Breakthroughs Blog: Access

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. Excision BioTherapeutics is investigating whether a single Crispr infusion can effectively keep HIV at undetectable levels in the body. If effective, this innovation could eliminate the need for daily antiretroviral therapy. The Crispr therapy attempts to disrupt the replication process by targeting regions in the HIV genome that are critical in that process. While antiretroviral drugs can stop the virus from replicating, the Crispr therapy is designed to go further by ensuring that the virus cannot reactivate in the future. The trial aims to enroll nine participants and compare the efficacy of three different dosages. The Medicines Patent Pool has signed a voluntary licensing agreement with Japanese pharmaceutical company Shionogi, to allow low- and middle-income countries (LMICs) rapid access to its COVID-19 antiviral treatment pill, contingent on its regulatory approval. Under the agreement, the Medicines Patent Pool will grant sub-licenses to qualified generic manufacturers to produce the antiviral (ensitrelvir fumaric acid) in 117 LMICs. The candidate, which showed promising results in phase 2/3 trials, could make a significant difference in low-and middle-income countries with low vaccination rates.The Biomedical Advanced Research and Development Authority has granted a multi-year contract to Vir Biotechnology with US$55 million in funding to support its influenza-focused antibody drug that is expected to continue trials soon. The contract also allows for a potential billion-dollar investment for the development of candidates against emerging infectious diseases, including influenza. The funding is aimed at improving pandemic preparedness efforts through investments in technologies that target pathogens with pandemic potential.

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 a clinical trial of one or possibly two experimental vaccines designed to protect against the rare Sudan strain of the Ebola virus that has been identified in the recent, rapid outbreak in Uganda. The trial could begin within weeks depending on the Ugandan government’s permission, which is expected soon, as well as regulatory and ethics review approvals. The trial was announced by the WHO’s Health Emergencies Program, which has been conferring to identify vaccines that are far enough along in their development to undergo clinical testing. There are six vaccine candidates in development that are designed to target the Sudan strain, only half of which have advanced to the stage of human clinical trials. Of those, a candidate developed by the Sabin Vaccine Institute and the Vaccine Research Center at the National Institute of Allergy and Infectious Diseases is the furthest along in its development. Dengue resurged across Asia following a period of lower transmission due to reduced mobility because of COVID-19 restrictions, but an exciting vaccine has the potential to make huge strides in reducing the burden of the disease not only in the region but around the world. In August, Indonesia became the first country in the world to approve Takeda’s Qdenga, or TAK-003, vaccine for use against dengue in 6- to 45-year-olds. Qdenga showed incredibly promising results in clinical trials and is under review by the European Medicines Agency and other regulatory agencies in dengue-endemic countries, although it is yet to receive WHO prequalification. The vaccine addresses the complexity of dengue’s four strains by using a weakened version of the DENV 2 strain as its base and including genes from the other three strains.In 2020, a clinical trial in South Africa testing PrEP as a shot delivered every few months found incredible success with results showing high efficacy compared to the daily pill. The drug used in the trial (long-acting cabotegravir or Cab-LA) made by ViiV Healthcare has only been awarded regulatory approval in the United States to date. Access to the shot in low- and middle-income countries has been hampered by the company’s decision to not grant licenses for generic makers to produce the drug at a lower cost. The company has made an agreement with the Medicines Patent Pool that permits three or fewer companies to make generic versions of the drug in 90 low- and middle-income countries, but it could take at least three years for regulatory approval. Viiv Healthcare has submitted its drug for WHO prequalification, which could speed up this approval process. 

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 Medicines Patent Pool (MPP) and ViiV Healthcare last week announced a new voluntary licensing agreement that would allow for generic manufacturing and distribution of long-acting cabotegravir in an effort to expand access to the HIV prevention drug. Long-acting cabotegravir—an injectable form of preexposure prophylaxis, or PrEP—can provide two months of protection against HIV infection with a single shot, while most other forms of PrEP require daily pills. The new licensing agreement between the United Nations-backed MPP and ViiV will let select generic manufacturers apply for sublicensing to develop, manufacture, and supply generic forms of the drug in 90 countries—pending regulatory approvals—where the HIV burden and potential use of cabotegravir is the highest.The Coalition for Epidemic Preparedness Innovations (CEPI) is supporting an initiative to develop a standardized approach to test the performance of vaccines being used or in development against monkeypox. The new funding, announced days after the World Health Organization declared monkeypox a public health emergency of international concern, will go to the UK Medicines and Healthcare products Regulatory Agency and the UK Health Security Agency to pursue tools able to assess the strength and duration of immune responses generated by current vaccines, as well as for tests used to detect monkeypox antibody levels. These tools will subsequently be made available to the global scientific community for free, apart from administration fees, enabling a standardized assessment between countries documenting vaccine performance against monkeypox, according to CEPI.Researchers have identified a specific area of the SARS-CoV-2 spike protein as a good target for pan-coronavirus vaccines, making a promising advance in the development of a shot to protect against COVID-19 variants and common colds. A universal coronavirus vaccine would need to induce antibodies that recognize and neutralize a wide range of viruses—a challenge, given the complexities of the coronavirus family, according to scientists. In the new study, scientists investigated whether antibodies targeting the S2 subunit of SARS-CoV-2’s spike protein could also neutralize other coronaviruses, including a strain of the common cold as well as several COVID-19 variants, and found promising results among mice. The researchers plan to continue to study the method as potential pan-coronavirus vaccine target and evaluate how it could be integrated with currently licensed vaccines.

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 Friday, the US Food and Drug Administration (FDA) authorized Moderna’s and Pfizer’s COVID-19 vaccines for children as young as 6 months—making kids under 5 years old eligible for the first time. The decision followed a unanimous recommendation from a panel of independent advisers to the agency to authorize Pfizer’s three-dose vaccine for children 6 months to 4 years and Moderna’s two-dose vaccine for children 6 months to 5 years. The FDA also authorized on Friday Moderna’s vaccine, previously cleared in adults over 18, for children and adolescents ages 6 through 17 years old. Centers for Disease Control and Prevention Director Rochelle Walensky signed off on recommendation of the shots this past weekend, and vaccinations are beginning this week.The South African Health Products Regulatory Authority last week approved a sweet-tasting, heat-stable, “4-in-1” fixed-dose combination of four antiretroviral (ARV) treatments—abacavir, lamivudine, lopinavir, and ritonavir—specifically designed for infants and young children with HIV. The new formulation, developed by Cipla Limited and the Drugs for Neglected Diseases initiative (DNDi), does not require refrigeration, has a sweet taste, and is easy to administer to infants and children of different weights and ages, making it a significant improvement over existing pediatric ARV formulations. The accelerated review in South Africa is notable and encouraging for other countries with a high burden of HIV, according to DNDi, which also expressed hope that the necessary steps will be taken to ensure the broadest possible access to the treatment for children who need it.Japanese drugmaker Shionogi and the Global Antibiotic Research and Development Partnership (GARDP) announced Wednesday an agreement to expand access to a novel antibiotic for drug-resistant infections in lower-resource countries. The deal aims to provide access to cefiderocol, which is used to treat serious Gram-negative bacterial infections that may be resistant to other antibiotics, in countries that have experienced delayed or limited access to newer antibiotics. Under the agreement, GARDP will work with partners to manufacture and commercialize the antibiotic, developed by Shionogi, in up to 135 countries. The Clinton Health Access Initiative will also help navigate the technical, regulatory, legal, and economic barriers to getting the antibiotic to patients in these countries.