Adult and Pediatric COVID-19 Vaccines Q_A.pdf

Adult and Pediatric COVID-19 Vaccines

RFP Nos. 75D301-22-R-72483 and 75D301-22-R-72484

Consolidated Questions and Answers as of November 18, 2022

(1) (Adult and Pediatric solicitations) Question: Section B – Continuation of SF1449, Note 2 states (composite of Adult and Pediatric solicitations):

Offerors may propose any number of vaccines or presentations of Emergency Use

Authorizations (EUA) and/or Biologics License Application (BLA) COVID-19 vaccines indicated for persons aged 19 and older (or for children 0 through 18 years of age)

Is the expectation that only vaccine products that currently have BLA or EUA are included in the solicitation (both prime series and booster) or should future vaccine product presentations currently under development (e.g. Single-Dose Vial presentation) be included as well even if they do not yet have BLA or EUA?

Answer: COVID-19 vaccines proposed in response to the Adult and Pediatric solicitations may include both prime series and boosters and must currently have a

Biologic License Application (BLA) or an Emergency Use Authorizations (EUA) issued by the U.S. Food and Drug Administration.

COVID-19 vaccines under development without a BLA or EUA will not be considered for the initial contract awards but may be considered for addition to the contract(s) at a later point in time once a BLA or EUA is received.

(2) (Adult and Pediatric solicitations) Question: Section B – Continuation of SF1449 requests pricing that includes Federal Excise Tax (FET). Since COVID-19 vaccines are not expected to be covered under the National Vaccine Injury Compensation Program

(VICP) at the time of contract award, should we use a FET of $0 in the solicitation and then update pricing at a later date to include Federal Excise Tax once these vaccines are covered under VICP?

Answer: Yes, please use a $0 value for the FET, as COVID-19 vaccines are not yet covered under the VICP. Please see Amendment 1 to both solicitations.

(3) (Adult and Pediatric solicitations) Question: How soon after the contract award date of

January 17, 2023 is the first order expected to take place? Is the expectation that orders under this contract would begin immediately following contract award or following expiration/full use of current US Government procured vaccine (prime and booster)? Is this intended to be a seasonal award like the flu program with all doses delivered in one timeframe, or a continuous order opportunity starting in January 2023?

Answer: We do not yet have a firm schedule for orders once these contracts are awarded.

Recipients of awarded contracts should be prepared to execute orders upon commencement of the ordering period. That being said, ordering under these contracts is not intended to begin until U.S. Government makes a decision about the date for a transition from the current national response to a commercial market. We intend to make the procurement of COVID-19 vaccines a continuous requirement moving forward, with year-round ordering as currently exists in CDC’s adult and Vaccines for Children (VFC) contracts.

(4) (Adult and Pediatric solicitations) Question: Section 3.3.5 Place of Delivery states that

Frozen products will be delivered to CDC Centralized Distribution or Occupational

Health Clinic locations. Will the CDC provide the contractor with the aggregate order volume from the Awardee sites or will the contractor receive the individual Awardee orders from VTrckS to support these shipments?

Answer: Please note that the requirement to potentially ship to five CDC occupational health clinics exists under the Adult solicitation only. Meanwhile, only the Pediatric solicitation includes a requirement to ship stockpile order(s) to a single location as part of

CDC’s national pediatric vaccine stockpile program.

For frozen vaccines, the intention is that the manufacturer will ship the vaccines to the

CDC Centralized Distributor in response to bulk order requests. CDC’s Centralized

Distributor will be responsible for order fulfillment to the provider locations. Therefore, CDC will not provide individual provider orders to the manufacturer.

(5) (Adult solicitation only) Question: Our company does not yet have an interim agreement with the Department of Veterans Affairs Federal Supply Schedule Service (FSS), as we have not yet commercialized a product in the US. Is it appropriate for us to estimate the federal ceiling price (FCP) based on our anticipated sales in 2023?

Answer: This is acceptable. Because COVID-19 vaccines have not been commercialized in the U.S. yet, we are not anticipating that proposed vaccines will have FCPs at the time of contract award. After award, however, the clause regarding maximum contract price at section C.3.11 will mandate that the contract price for vaccines do not exceed the FCP once established. If the FCP, once established, is lower than the contract price, the contract price shall be reduced to be no higher than the FCP.

(6) (Adult and Pediatric solicitations) Question: Initial response date is listed at 11/28 by 430

PM EST. We noticed quite a few new FAR clauses we will need to review internally.

Given Thanksgiving next week, would it be possible to give us until Wed, 11/30 at 5 pm

EST?

Answer: Yes. Please see Amendment 1 to both solicitations.