In support of the U.S. Government’s global response to the COVID-19 pandemic, the United States Agency for International Development (USAID) introduced test-to-treat programming (T2T) in ten priority countries for populations at high risk of severe illness from COVID-19 in May 2022. The Promoting the Quality of Medicines Plus (PQM+) program is supporting the T2T initiative by facilitating product registration of COVID-19 therapeutics in the countries identified by USAID; which are: Bangladesh, Botswana, Cote D’Ivoire, El Salvador, Ghana, Lesotho, Malawi, Mozambique, Rwanda, and Senegal.
PQM+ prepared a scientific and technical information package (see below) to assist national medicines regulatory authorities (NMRAs) in low- and middle-income countries (LMICs) to make informed regulatory decisions on market authorization of COVID-19 antivirals, nirmatrelvir (co-packaged with ritonavir) and molnupiravir. Both medicines are used to prevent serious disease and death in high-risk populations when administered early in a COVID-19 infection. The information is also useful for manufacturers/applicants, procurement agencies, donor communities, and healthcare providers. It offers a compilation of relevant data and scientific recommendations concerning the safety, efficacy, and use of these two antiviral products.
PQM+ conducted a comprehensive review of regulatory and scientific documents that can be used to support an evaluation of the quality, safety, and efficacy of nirmatrelvir (co-packaged with ritonavir) and molnupiravir. The comprehensive review included public review documents, regulatory committee meeting resources, other supportive regulatory documents, and health guidance, which were reviewed from the European Medicines Agency, Liverpool Drug Interactions Group, US Food and Drug Administration, US National Institutes of Health, and World Health Organization (WHO). Scientific journal articles reporting clinical trial results or other supportive safety and efficacy data related to nirmatrelvir (co-packaged with ritonavir) and molnupiravir are also included. The journals include The New England Journal of Medicine, The Lancet, and Clinical Infectious Diseases. The resources were published from the beginning of the COVID-19 pandemic to August 2023.
The information is divided in 8 sections. The Information Package Guidance provides guidance on navigating the overall document, including an outline of the overall contents. They are organized by general information on COVID-19 and treatments (Package 1) followed by specific information related to nirmatrelvir (co-packaged with ritonavir; Packages 2A-C) and molnupiravir (Packages 3A-C). In addition to links to the original sources, individual pdfs of the outlined resources are provided if available under open access creative commons licenses or their reproduction is not otherwise limited.
