Acquisition of MCMs for Pandemic Influenza Preparedness and Response

Department of Health and Human Services
United States

Solicitation Number: 11-100-SOL-00020

Notice Type: Presolicitation

Human influenza pandemics continue to be a public health concern. Four human influenza pandemics have occurred in the past century. BARDA has recently completed the preparation and response to the 2009 H1N1 pandemic influenza virus. The WHO estimates approximately 59% case fatality of the currently circulating H5N1 avian influenza virus. At this time it is uncertain which influenza virus variant will cause the next pandemic.

The BARDA Strategic Plan 2011-2016 outlines the approach to enhance national MCM preparedness and response. BARDA plans to continue the programs for the development and procurement of MCM for pandemic influenza preparedness and response.

To accomplish this goal, BARDA intends to publish a Request for Proposals for the supply of the following items and/or services: pre-pandemic master/working virus seeds; pre-pandemic and pandemic pilot, clinical and commercial bulk vaccines and adjuvants; storage and stability studies of vaccines and adjuvants; formulation-fill-finish of vaccine and adjuvants; preclinical and clinical studies with pre-pandemic and pandemic vaccine; international shipping; storage services and stability program for vaccine and adjuvants, (bulk and final containers) from current contracts when applicable; and disposal of vaccine bulk and final containers.