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New HHS contracts enhance pandemic preparedness
BARDA takes historic steps with master vaccine seed lots, vaccines for pre-pandemic stockpile

The U.S. Department of Health and Human Services has awarded three-year contracts to all five U.S.-licensed influenza vaccine manufacturers to produce master vaccine seed stocks for viruses with pandemic potential before a pandemic occurs. The contracts also allow HHS to purchase cell-based vaccine in addition to conventional egg-based vaccine in a pandemic. Both steps are new in the department’s pandemic preparedness efforts.

Master vaccine seed stocks are used in developing vaccines against specific viruses, and with these seed stocks ready, the federal government can have vaccine available to the public sooner in a pandemic. HHS will determine which viruses require this new preparedness measure.

Since 2010, HHS has taken steps to increase national vaccine manufacturing capacity with nimble and flexible technologies, such as cell-based vaccine technologies. These technologies may assist HHS in providing more pandemic influenza vaccine sooner. Cell-based vaccine production could more easily meet surge capacity needs because cells could be frozen and stored in advance of an epidemic, or developed rapidly in response to an epidemic.

The contracts will be overseen by the HHS Biomedical Advanced Research and Development Authority (BARDA) and are awarded to Sanofi Pasteur of Swiftwater, Pa., Novartis in Cambridge, Mass. and Holly Springs, N.C., GlaxoSmithKline of Philadelphia, Pa., CSL Biotherapies of King of Prussia, Pa., and MedImmune of Gaithersburg, Md.

The contracts also support clinical trials and stockpiling of vaccine and adjuvants, enabling HHS to respond quickly to flu outbreaks and pandemics. Although current licensed seasonal flu vaccines do not contain adjuvants, clinical trials using adjuvants is an important part of pandemic preparedness. Adjuvants can be added to influenza vaccine to lower the amount of the active ingredient in vaccine, called antigen, needed for the vaccine to produce an immune system response. Adding adjuvant results in more doses of vaccine being available during a pandemic.

Initially HHS will commit a total of $4.4 million for the companies to produce master vaccine seed stocks and $7.3 million for the companies to store pre-pandemic vaccines.

“These contracts build on the lessons learned from the 2009 H1N1 pandemic and nearly a decade of stockpiling avian flu vaccines,” stated BARDA Director Robin Robinson, Ph.D. “The increased national manufacturing capacity for pandemic influenza vaccines afforded by this effort is derived from successful public-private partnerships resulting in more U.S.-based vaccine manufacturing facilities and innovative vaccine technologies.”

Increasing domestic manufacturing facilities and new vaccine technology were recommended by the Public Health Emergency Medical Countermeasures Enterprise Review Report released by HHS Secretary Kathleen Sebelius in 2010 and a 2010 report by the President's Council of Advisors on Science and Technology.

The contracts announced today build on a previous set of HHS contracts with these vaccine manufacturers which proved vital in responding to the 2009 H1N1 pandemic. Ensuring continuity of the stockpile contracts and capitalizing on new developments in the field of influenza vaccine production will provide more flexibility and allow vaccine to be available quickly in the next pandemic.

Similar to these previous contracts, today’s contracts are flexible enough to be used to develop vaccine for emerging influenza strains. In addition to being used for the 2009 H1N1 vaccine, the previous contracts were used earlier this year to develop a vaccine against the new H3N2v influenza virus which has infected people coming in contact with pigs carrying the virus.

Human influenza pandemics continue to be a public health concern. An influenza pandemic occurs when a novel virus emerges in the human population, with no or low levels of pre-existing immunity, is readily transmissible from person to person. Since 2004, HHS has purchased and stockpiled H5N1 avian flu vaccine and new oil-in-water adjuvants from manufacturers based on annual assessments of novel influenza viruses with pandemic potential.

There have been four influenza pandemics in the past century, including the 2009 H1N1 influenza pandemic. While the 2009 H1N1 pandemic influenza virus produced mild illness in most infected people, severe disease was observed in people over 65 years old, pregnant women, young children and individuals with underlying health conditions. There were approximately 18,500 laboratory-confirmed deaths caused by the 2009 pandemic influenza A H1N1 reported worldwide from April 2009 to August 2010. The majority of deaths from 2009 H1N1 influenza occurred in children and young adults.

Within the office of the Assistant Secretary for Preparedness and Response (ASPR), the mission of the BARDA is to develop and procure medical countermeasures that address the public health and medical consequences of chemical, biological, radiological, and nuclear (CBRN) accidents, incidents and attacks, pandemic influenza, and emerging infectious diseases.

For more information about BARDA and the advanced research and development of medical countermeasures, visit www.medicalcountermeasures.gov. Contract opportunities and awards are announced at www.fbo.gov.

HHS is the principal federal agency for protecting the health of all Americans and providing essential human services, especially for those who are least able to help themselves. To learn more about HHS, visit www.hhs.gov and to keep up to date on flu, visit www.flu.gov. ASPR leads HHS in preparing the nation to respond to and recover from adverse health effects of emergencies, supporting communities’ ability to withstand adversity, strengthening health and response systems, and enhancing national health security. To learn more about ASPR and preparedness, response and recovery from the health impacts of disasters, visit the HHS public health and medical emergency website, www.phe.gov.