The US HHS has published a national vaccine plan that stresses the need for rapid and flexible manufacturing methods.
Since the first, and until now, only, national vaccine plan was published in 1994 countermeasures and threats have evolved. To drive the continued evolution needed to protect populations the US Department of Health and Human Services (HHS) has issued its 2010 National Vaccine Plan .
“New 21st-century vaccine supply concerns, such as vaccines for pandemic influenza, emerging diseases and bioterrorism threats, present different challenges for sustainability and may require surge manufacturing capacity”, says the report.
Protecting people in the US, and around the world, from new and established threats will require development of cost-effective, flexible and quick methods for manufacturing quality vaccines, says the HHS.
Chan Harjivan, partner, head of public health practice at management consultancy PRTM, told in-PharmaTechnologist the goal is to create flexible regional capacity which can, in times of need, quickly and cheaply produce vaccines.
To achieve this goal the HHS says vaccine manufacturers in developing countries must be supported with technical assistance. Establishing local production eliminates the supply-chain issues associated with vaccines.
Manufacturing expansions must be backed-up with regulatory enhancements. The plan aims to: “Promote and support the efforts of WHO (World Health Organization) and others to improve regulatory capacity in countries with limited infrastructures to assure vaccine quality.”
Development of manufacturing methods is just one step in the end-to-end strategy laid out in the plan, which spans biosurveillance through to vaccination. The document is a long-term implementation strategy and achieving the targets will be a “huge challenge”, said Harjivan.
HHS aligned the document with Healthy People 2020 to give a 10-year implementation timescale. Areas identified in the plan, such as improved access to vaccine pilot plants, will benefit from funding as the HHS works towards global end-to-end public health protection.
The five primary goals of the plan are: develop new and improved vaccines; enhance the safety system; support communications to improve informed decisions; ensure a stable supply of materials; and increase global prevention of death and disease.
Manufacturing capabilities underpin several of these goals. The plan calls for development of new approaches to vaccine manufacturing that meet demand for efficient, expandable production capacity.
Improved delivery methods, optimised stability profiles and new quality testing procedures are also goals. Appropriate regulations, guidance documents and policies are needed to support these developments.