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Reforms to a World Health Organization (WHO) program that focuses on certifying the safety and efficacy of health products have accelerated access to these innovations in low- and middle-income countries (LMICs), yet the program continues to struggle with challenging processes and practices that could lead to unnecessary delays.This is the central finding of a new report released today by the Global Health Technologies Coalition (GHTC) and the Duke Global Health Innovation Center (GHIC) that examines the WHO prequalification program. The program conducts comprehensive reviews of the safety, efficacy and quality of medical products, work that became even more important during the COVID-19 pandemic. Approvals clear the way for procurement of new drugs, vaccines, vector control products and diagnostics by aid agencies and LMICs.“We found that WHO has embraced reforms that can speed access to health technologies through expedited reviews of safety and efficacy,” said Jamie Bay Nishi, executive director of GHTC. “But we also identified issues that can be confusing for product developers and thus impede approvals. They included uncertainties regarding WHO review timelines, data needs and how prequalification is impacted by other WHO processes.”Experts at Duke GHIC and GHTC analyzed the review timelines for two dozen WHO prequalified products. They also conducted interviews with WHO staff, product developers and regulatory experts.  They found a WHO process for expediting reviews of products already approved through the stringent reviews of high-functioning national regulatory agencies substantially reduced the time it took to achieve prequalification — from an average 17 months to just six months. Also, they noted the benefits of a new collaborative registration procedure in which regulatory product reviews conducted by WHO prequalification staff occur jointly with assessments by regulatory officials in LMICs. Regulators in LMICs still conduct their own independent assessments of new medical products regardless of their approval by WHO. But doing this work jointly with WHO reviewers providing technical assistance and guidance allowed the first national product approval following WHO assessment of prequalification to occur within five months, on average, compared to a year lag when they were done separately. The report notes that the faster timelines achieved through the expedited and joint review processes are illustrative of tangible benefits emerging from WHO reforms. It also applauded WHO for piloting procedures to streamline reviews of innovations targeting COVID-19 and drug-resistant tuberculosis, noting the potential to apply these practices more broadly in the future. But the analysis of the prequalification program also revealed a number of pain points in the WHO review process that warrant immediate attention. For example, WHO does not provide estimated review timelines for all product types. This lack of visibility into the process makes it difficult for product developers to anticipate when WHO might reach a decision or request additional data. WHO also does not report performance indicators — data that could reveal whether reviewers are meeting internal expectations for completing product assessments. Furthermore, the report noted product developers were sometimes confused about how WHO was conducting reviews within the parameters of its own stated policies. For example, WHO PQ procedures state that before a product can be prequalified, it already must be included in WHO policy or treatment guidelines. However, there were instances when the processes for developing guidelines occurred either in parallel with prequalification reviews or after the product was prequalified. While this kind of flexibility by WHO could be beneficial for expediting reviews, product developers found the lack of clarity around the process was challenging to navigate. Finally, the report raises concerns that WHO staffing policies are putting a strain on the program’s ability to deliver on its mandate at a time when demands are increasing. The authors identify specific actions that can address inefficiencies and bottlenecks in the prequalification program: Improve reporting and communication to generate greater clarity for stakeholders. This includes publicly releasing performance indicators and launching a public database with complete timeline information on all prequalified products. It also recommends developing additional resources that help product developers navigate the prequalification process and clarifying how it interacts with other WHO treatment and technical guideline development processes.  Support the expanded use of interim or “living” guidelines for other novel products. The report notes that WHO recently relied on early or interim evidence to issue interim treatment guidelines for COVID-19 therapeutics and the treatment of drug-resistant tuberculosis. The report calls for expanding this practice. It’s a faster way to provide real-time information to health decisionmakers and reduces delays in the prequalification process.Provide greater opportunities for external stakeholder to inform prequalification processes and strategy. The report urges WHO to improve platforms and consultation processes for gathering ongoing feedback from product developers, regulators and product access ecosystem actors. It also recommends new efforts focused on expanding country and product developer participation in WHO’s collaborative registration procedure, given its success in speeding regulatory approvals.Adopt a new policy to enable the prequalification program to hire additional permanent staff and reduce reliance on consultants. The report explains that this would require WHO member states to approve changes to existing staffing policies, which currently limit the number of permanent staff that can be hired at WHO headquarters.“Our research unearths important advances the WHO prequalification program has made in enabling greater access to lifesaving health products in low-income countries, said Elina Urli Hodges, assistant director of programs at Duke GHIC. “But by adopting additional stepwise changes to the way it communicates and engages with developers and regulators, we believe the program can better deliver on its mission to make quality essential medical products available to all who urgently need them.”###The Global Health Technologies Coalition (www.ghtcoalition.org) works to save and improve lives by encouraging the research and development of essential health technologies. We bring together more than 40 nonprofit organizations, academic institutions, and aligned businesses to advance policies to accelerate the creation of new drugs, vaccines, diagnostics, and other tools that bring healthy lives within reach for all people.The Duke Global Health Innovation Center (www.dukeghic.org) supports the scaling of health care delivery and policy innovations through applied research and education to improve health worldwide. Duke GHIC links global health, health policy, and health innovation efforts across Duke University, and partners with Innovations in Healthcare, a Duke-hosted non-profit that aims to increase access to quality, affordable health care worldwide by scaling leading innovations.

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. A novel antibody treatment designed to prevent malaria was able to protect against infection in a majority of participants in a phase 1 trial, according to results published last week. The method utilizes a monoclonal antibody, dubbed L9LS, that is optimized to target a protein used by the malaria parasite to infect hosts. The recent trial tested three different doses of the antibody treatment, administered either intravenously or subcutaneously, among 17 healthy volunteers. All participants were then exposed to malaria-carrying mosquitos, and just two participants developed malaria in the weeks following. The results provide proof of principle for a next-generation monoclonal antibody, researchers say, suggesting it could be an important tool in eradicating malaria when used in combination with effective vaccines and other prevention measures.  The US National Institutes of Health is preparing to launch a clinical trial evaluating methods to stretch doses of Jynneos, the only vaccine approved for use against monkeypox in the United States. Researchers will study two adjusted regimens in comparison to the current method, which involves two full doses given 28 days apart. One test group will receive a single dose of the vaccine, and another group will receive two doses, given 28 days apart, that are each one-fifth of a full dose and administered intradermally—or into the skin, rather than under the skin—which has potential to activate powerful immune responses. The study will test whether the dose-sparing approaches generate antibody levels similar to those of the full, two-dose regimen, as well as compare the tolerability and reactogenicity of the two different routes. Results are expected toward the end of 2022.A clinical trial in South Africa has shown that a new vaccine candidate for tuberculosis (TB) is safe for newborns and has fewer side effects than the existing TB vaccine, Bacillus Calmette Guérin (BCG). The experimental vaccine, VPM1002, was developed by genetically modifying the attenuated BCG vaccine strain so that immune cells better recognize the pathogens, in an effort to increase safety and improve efficacy for immunocompromised children. The phase 2 trial compared VPM1002 with BCG in HIV-exposed and non-HIV-exposed newborns and examined the associated safety and immune response, ultimately finding the vaccine candidate safe in both groups of newborns, with fewer side effects than BCG as well as a similar immune response. Researchers plan to continue to evaluate the vaccine among newborns, including its ability to protect against infection, in a phase 3 trial.

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.