New funding will help expand access to COVID-19 vaccines by strengthening manufacturing capacity and regulatory oversight
USP Media Contact:
Anne Bell (she/her)
Rockville, Md., August 2, 2022 – As part of the U.S. Government’s Initiative for Global Vaccine Access, also known as Global VAX, the U.S. Agency for International Development (USAID) has obligated $7.1 million in additional funding to the U.S. Pharmacopeia (USP) through the Promoting the Quality of Medicines Plus (PQM+) program.
The PQM+ program will strengthen regulatory and/or manufacturing capacity in six African countries - Ghana, Kenya, Nigeria, Rwanda, Senegal, and South Africa - to expand access to COVID-19 vaccines. The program will work in concert with national stakeholders, such as regulatory authorities and local USAID missions to develop tailored assistance to achieve country-specific goals.
National regulatory authorities play important roles in assuring the quality, safety, and efficacy of medical products, like COVID-19 vaccines. PQM+ will support national regulatory authorities in the six countries to fulfill these obligations so their populations can get timely access to live-saving vaccines.
PQM+’s assistance will contribute significantly to the countries’ progress towards achieving the World Health Organization’s Global Benchmarking Tool (GBT) Maturity Level 3 (ML3), and will include building laboratory capacity to test vaccines where applicable. The GBT assesses regulatory functions against a set of more than 260 indicators. Ghana and Nigeria’s regulatory authorities have achieved ML3 status.
In addition, PQM+ will support in-country manufacturing of COVID-19 vaccines in several countries. This assistance will include working with manufacturers to comply with good manufacturing practices (GMP) and developing a biomanufacturing workforce.
These efforts to expand access to COVID-19 vaccines build on a long partnership between USAID and USP to increase the availability of safe and quality-assured medical products and to strengthen regulatory and quality assurance systems, work that has spanned nearly 40 low- and middle-income countries.
"For decades, USP has worked in Africa to break down barriers to the advancement of pharmaceutical quality and – more recently – to lay the groundwork for vaccine manufacturing in Africa,” said Jude Nwokike, Director of the PQM+ program. “We are thrilled to continue our longstanding partnership with USAID and to provide crucial support to countries to strengthen their regulatory systems and help ensure the quality of medical products, including vaccines."
The PQM+ program works to sustainably strengthen medical product quality assurance systems and helps ensure access to quality-assured essential medicines for HIV/AIDS, tuberculosis, malaria, neglected tropical diseases, COVID-19 and other infectious diseases as well as for maternal, newborn, and child health.
USP is an independent, international, and scientific nonprofit organization focused on building trust in the supply of safe, quality medicines. We are working to strengthen the global supply chain so the medicines people rely on for health are available when needed and work as expected. USP has 16 offices across 13 countries and implements global health programs in 40+ countries worldwide.