News

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. On Thursday, US Centers for Disease Control and Prevention (CDC) Director Rochelle Walensky signed off on a recommendation from a CDC advisory panel endorsing Pfizer-BioNTech COVID-19 booster shots for millions of older or otherwise at-risk Americans, following an emergency use authorization from the US Food and Drug Administration the previous day. Dr. Walensky expanded on the advisory panel’s recommendations—which supported the use of boosters in people 65 and older, nursing home residents, and those ages 50 to 64 who have risky underlying conditions—to also include those ages 18 to 64 who are health care workers or live in institutional settings that put them at increased risk for COVID-19 exposure. Boosters will begin rollout among individuals at least six months past their last dose of the Pfizer-BioNTech vaccine.The World Health Organization (WHO) updated its COVID-19 therapeutics guidelines Friday to include a recommendation for use of Regeneron’s antibody cocktail among non-severe patients at higher risk for hospitalization. The antibody treatment, a combination of casirivimab and imdevimab, is currently recommended in the United States for use in patients with mild-to-moderate COVID-19 cases to prevent a need for hospitalization, but WHO will now work to expand its use to low- and middle-income countries where access has been more difficult due to its high cost and limited availability. WHO and Unitaid are working with manufacturers to ensure equitable distribution around the world, as well as potential donation and distribution of the drug through UNICEF.A COVID-19 vaccine candidate developed by Clover Biopharmaceuticals showed 67 percent efficacy against illness in a global phase 2/3 clinical trial, the company announced last week. The vaccine demonstrated 84 percent efficacy against moderate-to-severe COVID-19 and 100 percent efficacy against severe COVID-19 and hospitalization. The results also varied among variants of the virus, with efficacy at 79 percent against the delta variant and 59 percent against the mu variant. Clover plans to use the data to seek conditional approval later this year in China and the European Union, as well as emergency use listing from WHO, which would clear the vaccine for use by the COVAX vaccine-sharing facility, to which Clover has agreed to provide up to 414 million doses. The shot is stable under normal refrigeration conditions for at least six months, making it well-suited for global distribution.

GHTC’s director Jamie Bay Nishi was invited by the White House to deliver video remarks for yesterday’s Global COVID-19 Summit. Nishi’s remarks committed GHTC and its members to the shared summit targets and emphasized the need for world leaders to bolster surveillance and data sharing, increase testing to detect variants, support R&D and clinical trials for second wave therapeutic and vaccine candidates, and increase regional manufacturing capabilities. Video remarks and transcript are below:Transcript of remarks:My name is Jamie Bay Nishi, and I serve as the Director of the Global Health Technologies Coalition—a coalition of over 35 nonprofit organizations, academic institutions, and aligned businesses advancing policies to accelerate the creation of new drugs, vaccines, diagnostics, and other medical technologies that bring healthy lives within reach for all people.GHTC is committed to the shared targets of this global COVID-19 summit, and in particular, the targets related to advancing research and development and manufacturing. This includes:Bolstering robust surveillance and data sharing, including for genomic sequencing Increasing testing and analysis to detect emerging variantsSupporting R&D and clinical trials for a second wave of therapeutic and vaccine candidates, andIncreasing regional manufacturing capacities for ALL types of medical countermeasuresGHTC will continue to convene partners to assess gaps in the upstream R&D aspects of the COVID-19 response, work to remove policy barriers, and in turn will optimize product developer’s abilities to advance research, deliver, and deploy technologies fit for purpose and that can reach the last mile. GHTC also supports the creation of a global health security financial intermediary fund and will leverage our platform to elevate perspectives of national and regional stakeholders, especially those from lower- and middle-income countries to ensure global investments in increasing R&D and manufacturing capabilities are driven in a way best suited to strengthening pandemic preparedness in each local context.No one is safe until everyone is safe, and tangible collective action is the only way we will meet the targets of vaccinating the world, saving lives, and building back better.

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 Biden administration plans to host a virtual summit Wednesday on the global COVID-19 response, during which President Joe Biden will call on leaders from around the world to make new commitments to fight the pandemic. The summit’s goals, similar to those laid out by the World Health Organization (WHO) and other global health experts, include vaccinating at least 70 percent of the world’s population by next September; providing billions of dollars in tests, oxygen, and other supplies to low- and middle-income countries; setting up a financing system to pay for the global health response by next year; and more worldwide objectives to end the pandemic. The event will be the first in a series of planned summits intended to hold participants accountable for their commitments.The European Union will fund a new agency intended to bolster the region’s health preparedness and rapid response for future crises, the European Commission confirmed last week. The Health Emergency Preparedness and Response Authority (HERA) will establish new, adaptable production capacities and secure supply chains to ensure critical equipment, medicines, and vaccines are available when needed. The agency will receive EUR€30 billion, or around US$35 billion, in funding from the European Union over the next six years, in addition to potential financing from individual member nations or the private sector. The overall total could reach EUR€50 billion, or US$59 billion, by 2027. HERA should be fully operational as of early next year.A single dose of typhoid conjugate vaccine is safe and 84 percent effective in protecting against the infection, according to a study conducted in Malawi. The results, part of a five-year, multi-country project to accelerate introduction of the vaccine, are the first efficacy results from Africa and will be critical as typhoid is increasing as a public health threat across the continent due to the emergence and spread of multidrug-resistant strains. WHO recommended the vaccine in 2017 for children six months of age and older in typhoid endemic settings, making it the only approved typhoid shot for children and infants less than two years old.