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Chinese SFDA recalls contaminated Merck vaccine

Officials from the Chinese State Food and Drug Administration recall more than 100,000 vials of Hib child vaccines manufactured by Merck & Co in the country

Officials from the Chinese State Food and Drug Administration (SFDA) have recalled more than 100,000 vials of Hib child vaccines manufactured by Merck & Co in the country.

The Hib vaccines, Pedvaxhib and Comvax, which Merck & Co recalled in an announcement on 12 December, protect against meningitis, pneumonia and other infections. It is administered as a three-dose regimen to children under age five. The first dose is normally given at the age of two months.

Merck & Co said it could not guarantee the sterility of 1.2 million vials made in a Pennsylvania manufacturing facility. Once China officials received the recall notice, they realised that almost 10 per cent of the recalled supplies were in China.

The vaccine has been administered since October 2007. Up to now, no serious adverse effects have been noted. Parents have been warned to check for redness around the administration site as a precaution.

The 1.2 million vials of potentially contaminated vaccines were delivered to eight municipalities and provinces in China, including Beijing.

20th December 2007

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