Vietnam Investigates Approval Of HPV Vaccines
Make a commentBy Ed Silverman // December 22nd, 2008 // 7:29 am
The health ministry will investigate allegations that Merck and Glaxo ran inappropriate lobbying campaigns before their vaccines were approved for use, according to the Vietnam News Agency.
On July 24, Deputy Health Minister Cao Minh Quang, who is also a deputy health minister, approved the sale of Merck’s Gardasil for females aged nine to 26 years. Then, on November 18, he also approved Glaxo’s Cervarix vaccine for females aged 10-55 years.
However, Do Gia Canh, head of the Clinical Experiment Department under the National Institute of Hygiene and Epidemiology, says Cervarix should not have been approved for the 10-55 age group, since the EU did not allow women beyond 24 years of age to use the vaccine. There is, unfortunately, no additional info about the probe, other than that the ministry will review approval procedures.
For its part, the ministry argues that 40 countries have approved the vaccine for women above 10 years old; two countries for women aged 10 to 55 years old age; and six countries for women aged 10 to 45 years old.
According to Prof. Nguyen Ba Duc, head of the Cancer Treatment and Prevention Institute in Ha Noi’s K Hospital, the vaccines supposedly protect women for life. But the vaccines have been in circulation for only three years, and the claims had not been conclusively proven, he said
A Glaxo spokesman send us this: “As in all countries in which we operate, GSK followed the approval procedure appropriate for Vietnam and provided by the Vietnamese Ministry of Health. GSK received approval for Cervarix based on submitted data appropriate for that country and there were no issues with the dossier. GSK did one safety and tolerability study in Vietnam, which is a local requirement for registration. It recruited 225 women aged 25-40 years old.
“We take any allegations seriously and are watching this situation carefully. We have not received a letter from the Vietnam Ministry of Health regarding any contravention of the approval process. GSK has a good working relationship with the Vietnamese authorities and speaks to the Ministry daily and we are satisfied that all requirements have been met.”
UPDATE: A Merck spokesman writes us with this reply: “Merck is fully cooperating with the Vietnam Ministry of Health (MoH) to review the applications for registration visas for cervical cancer vaccines in Vietnam. We anticipate and trust that the MoH review will be resolved in the very near future in the best interests of Vietnamese women.”
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Cervarix, Gardasil, GlaxoSmithKline, HPV Vaccines, Merck, Vaccines, Vietnam