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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. Sanofi and GlaxoSmithKline (GSK) plan to submit their COVID-19 vaccine for authorization following strong phase 3 trial results, the companies announced Wednesday. The two-dose adjuvanted protein-based vaccine showed 100 percent efficacy against severe disease and hospitalization and 57.9 percent overall efficacy against symptomatic COVID-19 disease, which, while lower than rates originally reported for other vaccines, reflects efficacy expectations in an environment now dominated by variants of concern, the companies said. The vaccine can also be used as a booster, including in people who originally received an mRNA vaccine, and is stable at refrigerator temperatures, making it more suitable to reach low-resource settings than vaccines with stricter cold-chain requirements. Sanofi and GSK are submitting the vaccine for authorization from the US Food and Drug Administration and the European Medicines Agency.  An international trial will investigate COVID-19 booster shots administered at reduced dosages in an effort to increase global access to vaccines. The trial, supported by the Coalition for Epidemic Preparedness Innovations, will test boosters of the Pfizer-BioNTech, Moderna, and Oxford-AstraZeneca vaccines among up to 3,300 healthy adults across Australia, Indonesia, and Mongolia. Results are expected to provide data on the merits of vaccinating with fractional booster doses of the COVID-19 vaccines and offer information on whether fractional doses produce fewer side effects, which could guide future vaccination strategies. The three booster vaccines being tested have received emergency use listing from the World Health Organization (WHO) and are being supplied to the COVAX vaccine-sharing initiative.WHO is establishing a new global biomanufacturing training hub in South Korea to support production of biologicals, including vaccines and monoclonal antibodies, in low- and middle-income countries. The hub, to be located in a large facility outside Seoul that is already providing biomanufacturing training for companies based in the country, will provide technical and hands-on guidance to trainees from around the world and complement specific trainings developed by the mRNA vaccine technology transfer hub recently established in South Africa. The WHO Academy will work with the Korean Ministry of Health and Welfare to develop a comprehensive curriculum on general biomanufacturing. South Korea plans to start training 370 professionals from Asia, Africa, and South America in July.

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.