Behind the H1N1 Vaccine Shortage

Despite the media focus on manufacturers of the H1N1 vaccine there are many reasons behind the delay in deliveries.

Dr. Scott Gottlieb, former deputy commissioner of the FDA, this morning summarized his thoughts in an op-ed piece in the Wall Street Journal and suggested that the conservative nature of the FDA is partly to blame.  It is worth repeating for my readers.

Several regulatory policy decisions have played a part in creating the shortage.

  1. The decision to forgo vaccine additives – additives, or adjuvants, can stimulate the body’s immune system thus reducing the amount of raw vaccine required per dose.
  2. The need for a single shot – vaccines require preservatives, in this case mercury-containing thimerosal, and single shots cut the amount of preservative needed.
  3. Continued use of chicken eggs to grow the raw vaccine material – there are other more advanced technologies in use around the world, however they are not approved by the FDA

Dr. Gottlieb goes on to suggest ways to improve our process to adequately prepare for the next pandemic.

  1. Create a review pathway allowing for the use of adjuvants – a newly approved vaccine for cervical cancer contains an adjuvant.
  2. Develop better release assays allowing for quicker shipment – currently vaccines need to sit for weeks after manufacture to make sure they haven’t grown impurities.
  3. Invest in more modern manufacturing facilities – current facilities cannot support new methods for growing the virus nor can they scale quick enough.

The world population is always susceptible to a new virus.  Our ability to react quickly to an outbreak is of national importance.




About Mike

Mike has been an executive in the biotechnology industry for the past 20 years. Mike is a graduate of University of California, Santa Barbara, earning Bachelors degrees in Business Economics and Geography. Mike also earned his MBA in Finance from California State University, Fresno. Mike is married to the mother of his 3 children and currently lives outside of Boulder, CO. In his spare time Mike enjoys hiking, fishing, skiing, reading and coaching basketball.
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