Pharma company clarifies on effects of Gardasil vaccine

The Hindu

‘Clinical trials evaluating safety have included more than 25,000 women from 33 countries’

‘Conducting long-term follow-up studies to confirm whether immunity is long-lasting’

NEW DELHI: MSD Pharmaceuticals Private Limited, the company that markets Gardasil in India, has said that the vaccine can help prevent cervical, vulvar and vaginal cancers and genital warts caused by the HPV (human papilloma virus) types 6, 11, 16 and 18, as also some protection against 10 additional cervical cancers.

‘Ten years of research’

“Gardasil is the result of over 10 years of research and development. As part of the rigorous scientific vaccine clinical development programme, clinical trials evaluating the efficacy and safety of the vaccine have included more than 25,000 women from 33 countries from around the world,” a statement issued by the company said in response to criticism of its clinical trials in India reportedly carried out in an unethical manner.

In India, the Indian Academy of Paediatrics Committee on Immunization (IAPCOI) stated that the HPV vaccine was of public health importance and recommended giving it prior to sexual debut.

U.S. recommendations

In 2006, the United States Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices recommended that girls and women between 11-26 years be vaccinated with an HPV vaccine such as Gardasil, the statement said.

While it is difficult to determine the exact number of doses administered, since its launch in 2006, more than 55 million doses of the anti-cancer vaccine have been distributed worldwide as part of the global fight against HPV diseases. The statement claimed that MSD has established a robust surveillance programme to monitor the long-term safety, efficacy and duration of protection of people vaccinated with Gardasil.

“MSD monitors vaccine safety by conducting analyses of adverse events reported to MSD, and we share these adverse event analyses with regulatory and medical authorities around the world.

Preliminary studies

“Preliminary studies conducted to date have encouragingly demonstrated that there is no waning of protective immunity at five years following vaccination.

“MSD is conducting long-term follow-up studies to confirm whether immunity to HPV disease is long-lasting,” the statement said.

Information reviewed

While no vaccine or medicine is completely without risk, leading international health organisations throughout the world — including the Drug Controller-General of India, World Health Organisation, the CDC, Health Canada, the European Medicines Agency (EMEA), and the Australia Therapeutic Goods Administration (TGA), among others — have reviewed all of the safety information available to them about Gardasil and continue to recommend its use, the statement added.

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Author: Leslie Carol Botha

Author, publisher, radio talk show host and internationally recognized expert on women's hormone cycles. Social/political activist on Gardasil the HPV vaccine for adolescent girls. Co-author of "Understanding Your Mood, Mind and Hormone Cycle." Honorary advisory board member for the Foundation for the Study of Cycles and member of the Society for Menstrual Cycle Research.