Cervical Cancer Vaccine Nearing FDA Review
Cervical Cancer Vaccine Nearing FDA Review
1 Vaccine to Be Submitted This Year; Other Vaccines Are in the Works
Oct. 31, 2005 -- A vaccine against the leading causes of cervical cancer will soon be up for FDA review.
The vaccine, called Gardasil, is being filed for consideration "imminently," Eliav Barr, MD, told reporters in a conference call. Barr works for Merck Research Laboratories. Merck is Gardasil's developer. Merck is a WebMD sponsor.
"By the end of the year, we'll be submitting a regulatory file to the U.S. and other countries as well," says Barr.
"The regulatory process occurs at the regulators' speed. So when they're ready, we'll know. A typical regulatory approval process is six to 12 months, something like that," he says.
WebMD reported in October on Gardasil's phase III clinical trials, the last set of studies required for FDA review.
Gardasil targets four types of HPV (HPV 6, 11, 16, and 18). Two of those types -- HPV 16 and 18 -- are together responsible for 70% of cervical cancers. Gardasil was 100% effective against these two types.
Gardasil can reduce cervical cancer, says Barr. But the vaccine won't completely get rid of the disease.
That's because some cervical cancers aren't caused by the types of HPV targeted by the vaccine. Vaccinated women would still need to get Pap tests to check for abnormalities in their cervical cells.
Also, the vaccine isn't intended to prevent cervical cancer in women who haven't been infected by the HPV vaccine. It's not designed to treat cervical cancer or HPV infection.
HPV is very common. It's transmitted through sexual contact. Many people are infected and don't know it.
HPV doesn't always cause cervical cancer. However, there are 490,000 cases of cervical cancer worldwide per year and 290,000 deaths annually, says Barr.
"You can actually reduce those cancers by administration of a prophylactic [preventive] vaccine," says Barr.
Cervical cancer is an especially big problem in developing countries with limited resources to screen women.
Another cervical cancer vaccine, GlaxoSmithKline's Cervarix, is also in the works. GlaxoSmithKline is a WebMD sponsor.
Cervarix has shown 100% effectiveness against HPV 16 and 18 in phase II studies. Phase III studies of Cervarix are under way.
Other cervical cancer researchers are trying to develop additional vaccines.
One of those vaccines targets an HPV-related protein called L2. That vaccine is made from bacteria, which is "a relatively inexpensive way to make a vaccine," researcher Richard Roden, PhD, of Johns Hopkins University, told reporters in the conference call.
Another possible vaccine is being developed by researchers including Tzyy-Choou Wu, MD, of Johns Hopkins University. It uses DNA to target HPV-related proteins in the hopes that the vaccine might help treat as well as prevent cervical cancer.
The vaccines being worked on by Roden, Wu, and colleagues are in the early stages of development.
Cervical Cancer Vaccine Nearing FDA Review
1 Vaccine to Be Submitted This Year; Other Vaccines Are in the Works
Oct. 31, 2005 -- A vaccine against the leading causes of cervical cancer will soon be up for FDA review.
The vaccine, called Gardasil, is being filed for consideration "imminently," Eliav Barr, MD, told reporters in a conference call. Barr works for Merck Research Laboratories. Merck is Gardasil's developer. Merck is a WebMD sponsor.
"By the end of the year, we'll be submitting a regulatory file to the U.S. and other countries as well," says Barr.
"The regulatory process occurs at the regulators' speed. So when they're ready, we'll know. A typical regulatory approval process is six to 12 months, something like that," he says.
Gardasil's Results
WebMD reported in October on Gardasil's phase III clinical trials, the last set of studies required for FDA review.
Gardasil targets four types of HPV (HPV 6, 11, 16, and 18). Two of those types -- HPV 16 and 18 -- are together responsible for 70% of cervical cancers. Gardasil was 100% effective against these two types.
Reducing Cervical Cancer
Gardasil can reduce cervical cancer, says Barr. But the vaccine won't completely get rid of the disease.
That's because some cervical cancers aren't caused by the types of HPV targeted by the vaccine. Vaccinated women would still need to get Pap tests to check for abnormalities in their cervical cells.
Also, the vaccine isn't intended to prevent cervical cancer in women who haven't been infected by the HPV vaccine. It's not designed to treat cervical cancer or HPV infection.
About HPV
HPV is very common. It's transmitted through sexual contact. Many people are infected and don't know it.
HPV doesn't always cause cervical cancer. However, there are 490,000 cases of cervical cancer worldwide per year and 290,000 deaths annually, says Barr.
"You can actually reduce those cancers by administration of a prophylactic [preventive] vaccine," says Barr.
Cervical cancer is an especially big problem in developing countries with limited resources to screen women.
Next Line of Vaccines?
Another cervical cancer vaccine, GlaxoSmithKline's Cervarix, is also in the works. GlaxoSmithKline is a WebMD sponsor.
Cervarix has shown 100% effectiveness against HPV 16 and 18 in phase II studies. Phase III studies of Cervarix are under way.
Other cervical cancer researchers are trying to develop additional vaccines.
One of those vaccines targets an HPV-related protein called L2. That vaccine is made from bacteria, which is "a relatively inexpensive way to make a vaccine," researcher Richard Roden, PhD, of Johns Hopkins University, told reporters in the conference call.
Another possible vaccine is being developed by researchers including Tzyy-Choou Wu, MD, of Johns Hopkins University. It uses DNA to target HPV-related proteins in the hopes that the vaccine might help treat as well as prevent cervical cancer.
The vaccines being worked on by Roden, Wu, and colleagues are in the early stages of development.
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