International Influenza Vaccine Manufacturing Capacity Building Program

The BARDA International Influenza Vaccine Manufacturing Capacity Building Program was established in 2006 to raise global pandemic preparedness by helping developing countries build and operate influenza vaccine manufacturing facilities. In partnership with the World Health Organization's (WHO) Global Action Plan, BARDA used public-private partnerships to expand global vaccine manufacturing capacity, trained skilled workforces to make vaccines, provided in-country technical implementation assistance, and made available technology for scalable manufacturing.

BARDA’s International Influenza Vaccine Manufacturing Capacity Building Program has provided technical and financial support for influenza vaccine production to fourteen (14) manufacturers in thirteen (13) countries. Over 250 technical staff from these developing countries attended comprehensive vaccine manufacturing training programs at BARDA-supported academic institutions in North Carolina and Utah. BARDA continued to provide on-site technical support and advanced biomanufacturing training through North Carolina State University's Biomanufacturing Training and Education Center to ensure developing country workforces were able to implement production practices in their own facilities. BARDA also partnered with PATH to provide targeted technical support to manufacturers with influenza vaccines nearing eligibility for licensure. This program raised global preparedness levels for influenza pandemics from 1 to 300 million doses in 2005-2014. In addition, four seasonal influenza vaccines (with one receiving WHO pre-qualification) and seven H1N1 pandemic vaccines (with two receiving WHO pre-qualification) were licensed in six developing countries. The program garnered significant local support, with every dollar of BARDA funding leveraging seventeen dollars of local investment.

Future objectives for the International Influenza Manufacturing Capacity Building Program include moving promising vaccines toward licensure and establishing regional production capabilities. In 2014, BARDA partnered with Infectious Disease Research Institute (IDRI) of Seattle, WA to establish a hub to enable developing country vaccine manufacturers to produce adjuvanted influenza vaccines. This program could greatly increase pandemic vaccine production capabilities. BARDA continues to support targeted clinical trials, with special focus on manufacturers in Vietnam, Serbia and Brazil. BARDA also continues to fund the Biomanufacturing Training Program, with focus on training participants in National Regulatory Authorities to evaluate vaccines for licensure. Lastly, in 2015, BARDA supports sustainability transition activities, as the WHO GAP for Influenza Vaccines draws to a close in 2016. With continued financial and technical support from BARDA, these manufacturers should have the capability and capacity by 2016 to produce up to 500 million doses of vaccine to respond to a pandemic. The capability of developing countries to produce vaccine within their borders and as potential regional resources is critical to reduce the global threat of pandemic influenza, provide international stability and security, and reduce the burden on the United States to produce and distribute limited supplies of vaccine outside the country during a public health emergency.

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