MSD Pharmaceuticals, the wholly-owned subsidiary of global leader Merck, which had launched its vaccine against cervical cancer in India, has tied up with Indian Council for Medical Research (ICMR) for a long-term study on the feasibility of the product for a possible universal vaccination programme in the country.
Gardasil, the vaccine for the prevention of fatal cervical cancer and genital warts caused by certain types of HPV, has been used in many countries for universal vaccination and will be used for the same in the country also, depending on the outcome of the study, company sources said.
The company, which had already done the required trials before the introduction of the same sometime back, was approached by the government for a three-year study on larger number of subjects and to prove its immunity and hence the ICMR and MSD signed the public private partnership programme. The study would be done on at least 600 girls, from across the four regions of the country. The company has already given necessary documents and results to the ICMR in this regard.
Besides, Bill and Melinda Foundation has also given support to the company to carry out an extensive study for three years on the similar lines in Maharashtra and Karnataka. "We are ready to ensure the supply of this vaccine at affordable prices for the government programme if the government takes a move for universal vaccination programme," MSD managing director Naveen A Rao disclosed at a recent media workshop.
Meanwhile, Merck is also in the process of developing a similar vaccine for boys between nine to 15 years and antibody responses in the trials were said to be encouraging. Trials are also going on for the vaccine on women between the age of 16 and 21 and the findings have already been submitted to the US FDA for approval, sources said.
Cervical cancer takes the lives of eight women every hour in India. It is the commonest cause of cancer deaths among Indian women, and the second most common cause of cancer deaths among women worldwide.
Every year, almost 74,000 women die due to cervical cancer in India, which is more than one fourth of the world deaths due to cervical cancer. Woman in India have a 2.5 per cent life time risk to get cervical cancer, which is double the risk as compared to the data worldwide (1.3 per cent).
Many countries, including the US, Canada, Australia and several European Union member states, already recommend routine HPV vaccination for pre-adolescent girls, usually coupled with catch-up programmes for adolescent girls and young women. Several of these countries, including the US, Australia, Germany, France, Sweden and Italy, have started publicly-funded vaccination programmes.