Adult and Pediatric COVID-19 Vaccines Q_A (12.09.22).pdf

Adult and Pediatric COVID-19 Vaccines

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

Consolidated Questions and Answers as of December 9, 2022

The question and answer added since November 30, 2022, is numbered 21 below.

(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.

(7) (Adult and Pediatric solicitations) Question: Both solicitation documents mention the

Federal Excise Tax (“FET”) – I assume because it’s in here, the COVID vaccine will have to be charged FET? Even with Emergency Use Authorization (EUA) vaccine?

Answer: Please see question #2 above. Because COVID-19 vaccines are not yet covered under the National Vaccine Injury Compensation Program (VICP), we’ve directed offerors to use a $0 value for the FET. Please also see Amendment 1 to the RFPs.

(8) (Adult and Pediatric solicitations) Question: Regarding section C.3.4, what specific “EDI documentation” are you referring to? The 856 Advance Shipping Notice (ASN)?

Answer: This section states, in part:

Delivery of vaccine and required documentation is required to be made at destination within 15 working days after receipt of electronic, written, or telephonic order (telephone orders to be confirmed in writing). The required documentation includes the packing list, Electronic Data Interchange (EDI), and

Drug Supply Chain Security Act (DSCSA) documentation. (emphasis added)

In this section, we are specifically referring to the 856 ASN. However, the full list of required EDI transactions includes the following:

(a) 850 (purchase orders)

(b) 856 (ASNs)

(c) 810 (Invoices)

(d) 860 (Purchase Order change)

(e) 180 (Return order)

(f) 812 (Credit memo)

In addition, there is a 997 acknowledgement message.

(9) (Adult and Pediatric solicitations) Question: Regarding section C.3.4, in what case would the product be in quarantine at CDC? They state the 15 days to deliver includes any quarantine time at CDC – wondering why the mention it as we will only ship to them after a full U.S. Food and Drug Administration (FDA)/Center for Biologics Evaluation and Research (CBER) and internal quality release.

Answer: This section states, in part:

Shipments delivered with incorrect or missing packing list, EDI, or DSCSA documentation will be quarantined and considered not ready to be received into inventory until the discrepancy is resolved. Days during which vaccine is in quarantine at CDC's depots count toward the 15 working day requirement.

Products can be quarantined for a variety of reasons – temperature excursions, product damage, short-dated product, overage or shortage of order, as well as incomplete or missing documentation.

(10) (Adult and Pediatric solicitations) Question: Regarding maximum quantities, what is the business thought behind 30 million doses for each contract? What specifics have gone into that specific amount?

Answer: The maximum ordering quantity was determined by considering the size of the population group recommended for vaccination, the recommended vaccination schedule, and the estimated increase in vaccination coverage by age group. In addition, we assumed that boosters would be recommended for all groups on an annual basis.

(11) (Adult and Pediatric solicitations) Question: We are requesting that the US Government team consider an extension of 1 week to shift the submission due date to December 5.

Answer: Please see Amendment 2 to the RFPs; we’ve extended the due date for questions to November 29, 2022, and the due date for proposals to December 5, 2022.

(12) (Adult and Pediatric solicitations) Question: Regarding section C.3.13 and invoice submission, can you confirm that we will submit invoices only to the CDC and not to individual awardees?

Answer: Orders may be placed in the Vaccine Tracking System (VTrckS) by either CDC on behalf of awardees, or by the awardees themselves (see section C.3.7 in the Adult solicitation, and section C.3.8 in the Pediatric solicitation). The origin of the order will dictate how the invoice is to be submitted.

For orders issued by CDC, the contractor shall submit invoices to CDC through the electronic data interchange (EDI) in VTrckS in accordance with section C.3.13(a).

For orders issued by the awardees themselves, the contractor shall submit one hard copy of its invoice to the address specified in the awardee delivery order in accordance with section C.3.13(b).

(13) (Adult and Pediatric solicitations) Question: Regarding section C.3.13 and invoice submission, this section specifies that the contractor will submit invoices to the CDC via

Electronic Data Interchange. We are currently submitting invoices electronically to the

U.S. Government via the Invoice Processing Platform (IPP) system for existing contracts;

can you confirm that this is the system we will be using to submit invoices for these contracts?

Answer: Invoices for orders placed by CDC shall be submitted by the contractor in

VTrckS, rather than IPP.

Additional information about VTrckS can be found here:

https://www.cdc.gov/vaccines/programs/vtrcks/index.html

Each solicitation (sections C.3.7, E.2(e)(1)(v), and E.2(e)(2)(v) in the Adult solicitation, and sections C.3.8 and E.2(f)(1)(v) in the Pediatric solicitation) addresses the requirement for the contractor to interface with VTrckS. If unable to interface at the time of award, the contractor shall complete interface implementation no later than 3 months after contract award.

If a contractor is unable to interface with VTrckS at the time of award, invoicing will likely be done by e-mail to CDC until such time as the offeror completes interface implementation.

(14) (Adult and Pediatric solicitations) Question: Can CDC provide any guidance or expectation for volume needs for both adult/VFA and pediatric/VFC contracts, realizing there are substantial U.S. government doses remaining? Is this something that we will need to include with the response due on 11/30?

Answer: Ordering under these contracts is not intended to begin until the U.S.

Government transitions from the current national response to a commercial market. See the response to question #10 regarding how the maximum ordering quantity in each solicitation, 30 million doses, was determined.

Offerors may offer a maximum quantity of up to 30 million doses in response to each solicitation. The expected ordering volume from awardees is indefinite at this time, given that the national response is still on-going.

While offerors are required to provide proposed vaccine maximum quantities in their proposals, in accordance with the proposal instructions (see sections E.2(e)(1)(ii) and

E.2(e)(2)(ii) of the Adult solicitation and section E.2(f)(1)(ii) of the Pediatric solicitation), this is something that may be negotiated during discussions, if discussions are held, following receipt of proposals. Please also note that, per question #11 and

Amendment 2 to the RFPs, the proposal due date has been extended to December 5, 2022, for both solicitations.

https://www.cdc.gov/vaccines/programs/vtrcks/index.html

(15) (Adult and Pediatric solicitations) Question: Regarding section C.3.5, Place of Delivery:

It is our understanding that currently McKesson Specialty Distribution LLC, CDC’s current centralized vaccine distribution contractor, does not have the capability to store & deliver at ultra-low temperature (ULT) at this time. Is that correct, and if so, is there an expectation that McKesson will have these capabilities in 2023?

Answer: CDC is still in the process of determining how ultra-cold vaccines will be distributed to providers. To provide maximum flexibility, we have requested that a vendor offering ultracold vaccines propose two options for consideration – (1) bulk shipment of vaccine to CDC’s centralized vaccine distributor, and (2) direct shipment

(drop-shipment) of vaccines directly to providers, as described in section C.3.5.

(16) (Adult and Pediatric solicitations) Question: Regarding section C.3.5, Place of Delivery:

For drop shipping, it seems like contractors could follow the existing model for frozen vaccines (e.g., Varicella, MMR) that also need diluent. Is there any further information

CDC can provide on this shipping process that may help as we evaluate our current capabilities?

Answer: CDC currently contracts for drop ship frozen vaccines (e.g., varicella and

MMR-V) as part of the routine program. Providers receive shipments in specialized shippers that contain both frozen vaccine and diluent. CDC does not have any information about how these shippers were developed or qualified.

(17) (Adult and Pediatric solicitations) Question: In Attachment A-1, the list of products that is part of the Authorized Distributor of Record (ADR) Agreement on page 26 of each solicitation, are offerors to use the National Drug Code (NDC)-inner “unit of use” NDC number or the outer pack/“unit of sale” NDC number?

Answer: In the list of products table “NDC” column on page 26, offerors are to use the package-level, “unit of sale” NDC.

Of note, offerors are to provide both the “unit of sale” and “unit of use” NDCs in completing section C.3.24 of both solicitations.

(18) (Adult and Pediatric solicitations) Question: If we have applications pending for additional product size presentations as well as shelf-life extensions, should we include those in a summary in the solicitation?

Answer: COVID-19 vaccines proposed in response to these solicitations must currently have a Biologic License Application (BLA) or an Emergency Use Authorizations (EUA) issued by the U.S. Food and Drug Administration in order to be placed on a resulting contract award.

COVID-19 vaccine products with pending applications for additional size presentations and/or shelf-life extensions may be discussed in an offeror’s proposal. However, those products are ineligible to be included on any resulting contract.

COVID-19 vaccine products with pending applications may be considered for addition to the contract(s) at a later point in time once a BLA or EUA is received.

(19) (Adult and Pediatric solicitations) Question: Can you provide us with the ship-to addresses for the locations we would be shipping? We need that info for the electronic data interchange (EDI) set up. Thank you.

Answer: The addresses for the CDC centralized distribution locations – currently located in Aurora, CO and Memphis, TN – will be provided post-award. The address for pediatric stockpile orders and, if required, the addresses for adult vaccine orders for shipment to the five CDC occupational health clinics, will also be provided post-award.

(20) (Adult and Pediatric solicitations) Question: In accordance with FAR 25.403(c) will

CDC consider issuing a non-availability determination for this procurement? Based on the solicitation terms, it does not appear that some of the products sought by CDC are mined, produced, or manufactured in the United States or a designated country as required by the Trade Agreements Act in sufficient quantities to fulfill the agency’s requirements. Additionally, can you confirm that the Trade Agreements Act (TAA) applies to this acquisition. It is our understanding that the Buy American Act, and not the

TAA applies pursuant to FAR 25.401(a)(2).

Answer: Per item (50) on page 7 of both solicitations, FAR 52.225-5, Trade Agreements, applies to these procurements.

This clause applies, in accordance with FAR 25.1101(c)(1), because (a) the resulting contracts are anticipated to be valued at $183,000 or more; (b) the acquisition is covered by the World Trade Organization Government Procurement Agreement (WTO GPA), as none of the exceptions to the WTO GPA apply; and (c) CDC has determined that the restrictions of the Buy American statute are not applicable to U.S.-made end products.

Per FAR 25.402(a)(1), in acquisitions covered by the WTO GPA, the Buy American statute and other discriminatory provisions for eligible products are waived. Accordingly, the Buy American Act would not apply to these procurements.

The exception to the Trade Agreements Act provided in FAR 25.401(a)(2) is for

“[a]cquisitions of arms, ammunition, or war materials, or purchases indispensable for national security or for national defense purposes.” Because these procurements are for routine vaccines, they do not meet the criteria for this exception.

Under the Trade Agreements Act, in acquisitions covered by the WTO GPA, the

Government may only acquire U.S.-made or “designated country” end products, unless offers for such end products are either not received or are insufficient to fulfill the requirements.

CDC is aware that some BLA/EUA COVID-19 vaccines are not U.S.-made or designated country end products. If CDC receives an offer for vaccines that are not U.S.-made or designated country end products, CDC intends to pursue a nonavailability waiver if the offerred vaccines are needed to meet CDC’s full requirement for COVID-19 vaccines. To fulfill CDC’s full requirement, it is possible that vaccines that are not U.S.-made or designated country end products will need to be accepted.

Please note that offerors are required to complete the certification at FAR 52.225-6 in section E.5 of both solicitations if offering supplies that are not U.S.-made or designated country end products. Section (b) of this certification requires offerors to list those products which are not U.S.-made or designated country end products. This certification, if completed, shall be submitted with the business volume in accordance with the business volume instructions.

(21) (Adult and Pediatric solicitations) Question: Can you share if there’s an expectation for awardees and providers to pre-book for the COVID-19 vaccines on CDC contracts next year?

Answer: Based on the information currently available about COVID-19 vaccine recommendations, there is not an expectation for a COVID-19 pre-book.