Gardasil vaccine: description and instructions for use

To prevent a large number of serious and fatal diseases, a calendar of mandatory vaccinations has been created, which every person should receive.

The Gardasil vaccine appeared on the pharmacological market not so long ago, but has already managed to gain popularity and interest many people.

Some experts believe that this vaccine is an ideal tool for the prevention of oncological processes in the genital area, others are sure that the vaccine has not been sufficiently studied and there is no data on the full period of life of vaccinated patients.

In what cases is the drug prescribed?

The vaccine is indicated for use in children and adolescents – 9-15 years old, as well as women – 16-45 years old for prevention:

• precancerous dysplastic conditions, as well as cervical cancer, which are provoked by oncogenic strains of the papillomavirus;
• genital papillomas on the genitals, which are associated with various types of HPV;
• cervical intraepithelial neoplasia;
• oncology of the anal canal provoked by HPV.

Description of the drug

Gardasil is a white opaque suspension. Enter it intramuscularly.

Manufacturer and packaging

The Gardasil vaccine was created by the American company Merck & Co, it appeared in Russia in 2006. Vials with a volume of 3 ml are packed in cardboard packs of 1 or 10 shields. The kit includes disposable pins 1 or 6 pcs., sterile needles – 6 or 12 pcs. packaged.

Composition and dosage form of the drug

0.5 ml of suspension contains 120 µg of human papillomavirus L1 protein, as well as excipients:

• amorphous aluminum hydrophosphate-sulfate adjuvant – 225 mcg;
• sodium chloride – 9.56 mg;
• L-histidine – 780 mcg;
• polysorbate – 50–80 mcg;
• sodium borate – 35 mcg;
• water for injections.

Pharmacological properties of the vaccine

The vaccine has an antiviral effect. After a full course of vaccination in the human body, specific antibodies are formed to certain types of HPV, namely 6, 11, 16, 18.

According to ongoing studies, in 99% of vaccinated patients, protection against oncology of the genital organs, precancerous dysplasia and genital warts, provoked by certain types of HPV, was maintained for at least 4.5 years after vaccination. The vaccine forms protective immunity with the development of a cellular and humoral immune response against HPV.

Pharmacokinetics

No data available due to lack of research.

Efficacy and duration of drug exposure

The clinical efficacy of the drug has been confirmed by a large number of studies of vaccinated girls, boys, adolescents, men and women. In women aged 16 to 26 years, the vaccine prevented the development of oncology and precancerous conditions of the female genital organs in 98% of cases.

In women about 34 to 45 years of age, the effectiveness of the vaccine was 88.7%.

In men and boys, the vaccine effectively prevented the occurrence of external genital neoplasms in 90.6% of cases, as well as anal intraepithelial neoplasia in 77% of cases.

In women who received an additional dose of the vaccine after 5 years, a rapid and pronounced immune response was observed, and the geometric mean antibody titers were higher than the titers that were measured after the primary vaccination.

Dosage regimen, HPV vaccination schedule

Gardasil is injected into the deltoid muscle of the shoulder or the anterolateral region of the thigh, intramuscularly.

Maintenance is carried out in three stages of 0.5 ml, according to the following scheme:

• the first time – any day;
• the second time – 2 months after the first injection;
• the third time – 6 months after the second injection.

Instructions for use

Instructions for using a single dosage:

• open the ampoule, observing all the rules of hygiene;
• draw 0.5 ml of the drug solution from the vial into a disposable syringe with a sterile needle. The ampoule with the remnants of the drug must be immediately discarded and disposed of;
• treat the site of the proposed injection with 70% medical alcohol;
• inject the contents of the syringe.

For injection, you can use the needle that is included in the package. To do this, remove the protective cap from the syringe – press on the existing protrusions, then connect the syringe to the Luer needle – turn it clockwise. Then remove the protection.

After the introduction of the vaccine, the patient’s reaction should be observed for half an hour. It is quite common for young women to faint.

Special instructions for vaccination

If the patient has a high fever or an exacerbation of a chronic illness, the doctor may reschedule the vaccination date. In case of problems with blood clotting, as well as in the presence of thrombocytopenia, the administration of the vaccine should be carried out as carefully and slowly as possible, since there is a risk of bleeding after a muscle puncture.

Pediatric use

In children under 9 years of age, studies on the safety and efficacy of the Gardasil vaccine have not been conducted.

Use during pregnancy and lactation

During lactation, the introduction of the vaccine is not prohibited. Studies on the safety and efficacy of the vaccine during childbearing have not been conducted.

The potential effect of the drug on the fetus and reproductive function of women has not been studied. There is no evidence that the vaccine adversely affects fertility in any way.

For elderly patients

Studies on the use of the vaccine in patients of the older age group – after 45 years of age have also not been conducted.

Contraindications for use

Gardasil is not recommended to be administered to the patient in the following cases:

• the presence of HPV in the body;
• age up to 9 and over 45 years;
• a situation where close relatives of the patient had a pronounced reaction to the vaccine;
• weakened immunity.

Relative indications include:

• pregnancy;
• blood clotting disorder.

Possible side effects

It is impossible to call the Gardasil vaccine safe, the following side effects may appear:

• redness at the injection site;
• local allergic reaction in the form of urticaria;
• temperature increase;
• muscle pain;
• malaise, weakness, dizziness, nausea, headaches.

In severe cases, loss of consciousness, blockage of blood vessels, or shock is possible.

drug interaction

It has been established that the Gardasil vaccination can be combined with hepatitis B vaccination, in another part of the patient’s body, of course.

Taking analgesics, corticosteroids, vitamins, antibiotics, hormones (including contraceptives), anti-inflammatory drugs has no effect on the safety of the vaccine. The effect of immunosuppressive drugs on the vaccine has not been studied.

Combining vaccination with alcohol

Combining Gardasil vaccination and alcohol is not recommended, the combination of ethanol and the active components of the vaccine can lead to an unpredictable reaction.

Cost, and conditions for dispensing from pharmacies

The cost of 1 dose of the vaccine ranges from 6,000 to 7,000 rubles. You can buy a drug only with a doctor’s prescription.

Duration and storage rules

The vaccine can be stored only at a temperature of +2 to +8 degrees, the drug should not be exposed to direct sunlight, the shelf life is 3 years from the date of release of the drug.

Analogues

The Gardasil vaccine has only one analogue – Cervarix . This is a Russian vaccine produced by GlascoSmithKline Trading. Both Gardasil and Cervarix have the same composition, so there is no way to determine which one is more effective.

Patient reviews and doctors’ opinion

Uvarova NL, immunologist. “I consider vaccination against the human papillomavirus an extremely necessary measure. According to my observation, the Gardasil vaccine is quite effective and is a reliable protection against serious diseases, especially since cervical cancer is becoming an increasingly urgent problem every year.”

E.D. Miroshnichenko, gynecologist. “The papillomavirus is not as scary as it is positioned. In most cases, a person lives with this virus all his life, and this neighborhood does not affect his health in any way.

I am sure that you should not go to extremes, but for effective prevention of erosion and other serious violations, regular visits to the antenatal clinic are sufficient.

It also requires timely diagnosis of the presence of the virus, and the right approach to treatment. As for the Gardasil vaccine and its analogue Cervarix, their effect on the human body has not been studied enough, therefore, it is not worth the risk.

Yuryina G.A., gynecologist. “I recommend vaccinating girls before sexual activity. Unfortunately, the growth of oncology of the genital organs in women is becoming more significant every year. The HPV vaccine  can protect younger generations from dangerous diseases.”

Orekhova Julia, 25 years old, Yekaterinburg. “I got vaccinated with Gardasil a month and a half ago, there were no side effects. I will complete the course completely, and I highly recommend that all people protect themselves from the papillomavirus.”

Daria Samoilova, 32 years old, Omsk. “After the vaccination with Gardasil, my head ached a lot, but all the negative phenomena ended there. Do not be afraid of vaccination – this is a necessary measure in the modern world.

Maria Kirsanova, 23, Barnaul. “Vaccination with Garesil is terrible. Immediately after the introduction of the vaccine, I lost consciousness. When the doctors brought me back to my senses, my head was splitting and I vomited. Side effects lasted more than a day. I will no longer be vaccinated with this remedy. ”

Reviews of doctors and patients about Gardasil vaccination are ambiguous. Of course, this is due to the fact that the vaccine has not yet been sufficiently studied, and has many side effects.

Upon careful reading of the instructions, you can see that research on Gardasil has been carried out for only a few years, and surveys of vaccinated individuals, for example, during menopause, have not yet been conducted. It is necessary to decide on the appropriateness of vaccination in each case individually.