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

  1. One piece of news that is likely reducing the public’s interest in the vaccine are the reports that even among health professionals, interest in taking it seems lukewarm (only about half say they plan to take it, according to several surveys). So there still seem to be questions regarding how helpful the vaccine will actually be, in comparison to the threat level, which at this time is not especially high. For a nontechnical person such as myself it is difficult to know what to think at present … these doubts among the general population will need to be more directly addressed if the FDA wants wider acceptance of the vaccine.

  2. H1N1 = Conspiracy?
    H1N1 notepad
    October 2009
    On October 1 2009, a former federal health minister dismisses as “crackpots and conspiracy theorists” those who would actively discourage Australians from having their swine flu vaccine’. October 2nd, the San Fransisco Chronicle publishes that ‘Everybody seems to be saying TRUST THE GOVERNMENT but it’s hard to trust the H1N1 vaccination campaign’ and on October 4rd, the Washington Post wonders ‘When the swine flu vaccine finally arrives this week, will Americans line up to get it?’ and CBS News writes about health care workers protesting the flu vaccine mandate. October 6th Foodconsumer publishes ‘Do NOT Let Your Child Get Flu Vaccine — 9 Reasons Why’ and writes that ‘modern medicine has no explanation for autism, despite its continued rise in prevalence. Yet autism is not reported among Amish children who go unvaccinated’. October 7th Healthnews writes that 72 percent are concerned about potential vaccine side effects and the Examiner writes that’ theorists believe that government may force people to take the vaccine’. October 8th Times&Transscript publishes that ‘a mercury-based preservative called thimerosal would be included as one of the substances in the H1N1 vaccine’, Medill Reports writes that Dr. Mayer Eisenstein is advising his patients to say no and is convinced that vaccines cause autism and the Los Angeles Times Blog publishes that media commentators Glenn Beck and Rush Limbaugh have apparently fallen prey to the loony websites of the anti-vaccine folks and that Beck would do “the exact opposite” of what the government recommended and attend a swine flu party. October 9th, The Christian Science Monitor publishes that ‘the vaccine is opposed, moreover, by naturopaths and even a well-known epidemiologist’ and that Glenn Beck from Fox News has devoted hours to ask ‘why the World Health Organization, “Big Pharma,” and the government are hyping a pandemic’?
    Read the full article with all media references @
    notepad publishing (a non-profit news agency based in Switzerland)

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