Showing that drug product safety concerns cut both ways, Chinese officials pulled more than 100,000 vials of a childhood vaccine manufactured by Merck (MRK) from Chinese shelves. However, it may be better to import than to produce domestically, as China officials claimed that parents need not be worried because foreign-sourced drugs are subjected to regulatory scrutiny before they are allowed into China. That scrutiny did not stop China from removing the drug from further sales.
The vaccine, known as Hib, protects against meningitis, pneumonia and other infections. It is administered as a three-dose regimen to children under age five. Typically, the first dose is given at the age of two months.
Last Wednesday, Merck made the announcement that it could not guarantee the sterility of a run totaling 1.2 million vials of its Hib vaccine, made in a Pennsylvania manufacturing facility. Once China officials received the recall notice, they realized that almost 10% of the recalled supplies were in China.
The vaccine has been administered since October. So far, no serious adverse effects have been noted. Experts told parents to check for redness around the administration site as a precaution.
The 1.2 million vials of possibly-contaminated vaccines made their way to eight municipalities and provinces in China, including Beijing.
Disclosure: none.
