No recall for glass found in vaccines made in Monroe County
December 31st, 2016
December 10, 2016 - Story reported by Sam Kennedy of the Morning Call - 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.
Nonetheless, the U.S. Food and Drug Administration has warned that lamellae could cause serious health problems such as an adverse immune system reaction. When confronted with glass contamination, medical manufacturers have erred on the side of caution, alerting the public and issuing sweeping product recalls.
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.
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