Consumers who have vaccinated their young daughters against cervical cancer would be closely following a case at the Supreme Court, regarding the safety of cervical cancer vaccines.

The SC had earlier this week sought a response from the Government, following a Public Interest Litigation that alleged cervical cancer vaccines were not safe and were being sold locally without adequate safety and efficacy tests.

With the licencing of the two vaccines on the SC radar – the Government, through its response, will have to clear the air on the products and trials they were put through, before they were approved for sale locally.

Gardasil, the cervical cancer vaccine from Merck Sharp & Dohme (MSD), was launched in India in late 2008, while GlaxoSmithKline Pharmaceuticals launched its Cervarix in early 2009.

The vaccines came in for scrutiny some years ago, following the death of tribal girls who had participated in feasibility studies evaluating the use of cervical cancer vaccines for mass vaccination.

The studies, undertaken by non-government organisation PATH, used MSD’s vaccine in a study in Andhra Pradesh, while GSK provided vaccines for a study in Gujarat.

About 25,000 young girls had been vaccinated by the two projects. And the Indian Council of Medical Research had played an advisory role to the project, whose agreement had been signed in 2007.

In fact, Rukmini Rao, co-petitioner in the PIL, told Business Line that consumers need to demand for more data on the vaccine, besides information on adverse events linked to the vaccines reported from other countries.

GSK, MSD respond

Since the issue was in Court, the two companies did not want to comment in detail on the development.

A GSK spokesperson said, “we understand that we have been made party in the proceedings but no papers have yet been served on us; once we receive the papers we would be filing our reply before the Supreme Court.” GSK’s vaccine continues to sell in the market.

In its response, MSD reiterated the “proven safety and efficacy of our vaccine, Gardasil, which is the result of over ten years of research and development and since its launch in 2006, more than 80 million doses of the vaccine have been distributed world-wide.”

Gardasil is recommended by several health authorities and is part of the national immunisation programme in several countries across the globe, the spokesperson said, adding “MSD has launched Gardasil in India after following all necessary local regulations and procedures”.

The World Health Organisation data estimates approximately eight women die every hour in India due to this disease, with nearly 73,000 deaths reported every year. Gardasil (HPV vaccines) play an important role in helping reduce the burden of HPV-related diseases, including cervical cancer, the spokesperson said, without commenting on whether the product was still selling in the market.