News

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.

At GHTC, we get to read stories every day about incredible innovations in global health. Most of the technologies we see are inventive, some are revolutionary, and a few are so unusual, one might think they were ripped from the pages of a science fiction novel. Now, we’re testing how well you know these global health technologies with our annual Halloween game: the TRICK or TREATment quiz.For each question, we will present a description of a global health technology. Choose TREATment if you believe this innovation exists. Choose TRICK if you think we are trying to pull one over on you and, instead, the product is still in development or is just a figment of our imagination. 

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. Johnson & Johnson on Friday presented new data showing that its pill for dengue fever appeared to protect against a form of the virus in a small human challenge trial done with the Johns Hopkins School of Public Health, providing hope for the first-ever specific treatment for dengue, which is a growing threat around the world due to climate change. The pill, which is the first-ever drug to show antiviral activity against dengue, will also be tested as a treatment method. If the drug is successful in larger-scale trials, ensuring access to the new drug in low- and middle-income countries —especially as the threat of dengue rises in high-income countries alike—will be essential to effectively tackle the disease around the world.The Sabin Vaccine Institute has launched a phase 2 clinical trial for its vaccine candidate against Marburg virus, a lethal filovirus for which there are currently no vaccines or antiviral treatments approved. The trial will take place in Kampala, Uganda, which has experienced various Marburg outbreaks in the past few decades. The single-dose candidate was previously found to be safe and elicit rapid and robust immune responses in phase 1 clinical and non-clinical studies. The ChAd3 platform, which forms the basis of the Marburg vaccine candidate, also undergirds Sabin's Sudan ebolavirus vaccine candidate, which recently received US funding for phase 2 clinical trials. The need for a vaccine against both deadly diseases has been brought to the fore by recent outbreaks.Last week, Gilead Sciences Inc. announced PURPOSE 5, the first phase 2 clinical trial to evaluate an investigational, long-acting HIV prevention option in Europe. Lenacapavir for HIV prevention, compared with a currently used drug combination, could offer a fewer-dose, long-acting solution to individuals who could benefit from pre-exposure prophylaxis (PrEP). Lenacapavir, which can be administered as a twice-yearly injection, is currently approved in combination with other antiretrovirals for HIV treatment in people with multidrug-resistant HIV-1 infection. The study has an intentional focus on recruiting participants who are disproportionately affected by HIV and often underrepresented in clinical trials, given the importance of making available a variety of HIV prevention methods to meet the diverse needs of those who could benefit from PrEP.