SPECIAL NOTICE
99 -- Requirement to Maintain an Embryonated Egg Supply for the Non-Seasonal Production of Pandemic Vaccine
- Notice Date
- 1/18/2018
- Notice Type
- Special Notice
- NAICS
- 325414
— Biological Product (except Diagnostic) Manufacturing
- Contracting Office
- Department of Health and Human Services, Office of the Secretary, Acquisitions Management, Contracts, & Grants (AMCG), Office of the Assistant Secretary for Preparedness & Response (ASPR), Department of Health and Human Services, 330 Independence Ave. SW, G640, Washington, District of Columbia, 20201, United States
- ZIP Code
- 20201
- Solicitation Number
- NOI-BARDA-ES18
- Archive Date
- 2/2/2018
- Point of Contact
- Enrique Mañán,
- E-Mail Address
-
enrique.manan@hhs.gov
(enrique.manan@hhs.gov)
- Small Business Set-Aside
- N/A
- Description
- SPECIAL NOTICE: REQUIREMENT TO MAINTAIN AN EMBRYONATED EGG SUPPLY FOR THE NON-SEASONAL PRODUCTION OF PANDEMIC VACCINE 1. Background The Biomedical Advanced Research and Development Authority (BARDA), within the Office of the Assistant Secretary for Preparedness and Response (ASPR) of the U.S. Department of Health and Human Services (DHHS), provides an integrated, systematic approach to the development and purchase of the necessary vaccines, drugs, therapies, and diagnostic tools for public health medical emergencies. Historically, several pandemics of influenza have been described each century for the past 500 years. The 2009 outbreak of H1N1 is the most recent example. The threat of a new pandemic caused by emerging influenza viruses has continued, as outbreaks of H5N1 virus infection in poultry and man have continued since late 2003 and the recent outbreak of H7N9 infections in man have demonstrated. The global population has little or no immunity to H5N1 and H7N9 viruses and these viruses are highly pathogenic man (mortality rate ~ 60% in man and 30%, respectively). The periodic emergence of influenza viruses of novel subtypes means there is great uncertainty in regard to when the next pandemic will occur and which virus will emerge to be the cause. In less than 100 years there have been four influenza pandemics: The Spanish Flu of 1918, the Asian Flu of 1957, the Hong Kong Flu of 1968, and most recently the 2009 H1N1 outbreak. Production of a vaccine to immunize against the influenza strain causing the next pandemic must occur as quickly as possible at any time of year. The ability to achieve this objective currently is limited by the seasonal nature of influenza vaccine production and seasonal variability in the availability of supplies essential to vaccine manufacture. Assuring the early availability of a sufficient quantity of vaccine for the U.S. population, in the setting of a pandemic, will potentially prevent thousands of deaths and save billions of dollars. The Department of Health and Human Services (DHHS) has an obligation to promote capabilities that assure a pandemic vaccine can be produced at a U.S.-licensed influenza vaccine facility at any time of the year, without limitations imposed by the availability of essential supplies. In addition DHHS is interested in development of investigational influenza vaccine lots against potential pandemic strains. An ongoing program is designed to support these interests. 2. Anticipated Requirement MANDATORY AND REGULATORY REQUIREMENTS The anticipated scope of work is centered on a vaccine composed of the raw material of embryonated eggs, for the production of Food and Drug Administration (FDA) licensed egg-based vaccines, with influenza vaccine as the requirement. The incumbent will demonstrate a domestic (Contiguous United States) network of incubation facilities and flocks to provide a year round supply of embryonated eggs developed specifically for a FDA approved seasonal and possible pandemic influenza vaccine. The incumbent shall provide evidence of necessary subcontracts required to provide the approved level of embryonated eggs, prior to contract award. SUPPLY AND CAPACITY The incumbent shall provide an adequate supply of embryonated eggs (raw material), through contracted incubation facilities, to produce a minimum of ten (10) million monovalent influenza vaccine doses a week, in the case of a declared pandemic. HIGH (OR LOW) PATHOGENIC AVIAN INFLUENZA RISK MITIGATION The incumbent shall provide an Avian Influenza (High or Low Pathogenic) Plan for its sites and personnel, as well as a plan for dynamic testing of flocks and facilities to mitigate risks during a High (or Low) Pathogenic Avian Influenza impact to the embryonated egg supply, during pandemic vaccine production. 3. Government's Intent to Sole Source The United States Government (USG) intends to solicit a proposal, and enter into negotiations, with Sanofi Pasteur, Inc., the only known producer of egg-based influenza vaccine in the Contiguous United Status, for a sole source contract as authorized by 41 U.S.C. 3304 and as permitted by FAR 6.302-3(a)(2)(i). In the event that another capable domestic source exists, than can provide the above requirements as a prime contractor, capability statements shall be submitted to the USG Contracting Officer listed in this Special Notice, no later than 2:00pm Eastern Time on Thursday, February 1, 2018. PLEASE NOTE that this Special Notice is not required under Part 5-- Publicizing Contract Actions of the Federal Acquisition Regulation (FAR), with specific exemption referenced in FAR 5.202(a)(10), as it relates to 6.302-3. 4. Availability of Justification The USG will make the justification for other than full and open competition (JOFOC) publicly available within fourteen (14) calendar days after a resulting award, as required by FAR 6.303-1.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/OOS/OASPHEP/NOI-BARDA-ES18/listing.html)
- Record
- SN04793248-W 20180120/180118231337-689e2c223be63c760ea694b2f98998ec (fbodaily.com)
- Source
-
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