Wednesday, December 10, 2014

Gardasil 9® Gets FDA Approval Nod, Just As Dr. Gerberding Is Promoted "Up and Out" Of Merck's Vaccines Businesses

Dr. Gerberding certainly has earned the right to take a victory lap, as she is promoted -- and point toward this new approval as being her handiwork -- at the vaccines businesses helm.

While the vaccine now protects against a greater portion of cancer causing viral strains, it remains to be seen whether US vaccination rates will ever achieve the levels Merck had originally hoped for, in younger girls (and boys) when it started marketing the original version of quadrivalent Gardasil®. Here's a link to the FDA's announcement -- and a bit from it:

. . . .The U.S. Food and Drug Administration today approved Gardasil 9 (Human Papillomavirus 9-valent Vaccine, Recombinant) for the prevention of certain diseases caused by nine types of Human Papillomavirus (HPV). Covering nine HPV types, five more HPV types than Gardasil (previously approved by the FDA), Gardasil 9 has the potential to prevent approximately 90 percent of cervical, vulvar, vaginal and anal cancers.

Gardasil 9 is a vaccine approved for use in females ages 9 through 26 and males ages 9 through 15. It is approved for the prevention of cervical, vulvar, vaginal and anal cancers caused by HPV types 16, 18, 31, 33, 45, 52 and 58, and for the prevention of genital warts caused by HPV types 6 or 11. Gardasil 9 adds protection against five additional HPV types—31, 33, 45, 52 and 58— which cause approximately 20 percent of cervical cancers and are not covered by previously FDA-approved HPV vaccines.

“Vaccination is a critical public health measure for lowering the risk of most cervical, genital and anal cancers caused by HPV,” said Karen Midthun, M.D., director of the FDA’s Center for Biologics Evaluation and Research. “The approval of Gardasil 9 provides broader protection against HPV-related cancers. . . .

While this is clearly good news for Whitehouse Station, it is also clearly a product that will cannibalize almost all the old Gardasil revenue -- so it may not result in much incremental new revenue for the company. Now you know.

1 comment:

Anonymous said...

Well, don't you think new/incremental revenue would come from eating away the GSK Cervarix competitor product? Gardasil 9 is now clearly medically superior and more cost effective outcomes-wise.