I wondered if I had read this correctly at first, but it's true. FDA announced it refused approval for Merck's HPV vaccine for use in women 27-45, as it had not demonstrated to 'prevent' HPV-related cervical cancer in women older than 26.
This is a real blow and setback to Merck's marketing department, as FDA had previously postponed and refused approval for this age demographic, even after requesting and reviewing additional studies.
The vaccine is already approved to protect against the 6, 11, 16 and 18 strains of the human papillomavirus, which can lead to cervical cancer, in girls and women ages 9 to 26. Gardasil is also approved to prevent genital warts, anal cancer, anal dysplasias and precancerous lsesions in males of the same age.
It's no surprise that Gardasil sales have slowed substantially, from $1.4 billion in 2008 to $988 million last year.
Gardasil has been a hot button for Laguna Natural Health. Read more about Gardasil in the LNH blog archives.