MSD Pharmaceuticals (India), the local affiliate of Merck & Co., Inc., Whitehouse Station, N.J., USA today announced the launch of GARDASIL® [Quadrivalent Human Papillomavirus (Types 6, 11, 16 & 18) Vaccine], India’s first vaccine to help prevent Cervical Cancer caused by the HPV types contained in the vaccine.
GARDASIL® [Quadrivalent Human Papillomavirus (Types 6, 11, 16 & 18) Vaccine] is the only vaccine that helps protect against 4 types (Types 6, 11, 16, 18) of HPV. The vaccine helps prevent diseases such as cervical cancer; abnormal and precancerous cervical lesions, vaginal lesions, vulvar lesions; and genital warts, caused by these types of HPV. GARDASIL® is recommended to be given to females aged between 9 to 26 years. GARDASIL® [Quadrivalent Human Papillomavirus (Types 6, 11, 16 & 18) Vaccine] is also the only USFDA approved vaccine to help prevent against cervical cancer and other diseases caused by HPV types contained in the vaccine.
Cervical Cancer, or cancer of the uterine cervix, is a serious disease that can be life-threatening. This disease is caused by certain high-risk HPV types that can cause the cells in the lining of the cervix to change from normal to precancerous lesions. If these precancerous lesions are not diagnosed early and treated, they may turn cancerous after a few years. Cervical Cancer takes the lives of 8 women in India every hour. 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% life time risk to get Cervical Cancer, which is double the risk as compared to the data worldwide (1.3%).
Announcing the launch, Dr. Naveen A. Rao, Managing Director, MSD India, said, “MSD India is committed to addressing diseases of high burden in India. With the launch of GARDASIL®,we have initiated the war against Cervical Cancer, the number one cause of mortality amongst Indian women due to cancer. In line with our commitment to putting patients first, MSD India will work with partners and communities to enhance awareness for the disease and access for the vaccine.”
Dr. Neerja Bhatla from the All India Institute of Medical Sciences (AIIMS, New Delhi) said, that “Placebo controlled, double blind, randomized, multicentric studies done in more than 20,000 females across 5 continents show that in women who did not have evidence of exposure to HPV types contained in the vaccine GARDASIL® provides 98% protection against cervical pre-cancers caused by HPV types 16 & 18, which are responsible for 70% of all Cervical Cancer cases worldwide. Similarly, in large placebo controlled, double blind, randomized, multicentric studies, the vaccine has also been proven to be 99% effective in the prevention of genital warts caused by HPV types 6 and 11, which are responsible for 90% of all genital warts cases worldwide. In India the number of cases is increasing every year. This is a very promising breakthrough but women must remember that they still need to visit their doctors for regular screening for cervical and other cancers” she added.
Also present at the launch, Dr. Y. K. Amdekar, from Jaslok & Breach Candy Hospital, Mumbai (who is also Ex president of Indian Academy of Pediatrics) said, ” This quadrivalent HPV vaccine, has demonstrated efficacy in a number of diseases including Cervical Cancer and Genital warts. HPV vaccination is now unequivocally recommended by the IAP Committee of Immunization (COI) for females over the age of ten. This decision is based on expected high impact on public health in future as it will help prevent mortality due to cervical cancer in women in their prime age and keep families united and safe. We will be counseling parents about the risks of cervical cancer and the role of HPV while recommending the vaccination”
According to the Indian Academy of Pediatrics Committee of Immunization (IAPCOI) 2008 recommendations: “This vaccine has a favorable tolerability profile and the IAP-COI recommends offering HPV vaccine to all females as per label. The recommended age for initiation of vaccination is 10-12 years and catch up vaccination is permitted up to the age of 26 years. It is recommended to be given in three doses at 0, 2 and 6 months.”