Anna Kovacevich

Prior to COVID-19, tuberculosis (TB)—another airborne disease—was the world’s leading global infectious disease killer, claiming the lives of around 1.5 million people annually. Insufficient and inadequate tools and treatments, and growing drug resistance, have challenged global efforts to bring the TB epidemic to an end, and more recently, disruptions from COVID-19 have reversed years of TB progress. In 2020, global TB deaths increased for the first time in more than a decade, and about 1 million fewer people were tested and treated for TB compared to 2019. At the same time, global funding for TB diagnostic, treatment, and prevention services fell by $500 million from 2019 to 2020, and total funding for TB research and development dropped by $33 million.Scientists hope the tide can be turned as new technologies and innovations advance to market—but to achieve that, more investment is urgently needed to boost resources and reverse setbacks.In recognition of World TB Day, test your knowledge of innovations to end TB with GHTC’s quiz below:

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 phase 3 clinical trial of Valneva’s single-shot chikungunya vaccine is now complete, the company announced last week, with analysis confirming a high level of protection and strong immunogenicity profile. One month after receiving the live-attenuated, single-dose shot, 98.9 percent of participants achieved protective levels of neutralizing antibodies against chikungunya virus, and after six months, 96.3 percent of participants showed protective neutralizing antibody titers against the virus. The results represent the first final phase 3 trial data for a chikungunya vaccine candidate. Valneva expects to start the pre-submission process with the US Food and Drug Administration in the second quarter of this year.An investigational antimalarial drug showed effectiveness against blood-stage Plasmodium falciparum malaria in its first stage of human testing, according to new analysis published in The Lancet. The drug, ZY19489, was found through a screening of around 500,000 compounds conducted by AstraZeneca and the Medicines for Malaria Venture. After demonstrating activity at the blood stage of infection in preclinical studies, the phase 1 trial was conducted to evaluate optimal dosing, assess effects of food intake on oral absorption and kinetics, and confirm the parasite was cleared without developing treatment resistance. The drug would likely need to be used in combination with another agent and with possible additional doses to attain a curative regime, but its demonstrated safety, pharmacokinetic profile, and antimalaria activity support its further development as a novel therapy, researchers said.Global leaders and stakeholders last week pledged a total of US$1.535 billion to the Coalition for Epidemic Preparedness Innovations (CEPI) to implement its five-year plan to prepare and protect against emerging diseases with pandemic potential. The five-year road map, for which CEPI has a total budgetary ask of $3.5 billion, includes plans to compress vaccine development to 100 days, develop a broadly protective vaccine against COVID-19 and other Betacoronaviruses, and create a “library” of vaccine candidates for use against known and unknown pathogens. In addition to monetary pledges, the Global Pandemic Preparedness Summit brought announcements on several research collaborations and commitments, including a partnership to develop a pan-coronavirus vaccine.

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 Pfizer-BioNTech COVID-19 vaccine’s effectiveness among children ages 5 to 11 wanes over time but continues to protect against the most severe outcomes, according to new real-world evidence released last week. Analysis from the US Centers for Disease Control and Prevention, summarizing data from ten states, suggested that while vaccine effectiveness faded during omicron and generally decreases relative to the time since vaccination, the vaccine was protective against hospitalization and death in 5-to-17-year-olds, even after omicron emerged. A preprint study by the New York State Department of Health, also published last week, showed a substantial decline in protection among the younger age group in the state, including a significant decline in protection against hospitalizations. The new data comes amid developments involving vaccines for children under 5, which the US Food and Drug Administration plans to wait to review until data on third doses is available.The Biden administration plans to share government-backed COVID-19 technology with the World Health Organization (WHO) to help bolster access to medicines in low- and middle-income countries. The technologies, developed by the National Institutes of Health (NIH), would be licensed to the WHO’s COVID-19 Technology Access Pool as well as sublicensed through the United Nations-backed Medicines Patent Pool. Details on which technologies would be made available through the deal are still being determined, but the policy is not intended to apply to vaccines and therapeutics in the US market developed by private companies. Sharing NIH-devised technologies is meant to allow other countries to replicate the manufacturing process and therefore more quickly boost the global stockpile of pandemic supplies.On Wednesday, a WHO panel backed the use of Merck & Co., Inc.’s COVID-19 antiviral pill for high-risk patients. The recommendation, based on new data from six clinical trials involving 4,796 patients, conditionally endorses the pill, molnupiravir, for use among patients with non-severe disease who are at high risk of hospitalization. This could include immunocompromised individuals, the unvaccinated, older people, and those with chronic diseases. No recommendation has been made for use of the pill among patients with severe or critical illness, as there is no trial data for the group. The WHO panel is also preparing recommendations for Pfizer’s COVID-19 antiviral pill, Paxlovid.

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.