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Last Wednesday, Moderna announced that its combination COVID-19 and flu shot, mRNA-1083, demonstrated strong immunogenicity in a phase 1/2 trial. The trial found that mRNA-1083 was similarly effective to two already approved flu vaccines developed by GSK and Sanofi and Moderna’s own SpikeVax COVID-19 vaccine. There were also no new safety concerns reported with the combination vaccine compared to each of the vaccines used alone. A phase 3 trial testing the combination shot will begin before the end of the year with potential regulatory approval in 2025 if successful. The company also laid out its broader efforts on combination vaccines, including a combination shot for COVID-19, flu, and respiratory syncytial virus.
The Biomedical Advanced Research and Development Authority (BARDA) has awarded Vir Biotechnology $50 million in Project NextGen funds to advance the development of novel monoclonal antibody (mAb) candidates and delivery solutions for COVID-19 and future pandemic threats. The new funding will support development of alternative mAb delivery technologies that increase antibody expression relative to existing solutions, which could revolutionize mAb delivery by expanding administration options and shortening development and manufacturing timelines. Four-fifth of the funding will specifically go toward advancing Vir’s next-generation COVID-19 mAb, Vir-7229, through a phase 1 trial, expected to be completed in late 2025, while the remainder will support the discovery of new mAbs against a second pathogen of pandemic potential.
The World Health Organization (WHO) last week recommended the R21/Matrix-M malaria vaccine, developed by the University of Oxford. This follows two years after WHO recommended RTS,S, the first malaria vaccine. Both vaccines have a similar efficacy profile and delivery method and are targeted to children, but doses of R21 are expected to be cheaper—between $2.00 and $4.00 compared to about $7.25 now charged for RTS,S. The Serum Institute, which will produce R21, has also announced plans to deliver a much higher volume of doses compared to GSK’s current marketing plans for RTS,S. Although it will take more time to collect further safety monitoring data for R21, the recommendation of a second vaccine will hopefully help to ensure adequate supply for malaria-endemic countries that are planning to integrate a vaccine into their national malaria control plans.