[SaneVax: Last year India called a halt to two clinical trials of HPV vaccines being conducted under the title of ‘demonstration projects’ due to allegations of multiple serious ethics and safety violations. After much investigation, the Union health ministry is expected to initiate punitive actions. Let’s hope health authorities in other countries are watching, paying attention, and beginning their own investigations.]
Health ministry to initiate action against violations in HPV vaccine trial soon
By Ramesh Shankar, Mumbai
The Union health ministry will soon initiate punitive action against violations in the clinical trial of human papilloma virus vaccines (HPV vaccines) in Andhra Pradesh and Gujarat in early 2010 in which six children were allegedly died after they were administered the controversial vaccine being marketed by MSD Pharmaceuticals (Gardasil) and GSK Pharmaceuticals (Cervarix).
Sources in the union health ministry said that the files regarding this issue are being examined by the senior officials in the ministry and there will be some action on the issue very soon.
After the alleged deaths of six children, the trials were suspended on April 7, 2010 and the Union health ministry appointed a three-member expert committee to investigate ethical issues raised in the matter.
The final report of the panel had ruled out direct linkage between the deaths and the trials held in Khammam (where 13, 791 girls were vaccinated) and Gujarat’s Vadodara (where 9,637 were vaccinated). But at the same time, it said “the reported deaths were most probably unrelated to the vaccine. However, the cause of death in all cases could not be established with certainty”.