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February 13
Changing the Landscape for Global Pandemic Influenza Vaccine Manufacturing

Author: Julie Schafer, Project Officer, Biomedical Advanced Research and Development Authority, HHS Office of the Assistant Secretary for Preparedness and Response

In the event of a severe influenza pandemic, the global need for vaccine would far outstrip current production capacity. To address this gap between potential need and capacity to meet the need, the BARDA International Influenza Vaccine Manufacturing Capacity Building Program has used smart investments and strong partnerships to support thirteen influenza vaccine manufacturers in twelve low- to middle-income countries to enhance their capacity to produce influenza vaccine. In 2005, vaccine producers in these countries, collectively, could produce less than one million doses of pandemic influenza vaccine. Today, vaccine producers in these countries have a combined pandemic influenza vaccine production capacity of over 280 million doses, on track for the program goal of a production capacity for 500 million doses of vaccine by 2016.

Expanding and diversifying worldwide influenza vaccine manufacturing capacity may reduce the global threat of pandemic influenza, provide international stability and security, and reduce demand for the United States to produce and distribute limited supplies of vaccine outside the country during a public health emergency.

BARDA has partnered with the World Health Organization (WHO), PATH, US- based and international universities, and other HHS agencies to develop and implement this program. In recognition of the considerable challenge of developing sustainable influenza vaccine manufacturing capacity, BARDA uses a three-pronged approach: 1) expanding vaccine manufacturing capacity through the WHO Global Action Plan to increase vaccine supply, which has supported thirteen manufacturers in twelve under-resourced countries; 2) ensuring a skilled workforce through biomanufacturing training programs at two US-based universities and through on-site training; 3) providing in-country technical implementation assistance to complement and reinforce training and to provide targeted clinical trial and manufacturing technical assistance to manufacturers with influenza vaccines nearing eligibility for licensure. BARDA also supports efforts to make new vaccine technologies available to these manufacturers.

BARDA’s International Influenza Vaccine Manufacturing Capacity Building Program has, in a short time, contributed to a significant change in the global influenza vaccine landscape. Since the program’s inception in 2006, four pandemic and three seasonal vaccines have been registered for used by National Regulatory Authorities including the recent approval of a Serum Institute of India seasonal Live Attenuated Influenza Vaccine (LAIV) in India. Two pandemic and one seasonal vaccine have been prequalified by WHO, which enables potential use in other countries, thus creating the potential for regional pandemic response capabilities.

BARDA’s efforts to increase international influenza vaccine manufacturing capacity are a complement to its ongoing domestic pandemic influenza vaccine capacity building. These initiatives have contributed to a dramatic increase in the global influenza vaccine production capacity critical to pandemic response. For more information, see BARDA’s Pandemic Influenza Program.

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