Pharmaceutical

Malaysian government set to vaccinate girls with Gardasil

SM Mohammed Idris, president of the Consumers Association of Penang, recently wrote an opinion piece for the Malaysia Kini website, asking that the government reconsider its decision to vaccinate all 13-year-old girls in the country with Gardasil or Cervarix. According to the column, the country’s Ministry of Health (MOH) will spend RM 150 million annually for the vaccinations, which will affect about 300,000 girls. Idris warns the vaccine is “unnecessary, unscientific and unsafe.”

Gardasil, manufactured by Merck & Co., and Cervarix, manufactured by GlaxoSmithKline, are promoted for the prevention of the human papillomavirus (HPV), a sexually transmitted virus linked to the development of cervical cancer. However, the vaccines only treat four of the more than 40 types of HPV, and experts say studies show that the human body naturally eliminates more than 90 percent of HPV infections, making the vaccine irrelevant and redundant. Medical professionals also point out that pre-cancerous lesions can be safely detected with regular annual Pap smears, eliminating the need for the vaccine.

The columnist also points out that the HPV vaccine is controversial because of its spotty safety record. In the United States, the Vaccine Adverse Event Reporting System (VAERS) has logged consumer complaints about serious adverse events following the Gardasil vaccine, including pulmonary emabolism and Guillain-Barre syndrome, as well as more than 50 reports of death among girls who received the vaccine. It is estimated that the number of adverse events linked to these vaccines may be even higher, as not everyone who experiences a serious side effect reports it.

Gardasil was approved by the U.S. Food and Drug Administration (FDA) for use in 2006, and Cervarix by the FDA in 2009.

In addition to its concerns about the efficacy and safety of HPV vaccines, the Consumers Association of Penang is concerned about the plan for the MOH to work in conjunction with the Ministry of Education to administer the vaccine to the school-age girls without providing additional information about the vaccine to their parents. At the very least, Idris says, the MOH must provide parents with the opportunity to exercise their right to informed consent by supplying them with comprehensive information about the vaccination process and the risks involved.