Recent shortages of H1N1 flu vaccine have spurred numerous news reports highlighting alternative vaccine manufacturing options that could have rapidly filled current shortages and provided vaccines to consumers in the United States.  It is clear that the current approach to vaccine production (i.e. growing virus in chicken eggs) is antiquated, cannot deliver vaccine in a timely fashion (other than routine annual vaccines with a long lead time), and is severely limited by availability of large quantities of raw materials.  Vaccine alternatives, including use of adjuvants to improve the efficacy of existing vaccines (thereby allowing current vaccine supplies to be stretched farther) and cell culture based production methods that promise to reduce production time from months to weeks, are being highlighted while failing to recognize that these options are untested in large populations.  From the layman’s perspective, these options are a failure of the system to act.  The industry and government’s perspective is somewhat different, recognizing that unproven processes carry unknown risk that the public is unwilling to tolerate.  This disconnect is the basis for misconception and confusion, driving specific agendas from across the business and political spectrum.  While an informed public is the answer to this dilemma, it is virtually impossible to deliver a consensus opinion, since leading voices are afflicted with the agendas already mentioned.

Despite regular news segments showing anxious consumers in long lines waiting for H1N1 flu vaccine, there is considerable evidence to expect that consumers are unwilling to accept novel innovations that could deliver equivalent vaccine protection with some degree of risk for unknown side effects of unknown severity.  For the vast majority of consumers, there would likely be no significant adverse effects of any kind.  However, for the unfortunate few, severe side effects, including death, might be possible.  The side effect might have nothing to do with the vaccine itself, but would be caused by the adjuvant or the production vehicle (e.g. think egg allergies for current vaccines).  Until broadly tested and proven, these unknowns are a real and distinct risk.  Current news stories fail to highlight any of these concerns.  As a likely organization that should be getting the message out, one would think that the FDA should be regularly be on the public airwaves to highlight the right path.  One presumes that this could be problematic in that the FDA might be seen as either pro-business (pushing experimental vaccines) or anti-business (overhyping unproven fears), resulting in their relative quiet posture.

Until the H1N1 flu awakens epidemic fears in the general public where everyone is willing to do whatever it takes to protect themselves (think surgical masks on public transit and signing away their right to sue to access experimental vaccines), these experimental solutions will languish in the background.  In some ways, the current flu pandemic has accelerated FDA approvals of new flu drugs, although the drugs had already completed most required testing.  Getting everyone on the same page will always be a challenge and the current flu pandemic is no exception.  Expect business as usual if the pandemic does not exceed ordinary flu boundaries (i.e. deaths) along with any lasting impacts.  If the H1N1 flu lives up to potential fears, there is potential for rapid progress in developing and commercializing innovative treatment solutions that will come at a price, including some unexpected severe side effects and fatalities. 

Analogous to a war, there are few things that have the potential to bring people together for the common good.  For better or for worse, the current H1N1 flu may be one of them.

As always, I welcome comments and discussion from our readers.