Breakthroughs Blog: Antimicrobial resistance

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.President Biden signed an executive order establishing a new national biomanufacturing initiative and pledging more than US$2 billion to fund building or expanding drug manufacturing facilities and ensuring an adequate supply of raw materials. The Biden administration’s goal is to strengthen the biotech supply chain and maintain US competitiveness with foreign manufacturers in the wake of major supply chain challenges and shortages during the COVID-19 pandemic. $40 million of the pledge will go toward expanding the production of antibiotics and the base materials needed to produce products for future pandemic responses.A new study looking at antimicrobial resistance (AMR) records from laboratories in 14 African countries found that the basic requirements for testing for drug-resistant pathogens are unmet in most areas despite plans to tackle antimicrobial resistance on the continent. The researchers found that only 1.3 percent of the 50,000 medical laboratories included in the study were conducting bacteriology testing. Of those laboratories that were, even fewer were equipped to test for AMR and among those who were testing for AMR, only a third of the high-priority antibiotic-resistant pathogens designated by the World Health Organizations were being tested consistently. The study highlights larger challenges in Africa including limited access to antibiotics, imperfect use of antibiotics, and a lack of information about the impact of AMR because of incomplete and fragmented data.The smallpox treatment tecovirimat, or TPOXX, is undergoing a phase 3 clinical trial to test efficacy in treating monkeypox after preliminary data from the Centers for Disease Control and Prevention showed some alleviation of symptoms in patients. The trial is being run by the AIDS Clinical Trial Group in locations nationwide and will enroll more than 500 people who test positive for monkeypox. The intent is to provide stronger data that federal officials and agencies can use to inform decisions about the use of TPOXX in the national response to monkeypox.

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 Wednesday, the US Food and Drug Administration (FDA) authorized Novavax’s COVID-19 vaccine for individuals 18 and over, making it the fourth COVID-19 shot recommended by the agency for use in the United States. The Novavax vaccine is also the first authorized protein-based COVID-19 shot, which works by delivering a protein present on the virus’s service, along with a chemical adjuvant that spurs the immune system to recognize it. The new authorization is for a series of two shots, separated by three weeks; it does not cover use of the Novavax vaccine as a booster shot, which the agency will need to evaluate separately. The vaccine must still be recommended by the Centers for Disease Control and Prevention (CDC) before becoming widely available; the United States has acquired 3.2 million doses of the vaccine to be shipped to states once authorized by the CDC director.The National Institutes of Health has launched a clinical trial of an mRNA vaccine candidate to prevent Nipah virus infection, a zoonotic disease with no currently authorized vaccine or treatment. The phase 1 clinical trial will test an mRNA-based vaccine developed by Moderna and the National Institute of Allergy and Infectious Diseases (NIAID) to evaluate its safety, tolerability, and ability to generate an immune response in 40 healthy adults. NIAID’s Pandemic Preparedness Plan, published earlier this year, established a framework to study viruses of pandemic potential, like Nipah, and prioritize research on prototype pathogens. The newly launched study is the first clinical trial to use the prototype pathogen approach since the plan’s publication.In a new report, the World Health Organization outlines the pipeline of bacterial vaccine candidates and emphasizes the urgent need to step up investment and research into vaccines that can help combat antimicrobial resistance (AMR). The analysis is the first to provide detailed analysis of the pipeline of vaccines with potential to address drug resistance from priority pathogens, identifying 61 vaccine candidates in various stages of clinical development and 94 candidates in preclinical development. While highlighting existing vaccines and the promising candidates in late-stage development, the report also notes a critical need to accelerate trials of vaccines to address AMR and makes a case for bolstered investment that can lead to increased global health equity.

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. Biotech companies Afrigen Biologics and Univercells on Tuesday announced a collaboration to pave the way for the development of the first African-owned COVID-19 vaccine through open-access intellectual property. The companies will focus on the development of a novel mRNA vaccine, using intellectual property from partners, with an emphasis on tackling two major challenges that have hindered COVID-19 vaccine rollout in Africa and other low- and middle-income countries: cold or super-cold chain requirements and a lack of local cost-effective production. The collaboration will be hosted in Cape Town, South Africa, by Afrigen, which also hosts the World Health Organization’s (WHO) global mRNA vaccine technology transfer hub, and the new agreement will build on expertise developed using the hub.At last week’s Kigali Summit on Malaria and Neglected Tropical Diseases (NTDs), Novartis and GlaxoSmithKline (GSK) each pledged to make significant new investments in research and development (R&D) for neglected diseases. Novartis committed $250 million over a period of five years to support work on malaria, Chagas disease, leishmaniasis, dengue fever, and cryptosporidiosis. The funding announcement was made as part of Novartis’ endorsement of the Kigali Declaration, a commitment to ending NTDs. GSK’s pledge—$1 billion over ten years—will be used to accelerate R&D of infectious diseases that disproportionately affect lower-income countries. This research will focus on new and disruptive vaccines and medicines to prevent and treat malaria, tuberculosis, HIV, NTDs, and antimicrobial resistance (AMR).Development of new antibacterial treatments is inadequate to address the escalating threat of antibiotic resistance, according to an annual WHO pipeline report released Thursday. The report, which assesses antibacterial drugs in preclinical and clinical development, describes the pipeline as stagnant and far from meeting global needs. Since 2017, just 12 antibiotics have been approved, 10 of which belong to existing classes with established mechanisms of AMR—demonstrating a major gap in discovery of antibacterial treatments, especially innovative treatments. Urgent, concerted investments in R&D by governments and the private sector are needed to accelerate and expand the antibiotic pipeline, according to WHO, especially for products that can make an impact in low-resource settings, which are most affected by AMR.

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.