India suspends Merck’s cervical cancer vaccine Gardasil study after deaths of four girls in Khammam district

Indian government has suspended Merck’s cervical cancer vaccine Gardasil study in two states following reports of deaths of 4 girls and several complications.

Gardasil was to be tested for its “acceptability and service delivery issues” in about 32,000 girls aged 10-14 in the southern Indian state of Andhra Pradesh and Western state of Gujarat.

Gardasil vaccination programme is being conducted jointly with PATH, a Seattle-based NGO, the Indian Council of Medical Research (ICMR) and the two state governments. The vaccination drive is funded by the Bill and Melinda Gates Foundation

PATH-International, which is conducting the study for the maker of Gardasil Merck, an American pharmaceutical company since July 2009, has described the study as a “demonstration project.”

The human papilloma virus (HP) vaccine HPV vaccine Gardasil, meant to prevent cervical cancer among women, has been alleged to have led to the death of the four girls who were administered the dose in Khammam district of Andhra Pradesh.

Besides the death, more than 120 girls, who were given the vaccination, have complained severe adverse reactions of stomach disorders, epilepsy, headaches and early menarche.

The cervical cancer vaccination study is not part of the universal immunisation programme of the country and PATH had claimed it was a promotional programme for the vaccine in India. ICMR had clarified that it was, indeed, a clinical trial, human rights NGOs alleged.

Villagers in these states were told that Garadasil was an expensive vaccine and that they would not be able to afford it once the company’s project was over, hence they should get their daughters vaccinated, they alleged.

MSD Pharmaceuticals (India), the local affiliate of Merck & Co., Inc USA launched Gardasil a quadrivalent human papillomavirus vaccine. Gardasil is the only vaccine that helps protect against 4 types – types 6, 11, 16, 18 – of HPV. The vaccine helps prevent diseases such as cervical cancer; abnormal and precancerous cervical lesions, vaginal lesions, vulvar lesions; and genital warts, caused by these types of HPV, MSD said while announcing the launch.

Gardasil is recommended to be given to females aged between 9 to 26 years.

Announcing the launch, Dr. Naveen A. Rao, managing director, MSD India, said, “ With the launch of Gardasil,we have initiated the war against Cervical Cancer, the number one cause of mortality amongst Indian women due to cancer. In line with our commitment to putting patients first, MSD India will work with partners and communities to enhance awareness for the disease and access for the vaccine.”

Gardasil contains recombinant virus like particle (VLPs) assembled from the L1 proteins of HPVs 6, 11, 16 and 18. Since VLPs lack the viral DNA, they cannot induce cancer. They do, however, trigger an antibody response that protects vaccine recipients from becoming infected with the HPV types represented in the vaccine.

As per available data, till February 2009, 40 million doses of Gardasil had been distributed worldwide. There is no evidence the vaccine has caused serious adverse effects. According to the Centers for Disease Control, the vaccine was tested in over 11,000 women and girls (ages 9 to 26).

Fainting is more common among adolescents receiving the Gardasil vaccine than in other kinds of vaccinations. Patients should remain seated for 15 minutes after they receive the HPV vaccine. It is also reported that the shot is more painful than other common vaccines. General side effects of Gardasil may include joint and muscle pain, fatigue, physical weakness and general malaise.

Gardasil cannot be taken if you have or have had an allergic reaction after getting a dose of Gardasil or  a severe allergic reaction to yeast, amorphous aluminum hydroxyphosphate sulfate, polysorbate.

Gardasil is not recommended for use in pregnant women,  have immune problems, like HIV infection, cancer, or you take medicines that affect your immune system,  have a fever over 100°F (37.8°C)

Gardasil is a shot that is usually given in the arm muscle. Three shots are given on the following schedule:

• Dose 1: at a date you and your health care provider choose.

• Dose 2: 2 months after Dose 1.

• Dose 3: 6 months after Dose 1.

Gardasil, sold in 109 countries, generated $1.4 billion for Merck.

Sales of Gardasil fell 33 percent worldwide to $262 million and 39 percent in the U.S. in the first quarter, Merck said. Gardasil, approved in 2006 in girls and women ages 9 to 26, hasn’t been embraced for older girls within that age group, Merck said.