HHS has awarded two contracts totaling $132.5 million to expand the domestic influenza vaccine manufacturing capacity. The five-year, cost-reimbursable commitments were made to sanofi pasteur and MedImmune for $77.4 million and $55.1 million, respectively.
The companies will use the funding to retrofit existing domestic vaccine production plants on a cost-sharing basis and to provide warm-base operations wherein the contractor does not shut down the facility. These warm-base operations will extend over two years with options for an additional three years.
Under the cost-sharing portion of the contract, MedImmune will contribute approximately $14 million to the retrofitting of its U.S.-based vaccine manufacturing site. Sanofi pasteur will contribute approximately $25 million to the overall project.
Sanofi pasteur reports that the contract covers the cost of design, retrofitting, and the maintenance of the facilities at a state of readiness so the company can switch to pandemic influenza vaccine manufacture at the HHS' request.
The design phase will begin immediately, sanofi pasteur reports. The retrofit will begin when the FDA licenses its new influenza vaccine production site. The existing plant will then be phased out and decommissioned for the retrofit.
The current facility has produced approximately 50 million doses of vaccine for the U.S. market during the past several influenza seasons, sanofi pasteur states. When both facilities are validated, the capacity will approximately triple, according to the company.
Upon completion, these sites will expand domestic pandemic vaccine manufacturing capacity by 16%, says the HHS. Additionally, the facilities will afford year-round production of prepandemic influenza vaccines for the national stockpile, which currently is limited to three months each year.