FDA declines Gardasil’s usage for women aged 27-45

New York, January 10: Another roadblock for the much coveted cervical cancer vaccine, Gardasil, from Merck & Co! The Food and Drug Administration has asked for additional information before it approves Gardasil for women aged between 27 and 45.

It is pertinent to mention that the FDA had approved the use of this vaccine in females aged 9 through 26 in June 2006 itself.

When the FDA had rejected the administration of Gardasil on older women the first time in June 2008, Linda Bannister, an analyst for Edward Jones, had averred that the medicine faces an uncertain future. She had truly opined, "It's hard to get a feel for if this is a dead issue or if this is delayed. At the minimum, it's going to be delayed."

Gardasil, the signature cervical cancer vaccine from Merck & Co is used to prevent the initial establishment of human papillomavirus (HPV) infections. It also protects against vulvur and vaginal cancers. Gardasil targets four strains of the human papillomavirus (HPV) namely, type 6, type 11, type 16 and type 18 responsible for over 20,000 HPV caused cancers annually.

The vaccine's effectiveness diminishes as women get older; therefore the company had difficulty in getting the insurers’ nod. Sanford Bernstein analyst, Tim Anderson, observed, "Gardasil's efficacy drops sharply once females have been exposed to HPV and this is probably the genesis of the problem with the older female population that Merck has been pushing for in this new application."

The FDA’s decision does not, in any manner, impact the use of the drug in the approved age group. Nor does it impact Merck's recently filed request to expand the vaccine’s use to males. Merck research chief, Peter Kim, said, "Merck is committed to continuing to pursue the use of Gardasil in this important group of women - many of whom remain at risk for HPV-related disease throughout their lifetimes."

Merck revised its 2009 sales guidance of $23.7 billion to $24.2 billion. The company’s shares fell approximately 3 percent in midday trading.