SHANGHAI - Merck recalled more than 100,000 doses of its HIB vaccines exported to China, as part of its global initiative to recall certain lots of PedvaxHIB and Comvax vaccines due to sterilization concerns.
On Dec. 12, the U.S.-based pharma company announced the recall of 11 lots of its Haemophilus influenzae type B vaccine, PedvaxHIB, and two lots of its combination Haemophilus influenzae type B/ hepatitis B vaccine Comvax after quality-control checks found that production equipment might not have been properly sterilized.
“There are 104,930 doses of PedvaxHIB of this lot in the Chinese market which need to be recalled,” Merck's Chinese subsidiary, Merck Sharp & Dohme China, told PharmAsia News.
“Merck is conducting this recall because it can not assure sterility of these specific vaccine lots,” added MSD.
The potential contamination of the lot was identified as part of the company's standard evaluation of its manufacturing processes, according to MSD.
MSD informed all levels of government agencies, dealers and the CDC in China in accordance with China's new Drug Recall Provision and cooperated with regulatory authorities to implement a full recall, according to the company.
On December 13, China’s State FDA received the recall initiative from MSD’s Beijing Office.
SFDA coordinated the recall and asked all units to immediately stop using the vaccine batches and to closely monitor adverse reactions after injection.
“The recall progressed very rapidly, with the full support of all the relevant departments,” said MSD. “As of December 21, all of the vaccines have been recalled to Merck's importers.”
SFDA requested that MSD investigate potential safety problems and submit a detailed assessment report of recall plans.
MSD said that no adverse reactions were reported for this batch of vaccines.
“Sterility tests of the vaccine lots that are the subject of this recall have not found any contamination in the vaccine,” said MSD. “For single doses, the possibility of this kind of contamination is low and even if the possibility exists, the level of contamination is also low.”
“In China, only a very small number of the vaccines are being used,” said MSD. “The recall does not affect any other batches of Merck’s PedvaxHIB or other products.”
“The recall will not affect MSD too much,” Xia Qian, an analyst at Beijing-based Orient Health Ecommerce, told PharmAsia News. “The vaccine is to be taken on personal expense, and so only a few were used in China.”
– Ying Huang (pharmasia@elsevier.com)
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