Egg Supply Special Notice_Final.pdf

Special Notice

Maintaining 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 Administration for Strategic 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.

Historically, the influenza virus has caused several pandemics in the last century – years 1918 (H1N1), 1957 (H2N2), 1968 (H3N2), and 2009 (H1N1). The threat of a new pandemic caused by emerging influenza viruses has continued, as outbreaks of avian influenza H5N1/H5N6/H5N8 virus infection in poultry and people have continued since 2003 and the fifth epidemic wave of H7N9 infections in people demonstrated in 2017. Furthermore, the high pathogenicity avian influenza (HPAI) A(H5) viruses, predominantly HPAI A(H5N1) clade 2.3.4.4b viruses, have been circulating globally in wild birds in the U.S. since late 2021. These viruses have caused outbreaks in commercial and backyard poultry, with spillover resulting in sporadic infections in mammals.

As of March 29, 2024, USDA’s Animal and Plant Health Inspection Service (APHIS) confirmed the detection of high pathogenicity avian influenza (HPAI) in dairy herds, with wild migratory birds believed to be the source of infection. With the first reported human case of Influenza A(H5N1) clade 2.3.4.4b virus in the U.S. in late April 2022, and at least fourteen (14) additional human infections in the US in 2024, it is crucial to maintain rapid response and successful commercial scale production of vaccine if needed for a pandemic event. The USG has established several pandemic preparedness goals under Pandemic Plans such as the 2006 National Strategy for Pandemic Influenza, the 2017 HHS Pandemic Influenza Plan Update, the American Pandemic Preparedness Plan (AP3), and the National Biodefense Strategy and Implementation Plan for Countering Biological Threats, Enhancing Pandemic Preparedness, and Achieving Global Health Security.

These include delivery of first finished doses of pandemic vaccine within three (3) months of a pandemic declaration; having a sufficient supply to meet public demand within four (4) months of a pandemic declaration; manufacture, fill, finish, release, and deliver enough adjuvanted vaccine for the entire U.S. population within six (6) months of declaration (i.e., 660M doses)– two doses for every person. As egg-based vaccine is a major component of the USG’s influenza pandemic preparedness strategy, maintenance of enough SPF embryonated hen eggs is critical for immediate response capability. The primary objective of the USG is for domestic manufacturers to be able to produce enough vaccine for the entire U.S. population within one hundred thirty (130) days of a public health emergency (PHE) declaration.

A PHE 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, without limitations imposed by the availability of eggs or other essential supplies.

2. Anticipated Requirement

The Contractor shall maintain a dynamic raw material supply chain of embryonated hen eggs, for manufacturing of its pandemic influenza vaccine. The Contractor shall provide 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-licensed seasonal and possible pandemic influenza vaccine. In addition, the Contractor shall have the ability to produce a minimum of ten (10) million monovalent influenza vaccine final finished container, including losses, doses per week, in the case of a declared public health emergency.

The Egg Supply program also requires an Avian Influenza (High or Low Pathogenicity) Plan for the Contractor’s sites and personnel, as well as a plan for dynamic testing of flocks and facilities to mitigate risks during High (or Low) Pathogenicity Avian Influenza conditions.

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 6.302-1. 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 4:00pm Eastern Time on Tuesday, December 10, 2024.

4. Availability of the Justification

The USG will make the Justification and Approval for Other Than Full and Open Competition (J&A) publicly available within fourteen (14) calendar days after a resulting award, as required by FAR 6.303- 1.