The US based Merck & Co launched its blockbuster vaccine, Gardasil, claimed to prevent cervical cancer caused by HPV among the women between the age of 9 and 26 through its subsidiary, MSD Pharmaceuticals (India) in October last year. Gardasil, first launched globally in June 2006, is touted to be the only vaccine that can protect women from cervical cancer for life time with three shots within a period of six months. Merck is stated to have distributed 36 million doses of the vaccine across the world so far and trials were conducted in 17 countries involving over 23,000 women. In some countries like Australia, it had been included for the compulsory immunization against cervical cancer for girls below the age of 15. In India too, Indian Council for Medical Research has started a long term clinical study of Gardasil for a possible universal vaccination programme in the country. GSK, another drug multinational, has also managed to launch its cervical cancer vaccine, Cerverix, in the country in March this year to take advantage of the huge market potential and favourable response from the country’s regulatory authorities. Both the companies had presented impressive statistics to the government about the spread and dangers of cervical cancer in the country to get the approval from DCGI.
Proper evaluation of safety and efficacy data of a new drug is critical before it is allowed to be marketed in any country. That is expected to have been done in the case of two HPV vaccines by the office of DCGI before marketing permissions were granted. For both the MNCs, getting marketing approvals in India is very important considering the huge size of the market and the prices at which they are being sold in the market. In the urgency to launch a new drug what is usually overlooked by the pharmaceutical companies is the risk benefit parameters. With the recent death of a British girl soon after administering a HPV vaccine, scientists have started doubting the vaccine’s safety and its need to use among young girls. Usually cervical cancer is found to occur among women aged between 50 to 55 years and risk of developing this cancer is very low among girls less than fifteen years of age. Therefore, promoting the vaccine among young girls needs to be seriously debated by the scientific community. A major concern expressed by scientists is about the vaccine’s ability to cause genotoxicity. Another question is how many years the immunity from this expensive vaccine can last in young girls if at all that is administered. These concerns need to be answered by the regulatory authorities in India especially when ICMR is already undertaking a long term clinical study of Gardasil in the country.