No recall for glass found in vaccines made in Monroe County

No recall for glass found in vaccines made in Monroe County
Sanofi Pasteur, one the world’s leading vaccine makers, had a potentially serious and costly problem on its hands: Its Monroe County plant discovered tiny pieces of glass in batches of a vaccine intended for babies.
The glass was first detected in April 2013 in samples of a vaccine that had already been distributed to customers and which would not expire until September 2014.
Sanofi sent the samples to an outside laboratory for analysis. The lab found evidence of delamination — which occurs when vaccine vials shed flakes of glass called lamellae.
The health risks posed to any individual by vaccine vial delamination are widely believed to be minuscule. None has been documented.In at least one case, a manufacturer in 2013 recalled a vaccine with a glass contamination rate that was much lower than the rate Sanofi found in its Haemophilus b conjugate vaccine, or ActHIB.
Sanofi, on the other hand, allowed doctors and nurses throughout the country to continue injecting babies with the potentially problematic ActHIB for another year and a half.
The FDA did not push back, either. After the regulatory agency found out about the issue, it accepted the company’s assurances that the vaccine was safe.
Word of the delamination at Sanofi — the vaccine division of the French pharmaceutical behemoth Sanofi S.A. — would not reach the public until now. The Morning Call has pieced together what happened, including Sanofi’s behind-the-scenes interactions with the FDA, using government documents acquired through the Freedom of Information Act.

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