RFI - Protection Before Day One Vaccine: Seasonal Influenza Vaccines with Pandemic Coverage

Background
The Center for the Biomedical Advanced Research and Development Authority (BARDA) is addressing the persistent threat of influenza viruses to public health in the U.S. and globally. Seasonal influenza epidemics lead to significant morbidity and mortality, while novel zoonotic strains pose pandemic risks. A critical gap in pandemic preparedness is the delay in deploying strain-matched vaccines, typically taking at least three months after a novel strain is identified.

BARDA aims to develop improved influenza vaccines and enhance domestic manufacturing capacity to mitigate this vulnerability. The initiative focuses on 'Day One vaccines' that provide immediate seasonal protection and partial protection against emerging pandemic strains, thereby reducing infection rates and severe disease risks during a pandemic.

Work Details
BARDA seeks information on candidate Day One vaccines that can be routinely administered as seasonal influenza vaccines while demonstrating non-inferior or improved seasonal protection compared to currently licensed vaccines. The RFI requests details on vaccine candidates that:

1) Deliver seasonal influenza protection;
2) Provide partial protection against emerging pandemic influenza viruses;
3) Are capable of reducing total infections and delaying peak infection rates during a pandemic;
4) Have development maturity, technical feasibility, manufacturing readiness, and regulatory considerations addressed.

Specific technology areas of interest include broadly protective vaccine designs, T-cell-based approaches, adjuvants enhancing breadth and durability, alternative delivery strategies, combination strategies with licensed seasonal vaccines, and preclinical models supporting claims of breadth of protection.

Period of Performance
The geographic location(s) the contract will be performed (if provided).

Place of Performance
Responses should be submitted electronically; no specific geographic location for performance is provided.

Bidder Requirements
Respondents must provide an organizational overview including core expertise in influenza vaccine development, prior experience with vaccine development, and details about any partnering Contract Development and Manufacturing Organizations (CDMOs). They should outline their plan for end-to-end development of the vaccine candidate. Additionally, they must demonstrate how their candidate aligns with desired attributes of a Day One Vaccine, including safety profiles and clinical efficacy benchmarks.

Incumbent Analysis (see Incumbents section for more detail)
This opportunity appears to have a confirmed incumbent or closely related prior contract based on BARDA award 75A50122C00007 to Arcturus Therapeutics (value $63,239,785; 09/01/22–08/20/26). That prior effort includes development of a pandemic influenza vaccine (PANDFLU) alongside a quadrivalent seasonal influenza vaccine (QSFLU), covering preclinical and clinical activities and associated drug product manufacturing and regulatory/quality work. The requested “Protection Before Day One” concept—combining routine seasonal protection with partial early pandemic coverage—appears to align with the earlier PANDFLU/QSFLU development scope and could represent a continuation or expansion of that influenza dual-benefit vaccine development work.