The New 9 Vaccine against Cervical Cancer and Genital Warts

Vasilios Tanos MD PhD,

Professor of Obstetrics and Gynecology George’s Medical School of London,

University of Nicosia and Aretaeio Hospital, Nicosia

This article aims to provide information about the new 9-potency vaccine (9HPV) against human papillomaviruses (HPV). 9HPV has been administered with absolute success in the USA for the last 2 years and since March 2017 in Europe. 9HPV is now available in Cyprus and it can be administered to girls and boys as well as adults. There is no age limit for vaccination with 9HPV.The main goal of the vaccine is the primary prevention of cervical cancer and genital warts amongst young girls and boys between 9-26 years old. This age spectrum allows maximum sensitization of the immune system and antibodies to provide up to 90% protection against diseases caused by the HPV. It is also important that the vaccine is given at least 1 year before the first sexual intercourse, to exclude any infection with HPV prior to vaccination. Vaccination against HPV is encouraged and offered by medical services to both sexes in 14 countries and only to girls in 70 countries. In 56 countries, is free and usually available in schools for ages of 9-14.

It is estimated worldwide that the use of the HPV vaccine is 350 million doses. Since 2006, more than 210 million doses of 4HPV have been distributed worldwide. Data from many countries has shown efficacy in the 4 potency vaccine against HPV, providing protection from infection and disease-related conditions. Continued surveillance by the Health Authorities worldwide supports the good safety profile of the 4 potency vaccine against HPV and the same applies to 9HPV. Results in the USA show that the 9HPV is safe and well tolerated for the entire post-vaccination interval. An overview of the safety of the HPV vaccine confirms the absence of serious undesirable complications. Fainting episodes and headaches were some of the frequently occurring side effects and fever, redness and injection site swelling associated with use of vaccines in general. The World Health Organization once again confirms the good safety profile of vaccines against HPV and encourages the public to vaccinate against the HPV.

The 9HPV vaccine against genital warts

Warts are a sexually transmitted disease and are mostly due to human papilloma 6 and 11. They usually appear between ages 20-24. They are very infectious and there is 70% probability of transmission after sexual intercourse with an infected partner. The time between infection and disease is 3 to 6 months.

The most effective treatment is the destruction of lesions with special diathermy or laser. In cases where there are up to 5 lesions, warts can be treated with special cream (aldara, podophilin). Any treatment and application can be difficult and often painful, especially if there are warts in the rectum and urethra. Relapse accounts for 30% of the incidents. It significantly affects the quality of life, causing emotional stress and poor psychology with multiple consequences on sexual fertility, increases the risk of miscarriages and obstetric complications.

Wart prevention is achieved by vaccination with 9HPV (Gardasil 9) at an early age and before the first sexual intercourse. Data from 134,393 patients who visited Melbourne’s Sexual Health outpatient clinics between 2004 and 2014 testify to the surprising results of vaccination prevention with 4HPV. The disappearance of genital warts was observed in women and men 4 and 7 years after the start of the 4 HPV vaccination program, with a significant reduction in new cases of genital warts. Overall, in women it decreased from 18.6% to 1.9% (89% reduction) and to heterosexual men from 22.9% to 2.9% (87% decrease). Data from a long-term clinical study in the Scandinavian countries in 1,700 women aged 16-23 years shows that 10 years after vaccination there are the same beneficial effects and a significant reduction in HPV infection incidence.

Prophylaxis from human papillomavirus (HPV) infections.

The vaccine offers primary prevention against HPV. It has no effect on active HPV infections or on established clinical disease and has no therapeutic effect. The vaccine is not intended for the treatment of established HPV-related lesions nor for the treatment of dysplastic lesions of the cervix, vulva, vagina, and anus.

Gardasil 9 is indicated for the active immunization of individuals from the age of 9 years and older against cervical lesions of the cervix, vulva, vagina and anus and warts caused by the types of Human Papilloma Virus (HPV) Vaccine. Vaccination is not a substitute for routine Pap test of the cervix. Since no vaccine is 100% effective and because Gardasil 9 does not provide protection against all HPV types or against HPV infections already present at the time of vaccination, control remains crucial.

9HPV safety – The most common side effect of the vaccine was 84.8% pain at the injection site and 13.2% headache. Most injection site reactions were mild to moderate in intensity. Vaccination with a 9-HPV vaccine should be postponed until pregnancy is complete.

However, embryonic abnormalities in pregnant women receiving either 9HPV or 4HPV vaccines were comparable to the general population. A large number of pregnant women (more than 1,000 outcomes of pregnancy) do not indicate deformity or fetal / neonatal toxicity of the 9HPV vaccine.

Dosage and route of administration of 9 vaccine strength

Gardasil 9 is given in 2 doses to children 9 to 14 years of age at the time of first injection, and provides full coverage. The second dose should be given within 5 and 13 months after the first dose. If the second dose of the vaccine is given earlier than 5 months after the first dose, a third dose should always be given.

Gardasil 9 is given in 3 doses (0, 2, 6 months) to all subjects over the age of 15 at the first dose of the vaccine. The second dose should be given at least one month after the first dose and the third dose should be given at least 3 months after the second dose. All three doses should be given within a period of 1 year if the 0, 2, 6 months are not followed.

Individuals who have been previously vaccinated with a 3-dose regimen of the four-dose vaccine (Gardasil or Silgard) versus HPV types 6, 11, 16 and 18 may receive 3 doses of Gardasil 9. Individuals who have given the 4-fold vaccine 1 or 2 doses can continue to supplement the missing doses so that they have a full coverage of up to 70% of the HPV infection. However, my personal opinion and advice is to give up the 4-strength vaccine at any dose and to be vaccinated with the 9-strength vaccine that offers 90% protection against the HPV infection. When you compare the difference in protection of the 9 vaccine strength which is much higher by 30%, with the difference in cost between the 2 vaccines ($HPV and 9HPV) which is small then this approach is encouraged.

The safety and efficacy of Gardasil 9 in children under the age of 9 years old has not been established. There is no data available.

For older women over 27 years of age

The safety and efficacy of Gardasil 9 in women over 27 years of age and older have not been examined yet. However, experience with the HPV vaccine in older women has demonstrated both the clinical efficacy and the safety of vaccination against the HPA. Women who either themselves or their partners, abandon the monogamous relationship are advised to be vaccinated with the 9th strength vaccine. Also for women who are virgins or unmarried or do not have a stable love affair this is a good preventive and protective measure against genital warts, warts and fertility.

Method of administration

The vaccine should be administered by intramuscular injection. The preferred position is the deltoid region of the upper arm or the upper anterior foreleg area of the thigh.