Research Roundup: Oral antivirals to fight COVID-19, a new phase 3 vaccine candidate, and a pandemic intelligence hub

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. Moderna and Novavax are both developing vaccines for combined protection against COVID-19 and the flu, the companies announced last week. Moderna is working on a single-dose vaccine that combines a booster dose of its authorized COVID-19 and a booster of its furthest along experimental flu shot. Novavax has launched an early-stage trial for a combined flu and COVID-19 vaccine composed of its COVID-19 vaccine candidate, not yet authorized by the US Food and Drug Administration, and its influenza shot NanoFlu, along with an adjuvant or vaccine booster. The Novavax trial will be conducted in Australia among 640 healthy adults between the ages of 50 and 70 who have been previously infected with COVID-19 or given an authorized COVID-19 vaccine at least eight weeks prior to the study. Results are expected in the first half of 2022.The COVAX vaccine-sharing facility’s global vaccine deliveries will fall almost 30 percent below its original target of distributing 2 billion doses in 2021, the initiative’s leaders estimate. The new supply forecast predicts another 1.1 billion doses will be made available this year, in addition to the 330 million already released for delivery before the end of August, for an estimated total of 1.4 billion vaccine deliveries by the end of 2021. The shortfall is the result of a variety of factors, including restrictions on exports from the Serum Institute of India, problems increasing manufacturing at vaccine facilities, and lags in regulatory approval, according to COVAX leaders. Under the most likely forecast, COVAX would reach 2 billion available doses between January and February of 2022.COVID-19 has set back the fight against other global health challenges like HIV, tuberculosis (TB), and malaria, according to a report released by the Global Fund to Fight AIDS, Tuberculosis and Malaria. Compared to 2019, the number of people tested and treated for TB fell by about 18 percent in 2020—and the number of people treated for extensively drug-resistant TB by 37 percent. The number of people who sought testing for HIV declined by 22 percent, and those opting for HIV prevention services fell by 12 percent. However, the report also noted the adoption of innovations, from dispensing multi-month supplies of TB and HIV drugs to using digital tools to monitor TB treatment, adopted by health agencies and ministries around the world, which will hopefully outlast the pandemic.

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. New study results show that combining antimalarial drugs with a vaccine, given just before peak transmission period of rainy season, could reduce malaria deaths in children by more than 70 percent. The trial—conducted over three years among 6,000 young children in Burkina Faso and Mali—tested the RTS,S malaria vaccine, the world’s first-developed shot for the disease, along with seasonal malaria chemoprevention (SMC), an existing preventative drug regimen. Results indicated the RTS,S vaccine was as effective as SMC when administered to children ahead of rainy season in countries with seasonal transmission—and that combining the two methods reduced cases by around 60 percent, hospitalizations by around 70 percent, and deaths by around 73 percent, when compared to SMC alone. The World Health Organization (WHO) is set to review evidence from the study in October.The International Vaccine Institute (IVI) and Bharat Biotech have launched a phase 2/3 trial for their chikungunya vaccine candidate. The two-dose vaccine, BBV87, is an inactivated whole virion vaccine, which showed “optimum immune response” in phase 1 studies in India. The phase 2/3 trial, led by IVI through the Global Chikungunya vaccine Clinical Development Program (GCCDP) in partnership with Bharat Biotech and supported by the Coalition for Epidemic Preparedness Innovations and the government of India’s epidemic preparedness initiative, Ind-CEPI, will test BBV87 for safety and immunogenicity in healthy adults. GCCDP aims to develop and manufacture an affordable chikungunya vaccine with the goal of achieving WHO prequalification to enable distribution in low- and middle-income countries. The trial has begun in Costa Rica and is set to expand to Panama, Colombia, Thailand, and Guatemala in the coming months.On Tuesday, the US Food and Drug Administration granted its first emergency use authorization for an at-home COVID-19 diagnostic that delivers results through the user’s smartphone. The Veritor rapid antigen test, developed by BD and Scanwell Health, involves swishing a nasal swab in a tube of liquid reagents, after which drops on a testing strip trigger colored lines, which are then read and interpreted by the smartphone. The diagnostic is designed for use by individuals ages 14 and up and can be used for children as young as two with samples collected by an adult. The digital test, which does not require a prescription, will initially be made available to employers, schools, and public health organizations looking to support routine screening programs.