Shortcomings in the response to H1N1 prompted the US Department of Health and Human Services (HHS) to initiate a review of capabilities. Having identified a number of areas which would benefit from changes the HHS has allocated funding of $2bn for “the coming years”.
The funding will be used to address “major barriers” to development of countermeasures. For instance: “The review repeatedly revealed that aspects of the current regulatory framework and unmet need for regulatory science present both perceived and real barriers for developers.”
Strengthening capacity and investment in regulatory science and review, coupled to a reassessment of policy, will be initiated to eliminate this barrier. Greater clarity, better interaction with product sponsors and enhanced data collection capabilities are also called for by the review.
“In the eyes of many industry representatives interviewed in the course of this review, improvements in this area were some of the most important incentives the federal government could provide”, said the review.
Working with partners
The review also calls for more effective use of public-private partnerships. Drawing on the experience and expertise present in the private sector “will be essential to success” and collaboration should be used to drive rapid adaption to new needs or opportunities.
In particular, the review believes the US government should sponsor pre-competitive collaborations between multiple industry partners. This could drive development of vaccine potency assays, improve virus growth in cells and eggs or further clinical trial analytics.
Discoveries made by scientists should also be better supported. It is proposed that US National Institutes of Health (NIH) resources are used to guide promising discoveries through the developmental process.
The HHS also wants to use financial incentives to encourage discovery and development of countermeasures. This funding “could support those companies with ideas that have little hope of making huge profits but big potential to improve our public health preparedness”.
The HHS report and, in particular, a document put together by the President’s Council of Advisors on Science and Technology (PCAST) offer a number of proposals to improve the manufacturing process.
By implementing short-term changes, such as expanding fill-and-finish capacity, PCAST believes the time to delivery of the first pandemic response vaccine can be halved from the current 20 weeks.
In the long-term PCAST supports the adoption of either a cell-culture- or recombinant DNA-based method of production. This would replace “the inherently time-consuming egg-based method” which makes vaccine production “a long and unpredictable process”.
in-PharmaTechnologist will take a deeper look at the manufacturing proposals in future articles.