GSK submits cervical cancer vaccine for EU approval
We haven't yet posted about Merck's and GSK's vaccines against human papillomavirus (HPV), a sexually transmitted infection best known as the cause of cervical cancer (among other effects). By June, however, this will be the biggest vaccine ethics issue getting public attention.
A quick summary of where we stand today for those not following the developments closely... Both Merck (Gardasil) and GSK (Cervarix) have HPV vaccines nearing licensure. There are over 100 subtypes of the virus, but 2 are responsible for about 70% of cervical cancers. Both vaccines provide protection against these HPV subtypes. The Merck product also includes 2 additional subtypes that are the leading causes of genital warts in both males and females. As a result, both genders could directly benefit from Merck's vaccine, while the GSK product will target only females.
In the race to be the first on the market, Merck is in the lead, having submitted licensure applications in the U.S. and EU in December '05. Today's news courtesy of Reuters is that GSK submitted for EU approval of Cervarix. A decision is not expected for about a year. Their U.S. application is even farther behind; it's not expected until late 2006.
The reason why June is important is that two events scheduled for that month will determine the fate of Merck's Gardasil -- likely FDA approval early in the month followed by a recommendation from the CDC's Advisory Committee on Immunization Practices a few weeks later.
Why the likelihood of controversy? Several groups -- notably the Family Research Council -- have already expressed concerns about mandating HPV vaccination as a requirement for school entry. Why? 1) HPV is sexually transmitted. 2) To be maximally effective, the vaccine should be administered to pre-teen girls (age 11-13, perhaps as young as 9). 3) A key concern among some of these groups is that vaccinating girls of this age will encourage sexual activity -- a phenomenon known as 'behavioral disinhibition'. (It should be noted that there's no evidence that human papilloma virus is much of a factor at all in teens' sexual behavior -- factors such as pregnancy, religion, and risk of HIV dominate.) 4) These decisions should be left to families, they argue.
The FRC has tempered their position compared to comments made in this Fortune piece last October previewing the debate. Rather than broad opposition to the vaccine in principle, their key objection at this point is mandating vaccination for school attendance rather than leaving it a parental decision. The battleground is set for the June ACIP meeting and subsequent decisions by state departments of health.
The topic is more complex than this short preview allows. While it isn't on many people's radars just yet, the Fortune piece was right in dubbing it "the coming storm". We'll stay on top of it.
A quick summary of where we stand today for those not following the developments closely... Both Merck (Gardasil) and GSK (Cervarix) have HPV vaccines nearing licensure. There are over 100 subtypes of the virus, but 2 are responsible for about 70% of cervical cancers. Both vaccines provide protection against these HPV subtypes. The Merck product also includes 2 additional subtypes that are the leading causes of genital warts in both males and females. As a result, both genders could directly benefit from Merck's vaccine, while the GSK product will target only females.
In the race to be the first on the market, Merck is in the lead, having submitted licensure applications in the U.S. and EU in December '05. Today's news courtesy of Reuters is that GSK submitted for EU approval of Cervarix. A decision is not expected for about a year. Their U.S. application is even farther behind; it's not expected until late 2006.
The reason why June is important is that two events scheduled for that month will determine the fate of Merck's Gardasil -- likely FDA approval early in the month followed by a recommendation from the CDC's Advisory Committee on Immunization Practices a few weeks later.
Why the likelihood of controversy? Several groups -- notably the Family Research Council -- have already expressed concerns about mandating HPV vaccination as a requirement for school entry. Why? 1) HPV is sexually transmitted. 2) To be maximally effective, the vaccine should be administered to pre-teen girls (age 11-13, perhaps as young as 9). 3) A key concern among some of these groups is that vaccinating girls of this age will encourage sexual activity -- a phenomenon known as 'behavioral disinhibition'. (It should be noted that there's no evidence that human papilloma virus is much of a factor at all in teens' sexual behavior -- factors such as pregnancy, religion, and risk of HIV dominate.) 4) These decisions should be left to families, they argue.
The FRC has tempered their position compared to comments made in this Fortune piece last October previewing the debate. Rather than broad opposition to the vaccine in principle, their key objection at this point is mandating vaccination for school attendance rather than leaving it a parental decision. The battleground is set for the June ACIP meeting and subsequent decisions by state departments of health.
The topic is more complex than this short preview allows. While it isn't on many people's radars just yet, the Fortune piece was right in dubbing it "the coming storm". We'll stay on top of it.
posted by J. Schwartz at 9:50 AM
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