Wyeth-Lederle Vaccines and Pediatrics

Wyeth-Lederle Vaccines and Pediatrics BNUMBER: B-274490; B-274490.2 DATE: December 13, 1996 TITLE: Wyeth-Lederle Vaccines and Pediatrics ********************************************************************** Matter of:Wyeth-Lederle Vaccines and Pediatrics File: B-274490; B-274490.2 Date:December 13, 1996 Andrew N. Goldfarb, Esq., Elizabeth Goss, Esq., Albert F. Cacozza, Jr., Esq., and Samuel D. Turner, Esq., Fox, Bennett & Turner, for the protester. Barbara Robbins, Esq., Department of Health and Human Services, for the agency. Tania L. Calhoun, Esq., and Christine S. Melody, Esq., Office of the General Counsel, GAO, participated in the preparation of the decision. DIGEST 1. Under pediatric vaccine procurement conducted pursuant to statute which states that the agency "shall, as appropriate" award multiple contracts, protest that contracting agency improperly provided for a single award instead of multiple awards is denied where the record shows that the agency reasonably determined that the circumstances were not appropriate for multiple awards. 2. Under pediatric vaccine procurement, protest that contracting agency improperly failed to follow a "statutorily required" procedure with respect to use of the list of vaccines established by the Advisory Committee on Immunization Practices (ACIP) is denied where statute does not require any particular procedure, and ACIP clearly intended rapid incorporation of vaccine into the immunization program and the conditions ACIP established for such incorporation have been met. DECISION Wyeth-Lederle Vaccines and Pediatrics protests the terms of request for proposals (RFP) No. 96-170(N), issued by the Department of Health and Human Services, Centers for Disease Control and Prevention (CDC), to obtain diphtheria and tetanus toxoid with acellular pertussis (DTaP) vaccine pursuant to the Vaccines For Children (VFC) Program.[1] Wyeth-Lederle also protests the award of a contract to Connaught Laboratories, Inc. under this solicitation. We deny the protests. BACKGROUND The pediatric vaccination schedule to provide optimal protection against diphtheria, tetanus, and pertussis calls for five doses of vaccine--three doses given at ages 2, 4, and 6 months as the primary infant series, and two booster doses given between the ages of 12 and 18 months and between the ages of 4 and 6 years. Since 1948, whole-cell pertussis vaccines (DTP), which contain inactivated whole bacterial cells of the pathogen that causes the disease, have been recommended to fulfill the five-dose regimen. In recent years, DTP has been associated with a number of adverse reactions and side effects. Concerns about its safety led to the development of the DTaP vaccine, which contains acellular pertussis, a more purified vaccine which contains only components of the bacterium, rather than the whole cell. DTaP causes fewer adverse reactions in children and is considered to be a safer alternative than DTP. In 1991, both Wyeth-Lederle and Connaught received Federal Drug Administration (FDA) licenses to manufacture DTaP for use only as the fourth and fifth booster doses in the vaccination schedule. The requirements for the infant series in the schedule were still to be filled by DTP, as no manufacturer was licensed to provide DTaP for this purpose.[2] The CDC's contracts for the booster doses of DTaP were scheduled to expire at the end of August 1996. In a draft document dated July 25, 1996, the CDC outlined its options for meeting its DTaP requirements under the VFC Program.[3] Among other things, the agency considered whether it should award a single contract or different varieties of multiple contracts. In this regard, as discussed below, OBRA states that the agency shall, as appropriate, enter into contracts with each qualified manufacturer. The agency was aware that five manufacturers were currently seeking or planning to seek licensure to provide DTaP in the infant series, and expected that such licenses would be issued within 1 to 12 months. The CDC opted to negotiate a contract with "all vaccine companies that are licensed to provide DTaP for use in infants beginning at 2 months of age." On July 31, approximately 1 month before the CDC's current contracts for DTaP were to expire, the FDA licensed Connaught to distribute DTaP for the infant series. Hence, Connaught was now the only manufacturer licensed to provide DTaP for all five doses. On August 13, the contracting officer telephoned the manufacturers known or believed to be seeking licensure for the required vaccine.