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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.A malaria vaccine candidate showed up to 77 percent efficacy in a phase 2b trial among children in Burkina Faso, according to results published by researchers at the University of Oxford’s Jenner Institute. The vaccine is the first to meet the World Health Organization goal of 75 percent efficacy. Developers have begun recruitment for a large-scale phase 3 trial to test the vaccine for safety and efficacy in 4,800 children across four countries. Following final trial results, Oxford would apply for regulatory authorizations, with a best-case scenario of approval by the end of 2022, according to the director of the Jenner Institute. The researchers have made a deal with the Serum Institute of India to manufacture the vaccine at large scale and low cost. It has pledged to deliver 200 million doses a year if the vaccine is licensed.The National Institutes of Health (NIH) is launching three new clinical trials to evaluate COVID-19 therapeutics, including one trial for severely ill, hospitalized patients; one for a polyclonal antibody treatment; and one to assess repurposed drugs for COVID-19 symptoms. The trial for hospitalized patients will test a combination of NeuroRx’s Zyesami, which is a formulation of aviptadil acetate, and Gilead’s Veklury, which is the antiviral remdesivir. The antibody trial will test SAB Biotherapeutics’ investigative polyclonal antibody in mild to moderate cases of COVID-19, and the study on repurposed drugs will evaluate existing over-the-counter drugs to be used at home. All three trials are part of NIH’s Accelerating COVID-19 Therapeutic Interventions and Vaccines public-private partnership.Preliminary data on Pfizer’s and Moderna’s COVID-19 vaccines bolsters evidence that the mRNA shots are safe during pregnancy, based on reports from more than 35,000 women in the United States who received the doses while pregnant. The new evidence, published in the New England Journal of Medicine last week, showed rates of miscarriage, premature births, and other complications were comparable to those observed in pre-COVID-19 data on pregnancy. The study was led by US Centers for Disease Control and Prevention researchers, who noted continued monitoring and evidence is still needed, including on women who get COVID-19 vaccinations in the early stages of pregnancy.

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 Africa Centers for Disease Control and Prevention, African Union Commission, and Coalition for Epidemic Preparedness Innovations have announced a partnership to enhance vaccine research, development, and manufacturing in Africa. The agreement, announced following a two-day virtual conference on African vaccine manufacturing, will seek to strengthen the COVID-19 response and outbreak preparedness, build on key lessons from COVID-19, and leverage the successes of procurement and distribution of vaccines by COVAX and the African Vaccine Acquisition Task Team. Through the initiative, the partner institutions also intend to invest in capacity strengthening and innovations to accelerate vaccine production, strengthen African scientific institutions, and build partnerships that enable sustainable expansion of vaccine manufacturing in Africa.Regeneron plans to request an expanded emergency use authorization from the US Food and Drug Administration for its COVID-19 antibody cocktail after new data indicated it can prevent disease in healthy individuals. In a phase 3 trial run jointly with the National Institutes of Health, the antibody therapy cut the risk of developing symptomatic COVID-19 by 81 percent among healthy individuals who lived with an infected person. The antibody cocktail is currently authorized as an intravenous infusion to minimize disease progression in sick patients; the new request would allow the drug to be administered as a single-dose subcutaneous injection and used as a preventative measure. If authorized, the antibody cocktail could play a practical role in COVID-19 protection measures, including after high-risk exposures and in immunocompromised individuals who may not respond well to vaccines, according to a company statement.Amid reports of rare blood clot–related side effects among individuals who received COVID-19 vaccines developed by AstraZeneca and Johnson & Johnson, researchers are investigating whether and how the vaccines are causing this adverse reaction. Two papers published in the New England Journal of Medicine described 16 patients who experienced this cerebral venous sinus thrombosis, tied to the AstraZeneca vaccine, and offered a partial explanation for a potential link, finding blood clots were seen in conjunction with high levels of antibodies to platelet factor 4. The finding provides a first step toward explaining the extremely rare side effect but does not explain why a vaccine might cause the immune system to produce those antibodies. Researchers plan to continue investigating the reaction, assessing the data, and monitoring cases alongside regulatory authorities.

GHTC sent letters to House and Senate appropriations subcommittees with jurisdiction over the US Agency for International Development and Department of State, Department of Health and Human Services, and Department of Defense, urging these subcommittees to sustain and protect global health research and development funding in the fiscal year 2022 (FY22) budget.

At this week’s World Health Organization (WHO) inaugural forum with non-state actors, WHO, its member states, and civil society will be discussing reforms that could be spearheaded through the forthcoming World Health Assembly to better confront COVID-19 and future health threats, drive progress on the Sustainable Development Goals, and shore up sustainable financing for the institution.As WHO member states consider the broader concerns of civil society, GHTC urges them to prioritize the following actions to bolster research and development (R&D) to defeat COVID-19, combat other long-standing and emerging threats, and build resilient health systems: Ensure the Access to COVID-19 Tools Accelerator (ACT-A) is fully funded. ACT-A is facing a US$22.1 billion shortfall in funding for 2021 to realize its mission to develop and equitably deliver COVID-19 vaccines, treatments, tests, and other tools worldwide. This includes $8.7 billion for diagnostics, $3.2 billion for therapeutics, $3.2 billion for vaccines, and $7.3 billion for the health systems connector pillar.Integrate R&D into the International Health Regulations (IHR) and any future pandemic treaty that bolsters the framework. As conversations around WHO reform continue, member states should include R&D capacity indicators within IHR implementation and ensure that a potential pandemic treaty creates concrete mechanisms that support countries in strengthening their R&D and manufacturing capabilities and address some of the R&D coordination challenges encountered in the early days of the pandemic.  Provide more sustainable, predictable funding to WHO so it is adequately resourced to assess new health technologies and drive their uptake. Additional funding should be allocated to the WHO Science Division and the prequalification program to support and accelerate their vital normative activities to evaluate technologies and provide guidance to countries on their use. These funds should also provide greater support for the WHO Global Observatory on Health R&D to ensure its data is more effectively leveraged for assessing country and regional research capacity. Sustain robust investments in R&D for long-standing global health challenges. The pandemic has eroded global progress against HIV/AIDS, tuberculosis, malaria, and other poverty-related and neglected diseases and disrupted research efforts. To regain lost ground, member states must recommit to making strong sustained R&D investments and incentivize public-private partnerships to advance end-to-end product development of affordable, accessible tools. It is GHTC’s hope that WHO, member states, and civil society can come together to use this forum to help chart a new path and seize this moment to strengthen the global response to the current pandemic and other ongoing health threats.