Fainting – main side-effect of cervical cancer vaccine Gardasil

Fainting is likely caused by anxiety over the injection and pain associated with the shot, says Merck

Gardasil, the vaccine against cervical cancer, causes fainting as its most commmon side effects following the injection.

The US-based Merck & Co’s Gardasil causes faniting in eight women for every 100,000 shots. While fainting remains the main side-effect of Gardasil soon after getting injected, the cervical cancer vaccine also lead to irritation around the skin on the injection site and dizziness, according to a government analysis of side- effect reports.

Seven women will have reactions at the area of the injection and seven will become dizzy apart from the eight fainting for every 100,000 shots, according to a study published in the Journal of the American Medical Association and conducted by the Centers for Disease Control and Prevention in Atlanta.

Recepients are advised to remain seated for 15 minutes after they receive the HPV vaccine.

As of February 2009, 40 million doses of Gardasil had been distributed worldwide. Over23 million doses of Gardasil vaccine have been distributed in the U.S. alone since it came on the market in 2006.
Gardasil caused 32 reported deaths in vaccine users, 20 of which were verifiable, and none could be directly linked to the vaccine, reports said.

About 2,000 reported faintings following injection were reported. Among them 200 patients fell and suffered head injuries including fractured skulls that may be prevented if patients rest for 15 minutes after vaccination.

The Gardasil side-effects study has been conducted following concerns raised by privately funded groups such as the National Vaccine Information Center and Judicial Watch.
However, Merck sources maintained that the fainting is likely caused by anxiety over the injection and pain associated with the shot.

A total of 12,424 reports of side effects following injection with the vaccine have been submitted to the US FDA and CDC. This roughly comes about 54 reports for every 100,000 vaccine doses distributed. The side effect notices were made voluntarily by doctors, patients and consumers.

The total number of patients who have received Garadasil injection has not been estimated though more than 23 million doses in the U.S. have been distributed. Gardasil is given in three doses. All patients have not received the full course of shots.

2.5 million girls ages 13 to 17 received the vaccine in 2007, according CDC study last year.

A higher number of blood clots were also reported in those getting Gardasil than with other vaccines. There were 31 verifiable reports of blood clots. The majority of women who had blood clots were also taking birth control pills, which can increase the risk of clotting, the study said.

Gardasil is approved by the U.S. Food and Drug Administration for females ages 9 to 26. The vaccine protects against certain strains of the sexually transmitted human papillomavirus (HPV), which can cause cervical cancer and genital warts. About 4,000 women in the U.S. are projected to die from cervical cancer this year and 11,270 will be diagnosed, according to the National Cancer Institute.

Garadasil is the only cervical cancer vaccine that helps protect against 4 types of human papillomavirus (HPV): 2 types that cause 70% of cervical cancer cases, and 2 more types that cause 90% of genital warts cases. The duration of protection of Gardasil has not been established.

Gardasil costs $360 list price ($120 each for three shots).

Studies predict that vaccinating young women with Gardasil in combination with screening programmes may be more cost effective than screening alone. Many countries have started including cervical cancer vaccines in their vaccination programmes. Canadian government approved $300 million to buy the HPV vaccine in 2008.

MSD Pharmaceuticals (India), the local affiliate of Merck & Co., Inc., Whitehouse Station, N.J., USA launched Gardasil in India in October 2008.

Cervical Cancer, or cancer of the uterine cervix, is a serious disease that can be life-threatening. This disease is caused by certain high-risk HPV types that can cause the cells in the lining of the cervix to change from normal to precancerous lesions. If these precancerous lesions are not diagnosed early and treated, they may turn cancerous after a few years. Cervical Cancer takes the lives of 8 women in India every hour. It is the commonest cause of cancer deaths among Indian women, and the second most common cause of cancer deaths among women worldwide. Every year, almost 74,000 women die due to Cervical Cancer in India, which is more than one fourth of the world deaths due to Cervical Cancer. Woman in India have a 2.5% life time risk to get cervical Cancer, which is double the risk as compared to the data worldwide (1.3%).