The Swine Flu Vaccine is Approved – If You Build it Will They Come?

J0427626 Yesterday the Food and Drug Administration announced the approval of flu vaccines for the H1N1 flu virus, popularly known as Swine Flu, being manufactured by four separate firms.  The amount of time between the initial outbreaks of H1N1 this Spring, and the development and production of a vaccine has been nothing short of breathtaking – which is a two-edged sword.

On the one hand, it is a demonstration of the incredible bench-depth in research these companies have in  being able to produce something so quickly, which is reassuring indeed.  On the other hand, the short window of time for identification of the virus, development of a vaccine and the manufacture of it, may leave some in the public wary.  

That is one reason why Dr. Jesse Goodman, FDA's acting chief scientist, stressed in a quote in the press release that "[t]he H1N1 approved today undergo the same rigorous FDA manufacturing oversight, product quality testing and lot release procedures that apply to seasonal influenza vaccines."  That may be comfort to many, but some may also recall that a few years ago, a seasonal influenza production line was shut down, not by the FDA, but by the British Medical authorities.  That led to a scathing indictment of the agency's capacity for overseeing the manufacture of flu vaccines by Congressman Henry Waxman.   Granted, the Administration has changed and so has leadership at FDA and there is every indication that under Dr. Hamburg, the FDA is reinvigorated in its protection of the public health.  But for some, the events of the past may create a well of Doubting Thomases.

In addition to that, for older Americans who were alive during the Ford Administration, there will be some who remember that in 1976 when H1N1 crossed species to infect humans, there was a tremendous push to develop and distribute a vaccine and, after a public relations disaster and many delays and with the inoculation of 25% of the population,  more people ended up dying from the flu shots than from the flu.  And granted, 1976 scientific, research and testing standards and oversight are not what they are in 2009, but this may contribute to the pool of those who are fearful of the vaccine.

Yesterday I spoke with a few colleagues about the vaccine.  It was a very limited focus group.  But it was clear, there were very few takers in terms of intention to get vaccinated for H1N1.  That might be ok.  If there is a limited supply of vaccine and people who are public health savvy step up first, and those who are most vulnerable step up, then it might be enough to protect everyone else.

There is an additional complicating factor.  My guess is that if people were polled, there would be a huge portion of the population that does not perceive the difference between seasonal vaccine and H1N1.  That, too, is an education need that should be addressed.
  
The bottom line is this.  The FDA has done its job with H1N1 development.  But Health and Human Services still has a job in front of them.  That is to research the public on their intention to take the vaccine, their reasons for doing so and their reasons for not doing so, and launch a communications initiative that applies those lessons strategically.  Because there is a burden to the history of flu vaccine development that might otherwise impair the execution of a public health inoculation strategy.  This may not be a case where making a flu vaccine necessarily means that people will take the vaccine.
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