The Biomedical Advanced Research and Development Authority (BARDA), within the Office of the Assistant Secretary for Preparedness and Response (ASPR) in 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.

The periodic emergence of influenza viruses with pandemic potential requires the United States Government (USG) to establish and maintain a sustainable pandemic preparedness posture, and the necessary medical countermeasure response capacity, as specified in the National Strategy for Pandemic Influenza and Implementation Plan as updated by the Pandemic Influenza Plan in 2017. The primary objective of the USG is for domestic manufacturers to have vaccine ready for administration within three months of the emergence of a pandemic virus and to be able to produce enough vaccine for the entire U.S. population within 6 months of the declaration of a human influenza virus pandemic.

A pandemic may be declared at any time in the course of a calendar year. The Department of Health and Human Services has an obligation to maintain a domestic vaccine manufacturing capability that assures that a pandemic vaccine can be produced at a U.S.-licensed influenza vaccine facility at any time of the year.

2. Anticipated Objectives/Mandatory Requirement

Achieving the speed and capacity needed to meet the USG's objective, relies on the following current applicable technologies and factors:

• The newer recombinant influenza vaccine production technology can reliably be available in a shorter timeframe of 8 to 12 weeks, compared to the up to 20 to 23 weeks for traditional egg- and cell-based inactivated, monovalent, pandemic influenza vaccines.
• Protecting naïve populations against pandemic influenza will likely require 12 times the dose needed for seasonal influenza. Dose sparing technologies (i.e., adjuvants) will be needed to meet the 600 million pandemic vaccine dose goal within the targeted timeline.
• The capability to produce a recombinant pandemic influenza vaccine must be sustained by an existing U.S. licensed recombinant seasonal influenza vaccine.
• In order to meet the adjuvanted, pandemic influenza vaccine dose goals, additional large scale manufacturing of FDA licensed domestically manufactured recombinant vaccine and adjuvant capacities are required.

Consequently, BARDA has a critical need to develop and augment domestic manufacturing of recombinant, adjuvanted, pandemic influenza vaccines. To meet the quick response needed in a pandemic, the manufacturer must have and maintain production of a FDA licensed recombinant seasonal influenza vaccine.

3. Government's Intent to Sole Source

The United States Government intends to solicit a proposal, and enter into negotiations, with Sanofi Pasteur, Inc., the only known domestic manufacturer of FDA licensed recombinant influenza vaccine that meets the requirements to satisfy this critical need, for a sole source contract as authorized by 41 U.S.C. 3304, and as permitted by FAR 6.302-3(a)(2)(i) and 6.302-3(b)(1). Sanofi Pasteur has a FDA licensed recombinant seasonal influenza vaccine, access to the necessary adjuvants (both licensed in context of other vaccines and in development), and available facilities suitable for renovation. In the event that another capable domestic source exists, that 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 12:00 Noon Eastern Time on Thursday, March 14, 2019.

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 the 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.