Merck’s $1 Billion-a-Year Gardasil Vaccine Garners Another Safety Endorsement
For the past few years, the Merck (MRK) Gardasil vaccine for HPV, or human papillomavirus, has been a source of controversy. Social conservatives and some parents expressed concern that vaccination would be interpreted by teenagers as a green light for premarital sex. Merck complicated its own cause by conducting a surreptitious marketing campaign to encourage state officials nationwide to require mandatory vaccination for teenage girls.
Meanwhile, some parents questioned the safety of the vaccine, which is promoted to prevent cervical cancer, and asked the FDA to rescind approval. And last year, Gardasil became caught up in the Republican presidential primary campaign, when Congresswoman Michele Bachmann repeated unproven claims the vaccine caused mental retardation and questioned ties between Merck and Texas Governor Rick Perry, who approved the mandate in his state (see Pharma news).
Now, though, Merck is finally receiving some welcome news. A study published in the Archives of Pediatric & Adolescent Medicine shows that Gardasil was associated with fainting on the day of vaccination and skin infections for up two weeks later, but there was no link found with more serious health issues. The study, which was required by the FDA and the European Medicines Agency, examined Kaiser Permanente data of 190,000 females who were tracked for 60 days after receiving the vaccine.
Just the same, the findings are a boost for the drugmaker, which has had to cope with negative publicity that likely contributed to lagging vaccine rates among teenage girls, according to a study issued last year (see Pharma news). During the six months ended June 30, Gardasil revenue increased 24 percent, to $608 million, according to a recent regulatory filing.
For a company -- and an industry: hello Pfizer (PFE), AstraZeneca (AZN), Eli Lilly (LLY), GlaxoSmithKline (GSK), Sanofi (SNY) -- struggling for revenue growth, due a lack of new blockbusters and also to patent expirations on existing drugs, any positive movement is highly welcome.
“The take-home message is this is a very reassuring finding,” Nicola Klein, the lead study author and co- director of the Kaiser Permanente Vaccine Study Center, tellsBloomberg News. “Patients and providers should be aware to follow the Centers for Disease Control and Prevention guidelines for 15 minutes after this vaccine.” Last year, a database study of seven managed care organizations by the CDC and Kaiser failed to find a significant increased risk of fainting.
Gardasil, for those who may not recall, was initially approved for females between the ages of 9 to 26, and the FDA three years ago expanded approval to boys and men for preventing genital warts caused by certain types of HPV. A full course of Gardasil is supposed to include three doses over six months. Merck, by the way, does warn about such side effects as swelling, itching, pain, fainting, and bruising and redness at the injection site.
However, the drugmaker and public health officials have been on the defensive over side effect concerns. For instance, Judicial Watch, a conservative group, has regularly released reports about large numbers of adverse events and earlier this year, trumpeted a study that purportedly underscored its view (see this and this). The group has claimed Gardasil was associated with 26 deaths in the year ending Sept. 15, 2011, last year, as well as seizures, paralysis and blindness (read here).
However, the Kaiser review board determined that increases in the risk of experiencing epilepsy or convulsions after inoculation was not associated with the vaccine, Klein tells Bloomberg, adding that the board also analyzed 14 deaths and determined these were not associated with Gardasil. But one researcher who worked on developing Gardasil continues to raise the possibility that rare side effects may occur.
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