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BARDA Seeks Proposals for COVID-19 Immune Assay Development and Implementation
BARDA's Influenza and Emerging Infectious Diseases Division (IEIDD) opened a limited-term solicitation for a new area of interest (AOI), 8.4, under the Broad Agency Announcement (BAA) to advance the development of COVID-19 immune assays.
BARDA is seeking BAA submissions to develop one or more assays that can analyze clinical study samples in order to evaluate immune responses to COVID-19 vaccines, including those licensed or under development. Assays shall quantify responses relevant to ancestral SARS-CoV-2 and circulating variant(s) of concern. Offerors also shall establish high-throughput laboratory testing capability for these assays. Data from these assays should meet regulatory requirements and may be used to support a U.S. Food and Drug Administration (FDA) Emergency Use Authorization (EUA) or Biological License Application (BLA).
An enquiry period is open from April 3-10, 2023, for respondents seeking clarification. Inquiries submitted no later than 4:30 P.M. Eastern Time on April 10, 2023, may be considered for written response. Written responses to collected inquiries from respondents will be provided after the open enquiry period has concluded. Responses will be posted as a subsequent amendment to the BARDA BAA-18-100-SOL-0003. This AOI will be open until May 3, 2023, at 4:30 P.M. Eastern Time.
For full proposal requirements, see solicitation AOI #8.4 in the BARDA BAA (BAA-18-100-SOL-00003), Amendment 40:
https://sam.gov/opp/2b1a6e5f4d4a43159bd96e03d08fe281/view
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