Merck’s HPV Vaccine Gardasil Shown to Be Safe in Kaiser Study

By Anna Edney - 2012-10-01T21:17:45Z

Merck & Co. (MRK)s Gardasil, the human papillomavirus vaccine to prevent cervical cancer, was shown to be safe in the second large-scale study in the past year of side effects since the drug was approved six years ago.

Fainting and infection were among short-term side effects in a U.S. government-required study of 190,000 females in Kaiser Permanentes California insurance system who were tracked for 60 days after receiving the HPV vaccine. The study today in the Archives of Pediatric & Adolescent Medicine showed patients were six times more likely to have fainted the day of the shot than in the following weeks and 1.8 times more likely to report a skin and subcutaneous tissue infection in the two weeks after.

Gardasil sparked debate in 2007 as 24 states introduced legislation to mandate HPV shots for school girls, despite the lack of long-term safety studies. U.S. Representative Michele Bachmann of Minnesota brought the issue back to light last year at a Republican presidential debate, when she chastised Texas Governor Rick Perry for requiring girls in his state to be vaccinated. Todays report is the second to be published in the past year to show no significant side effects.

The take-home message is this is a very reassuring finding, said Nicola Klein, the studys lead author and co- director of the Kaiser Permanente Vaccine Study Center in Oakland, California. Patients and providers should be aware to follow the Centers for Disease Control and Prevention guidelines for 15 minutes after this vaccine.

The CDC recommends, and Gardasils prescribing information suggests, patients be monitored for 15 minutes after they receive the vaccine.

Merck had committed to studying the short-term safety of the HPV vaccine when the Food and Drug Administration approved Gardasil in 2006. Kaiser conducted the study in todays report with the input of Whitehouse Station, New Jersey-based Merck.

Gardasil and GlaxoSmithKline Plc (GSK)s Cervarix are the only two U.S.-approved vaccines to combat HPV. Mercks Gardasil generated $1.2 billion in revenue last year, while Cervarix brought in $812 million for London-based Glaxo.

Gardasil, initially approved for females ages 9 to 26, had its use expanded by the FDA to boys and men in 2009 for the prevention of genital warts caused by certain types of HPV. The shot is supposed to be given in three doses over six months. Merck warns about possible pain, swelling, itching, bruising and redness at the injection site as well as fainting.

A study of records from seven large managed care organizations by the Centers for Disease Control and Prevention and Kaiser published a year ago didnt find a significant increased risk of fainting associated with Gardasil.

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Merck’s HPV Vaccine Gardasil Shown to Be Safe in Kaiser Study