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. 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.

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. More newborn babies with sepsis are dying because their infections are not responding to the usual antibiotics, according to the largest global study on the subject to date. The study, sponsored by the Global Antibiotic Research and Development Partnership (GARDP), which enrolled 3,200 newborns diagnosed with sepsis in 11 countries, found that 11 percent of newborns died over the course of the study and that 15 percent were prescribed last-line antibiotics due to the high degree of resistance to standard recommended antibiotics in treatment units. Antibiotic resistance is now one of the major threats to newborn health globally, according to researchers, with virtually no studies underway to develop novel antibiotic treatments for babies with sepsis caused by multidrug-resistant infections. GARDP is now designing an interventional trial to identify better treatment regimens to combat rising resistance.World Health Organization (WHO) member states reached a preliminary agreement this week to gradually increase mandatory fees, or “assessed contributions,” to cover 50 percent of the organization’s core budget needs. WHO currently relies heavily on voluntary contributions and private donors, which can leave its financing inflexible and unpredictable. The new funding reforms would be contingent upon certain conditions, such as increased transparency, with the funding linked to a member state review of WHO progress on promised internal reforms. The agreement will still need to be formally approved by governments at the World Health Assembly in May to take effect.COVID-19 diagnostic testing has fallen by 70–90 percent around the world, making it increasingly difficult to monitor the pandemic’s evolution, treat patients, and track variants, according to FIND, a co-convener of the Access to COVID-19 Tools Accelerator diagnostics pillar. While reported cases and deaths are declining globally, changes in testing strategies and reductions in the number of tests being used globally means there is little confidence in actual case trends. The testing decline also undermines the ability to treat patients with new therapeutics—like Pfizer’s antiviral Paxlovid, which requires early diagnosis to get the most benefit—and has led to a decrease in the number of genomic sequences submitted to global databases, which helps track emerging variants.

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) has signed agreements with 27 generic manufacturing companies to produce and supply the oral COVID-19 antiviral molnupiravir for 105 low- and middle-income countries. The sublicense agreements follow a voluntary licensing agreement signed by MPP and Merck, Sharp & Dohme—which developed the drug—in October to facilitate global access of the COVID-19 treatment. The nonexclusive licenses allow generic manufacturers to produce the raw ingredients and finished drug itself: five companies will focus on producing the raw ingredients, thirteen companies will produce both raw ingredients and the finished drug, and nine companies will produce only the finished drug. Molnupiravir has not yet been approved by the World Health Organization (WHO), a step often regarded as a precursor to the negotiation of manufacturing licenses by a United Nations-supported group like MPP.Antimicrobial resistance (AMR) poses a significant threat to humanity, as it has become a leading cause of death worldwide killing about 3,500 people every day, according to a new study published in The Lancet last week. More than 1.2 million people—and potentially millions more—died in 2019 as a direct result of antibiotic-resistant bacterial infections. The analysis, which covered more than 200 countries and territories, is the most comprehensive estimate to date of the global impact of AMR, which has caused common infections to become untreatable. The report highlights an urgent need to scale up action to combat AMR and outlines immediate actions policymakers can take to help save lives and protect health systems, including optimizing the use of existing antibiotics, taking greater action to monitor and control infections, and providing more funding to develop new antibiotics and treatments.The COVAX vaccine-sharing facility has delivered 1 billion COVID-19 vaccine doses, across 144 countries, as of last weekend. The program, which was initiated in 2020 with the goal of delivering 2 billion doses by the end of 2021, began delivering vaccines in February 2021 but hit several setbacks throughout the year, including vaccine hoarding by high-income countries and export restrictions which limited vaccine supply. Shipments increased exponentially in the last quarter of 2021, but vaccine inequity remains high, according to the latest WHO data showing 67 percent of the population in richer nations have been fully vaccinated, compared with only 5 percent in poorer nations. More than 40 percent of the world's population has yet to receive a first dose. Gavi, the Vaccine Alliance, has launched a renewed call for COVAX funding to help reach WHO's goal of vaccinating 70 percent of the populations in poorer countries by July.

Prior to COVID-19, tuberculosis (TB), another airborne disease, was the world’s leading global infectious disease killer, claiming the lives of around 1.5 million people annually. Insufficient and inadequate tools and treatments, as well as the growth of drug resistance, have challenged global efforts to bring this epidemic to an end. But scientists hope that tide will turn as more new technologies and innovations advance to market. In recognition of #WorldTBDay, test your knowledge of innovations to #EndTB with GHTC’s quiz below: Loading... (function(i, s, o, g, r, a, m) { var ql = document.querySelectorAll('A[quiz],DIV[quiz],A[data-quiz],DIV[data-quiz]'); if (ql) { if (ql.length) { for (var k = 0; k