The US FDA's recent positive finding regarding the safety of the human papillomavirus (HPV) vaccine Gardasil will boost India's efforts to introduce the controversial vaccine in the country. Currently, the Indian Council of Medical Research (ICMR) is gearing up for the phase II trial of the controversial vaccine to study the tolerance level of this new three-stage vaccine among the Indian populace.

Amid rising concerns of consumers, parents, healthcare professionals and others in US over the safety of Gardasil, the US FDA has said that Gardasil is a safe and effective vaccine. The US FDA's latest findings are based on its monitoring system Vaccine Adverse Event Reporting System (VAERS). "As of June 30, 2008, there have been 9,749 VAERS reports of adverse events following Gardasil vaccination. Of these, 94 per cent were classified as reports of non-serious events, and 6 per cent as serious events", the US FDA said.

Ever since the US FDA approved Gardasil vaccine on June 8, 2006 for use in girls and women 9 through 26 years of age, there was severe criticism against the vaccine for fear of adverse effect.

The US FDA said that the Gardasil, produced by US drug multinational Merck & Co, is an important cervical cancer prevention tool that will potentially benefit the health of millions of women. Every year, about 12,000 women are diagnosed with cervical cancer and almost 4,000 die from this disease in the United States. Worldwide, cervical cancer is the second most common cancer in women, causing an estimated 470,000 new cases and 233,000 deaths per year.

In India, the ICMR will soon begin the phase II trial at multi locations in the country including at the Institute of Cytology & Preventive Oncology (ICPO), an arm of ICMR, at Noida near New Delhi. In fact, the ICMR was to begin the trial in April this year, but it could not commence so far as it is waiting for the DCGI approval.

Last year, Union health ministry had signed a memorandum of understanding (MoU) with the US company Merck & Co covering the entire gamut of the trial and its launch in the country. As per the MoU, this pre-introductory trial would be done at several centres in the country including ICPO and it would be done for a duration of 6 months as the three doses will be given at three stages of 0,2,6 months. The success or otherwise of this 'bridge study' would be known in a year's time after the commencement of the study as there would be a 6-month waiting period to observe the subjects, sources said.