Flu Shot Shortage Possible Because of Manufacturing Delays


With flu season getting underway, two influenza vaccine makers are facing setbacks in the production of their lots. GlaxoSmithKline and Sanofi have encountered manufacturing issues that have delayed and reduced vaccine distribution in the United States.


GSK’s Canadian flu vaccine plant in Quebec had contamination issues earlier this year. The U.S. Food and Drug Administration issued a warning letter to the plant in June because of endotoxins that caused the contamination. Endotoxins are proteins in the cell walls of gram-negative bacteria that can cause allergic reactions and other health problems. In August, Health Canada approved GSK’s action plan to fix the problems; GSK decided to throw out 20 lots of its Flulaval vaccine over fears of contamination.

Despite that, GSK officials said this summer the company would still be able to meet vaccine production targets for this flu season. That doesn’t appear to be the case now. A GSK spokesman told in-PharmaTechnologist.com the company is expected to deliver 26 to 27 million doses by the end of November instead of the 28 to 33 million originally projected.  GSK said it has shipped 20 million flu vaccine doses since August and has a limited supply available for order by health professionals.


Sanofi Pasteur is experiencing delays in production of is Fluzone influenza vaccine. The company has not disclosed the reason for the delay.

A Sanofi spokesman told in-PharmaTechnologist.com the company is committed to producing and shipping all of the more than 65 million doses it promised for the U.S. market. The company delivered most of its doses in October, but some have continued to ship in November. Sanofi said it is doing everything possible to expedite the process. In addition to GSK and Sanofi, there are five other manufacturers that contribute to the U.S. flu vaccine supply. The Centers for Disease Control and Prevention estimate 151 to 156 million doses will be available this flu season.

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