Anna Kovacevich is a senior program assistant at GHTC who supports GHTC's communications and member engagement activities.
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Novavax has completed submission of the final data package for its COVID-19 vaccine to fulfill the prerequisites for an emergency use authorization (EUA) request from the US Food and Drug Administration. The company plans to complete an official EUA application by the end of the month. The vaccine, NVX-CoV2373, received emergency use listing from the World Health Organization last month for its formulations manufactured in Europe and India, allowing Novavax and partner Serum Institute of India to ship doses to the COVAX initiative, which aims to supply vaccines to low- and middle-income countries. NVX-CoV2373 was also granted conditional marketing authorization in December by the European Medicines Agency to be produced in Europe. Novavax expects its global supply chain to exceed 2 billion doses in 2022.
A new COVID-19 vaccine developed by researchers from the Texas Children’s Hospital and Baylor College of Medicine is being offered patent-free to vaccine manufacturers around the world. The CORBEVAX vaccine—originally developed to combat SARS, which is caused by a strain of coronavirus—employs a long-established protein subunit technology that uses proteins from a virus or bacterium to induce an immune response but not cause disease. Clinical trials conducted in India found the vaccine to be 90 percent effective in preventing disease caused by the original COVID-19 virus strain and 80 percent effective against the delta variant, leading India’s regulatory agency to grant emergency use authorization in December. Indian vaccine manufacturer Biological E Limited has sold 300 million doses to the Indian government and plans to produce 100 million doses per month.
Dolutegravir-based antiretroviral therapy (ART) is more effective than standard treatments for HIV-positive children, reducing treatment failure by 40 percent, according to a new study published in The New England Journal of Medicine. The clinical trial, conducted at 29 clinical centers across Africa, Europe, and Asia, evaluated the safety and efficacy of dolutegravir-based ART as a first- or second-line treatment in children living with HIV in comparison to non-dolutegravir-based, standard-care ART. Results showed the dolutegravir-based ART reduced treatment failure by 40 percent in HIV-positive children 3 to 18 years old, indicating dolutegravir-based ART is superior to current standard-care treatment in children and adolescents living with HIV, according to researchers.