The Bureau of Food and Drugs (BFAD) recently approved Merck Sharp & Dohme's (MSD) quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine for use in women up to 45 years old. The MSD cervical cancer vaccine is now indicated for girls and women age 9 to 45. The vaccine prevented 91 percent persistent infection, cervical intraepithelial neoplasia (any grade), and external genital lesions caused by HPV types 6, 11, 16, and 18 compared with placebo (sugar pill), in women aged 24 through 45, according to new data presented during a press conference in Manila.
According to Dr. Ricardo Manalastas, Jr. of the UP-Philippine General Hospital and lead clinical investigator in the Philippines, "the primary results evaluated women – approximately one third (31 percent) of which were from Asia (Philippines and Thailand) who were free of infection from at least one vaccine HPV type when they began the study, and who remained free of infection with the relevant HPV type(s) until they completed the three‐dose vaccination regimen."
“Women are at significant risk for acquiring HPV infections and developing HPV‐related diseases throughout their lifetime. The international multi‐center study, designed to examine if the MSD cervical cancer vaccine is effective at reducing disease and persistent infection caused by HPV types 6, 11, 16, and 18, involved more than 3,800 women approximately one third (31 percent) of which were from Asia (Philippines and Thailand). Women included in the study also had no history of: LEEP (loop electrosurgical excision procedure) or hysterectomy; biopsy‐diagnosed cervical HPV disease in the past five years; or history of genital warts."
"Because the MSD vaccine is designed to prevent HPV 6, 11, 16, and 18 disease, rather than treat ongoing infection, the primary analysis of the study was conducted among women who were free of infection with at least one of the relevant HPV types at the start of the trial (baseline), remained free of infection with the relevant type(s) throughout the course of the vaccination period, and who received all three doses of vaccine and placebo," explained Dr. Manalastas.
Dr. Efren Domingo, president of the Asia-Oceania Research Organization in Genital Infection and Neoplasia (AOGIN) and another lead clinical investigator in the Philippines, said that "in the Philippines, 2005 data showed that there were reported 7,277 new cases and 3,807 deaths due to cervical cancer. It meant that at least 10 Filipino women die each day due to cervical cancer."
"Cervical cancer is most likely to develop among women 35 years or older. If not detected and treated early, cervical cancer could be fatal. The problem is that most women do not bother to have themselves screened for cervical cancer. A study by the University of the Philippines-Philippine General Hospital (UP-PGH) found that less than 40 percent of Filipino women had ever had a Pap smear. Women who are in the prime of their lives need to be protected from HPV that continue to infect about half of all people at some point in their lives," Dr. Domingo added.
"There are ways a person can reduce his or her risk of infection by staying in a long-term, mutually monogamous relationship with an uninfected partner or limiting the number of sexual partners; practicing protected sex using condoms, in particular but the level of protection from HPV infection with condom use has not yet been determined; refrain from any sexual genital contact with someone who has the virus; and women should talk to their doctors about having regular Pap screening tests and discuss results with them. But the more recent effective way is vaccination. Since cervical cancer is caused by a virus, vaccines work well in preventing the infection," Dr. Domingo further explained.
In the Philippines, the MSD vaccine was approved by BFAD in October 2006 and is indicated for children and adolescents 9 through 17 years of age and women 18 through 45 years of age for the prevention of cervical, vulvar, and vaginal cancers; precancerous or dysplastic lesions; genital warts; and infections caused by Human Papillomavirus (HPV).
The MSD cervical cancer vaccine is contraindicated in individuals who are hypersensitive to the active substances or to any of the excipients of the vaccine. The MSD vaccine is not recommended for use in pregnant women.
As for any vaccine, vaccination with the MSD cervical cancer vaccine may not result in protection in all vaccine recipients. The MSD vaccine is not intended to be used for treatment of active genital warts; cervical, vulvar or vaginal cancers; cervical intraepithelial neoplasia (CIN), vulvar intraepithelial neoplasia (VIN), or vaginal intraepithelial neoplasia (VaIN).
MSD cervical vaccine is approved in more than 92 countries
The MSD cervical cancer vaccine has been approved in more than 92 countries, including the United States, the 27 countries of the European Union, Mexico, Australia, Taiwan, Canada, Philippines, New Zealand and Brazil, and additional applications are currently under review with regulatory agencies in many more countries around the world.
MSD is a global research-driven pharmaceutical company dedicated to putting patients first. MSD currently discovers, develops, manufactures and markets vaccines and medicines to address unmet medical needs. For more information about cervical cancer prevention, visit www.everythingican.com.ph.