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Monday, December 22, 2008

Team to probe vaccine approvals

Source

An inspection team has been set up to investigate allegations that drug-makers ran inappropriate lobbying campaigns before their cancer vaccines were approved for use in Vietnam.

Vietnamese Health Minister Nguyen Quoc Trieu said the teams would investigate the actions of Merck Sharp & Dohme (MSD) and GlaxosmithKline (GSK), the makers of the Gardasil and Cervarix cervical cancer vaccines.

MSD’s Gardasil, which protects women against four strains of human papillomavirus (HPV) -- HPV-6, 11, 16, and 18 -- and GSK’s Cervarix HPV, which targets HPV-16 and HPV-18, were approved by Deputy Health Minister Cao Minh Quang.

However, questions have been raised about approval for the drugs to be used for women aged 10 to 55 instead of only for women aged 10 to 25.

Inspectors will review the research and assessment procedures for the drugs and whether drug-makers’ lobbying was appropriate.

Deputy Health Minister Trinh Quan Huan was assigned to lead the 15-day investigation. The results of the probe will be reported to the ministry.

More about GSK’s Cervarix:

SSHHHHHERVARIX

LOLA'S LAND PROMOTING HPV VACCINE

More debate on GSK's Cervarix


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