Research Roundup: Adapted TB treatment regimen reduces side effects, new partnership to help eliminate malaria, COVAX launches marketplace to boost production

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. 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.”