The Biomedical Advanced Research and Development Authority (BARDA) and the Office of the Assistant Secretary for Preparedness and Response (ASPR) at the US Department of Health and Human Services (HHS) issued a Request for Information (RFI) mid-January to collect data from current and potential biopharmaceutical partners.
“Information collected from this RFI will serve as continued market research for a possible program where BARDA would partner with multiple organizations to achieve the pandemic preparedness goals set forth by the US government.”
BARDA said it is particularly interested in novel vaccine candidates with a development plan, clinical data, and demonstrated cGMP manufacturing level/capability to allow submission of an EUA and/or BLA by December 2022.
Vaccines that have such attributes, that can improve efficacy, durability and/or coverage against potential variants, and have planned manufacturing capability of 50-100M doses/month are the focus, it added.
Data on development plans
Respondents were told to provide information about their high level integrated development plan for regulatory approval, including use of the product as a primary vaccine or a booster; they also needed to provide details about the clinical stage of development, whether the product has entered clinical trials, including summary data on safety, immunogenicity, and/or efficacy as well.
The agency also wanted to hear about clinical immunogenicity data to indicate the vaccine's likely durability, mucosal immunity, correlates of protection, and ability to prevent transmission.
Developers were asked to indicate whether they were willing to provide samples to the US government for testing in centralized assays.
BARDA was also seeking information of the number of doses, route of administration, and route of delivery, the breadth of protection, as well as data on neutralization against variants of concern.
In addition, it wanted information on manufacturing scale up timelines, including how much capacity has already been reserved is required, along with the estimated cost per dose.