called for human challenge trials to accelerate the development of a COVID-19 vaccine. During challenge trials, healthy volunteers are given a vaccine and then exposed to a virus to evaluate whether the vaccine prevents infection. While challenge trials are controversial, they would hasten the COVID-19 vaccine development process, as conventional efficacy trials can take months longer. Signatories of the letter also noted that challenge trials are more likely to yield interpretable results. Some US lawmakers already support the idea, and WHO guidance has stated that human challenge trials are ethical when in compliance with certain criteria.The Foundation for Innovative Diagnostics (FIND)—a GHTC member—and Cepheid, Inc., announced last week the launch of a new rapid molecular tuberculosis (TB) test that can simultaneously detect first- and second-line drug resistance. The Xpert® MTB/XDR test can provide TB drug-resistance profiles in less than 90 minutes and could be crucial in the fight against extensively drug-resistant TB (XDR-TB), the most complicated form of TB. Current methods for identifying drug-resistance profiles for XDR-TB can take up to 16 weeks to give results. Diagnosis and treatment of drug-resistant TB has been an essential part of TB elimination efforts for years. FIND and Cepheid have both conducted evaluations on the new test, and the data will undergo WHO review later this year. 

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.Dexamethasone, an inexpensive, decades-old drug is showing promise for treating COVID-19, per unpublished, preliminary results from a study called Recovery that was funded by the United Kingdom. The preliminary results indicated that the drug reduced the risk of death for patients on ventilators by 35 percent, those receiving oxygen by 20 percent, and overall mortality by 17 percent. Immediately following the results, the United Kingdom granted approval for use of the drug to treat COVID-19. According to FiercePharma, UK officials have enough dexamethasone stockpiled to treat 200,000 patients.  A recent study lends support to anecdotal evidence that blood type and genetics may be linked to worse outcomes from COVID-19 illness. Last Wednesday, a team of European researchers published a study in The New England Journal of Medicine indicating that people with type A blood have a 45 percent higher risk of catching COVID-19 and sliding into respiratory failure and people with type O blood have a 35 percent lower risk of developing respiratory failure compared to people with other blood types. Scientists are still unsure why blood type might be correlated with COVID-19 outcomes, but a nascent hypothesis is that it could be linked to blood clotting risk. The researchers also found that a cluster of genes are associated with higher risk of developing severe COVID-19 by 77 percent.A project led by researchers from Scripps Research, GHTC member IAVI, and the University of California San Diego School of Medicine published research in Science detailing a set of antibodies discovered in recovered COVID-19 patients that provide powerful protection against SARS-CoV-2. In theory, the antibodies could be given to patients who are just developing the illness to prevent progression to severe disease and to protect people who are at higher risk for contracting COVID-19. To discover the antibodies, the scientists isolated more than 1,000 distinct antibody-producing immune cells, obtained genetic sequences from these cells to produce more antibodies, and then tested the antibodies’ effectiveness against blocking the virus in vitro. The researchers discovered several antibodies that, even in small quantities, could block the SARS-CoV-2 virus. The work was funded by the US National Institutes of Health, IAVI, and the Bill & Melinda Gates Foundation, among others.

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.