Questions_and_Answers_7.12.19.docx

Pre and post Influenza Human Sera Panels Solicitation # 75D301-19-R-67951 Questions

1. Can the Offeror assume for Year 1 of the contract that Fluzone will be acceptable for the current seasonal quadrivalent egg-based vaccine and Flucelvax will be acceptable for the cell-based killed virus influenza vaccine? The current, licensed, seasonal, quadrivalent, killed virus influenza vaccine must be used. Yes, it can be assumed that for Year 1 Fluzone is acceptable for the egg-based vaccine and Flucelvax is acceptable for the cell-based vaccine. These are not acceptable will a list of the acceptable vaccines be provided? They (Fluzone and Flucelvax) are acceptable but yes, a list of the current, licensed, seasonal, quadrivalent, killed virus influenza vaccines is available on FDA website and can be provided.

2. If using Flucelvax, it is approved only for individuals 4 years and older. How will this affect the 3-8 y.o age group? The vendor must follow the ACIP recommendations/product inserts of the vaccine. It is acceptable if these 30 participants receiving the cell based vaccine are between the ages of 4-8y, because that falls within the acceptable age range of the cohort (3-8y)

3. Does the vaccine order need to be preapproved before being placed as stated in Section C.4.b (p.5) of the RFP? If so, this will impact ability to have vaccine onsite in September for Year 1 of the contract. As stated in the Statement of Work, the contractor shall inform CDC the specific vaccine that will be used for each age panel ahead of the order.

4. Can you provide definition of “healthy” for healthy volunteers? Anyone taking immune suppressing drugs or with a history of immune compromising disease is excluded from participation. Elderly participants must be community dwelling. Participants must not have any influenza –like illness, or with laboratory confirmed influenza infection at the time of the vaccination and pre/post sera collections. The vendor is responsible for establishing requirements for enrollment to obtain IRB approval.

5. For the 40 adult high volume donors should we assume a 50/50 split between the participants to receive the current seasonal quadrivalent egg-based killed virus influenza vaccine and the participants to receive the current licensed seasonal quadrivalent cell-based killed virus influenza vaccine? Yes, as stated in the Statement of Work, “for adult participants, the contractor shall arrange for the collection of approximately 100 ml of blood for the post-immunization sample (S2) from a total of 20 participants who received the egg-based vaccine and a total of 20 participants who received the cell-based vaccine.”

6. Please clarify the due date for past performance questionnaire in Page 63, it said no later than June 18, 2019. Response: The due date is July 18, 2019.