VADP_BAA_Amendment3.pdf

Amendment #3 to BAA-NIAID-75N93022R00022

VACCINE ADJUVANT DISCOVERY PROGRAM

Amendment to Solicitation No.:

BAA-NIAID-75N93022R00022

Amendment No.: 3

Issue Date: April 24, 2023

Effective Date:

Proposal Due Date:

April 24, 2023

May 30, 2023 until 3:00 pm EST (UNCHANGED)

Issued By: Maribel Miranda Contracting Officer

NIH/NIAID

Office of Acquisitions 5601 Fishers Lane Room 3C20 MSC 9821 Rockville, MD 20852

Point of Contact: Maribel Miranda, Contracting Officer Maribel.Miranda@nih.gov

Name and Address of Offeror: To All Potential Offerors

The above numbered solicitation is amended as set forth below. The hour and date specified for receipt of proposals has NOT changed. Offerors must acknowledge receipt of this amendment. Failure to receive your acknowledgement of this amendment may result in the rejection of your offer.

NOTE: As part of this Amendment, we inform you the deadline of April 19, 2023, 3:00pm EST to submit questions to the Government pertaining to the BAA has passed.

The purpose of this amendment is to provide responses to questions which may be useful to all potential offerors.

SECTION 1- ADMINISTRATIVE

N/A

SECTION 2- QUESTIONS AND RESPONSES

This section of the amendment provides questions submitted by potential applicants/offerors and the responses provided by NIAID. The responses are offered for information only and do not modify or become part of this solicitation. All potential offerors are advised to refer back to all previous amendments for additional questions and clarification.

Question 1: Is the purchase of equipment allowable?

Response to Question 1: The offeror can propose to purchase equipment required for the proposed work that is not already available in the offeror’s lab and if well justified. Please describe to what extent the equipment would be used for the contract project vs. other projects and prorate the costs that would be charged to the contract accordingly.

Question 2: Can a contract proposal include technical cores that support multiple research areas of the project?

Response to Question 2: While contract projects frequently access institutional core facilities (e.g., through fee-for-service arrangements), it is uncommon, but acceptable, to establish core services specifically for a contract project.

Please make sure to provide a rationale for structuring the proposal that way to assist reviewers in their evaluation of the proposal.

Question 3: Is it acceptable to only propose work for study areas 2-4 if a high throughput screen of compound libraries has already been conducted by the offeror.

Response to Question 3: No, the BAA requires that proposals include work on all four study areas and an initial high throughput screening campaign needs to be proposed for the proposal to be responsive to the solicitation. Compounds identified during a prior screening can, however, be included in the proposal and will help de-risk the proposed projects. Such compounds can also be added to the list of hits to be pursued further (optimization, formulation, MOA studies, in vivo testing).

Question 4: We have proposed some of the work that would be required in a proposal under this BAA in another proposal we already submitted. How would such an overlap be handled?

Response to Question 4: If your previously submitted proposal is funded by the time proposals under this BAA are being considered for funding, any overlap would be removed during negotiations and NIAID Program staff will attempt to leverage the previously funded project.

Question 5: Does an mRNA vaccine system count as adjuvant?

Response to Question 5: The following approaches are examples of acceptable objectives – a) screen for adjuvant activity of mRNA-encoded putative immunostimulators, b) screen non-coding RNA sequences for adjuvant activity, or c) use an RNA scaffold to assure co-delivery of adjuvant and antigen or different co-adjuvants. In case of mRNA vaccine “systems”, the request presumably refers to LNP-formulated mRNA. In this case, the mRNA cargo is routinely modified to reduce or eliminate the inherent immunogenicity of mRNA. Therefore, the adjuvant in this case are the LNPs (see next question)

Question 6: Would empty LNPs qualify as “adjuvants”?

Response to Question 6: NIAID uses the FDA’s Office of Vaccines’ definition of adjuvants as “agents that are added to or using in conjunction with a vaccine antigen to augment or potentiate and possibly target the specific immune response to an antigen”. LNPs are used as both, delivery vehicle and (for example in the case of the licensed, mRNA-based COVID vaccines) adjuvants and would, thus, qualify under this solicitation if the purpose of the proposed project is to screen for novel LNP formulation (i.e., LNP formulations with different components)

Question 7: Do the molecules being developed need to have inherent immune activity on their own, or can they modify the immune responses of other immune stimulants?

Response to Question 7: An adjuvant-modulator without inherent adjuvant activity would need to co-delivered/co-formulated with a known immunostimulator. Since the activities of the two compounds are intrinsically linked in the formulation, such a combination would become the novel adjuvant. Therefore, the discovery of novel co-adjuvants that are intended to modify the activity of a known adjuvant is allowed under this solicitation.

Question 8: Attachment 7, Section 8: Other Considerations, states that the offeror should not propose government furnished resources including government employees. We have a potential collaborator who is a government employee. Are we permitted to propose government employees as consultants in our proposal? In other words, are government employees permitted to work as consultants (with written authorization from their supervisors) under any contract awarded pursuant to this BAA?

Response to Question 8: No, the government employee may not serve as a consultant on a potential contract because any government furnished resource must be made available to all offerors.