HEP B Vaccine

The Centers for Disease Control and Prevention intends to issue a sole source firm fixed modification to GlaxoSmithKline to increase the target quantities for HEP B vaccine on existing pediatric contract for GlaxoSmithKline (GSK) 200-2017-93272. The Centers for Disease Control and Prevention (CDC) has been awarding contracts for the purchase of standard commercial pediatric and adult vaccines by immunization awardees for over 15 years. Vaccines are one of the most cost-effective ways to prevent disease and reduce healthcare costs. The establishment of these contracts provides the opportunity for immunization awardees to utilize Vaccine for Children (VFC) and Section 317 vaccine purchase direct assistance (DA) cooperative agreement funds to obtain vaccines at prices below those available in the commercial market place. These federal funds are intended for state and local health departments to purchase vaccines for populations at greatest risk for under vaccination and disease. The immunization program works to ensure that children, adolescents and adults receive appropriate immunization by partnering with healthcare providers in the public and private sectors. The program helps assure the implementation of effective immunization practices and proper use of vaccines to achieve higher immunization coverage. The National Center for Immunization and Respiratory Diseases (NCIRD) requires the award of multiple indefinite quantity, indefinite delivery (IDIQ) contracts for the purchase of standard commercial pediatric vaccines, manufactured under a current establishment and product license issued by the U.S. Food and Drug Administration (FDA). The vaccines awarded under these contracts will be purchased for NCIRD's immunization awardees (the fifty state health departments, several large city program and current and former U.S. Territories) to support pediatric immunization programs as provided under Section 317(j) of the Public Health Service Act and section 13631of the Omnibus Budget Reconciliation Act of 1993. Awardees may also purchase these vaccines using their own state funds. Vaccines will be ordered through the NCIRD electronic vaccine ordering system. Project description. To increase the HEP B vaccine target quantity on contract number 200-2017-93272 as follows: Increase quantity of HEP B (ENGERIX-B) by 1,700,000 doses, for National Drug Code (NDC): 58160-0820-52, Vaccine - HEP B, Presentation - SYR, and Packaging - 10 Pack This contract action is for supplies for which the Government intends to solicit and negotiate with only one source under the authority of FAR 6.302-1 Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements and 41 U.S.C. 3304(a)(1). This acquisition is to increase target quantity for pediatric ENGERIX-B vaccine on the existing GSK pediatric contract 200-2017-93272 in light of ongoing supply constraints for a similar product offered by Merck. Hepatitis B infection is an established cause of acute and chronic hepatitis and cirrhosis. It is also the cause of up to 80% of hepatocellular cancers. There is no specific therapy for acute Hepatitis B infection and treatment for chronic Hepatitis B infection is successful only in 25 - 50% of cases. As such, vaccination is critical to preventing the disease. The US has instituted a comprehensive prevention strategy which includes vaccination of all infants and adolescents. In order to fulfill the demand for pediatric Hepatitis B vaccine for the contract period April 1, 2017 through March 31, 2018, CDC contracted with both Merck and GSK, the only companies with an FDA license to provide pediatric Hepatitis B vaccine to the US. During the summer of 2017, Merck initially notified CDC that it would be unable to supply any pediatric Hepatitis B vaccine until January of 2018. Due to ongoing supply constraints, Merck has recently notified CDC that the period of vaccine unavailability is being extended until April of 2018. In the face of this longer period of unavailability, CDC must increase the volume of pediatric Hepatitis B vaccine that can be purchased from GSK on the current pediatric contract. This notice of intent is not a request for competitive quotations; however, all quotations/responses received within fifteen (15) days of the issuance of this notice will be considered by the government. A determination by the government not to compete this proposed contract based upon responses to this notice is solely within the discretion of the government. Information received will normally be considered solely for the purpose of determining whether to conduct a competitive procurement. Any quotation/response should be emailed to contract specialist at tnr6@cdc.gov by noon on 12/26/17