Health ministry reviews cancer vaccine to check on claims

HCM CITY — The Health Ministry on Wednesday launched an investigation into the procedures used to approve two cervical cancer vaccines that entered the market this year.

The investigation reviews the clinical trials and regulatory approvals made in Viet Nam for the two drugs Gardasil and Cervarix.

Gardasil is manufactured by the US pharmaceutical company Merck Sharp-&Dohme and Cervarix by the UK drug company GlaxoSmithKline.

Deputy Health Minister Trinh Quan Huan said the results of the investigation should be completed within 15 days.

On July 24, Cao Minh Quang, who is also a deputy health minister, approved the sale of the Gardasil for females aged nine to 26 years.

On November 18, he also approved the Cervarix vaccine for females aged 10-55 years. (Japan gave its approval for Cervarix in September 2009, and the FDA of the United State gave its approval in October 2009.)

Do Gia Canh, head of the Clinical Experiment Department under the National Institute of Hygiene and Epidemiology, said 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.

However, the ministry said 40 countries have approved the vaccine for women above 10 years old; two countries for women aged 10-55 years; and six countries for women aged 10-45 years.

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.