Breakthroughs Blog: COVID-19

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.

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. An adapted version of an existing treatment regimen to combat highly drug-resistant tuberculosis (TB) maintains efficacy against the disease and reduces side effects, according to results from the ZeNix trial announced last week. The ZeNix study, led by TB Alliance, is a follow-up to the Nix-TB trial, which published results last year showing 89 percent of participants were cured of TB when treated for six months with a combination of bedaquiline, pretomanid, and linezolid—known as the BPaL regimen. ZeNix evaluated the same regimen among 181 people with cases of highly drug-resistant TB in South Africa, Russia, Georgia, and Moldova, but varied the doses and durations of the use of linezolid. Results showed significantly reducing doses and duration of linezolid can have the same levels of efficacy in addition to reducing the side effects significantly.A new partnership will aim to help endemic countries eliminate Plasmodium vivax malaria, a complex and persistent type of malaria that poses a risk to more than one-third of the world’s population. The Partnership For Vivax Elimination (PAVE), led by the Medicines for Malaria Venture and PATH, will conduct feasibility studies to evaluate the best treatment options for P. vivax relapse in diverse populations and settings. The partnership will scale up the single-dose treatment tafenoquine as well as a higher dose of a second drug, primaquine, that cuts treatment time to seven days compared to the 14-day regimen currently in use. PAVE will also generate and consolidate evidence to support malaria-endemic countries in developing and implementing new strategies for P. vivax malaria.The COVAX vaccine-sharing facility is launching a marketplace to address supply chain bottlenecks and accelerate the global production of COVID-19 vaccine doses. The platform will match vaccine manufacturers with suppliers of key inputs to boost production of vaccines for equitable distribution through COVAX. The marketplace will initially focus on six critical areas where there have been shortages, including bioreactor bags, lipids, and vials, but could eventually facilitate supplies for other lifesaving medicines and vaccines hit by global shortages, according to the Coalition for Epidemic Preparedness Innovations, which will facilitate the initiative. COVAX aims to make 2 billion vaccine doses available by the end of the year, but so far has only delivered 118 million vaccines to 135 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. Last week, the World Health Organization (WHO) recommended the use of interleukin-6 receptor blockers as a treatment for severe and critical COVID-19, making these only the second set of drugs it has deemed effective in treating the disease. The interleukin-6 blocking drugs, tocilizumab and sarilumab, showed efficacy in reducing deaths in data from more than 10,000 patients involved in 27 clinical trials. Tocilizumab, made by Roche under the brand name Actemra, and sarilumab, made by Regeneron and Sanofi under the brand name Kevzara, are monoclonal antibodies used to suppress overreactions of the immune system in patients with severe COVID-19. In its recommendation, WHO also emphasized a need for equitable access to the treatments, calling on manufacturers to reduce the drugs’ prices and make supplies available to low- and middle-income countries, especially where COVID-19 is surging. A chikungunya vaccine candidate developed by Valneva has received Breakthrough Therapy Designation from the US Food and Drug Administration (FDA). The single-dose, live-attenuated vaccine, VLA1553, also received FDA Fast Track designation in December 2018 and European Medicines Agency PRIME designation in October 2020. Valneva’s phase 3 trial to evaluate immunogenicity and safety of VLA1553 at 28 days following immunization completed recruitment in April, and top-line data is expected in the summer. The Breakthrough Therapy Designation is meant to facilitate and expedite development and review of new drugs for serious or life-threatening conditions where preliminary clinical data demonstrates the drug may have substantial improvement for at least one endpoint over available therapies.Pfizer intends to seek FDA authorization for a third dose of its COVID-19 vaccine in August, the company said Thursday, claiming another shot within 12 months could boost immunity and help combat virus variants. Early data from Pfizer’s booster study showed participants’ antibody levels jumped five- to ten-fold after a third dose, compared to their second dose months earlier. Research has also shown the current vaccine regimen offers strong protection against the delta variant, which is now spreading rapidly around the world and accounts for the majority of new US infections. On the same day as Pfizer’s announcement, the US Centers for Disease Control and Prevention and FDA issued a joint statement saying fully vaccinated Americans don’t need a booster shot yet, and any decision on boosters would happen only when “the science demonstrates that they are needed.”