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. Last Thursday, the US Food and Drug Administration (FDA) announced its approval of the first vaccine to prevent the disease caused by the chikungunya virus. The Ixchiq vaccine, developed by Valenva, is approved for adults at increased risk of exposure to the virus. It was previously granted fast-track and breakthrough therapy designations from FDA. Chikungunya is a chronic and debilitating disease that has no specific treatment, which has become an increasing global threat due to climate change. FDA is requiring that Valneva perform a post-market study to continue to monitor the vaccine’s safety and side effects.With support from Medicines for Malaria Venture (MMV), Kenyan manufacturer Universal Corporation Ltd has received prequalification from the World Health Organization (WHO) for sulfadoxine-pyrimethamine plus amodiaquine (SPAQ), an antimalarial drug used to prevent seasonal malaria in children during peak transmission periods. This approval, which makes UCL only the sixth African pharmaceutical company to have a product WHO-prequalified, will allow Africa to reduce reliance on imported generic versions of the drug from India and China. In the face of a myriad of barriers to quality local drug production and a persistently high burden of malaria cases and deaths, the approval will also make it easier for other African companies to enter the market and attract major buyers, as well as ensure the accessibility and availability of the drug where it is most needed and free up national resources to dedicate to other aspects of the malaria response.A new study found that more than half of tuberculosis (TB) patients in South Africa receiving treatment with a bedaquiline-containing regimen had isolates resistant to the drug, which was introduced in South Africa in 2012 and has recently become part of all standard drug-resistant TB regimens globally. The study is one of the first to report individual-level bedaquiline resistance gain over time among patients in a setting with a bedaquiline-containing regimen as the standard treatment. The results highlight the need for drug-susceptibility testing capacity to accompany the scale-up of new drugs like bedaquiline to monitor the emergence of drug 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. Last Wednesday, the Global Antibiotic Research and Development Partnership (GARDP) announced the results of a successful phase 3 trial, conducted in collaboration with Innoviva Specialty Therapeutics and supported by the National Institute of Allergy and Infectious Diseases, which found that a single dose of a first-in-class oral antibiotic, zoliflodacin, was as safe and effective as standard therapy for treating uncomplicated urogenital gonorrhea. The growing resistance of the gonorrhea bacteria to many classes of antibiotics has left only one remaining globally recommended treatment available as an option. Zoliflodacin, if approved, could not only help address those rising cases because studies have shown that it is active against multi-drug resistant gonorrhea strains, but the antibiotic will also simplify treatment because it is one pill rather than an injection and a pill like the current standard therapy. Last week, the Coalition for Epidemic Preparedness Innovations (CEPI) and the University of Oxford announced the launch of a new project to develop prototype vaccines against an arenavirus called Junin virus, which causes Argentine hemorrhagic fever. The project is aimed at kickstarting the broader development of vaccines for arenaviruses, which include the virus that causes Lassa fever, one of CEPI’s priority pathogens. CEPI will invest $25 million in the development of early prototypes of viral vector and mRNA vaccines against the Junin virus, as well as the improvement of the ChAdOx viral vector technology, part of the broader partnership between CEPI and Oxford to support vaccine development for a variety of viral families with future epidemic or pandemic potential. In a recent study, researchers have identified a new molecule in cells that is necessary for the Ebola and Marburg viruses to infect and spread in the body and that is also involved in SARS-CoV-2 infections. This discovery could eventually lead to new antiviral drugs for Ebola and Marburg, among other viral infections. The molecular, CCZ1, is a protein that regulates the transport of other molecules by cells. Researchers from the Karolinska Institutet and Institute of Molecular Biotechnology used advanced stem cell libraries and lab-grown organs to study how viruses infect the human liver and blood vessels and ultimately demonstrate how CCZ1 operates as a key factor in their spread through the body. 

GHTC contributed the below input to a World Health Organization (WHO) Science Division consultation around a new framework to align and expedite the two interrelated processes of prequalifying novel products and issuing technical guidelines to recommend use.GHTC feedback for new World Health Organization Prequalification evaluation procedure for novel productsThe Global Health Technologies Coalition (GHTC) is a coalition of more than 45 nonprofit organizations, academic institutions, and aligned businesses advancing policies to accelerate the creation of new drugs, vaccines, diagnostics, and other tools that bring healthy lives within reach for all people. GHTC has been focused on possible improvements to the WHO prequalification program (PQ) for several years and published a report last year together with Duke University that highlighted some of the perceived pain points and areas of opportunity.GHTC welcomes the updated guidance that WHO will apply parallel, rather than sequential processes, in its guidelines development and prequalification and/or emergency use listing (EUL) to all new and novel health products that it needs to assess. Many of our members and partners have outlined the reliance on guidelines being the first step in the process as a major bottleneck for innovative products and highlighted how it adds significantly to timelines, delaying access to critical new health technologies in low- and middle-income countries (LMICs).The following outlines questions GHTC hopes will be answered as part of the consultation process and general feedback on what should be considered as part of this consultation, or where there could be opportunity for additional clarification:Regulatory agencies in LMICs Questions we hope this consultation will address: How will this new procedure intersect with other shifts in the global regulatory ecosystem? How will PQ look beyond the traditional high-income country stringent regulators and start to integrate emerging regulatory authorities with higher maturity levels into this new PQ process?Will WHO work with global procurers to help assess how they can diversify their quality assessment portfolio?Beyond PQ review of dossiers to inform global procurement, and amid national and regional regulatory strengthening efforts, how will PQ reposition its role in assessing products manufactured in one geography for use in other markets (e.g. African made products which might be procured at a national or regional level in Asia)? GHTC contributions:Strengthen other regulatory agencies in LMICs: GHTC continues to hear from partners that they are concerned about additional regulatory barriers coming into play as new bodies, such as the African Medicines Agency (AMA) start to operationalize, and hopes WHO can play an essential role in harmonization (e.g. concerns of a product going sequentially through review by a stringent regulatory authority, PQ, AMA and then a lower maturity regulatory body before a product can be introduced). As WHO PQ develops its new framework for novel products, consideration needs to be given to other regulatory authorities, especially in LMICs, and how their product review can help promote local manufacturing. There could be some countries and regional blocks where WHO Listed Authority (WLA) Level could bypass PQ or significantly expedite PQ approval using maturity levels as markers of expertise. Promoting harmonization and operationalizing of national regulatory efforts (i.e. through AMA) would limit the remit and need for a completely centralized PQ gateway and free up bandwidth within WHO’s PQ team to provide more regulatory technical assistance to national regulatory authorities.Reviewing protocols between global procurers, regulators, and PQ: Across consultations we have done with product developers, national regulators and private sector organizations, there is a lack of consensus on how PQ should interact with global procurers. Some stakeholders are calling on global procurers to diversify the mechanisms to review and approve products. PQ could be one of a menu of mechanisms procurers could leverage for new health products, reducing bottlenecks. On the other hand, many stakeholders see PQ as a critical step before global procurement and would like WHO to update its protocols when working with other regulatory agencies to speed up approvals without sacrificing safety, efficacy, or reviews for programmatic suitability.Limiting the scopeQuestions we hope this consultation will address: How will the WHO PQ team handle prioritization for their pipeline?How can WHO ensure that it reviews based on global needs, and that when products see smaller changes or updates, WHO is not restarting the whole review process (e.g. not going through an entirely new dossier review when the casing of a diagnostic is changed by the manufacturer)?Might there be any types of products that will not require PQ or that can go through an expedited review after being approved through another WLA 3+ body?GHTC contributions:Update protocols for triaging generic versus innovative product dossiers: To ensure that PQ can focus and prioritize products with the greatest need and to fill health product gaps, PQ should work with WLA 3+ regulators to develop a category of health products which may not need to go through a full PQ assessment (e.g. generics where bioequivalents and CNC have been demonstrated). Having a more formalized abridged process for generics would enable PQ to better leverage its technical expertise and limited bandwidth to focus on reviewing novel or innovative product dossiers.Living policy guidelines Questions we hope this consultation will address: How will WHO work internally between the various divisions to ensure clarity for outside stakeholders on the interaction between PQ and policy teams for guidelines?How can WHO ensure that even with the new parallel process, there are no artificial bottlenecks for updating or making changes to guidelines?GHTC contributions:Further develop protocols for living guidelines: To increase uptake of innovative products, support and advise on the expansion of interim or “living” guidelines, similar to those issued recently for COVID-19 therapeutics and treatments for drug-resistant tuberculosis, for other innovator or novel products to expedite opportunities to address real-time needs.

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. Pfizer and BioNTech last week reported promising early-phase data on an mRNA combination vaccine against COVID-19 and influenza and announced plans to start a phase 3 trial of the vaccine, following Moderna’s similar announcement for its combination vaccine earlier this month. Moderna’s trial began last week, with Pfizer and BioNTech’s likely to start in the coming months as well. A combination vaccine for COVID-19 and influenza has the potential to greatly reduce the burden of these respiratory viruses on patients, providers, and health care systems, underscoring why these companies and the broader research community have placed a greater focus on combination vaccines coming out of the pandemic.At the annual meeting of the American Society of Tropical Medicine and Hygiene (ASTMH) last week, the World Health Organization reported the results of a major evaluation of a pilot rollout in three African countries of RTS,S, the first approved malaria vaccine, showing positive findings about the lives it has already saved. RTS,S cut deaths among young children by 13 percent over nearly four years and cut cases of severe malaria by 22 percent among kids young enough to have received a three-shot regimen. The RTS,S vaccine is notably not a perfect tool, given the limited durability of its protection and lower efficacy, but health experts say this data makes a strong case for broader rollout of RTS,S and the potential of integrating the second approved malaria vaccine, R21, into multipronged efforts to fight malaria.A research team at the Johns Hopkins Bloomberg School of Public Health has shown for the first time that human volunteers can be safely and effectively infected with Zika virus, which could benefit research efforts to gain a greater understanding of the disease and to develop vaccines and treatments to use against it, as none currently exist. This controlled human infection model is useful for research because during the 2015-2016 outbreak, researchers were unable to test experimental products in time before the epidemic subsided, and since, there have not been any large outbreaks. The new model is controversial but has been ruled by US regulators and the World Health Organization as safe and scientifically important.