Breakthroughs Blog: Pandemic preparedness

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.Last week, Ghana became the first country to approve a new malaria vaccine developed by the University of Oxford’s Jenner Institute. The vaccine, R21, is the second-ever vaccine for malaria authorized for use by regulators. Ghana’s Food and Drugs Authority approved the shot for use in children between 5 and 36 months old based on final data from an ongoing phase 3 trial in almost 5,000 children. The results have yet to be published but were shared with regulatory agencies. The vaccine could become an important tool in the fight against malaria and in reducing child mortality, especially if Ghana’s approval is echoed in other countries and by the World Health Organization. The COVID-19 pandemic revealed the consequences of limited genome sequencing capabilities on the African continent and has pushed national laboratories to ramp up their ability in preparation for future pandemics. Thirty-nine African countries now have the equipment and skilled workforce for sequencing, as part of a continent-wide network with specialized training centers and regional hubs. However, capacity levels across laboratories vary, and there is a need to move beyond sequencing the virus that causes COVID-19 to broader applications and for increased training in data analysis.The Biden administration last week announced the launch of Project Next Gen, the US$5 billion-plus program that succeeds the President Trump-era Operation Warp Speed to accelerate the development of new coronavirus vaccines and treatments to address COVID-19 and future coronavirus threats. The program will primarily focus on three objectives: creating long-lasting monoclonal antibodies, advancing vaccines that produce mucosal immunity, and developing pan-coronavirus vaccines. Administration officials expressed their hope that the program can generate strong next-generation vaccines and treatments, delivering breakthroughs that could also potentially benefit other health R&D areas as well

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 World Health Organization (WHO) has announced efforts to fast-track the testing of vaccines and therapeutics for Marburg following the recent outbreaks in Tanzania and Equatorial Guinea. Those trials should get underway soon, said WHO officials, as four or five of the 28 potential candidates already have doses ready. In the meantime, contact tracing, isolation, and supportive care are being used to prevent transmission in the countries. A lack of laboratory capacity in Equatorial Guinea has so far prevented the timely identification of cases, but the Africa Centres for Disease Control and Prevention is working to provide technical support, as well as build infrastructure and capacity to improve testing, which will be important in upcoming trials.Last week, the US Centers for Disease Control and Prevention (CDC) warned about the recent, rapid spread of the drug-resistant fungus Candida auris, or C. auris, in health care facilities and highlighted the serious risk the fungus poses to immunocompromised individuals. C. auris is resistant to typical antifungal treatments, and developing a vaccine for the fungus would likely take many years. There are currently no approved vaccines for any form of fungal infections. One vaccine candidate, being developed with support from the US National Institutes of Health, is designed to be cross-protective against several fungal pathogens, potentially including C. auris, although a phase 1 clinical trial is over a year away.Executives at three of the world’s leading flu vaccine manufacturers—GSK, Moderna, and CSL Sequiris— have said that they are preparing the capacity to develop hundreds of millions of avian flu shots within months if a new strain of avian flu jumps to humans. The companies are already or will soon begin testing sample human vaccines that match the subtype currently circulating among birds and mammals. Sanofi has also expressed its readiness to begin production, alongside its stock of existing H5N1 vaccines. However, there is concern about how to ensure equitable global access to such vaccines in the case of an outbreak, given a substantial portion of doses are already reserved for wealthy countries through preexisting preparedness contracts.

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.PANTHER, a newly launched pan-African platform for emergency research and preparedness, aims to address the lack of clinical trials carried out on the continent, despite it facing a disproportionate amount of the global disease burden. The researchers behind the initiative see the platform as a way to ensure essential data is captured in clinical trials during active outbreaks of existing or newly emerging diseases, especially following the recent Marburg and Sudan ebolavirus outbreaks. PANTHER hopes to prepare around 80 percent of the groundwork for trials before an outbreak by targeting at-risk spots, creating a network of researchers and health care providers, and proactively engaging funders so that when an outbreak is identified, this foundation can be quickly leveraged to adapt trials to local contexts and specific disease characteristics.Last week, researchers announced promising results from a phase 1 clinical trial, supported by the US National Institutes of Health, looking at a temperature-stable tuberculosis (TB) vaccine that can be freeze-dried and safely stored at higher temperatures for months. The shot, given to 45 healthy adults in the study, was found safe, well-tolerated, and elicited measurable responses in the body. If further testing of the vaccine proves successful, the shot could be a clear alternative to the bacille Calmette-Guerin vaccine—the only licensed vaccine for TB, which is more sensitive and cannot be frozen— and break down barriers to vaccine distribution in low-income and low-resource settings around the world.A new paper found that more than 10 percent of people in rural Myanmar have been exposed to a diverse range of sarbecoviruses, a group of coronaviruses that includes Sars and Sars-Cov-2. Researchers also emphasized that the paper confirmed the risk of direct spillover from bats, especially in remote, rural areas. While there were no signs of human-to-human transmission of these viruses, the findings highlight the ongoing occurrence of spillovers and the need for surveillance of both disease outbreaks and rural areas with high wildlife-human interface, as well as ensuring strong biosecurity laboratory measures are in place.

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 University of Minnesota’s Center for Infectious Disease Research and Policy last week announced the launch of a roadmap outlining a detailed strategy for the development of broadly protective and widely suitable vaccines to address future COVID-19 variants and other coronaviruses. The roadmap lays out the need for five broad and intersectional streams of work from virology to financing that will be necessary to break down the siloes of current vaccine development to achieve better coordination, accountability, and access. The initiative comes as a response to the COVID-19 pandemic, which is the third time in two decades that a coronavirus has become a public health crisis.A man in Germany has become at least the third person living with HIV formally declared HIV-free after undergoing a procedure in 2013 to replace his cancerous bone marrow cells with donor stem cells that contained a mutation making them effectively HIV-resistant. There remain questions about the full effects of the transplant and the factors behind the successful elimination of HIV in the body, even after follow-up studies. Experts say it is unlikely this procedure would ever be rolled out widely in people without leukemia due to high risk of a person rejecting donor marrow, but other ongoing and planned studies are looking at the potential of genetically modifying a patient’s own stem cells to include the HIV-resistant mutation.The United States is seeing a concerning rise in cases of syphilis, which has seen various cycles of rises and declines over the past century. There are few researchers that study syphilis, and the development of new diagnostics, treatments, and preventive tools has proved challenging because of past inability to grow the fragile Treponema pallidum bacterium that causes the disease in a lab and because of the virus’s ability to evolve resistance to antibiotics. A new technique that allows for lab-grown bacteria along with recent, promising studies of treatments and diagnostics for the disease provide hope. However, there is wide agreement that a vaccine is needed to eliminate the disease and the potential of resistance, and researchers are far from introducing a potential candidate.