Merck’s Gardasil received expanded indication to prevent anal cancer


Gardasil is a vaccine manufactured by Merck & Co. and is approved for prevention of certain types of human papillomavirus (HPV). Girls starting at age 9 are advised to get the vaccine to block the transmission of four strains of HPV, which collectively account for 75% of cervical cancers, 70% of vaginal cancers and 50% of vulvar cancer cases.  Two strains of HPV are responsible for ~90% of genital warts, both in men and women.  Gardasil received approval from Food and Drug Administration (FDA) to expand indication for prevention of anal cancer and associated precancerous lesions.

As per the American Cancer Society, HPV is responsible for around 90% of anal cancer diagnosed in the US every year, which could amount to 5,300 cases and 720 deaths.  In general, more women are diagnosed with anal cancer than men. The main highlights of Merck’s Gardasil vaccine are:

  • Gardasil may prevent 78% of anal lesions and anal cancer in men who have sex with men as per the Clinical data presented by Merck to the FDA.
  • The latest approval...

    for Gardasil covers people aged 9 to 26 for anal cancer.
  • FDA said that Gardasil won’t prevent development of anal precancerous lesions already present at the time of vaccination.

The most common adverse reactions to the vaccine include fainting, injection-site pain, headache, nausea and fever.

It was also reported that the federal government’s Advisory Committee in Immunization Practices is looking into a proposal to extend the recommendation to use Gardasil vaccine to include boys:

  • As an indirect means of preventing the transmission of HPV to women
  • As protection for themselves against anal cancer.

Source: USA Today


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