The FDA has approved the new cervical cancer vaccine, Cervix

The Food and Drug Administration of the United States, the FDA, this week approved the new cervical cancer vaccine Cervarix from the pharmaceutical company GlaxoSmithKline.

The new vaccine protects against five strains of the human papillomavirus, which are responsible for causing most cases of cervical cancer. The vaccine is more than 98% effective in protecting against papilloma virus strains 16 and 18 and also protects against 3 more common strains (45, 31, 33) that cause the disease.

So far, the vaccine has been approved in 100 countries around the world, including Israel, including the 27 member states of the European Union, as well as Australia, Brazil, South Korea, Mexico and Taiwan. In addition, it was approved this week by the Japanese Ministry of Health and became the world's first cervical cancer vaccine available in Japan. The vaccine has been submitted for registration in more than 20 other countries and even to the World Health Organization (WHO).

As of today, the vaccine is already sold in Israel with the approval of the Ministry of Health in all health funds and military clinics in Israel, which are operated by a doctor's visit, at a price of approximately 333 to 402 shekels per injection for women aged 10 to 45.

Doron Shalit, CEO of GlaxoSmithKline (GSK) Israel stated that: "This is a vaccine that is a significant breakthrough against the malignant disease that affects women in the prime of their lives. I hope that following the approval, more women around the country and the world will go to get the vaccine, which provides broad, effective and long-term protection and significantly reduces the risk of contracting the disease and dealing properly with its spread."

FDA approval - was based on clinical trial data in over 30 countries that included nearly 30,000 girls and young women. The FDA's decision included a thorough evaluation of the vaccine's safety profile and an in-depth examination of the common side effects, which are pain, local redness and swelling, fatigue, headache, joint and muscle pain, gastrointestinal symptoms, and fever.

And in the meantime it was learned that recently the most important international journal in the world, The Lancet journal, reported dramatic results for a new and comprehensive study of its kind with the participation of 18,644 women and girls aged 15 to 25 from 14 countries throughout Europe, Asia, North America and Latin America which tested the effectiveness Cervix vaccine in the prevention of cervical cancer. The study determined that Cerverix unequivocally protects against five strains of the human papillomavirus, which are responsible for causing cervical cancer - a greater number of strains than was known until now that can be prevented with the help of the vaccines available in the world to prevent the disease. The study determined that Cerverix is ​​more than 98% effective in protecting against papilloma virus strains 16 and 18 and also protects against 3 more common strains (45, 31, 33) that cause the disease. This increases the protection provided by Cervix by up to 16% more and amounts to a significant protection against 5 common strains that cause cervical cancer. The study was conducted by an extensive team of researchers from the University of Helsinki in Finland led by Professor Jorma Paavonen who participated in writing the article published in the latest issue of Lancet, the most important international medical journal in the world. The study proved for the first time that Cerverix is ​​effective in its protection against a wide spectrum of the virus strains that are not included in the vaccine and can cause disease and in particular strains 45, 31, 33. While until now it was known that the vaccines available in the world can only protect against two strains.

A previous study determined that Cerverix creates a better immune response than Gardasil
Previous results of a large-scale, first-of-its-kind comparative study published for the first time in May 2009 at the 25th International Medical Conference on the Papilloma Virus, in Malmo, Sweden, also determined that Cerverix creates a better immune response compared to Gardasil. This is the first comparative study in the world that tested the two vaccines approved in the world for use against the human papilloma virus designed to prevent cervical cancer. The comparative study examined two key indicators of the immune response, which are neutralizing antibodies and type B memory cells, which play an important role in protecting the woman in the long term. The study revealed for the first time conclusive medical evidence that the two vaccines (Cervix and Gardasil) do not lead to the creation of the same immune response against the papillomavirus strains 16 and 18, the two most common strains of the virus causing cervical cancer. These conclusions help illustrate the protective potential of Cervix in preventing cervical cancer and precancerous lesions caused by the human papilloma virus strains included in the vaccine. The study was conducted by Dr. Mark Einstein, from the Albert Einstein College of Medicine in New York, Prof. Peter Stern, from the Cancer Research Institute at the University of Manchester in England, and Dr. Anne Szarowski from the Cancer Research and Epidemiology Institute in England.

Servix in Israel
In Israel Cerverix is ​​the only vaccine prescribed for girls and women in Israel from the age of 10 to 45 as part of the supplementary insurances of all health insurance funds at a price of approximately NIS 333 to NIS 402 per injection. The vaccine is given in three doses of an injection in the arm over a period of six months, with the second injection being given about a month after the first injection and the third injection being given about six months after the first injection. The vaccine, as mentioned, is intended for girls and women between the ages of 10 and 45, compared to Gradasil, which is currently suitable for women up to the age of 26 only.

on cervical cancer in Israel and around the world
• According to the data of the Cancer Society, about 180 women are diagnosed every year in Israel with cervical cancer, most of them as a result of the human papilloma virus.
• According to global assessment data, cervical cancer is the second most common malignant disease among women under the age of 45 in developed countries, with approximately 500 women diagnosed with cervical cancer every year, a number that is expected to increase every year and even double by the year 2050 if preventive measures such as vaccination are not taken.
• Every year about 270 thousand women die from cervical cancer and it is the third leading cause of death in the world, after breast cancer and lung cancer.

As part of its social and health responsibility, GlaxoSmithKline Israel recommends to the female public that, at the same time as using the vaccine to prevent cervical cancer, one should persist in periodic Pap tests for the early detection of cervical cancer, according to the recommendation of the attending physician. It is also recommended to have protected sex by using a condom to reduce the risk of contracting the human papilloma virus and the AIDS virus.