Breakthroughs Blog: Access

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 signed a voluntary license agreement last week to share the patents and knowledge to manufacture its COVID-19 antiviral pill, Paxlovid, with the Medicines Patent Pool (MPP). The agreement will allow MPP to grant sublicenses to qualified generic medicine manufacturers to supply the treatment to 95 countries once regulatory authorization or approval is granted. Paxlovid, a five-day oral treatment regimen, was shown to reduce the risk of COVID-19-related hospitalization and death by 89 percent in phase 2/3 clinical trial results. The new licensing agreement will allow the rapid scale-up of manufacturing of the treatment, which is particularly well-suited for low- and middle-income countries and would contribute to global efforts to combat COVID-19, according to the executive director of MPP. AstraZeneca’s antibody cocktail is more than 80 percent effective at preventing symptomatic COVID-19, according to results released by the company Thursday. The study—in which more than 75 percent of participants had comorbidities that put them at risk of developing severe COVID-19—showed the long-acting antibody combination reduced the risk of symptomatic COVID-19 by 83 percent over a period of six months. There were also no cases of severe disease or death among those who received the antibody cocktail, which is administered as a one-time 300-mg dose in two separate, sequential shots. The preventative treatment is intended to help at-risk individuals, particularly those who do not develop an adequate immune response to the COVID-19 vaccine, to prevent serious illness from the virus. Merck KGaA (EMD Group) and the Pediatric Praziquantel Consortium have announced pivotal phase 3 trial results for schistosomiasis treatment arpraziquantel, indicating the drug has met the primary endpoint of clinical cure among children ages three months to six years. Arpraziquantel—an orally dispersible tablet derived from praziquantel, the formulation used for older children and adults—is tailored to the needs of the estimated 50 million preschool-aged children suffering from schistosomiasis, who currently have no treatment option. Merck KGaA intends to apply for a scientific opinion from the European Medicines Agency under a high-priority procedure for medicines intended for markets outside the European Union, which would facilitate prequalification by the World Health Organization as well as regulatory approvals in endemic 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.Pharmaceutical company Merck has announced an agreement to share its license for the oral COVID-19 drug molnupiravir with the United Nations–backed Medicines Patent Pool to expand access to the treatment in more than 100 countries. Molnupiravir, an easy-to-take pill, reduced hospitalizations and deaths by half among higher-risk COVID-19 patients diagnosed with mild to moderate illness in a global clinical trial. The agreement is the first public health license for a COVID-19 treatment or vaccine, allowing the medicine to be produced by all capable manufacturers—once the drug receives regulatory approval—to expand the drug’s availability, widen its manufacturing base, and potentially push down the price. Merck has applied to the US Food and Drug Administration for emergency use authorization, and the European Medicines Agency recently began a rolling review of the drug.The Access to COVID-19 Tools Accelerator (ACT-A) on Thursday launched its new strategic plan outlining a focus on addressing access inequities to tools in underserved areas. Over the next year, ACT-A—a global partnership set up to accelerate the development and delivery of COVID-19 tests, treatments, and vaccines—will aim to support low- and middle-income countries in vaccinating 70 percent of their populations, increasing their testing rates to at least 1 per 1,000 people per day, and treating up to 120 million COVID-19 cases through deployment of existing treatments and enabling access to new therapies. The plan outlines a required budget of $23.4 billion between now and September 2022, including $840 million for research and development.Inexpensive drug fluvoxamine could reduce hospitalization in adults with severe COVID-19, according to research published Wednesday in The Lancet Global Health. The findings, based on a clinical trial in Brazil evaluating high-risk, symptomatic adults who had recently contracted COVID-19, showed participants were less likely to require hospitalization or an extended emergency room stay when given a 100-milligram dose of fluvoxamine twice daily for ten days. Fluvoxamine is commonly prescribed to treat depression and obsessive-compulsive disorder and is known to reduce inflammation, which COVID-19 can cause throughout the body. The study findings, part of the larger TOGETHER Trial aiming to identify repurposed therapies effective against COVID-19 disease progression, have been shared with the World Health Organization and the US National Institutes of Health.

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 Monday, the COVAX vaccine-sharing facility and the World Bank launched a new financing mechanism to increase access to COVID-19 vaccines in low- and middle-income countries. The scheme builds on the existing COVAX advance market commitment (AMC) mechanism by allowing AMC-eligible countries to make additional advance purchases through COVAX—beyond the fully donor-subsidized doses AMC-eligible countries are already receiving—based on aggregate demand across countries, using financing from the World Bank. The new plan will also provide participating countries with greater transparency on vaccine availability, prices, and delivery schedules, enabling them to implement vaccination plans more effectively. COVAX has so far delivered around 150 million doses to 137 countries and aims to deliver 2 billion doses by the end of this year, in addition to 1.8 billion next year.BioNTech intends to begin clinical trials for a “safe and highly effective malaria vaccine,” based on the mRNA technology behind its COVID-19 vaccine, by the end of next year, the company announced last week. Developing a vaccine able to induce a strong, long-lasting antibody response against malaria is difficult, as the genome of the parasite that causes malaria is more complex than viruses, according to researchers—however, insights from developing an mRNA-based vaccine against COVID-19, combined with a growing understanding of how malaria works, could make this an optimal time to address the challenge, a BioNTech representative said. BioNTech is also looking to establish an mRNA vaccine production facility in Africa, bolstering manufacturing capabilities on the continent and ultimately producing various mRNA-based vaccines beyond COVID-19.Researchers were able to wipe out a population of malaria-transmitting mosquitoes using a genetic engineering method that renders females infertile, according to study results published Wednesday. The gene-drive technology aims to bypass natural selection by plugging in a set of genetic instructions that rapidly spread through a population and pass on an infertility trait—far faster than could be achieved through conventional selective breeding. The new study tested whether gene drive of a sex determination gene—which has been previously tested, successfully, in a smaller trial—would spread and cause the same population collapse in closer to real-world conditions. Researchers plan to continue with more comprehensive gene-drive testing and environmental risk assessments before moving to larger field trials. The self-sustaining and fast-acting technology is meant to work alongside existing tools, such as bednets, insecticides, and vaccines.

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 International Vaccine Institute (IVI) and Coalition for Epidemic Preparedness Innovations (CEPI) have announced a new clinical research program that will aim to improve and expand access to COVID-19 vaccines in Africa. CEPI will provide approximately $12.7 million to the Expanding Access and Delivery of COVID-19 Vaccines in Africa (ECOVA) initiative, which will be led by IVI, to conduct clinical trials of Sinopharm’s BBIBP-CorV vaccine. The BBIBP-CorV vaccine is already being deployed in more than 50 countries, and the COVAX vaccine-sharing facility is set to distribute around 170 million doses based on a deal announced July 12. However, there have been no clinical trials assessing BBIBP-CorV in African populations or against the variants of concern circulating in southern Africa. The ECOVA research initiative will aim to collect data that informs the utilization of the shot in Africa, as well as potentially expand its use to people with HIV/AIDS.On Wednesday, Pfizer and BioNTech announced a new partnership with Biovac to produce more than 100 million doses annually of their mRNA-based COVID-19 vaccine for distribution within the African Union. Cape Town-based pharmaceutical company Biovac will manufacture the vaccine at the “fill-and-finish” stage using active ingredients produced by facilities in Europe. Technical transfer, on-site development, and equipment installation will begin immediately, according to the announcement, but manufacturing of finished doses will not begin until early 2022—meaning the deal will not have impact in the near term on vaccine supply shortages in the region. At full operational capacity, the facility will exceed 100 million doses produced per year, all of which will be distributed within the 55 member states of the African Union.The US Food and Drug Administration (FDA) last week approved fexinidazole as the first all-oral treatment for both stages of sleeping sickness, also known as human African trypanosomiasis. About 65 million people in sub-Saharan Africa are at risk of sleeping sickness, which is transmitted by the bite of an infected tsetse fly and is almost always fatal if left untreated. Fexinidazole—developed by a partnership between the Drugs for Neglected Diseases initiative (DNDi), Sanofi, and national sleeping sickness programs of the Democratic Republic of Congo and Central African Republic—is the first all-oral treatment that works for both the first stage of the disease and the second stage of the disease in which the parasites cross the blood-brain barrier. The ten-day, once-a-day treatment method will expand options beyond those requiring hospitalization for infusion or injection. As a result of the approval, a priority review voucher (PRV) was also awarded to DNDi under the FDA’s Tropical Disease PRV program.