Report to the President

[indigo girl]

REPORT TO THE PRESIDENT ON REENGINEERING THE INFLUENZA VACCINE PRODUCTION ENTERPRISE TO MEET THE CHALLENGES OF PANDEMIC INFLUENZA

http://www.whitehouse.gov/sites/default/files/microsites/ostp/PCAST-Influenza-Vaccinology-Report.pdf

It might be helpful to think of the swine flu pandemic as a dress rehearsal while you are reading this.

In the case of 2009 H1N1, the time between the declaration of a need for a vaccine against the pandemic virus and the start of the second wave of the pandemic in the United States was 18 weeks, and the time to the peak of the second wave was about 26 weeks. Each pandemic will surely differ, but this provides a reasonable indication of the time in which a large supply of effective vaccine might be required in subsequent pandemics.

The case of 2009 H1N1 also shows the challenges in meeting these time lines. Due to difficulties in producing vaccine, initial doses became available only after about 26 weeks, sufficient doses to cover half the population became available at 38 weeks and supply adequate to protect the entire Nation would have taken approximately 48 weeks to produce. This timeline was far too slow, by approximately 3 to 5 months.

Protecting the nation from an influenza pandemic thus requires tightening the schedule for making vaccine substantially: in a serious pandemic, saving weeks could translate into saving tens of thousands of lives.

With the goal of identifying ways to reduce the time to protect the public from the next pandemic, PCAST examined each step in the manufacturing process now used to make influenza vaccines, addressed the impact of improvements in each component on the time required to deliver the first doses of a new pandemic vaccine and to deliver all of the vaccine that would be required to protect the United States population. In addition, PCAST assessed a number of economic and regulatory issues that, regardless of technological developments, are potential barriers to improving the Nation's ability to protect its residents against pandemic influenza. In its review, PCAST also considered how changes in the produc- tion of pandemic influenza vaccines would affect the manufacture of seasonal influenza vaccines, and its work was also recognized as related to simultaneous studies of the larger United States medical countermeasure effort, which also includes vaccine development as part of its charge. PCAST's delibera- tions were informed by discussions with government officials and others in industry and academia with expertise in vaccine development and manufacturing.

In considering a path forward for reengineering the Nation's influenza vaccine enterprise, PCAST has developed a series of specific recommendations for action by the Federal Government. PCAST's analysis identified several components of the current influenza vaccine manufacturing process that could be improved substantially within the next two years without substantial alterations to the overall influenza vaccine enterprise, as well as transformations that will require action and support for the next two to six or more years. The effects of PCAST's recommendations on the delivery of pandemic influenza vaccines are summarized in Table ER-1 below. Comparisons of the approximate timelines for delivery of the first dose of vaccine are shown in Figure ER-1 for the current production method, using virus grown in embryonated chicken eggs, and for two of the most promising techniques for shortening those time lines, vaccines that uses viruses grown in cultured cells and those made with proteins produced with recombinant DNA technology.

PCAST has not determined anticipated costs for the projects required to make these improvements and has not attempted to allocate the share of financial responsibility to be borne by the governmental agencies or the companies. It is fair to assume, however, that an initial $1 billion in Federal funds--and at least similar sums over the subsequent few years--would be required to make the changes that will allow the Nation to mount a vigorous effort that can protect its population as well as possible in the event of another pandemic, an event that could have catastrophic consequences. Even in the relatively mild 2009 pandemic, over 2000 lives--mostly relatively young people, with an average age of less than forty--could have been saved if vaccination had begun even one month earlier. Furthermore, as this report makes clear, most of the Federal funds used to increase capacity to respond more quickly to influenza pandemics would also help to develop the technical platforms and production facilities that would support medical countermeasures more broadly against a variety of pathogens. For these reasons, an investment of $1 billion or more for several years can be justified on a cost:benefit basis.

(hat tip Avian Flu Diary)