FDA committee to deliberate on Cervarix for HPV

Washington, September 5 -- Cervarix, a vaccine developed by GlaxoSmithKline Biologicals for treating human papilloma virus (HPV), will be reviewed for a probable sanction by the Food and Drug Administration (FDA) advisory committee on Wednesday in Washington.

Cervarix.jpg

The new vaccine is helpful in guarding against two strains of HPV that are responsible for 70 percent of cervical cancer cases.

The information that has been put in order for the FDA committee’s meeting points out that the effectiveness of the vaccine is up to 93 percent, which is almost the same as that of Merck’s Gardasil.

Cervarix already available in Europe
Cervarix has already been given a stamp of approval in Europe. However, its entry into the U.S. was held up because there was some evidence that the vaccine could actually lead to an even higher increase in the cases of muscular and neurological problems than Gardasil.

But elaborate studies have revealed that Cervarix does not cause any such problems.

Apart from this, the FDA panel will also take into account an application submitted by Merck for giving consent to the use of Gardasil in boys and young men.

Gardasil’s advantage over Cervarix debatable
Gardasil not only helps in providing protection against two strains of HPV that cause cervical cancer, it also shields against two other strains that are the reason for 90 percent of genital warts in males.

These strains have also been associated with cancers of the penis and anus. Gardasil is one up on Cervarix in this respect as these other two strains are not covered by Cervarix.

However, experts have different views regarding Gardasil. They believe that it is very costly and the $400 cost for a three-dose cycle does not justify the advantages it gives to women.

This cost-benefit ratio further declines in men as genital warts are mostly self-limiting. Moreover, less than one percent of the population is affected by penile and anal cancers. Furthermore, experts also mention the fact that it is still not certain as to how long Gardasil can guard against the HPV strains.

Despite all these arguments, the fact remains that if the male population is vaccinated then the sexually transmitted viruses will not be able to enter females.

It is being highly awaited as to what the FDA advisory committee will finally say but its decisions are not binding on the FDA.

Human Papilloma Virus (HPV)
A human papilloma virus (HPV) invades the epidermis and mucous membranes of humans and infects them. It is the major cause of the cancers of cervix, vulva, vagina, and anus in women. It can lead to cancers of the anus and penis in men.

There are almost 130 different types of HPV that have been identified so far. While some types can cause warts, others can lead to development of cancer. Some strains of HPV show no symptoms at all and do not harm the human body in any way.