We are just seeing the beginning of the totalitarian healthcare state

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SECTION C – STATEMENT OF WORK C.1 BACKGROUND The potential for a human pandemic resulting from an emerging infectious disease continues to be a public health concern. The threat of a human influenza pandemic has greatly increased over the past several years with the emergence of highly virulent avian influenza viruses like H5N1 and H7N9 viruses. Four influenza pandemics (1918, 1957, 1968 and 2009) occurred over the last century, and an unprecedented number of human infections with avian influenza A (H7N9) in the fifth epidemic wave during the winter of 2016-2017 in China and their antigenic divergence from the viruses that emerged in 2013 have shown that influenza viruses are unpredictable – we can never be certain of when or from where the next pandemic will arise. However, another influenza pandemic is inevitable in this interconnected world, and the question is not if we will have another pandemic, but when. Furthermore, we are in the midst of the COVID-19 pandemic with high mortality and infectivity around the world. The COVID-19 pandemic has underscored the importance of US preparation for outbreaks of respiratory and other infectious diseases

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BARDA's National Pre-pandemic Influenza Vaccine Stockpile (NPIVS) Program provides preparedness for influenza pandemics and maintains stockpiles of influenza vaccine antigens and adjuvants. The Program utilizes the HHS Influenza Risk Assessment Tool to identify and evaluate potential pandemic influenza virus threats.

Informed by these results, BARDA implements measured responses from development of candidate vaccine viruses, virus 'seeds', clinical investigational lot production, clinical safety and immunogenicity trials, to commercial scale vaccine manufacturing for stockpiling. The quality of stockpiled vaccines is routinely evaluated through vaccine potency assays as part of master stability programs at the vaccine manufacturers that store the stockpiled vaccines, and laboratory assays that measure the cross-reactivity of sera from animals and humans immunized with the stockpiled vaccines against previous and circulating influenza viruses with pandemic potential. Clinical studies started in 2015 to evaluate the immunity afforded by old and new stockpiled vaccines as well as to understand the antigenic space that vaccination with heterologous influenza virus strains may induce during the immune response.

The results from all of these studies continuously shape the NPIVS so that it continues to provide efficient and broadly effective protection against a potential influenza pandemic. BARDA maintains the NPIVS inventory through public-private partnerships with domestic influenza vaccine manufacturers using egg- and cell-based vaccine and oil-in-water adjuvant technologies. BARDA-industry partnerships proved vital during the 2009 H1N1 Pandemic when H1N1 monovalent vaccine was made available to meet U.S. demand. Together with its partners, BARDA has stockpiled hundreds of millions of doses of pre- pandemic H5N1 bulk vaccine covering several virus variants since 2005, and tens of millions of doses of H7N9 vaccine since 2013. BARDA also maintains a library of vaccine virus production 'seeds' to address lower-risk pre-pandemic threats.

BARDA's NPIVS Program will continue to sustain and expand the dynamic pre-pandemic influenza vaccine stockpile using modern vaccine technologies and stay ready for pandemic responses with vaccine manufacturers and the capabilities of BARDA's Centers for Innovation in Advanced Development and Manufacturing. The 2009 H1N1 influenza pandemic and the 2019 COVID-19 pandemic demonstrated how crucial it is to have active contracts with manufacturers to respond to a pandemic event. In 2009 the US Government rapidly modified existing stockpile contracts and issued task orders to manufacturers to produce millions of doses of H1N1 influenza vaccine.

This program will serve as a continuation and expansion of the US Pandemic Preparedness Plan which currently includes contracts with several influenza vaccine experienced companies. The competition will be open to companies that have licensed influenza vaccine (seasonal or pandemic). In addition, competition is open to Offerors that demonstrate a successful experience in the manufacturing of influenza vaccines at commercial scale, and have submitted a Biologics License Application (BLA) for seasonal or pandemic influenza vaccine, and finally, Contractors with a licensed influenza vaccine may respond with a proposal for manufacturing of vaccines or adjuvants for use in responding to an emerging pathogen during a Public Health Emergency (PHE)

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C.2 SCOPE OF WORK Independently and not as an agent of the US Government (USG), the Contractor shall furnish all the necessary services, qualified personnel, materials, supplies, equipment and facilities (US facilities preferred) not otherwise provided by the USG as needed to perform the work described below. The Contractor shall:

1) Provide Medical Countermeasures (MCMs), such as vaccines and adjuvants, for Pandemic Preparedness and Response or as required in response to a HHS designated PublicHealth Emergency.

2) Produce vaccines against influenza virus and influenza virus strains with pandemic potential

3) Produce vaccines and/or adjuvants to support USG efforts to modernize influenza virus vaccines (for which feasibility data is available). Examples may include the reduction in time from viral sequence identification of an influenza virus strain of interest to availability of first doses of vaccine, expanded vaccine delivery options, and/or other approaches to produce and deliver more vaccine doses in less time RFP #75A50121R00013 Page 15 of 110

4) For influenza, Contractor must demonstrate successful experience in themanufacturing of influenza vaccine by: • Hold a US influenza virus vaccine license OR • Have Developed an influenza vaccine as evidenced by - Submission of a BLA to the US FDA for seasonal or pandemic influenzavirus vaccine

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