INFLUENZA ADVANCED DEVELOPMENT AND STOCKPILING
BARDA supports a number of programs to develop and acquire a broad array of medical countermeasures for pandemic flu, including vaccines, therapeutics, diagnostics, and non-pharmaceutical countermeasures. BARDA's stockpiling efforts are focused on building reserves of critical countermeasures as they emerge from advanced development. Stockpiled medical countermeasures directly support readiness, as the stockpiled products can help to mitigate the effects of an event or outbreak. Establishment of the stockpile helps to ready suppliers to meet the increased demands that an event will bring about, becoming practiced in the production and delivery of products.
BARDA's acquisitions for the stockpile are not one-time events, complete upon the approval / licensure of a product. Rather, programs are structured to include incremental milestone acquisitions during late stage development, to make available products still in development that may increase preparedness in an event, pending Emergency Use Authorization. Furthermore, we aim to establish stockpiling milestones to address long term commitments post-licensure.
HHS/BARDA Vaccine Advanced Development Milestones
- BARDA has supported the development of cell-based systems for influenza vaccine production. BARDA awarded contracts to accelerate development and production of new cell-based and antigen-sparing technologies for influenza vaccines towards U.S.-licensure with manufacturing surge capacities for domestic production. In November 2012, Flucelvax® became the first US-licensed cell-based influenza vaccine.
- BARDA has supported the development of recombinant based influenza vaccines and helped to bring them to licensure. BARDA issued three contract awards, one in June 2009 and two in February 2011, for the advanced development of influenza vaccines using recombinant technologies. These awards required the contractors to provide domestic manufacturing surge capacity that makes first doses of vaccine available within 12 weeks and of 50 million doses of pandemic influenza vaccine within 6 months. In January 2013, FluBlok® became the first US-licensed recombinant influenza vaccine.
- BARDA has supported the development of pandemic influenza vaccines formulated with adjuvants and helped bring them to licensure. Adjuvants provide antigen sparing and the potential of broader immunity against related but different influenza viruses for influenza vaccines. BARDA has awarded four contracts since 2007. In November 2013, FDA licensed GlaxoSmithKline’s Q-PAN H5N1 pandemic vaccine with AS03 adjuvant and extended the age indication to include individuals six months and older in September 2016. This was the first adjuvanted pandemic influenza vaccine licensed in the U.S. The availability and intrinsic properties of these adjuvants have increased our pandemic influenza vaccine manufacturing capacity multifold.
- BARDA is leading a HHS interagency-industry partnership for a program called Mix-N-Match to determine whether Pre-pandemic vaccines from one manufacturer may be used effectively with adjuvants from other manufacturers to enable extension of the pandemic vaccine supply. Results of these studies indicate that adjuvants not only greatly enhance the effectiveness of the vaccines but also broaden the cross reactivity of the response to the vaccine. Dose-sparing effects were also observed when adjuvants were combined with H1N1 vaccines.
- In 2015, BARDA launched an initiative to support the advanced development of next generation influenza vaccines with the potential to stimulate broad, durable, more effective immunity than currently licensed products. BARDA awarded two contracts in September 2015 and continues to pursue the development of more effective influenza virus vaccine candidates.
Pre-Pandemic Vaccine Stockpiling
- BARDA established stockpiles of pre-pandemic influenza vaccines and adjuvants adequate to immunize 20M persons against influenza viruses that pose a pandemic threat. The Program addresses gaps created by emerging novel groups and subtypes and maintains stockpiles of influenza pre-pandemic vaccines and adjuvants. BARDA managed contracts and coordinated manufacturers during the 2009 H1N1 pandemic response. BARDA supported the development and manufacturing of the first licensed H5N1 vaccine..