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Sanofi warned over flu vaccine plant problems

FDA describes French company's response to concerns over contamination as ìinadequateî

Sanofi-aventis (S-A) has received a formal warning from the US Food and Drug Administration (FDA) for failing to remedy problems that caused contamination of a concentrate used to make flu vaccine.

In March, the French company reported to the FDA that ìa small proportionî of the concentrate had failed sterility testing, but assured the regulator that none of it had been used in finished flu vaccine shots and all of it had been destroyed. The FDA subsequently inspected S-A's manufacturing plant in Swiftwater, Pennsylvania in mid-April and gave the company a list of its concerns about general manufacturing practices there.

The FDA has since determined that S-A's response to the concerns was ìinadequateî and issued a warning letter dated June 20.

ìThe fact that no further sterility failures have occurred since early April is a good sign,î said Karen Midthun, deputy director of the FDA biologics centre. ìHowever, the fact that no root cause for failures has been identified to date means we can't know for sure if the problem has been corrected.î

The FDA ordered S-A to provide details within 15 working days on how it would fix the problems.

S-A said in a statement that it took the warning letter ìvery seriouslyî.

ìActions have been underway to address the agency's findings since the inspection, and we have been reporting our progress weekly during communications with the FDA,î said S-A. ìWe are confident we will meet our manufacturing goal of approximately 50 million doses of influenza vaccine for the US market [in the autumn].î

S-A said it planned to make 10 million fewer doses of the vaccine, called Fluzone, due to more manufacturers making it this year.

David Johnson, director for scientific and medical affairs at the company's vaccine unit, Sanofi Pasteur, said the contamination was probably caused by a faulty filtration system and contamination was limited to 11 batches of ingredients used to provide protection against one of the three strains targeted by the seasonal flu vaccine.

Flu vaccines are notoriously complex to manufacture and vulnerable to contamination problems. Two years ago, US firm Chiron had to delay release of 50,000 doses of influenza vaccine after serious contamination problems at one of its plants.

30th September 2008

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