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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 third person appears to have been cured of HIV, scientists announced last week, using a new treatment method involving umbilical cord blood. Cord blood is more widely available than the adult stem cells used in bone marrow transplants—the method used for the previous two patients cured of HIV—and does not need to be matched as closely to the recipient. The patient, a mixed-race woman who also had leukemia, received the cord blood to treat her cancer in August 2017. She discontinued antiretroviral therapy 37 months after the transplant, and now, more than 14 months later, shows no signs of HIV in blood tests and does not seem to have detectable antibodies to the virus. The news opens up the possibility of curing more people of diverse racial backgrounds than was previously possible, scientists said.BioNTech plans to set up modular mRNA vaccine facilities to produce its COVID-19 vaccine, codeveloped with Pfizer, in Rwanda and Senegal, with a fill-and-finish collaboration in Ghana. The initiative involves modular factories, dubbed “BioNTainers,” that consist of one drug substance and one formulation module, each of which is built from six standard shipping containers fitted with the necessary equipment. The first containers will be delivered in mid-2022, and the first vaccine batches will be produced in the following months. The facilities will be equipped to manufacture a range of mRNA-based vaccines, including BioNTech’s investigational malaria and tuberculosis vaccines if successfully developed and authorized by regulatory authorities.Dr. Robert Califf was officially confirmed as commissioner of the US Food and Drug Administration (FDA) last week after a 50–46 Senate vote, the narrowest confirmation in the history of votes to lead the agency. The FDA has been without a permanent leader for nearly 400 days, instead being led by an acting commissioner, Janet Woodcock, who will now serve as principal deputy commissioner under Califf. Califf, a cardiologist and researcher, was nominated for the role by President Joe Biden in November and will take the helm at the FDA for the second time, having previously held the role during the final year of the Obama administration. Califf was officially sworn in as commissioner on Thursday.

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 ANTICOV clinical trial will begin testing a new drug combination, fluoxetine and budesonide, as an early treatment for people affected with mild-to-moderate COVID-19. ANTICOV—a multi-country trial consortium coordinated by the Drugs for Neglected Diseases initiative—aims to identify COVID-19 treatments optimized for use in resource-limited settings that can prevent progression to severe disease and potentially limit transmission. The new drug combination includes fluoxetine, better known by its brand name Prozac, and inhaled budesonide, a corticosteroid known to have potent anti-inflammatory efficacy in the lungs. Fluoxetine inhibits the ability of the virus to replicate by preventing viral entry into cells, while budesonide, if taken in an early stage of infection, improves recovery time in COVID-19 outpatients and may reduce hospitalizations and deaths, according to studies. Both drugs are commercially available, affordable, and easy to access and administer.Public Health Vaccines (PHV) has launched a phase 1 clinical trial to evaluate a single-dose vaccine against Nipah virus, for which there is currently no available treatment or vaccine. The PHV02 vaccine, originally developed at the National Institute of Allergy and Infectious Diseases, is being advanced by PHV with funding from the Coalition for Epidemic Preparedness Innovations to support development through phase 2 clinical trials. The phase 1 trial will evaluate the vaccine candidate’s safety, tolerability, and dose response in humans and determine whether humans mount antibodies to neutralize Nipah virus similar to those found to be protective against illness and death in several animal models. If trial results are favorable, PHV plans to initiate a phase 2 trial in a disease-endemic region in 2022.The Africa Centers for Disease Control and Prevention (CDC) will be elevated to the status of an autonomous public health agency for the continent instead of a technical arm of the African Union (AU), Africa CDC Director Dr. John Nkengasong announced last week at the 35th AU Summit. This development is a result of leaders’ renewed perception of disease as a security threat for the continent, according to Nkengasong, and signals growing member state commitment to strengthening the continent’s response to current and future disease outbreaks. The agency will now report directly to heads of state of AU member countries. The summit also included renewed calls for support of the African Medicines Agency treaty, which is now backed by 30 African countries, to set up a new regulatory body to facilitate improved access to medicines across the continent.

Ahead of the 6th Global Forum on TB Vaccines, GHTC joined call-to-action letters to European leaders calling for them to increase national investments in tuberculosis (TB) R&D, including TB vaccine R&D, in line with global fair share targets.

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 phase 3 trial to evaluate Valneva’s chikungunya vaccine candidate in adolescents has launched in Brazil, the company announced last week. The live-attenuated, single-shot vaccine, VLA1553, is currently the most clinically advanced chikungunya vaccine candidate worldwide, having completed phase 3 trials in adults. Valneva announced positive top-line results of the phase 3 trial in adults 18 and over in August 2021, indicating the vaccine induced protective chikungunya virus neutralizing antibody titers in 98.5 percent of trial participants and was well-tolerated across age groups. The recently launched trial, funded by the Coalition for Epidemic Preparedness Innovations, is designed to evaluate the vaccine in adolescents aged 12 to 17 and to support its extension to use in the younger age group following potential initial regulatory approval in adults from the US Food and Drug Administration (FDA).Healthy, young people who were intentionally exposed to SARS-CoV-2 developed mild symptoms, if any, in a first-of-its-kind COVID-19 human challenge study, according to a UK study of 34 individuals aged 18 to 30. Around half of the participants who received a low dose of virus became infected, some of whom had no symptoms, while others reported mild-to-moderate symptoms, including sore throats, runny noses, and loss of smell and taste. While controversial due to the risk to participants, challenge trials present an opportunity to study viral infections in detail­—and, according to scientists interviewed, the new study results show such trials can be done safely and lay the groundwork for more in-depth studies of vaccines, antivirals, and immune responses to SARS-CoV-2 infection.The HIV treatment Cabenuva has been approved by the FDA for use every two months, reducing treatments to only six times a year. The injectable treatment was first approved last year for use once a month, offering an alternative to antiretroviral regimens that require daily pills. The updated approval is based on data from a phase 3b study that showed dosing of Cabenuva every other month was non-inferior to monthly dosing and that rates of virologic suppression were similar for dosing monthly or every two months. Cabenuva is a combination of cabotegravir and rilpivirine, forming a complete regimen for HIV-1 infection in adults who are virologically suppressed on a stable antiretroviral regimen with no history of treatment failure.