Concerns raised about flu vaccine supply, again

FDA investigates sterility problems

Problems with a major flu manufacturer have raised the possibility of another vaccine shortage or delay this fall. The FDA issued a warning letter to Sanofi Pasteur citing "significant deviations from current good manufacturing practices."

FDA investigators said there were sterility failures in 11 vaccine lots manufactured between February 2006 and April 2006, and that the company had not sufficiently investigated those concerns. The FDA also cited other quality control and record-keeping deficiencies.

"At this time, the deficiencies noted in the inspection of Sanofi Pasteur's Swiftwater, PA, manufacturing facility are not expected to significantly affect the availability of Fluzone for the 2006-2007 flu season, but we continue to review the progress made by the company," the FDA said.

The Centers for Disease Control and Prevention in Atlanta projected that about 100 million doses would be available for 2006-2007, an increase of about 16% from last year. Yet it cautioned that health care providers should have contingency plans in case of supply disruptions.

The agency asks health care facilities to prepare for both best- and worst-case scenarios: "[D]evelop plans for expanding outreach and infrastructure to vaccinate more persons than last year and develop contingency plans for the timing and prioritization of administering influenza vaccine, if the supply of vaccine is delayed and/or reduced."1

Vaccination efforts should continue through December, "and possibly later." If there is a shortage, the live, attenuated influenza vaccine (available as FluMist for nasal administration) "should be used preferentially for all healthy persons aged 5 to 49 years (including health care workers) to increase the availability of inactivated vaccine for groups at high risk," the CDC says.


1. Centers for Disease Control and Prevention. Prevention and control of influenza: Recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR 2006; 55 (Early Release):1-41.