More Than 60 Side Effect Cases Linked to Merck & Co.'s Gardasil

February 6, 2015
By Jessica Wilson, BioSpace.com Breaking News Staff

Gardasil, Merck & Co. human papillomavirus (HPV) vaccine has been linked to more than 60 cases of severe side effects, including one death in Canada, said a news report Friday, sparking debate about one of the world’s most common vaccines, which is routinely give to children.

Gardasil is administered to protect girls and women from HPV, which is the most common sexually transmitted virus in the U.S., according the U.S. Centers for Disease Control (CDC) and can lead to complications like cervical cancer. “Almost every sexually active person will acquire HPV at some point in their lives,” the CDC reports on its web site. For this reason, the CDC recommends that girls and boys at age 11 or 12 years receive the HPV vaccine, which is most effective if administered before a person becomes sexually active.

With a caveat that no conclusive evidence exists between the side effects reported and Gardasil, the article cataloged the experiences of five women who believe the vaccine caused their conditions. The article’s subtitle reports that, “at least 60 Canadians experienced debilitating illnesses after inoculation” since the vaccine’s 2006 approval.

Kaitlyn Armstrong explained that by her third injection of the vaccine, which is administered in a series of three shots over the course of six months, pain had “spread through her body…migrating from her back to her knees to her hips.” Part of the issue is that Kaitlyn is allergic to metal and the vaccine contains aluminum salts. Although Kaitlyn informed the nurses who administered the vaccines of her allergy, none of them informed her of the aluminum salts in Gardasil.

Natalie Kenzie reported she “developed egg-size lumps on the soles of her feet, her joints swelled and her limbs twitched uncontrollably” sometime after she received the first injection.

Annabelle Morin died in the bathtub two weeks after receiving the second injection of the vaccine. The Quebec coroner’s office ruled the death a drowning, but also said, “that any role Gardasil might have played should be further investigated,” according to the Star.

The Star reviewed side effect reports in Health Canada’s database and discovered Frédérick St-Germain, a 14-year-old who had a heart attack some time after her vaccinations. A cardiologist suspected Gardasil caused the heart attack, reported the Star.

Jen Keats, the last woman profiled, experienced nausea, weakness and migraines after receiving the shots.

The approval of the vaccine was based on clinical trials that involved 11,000 patients. Of these patients, five had reactions that could “probably or definitely” be related to the vaccine.

“I’m extremely comfortable that this is a safe vaccine,” Jennifer Blake, president of the Society of Obstetricians and Gynecologists of Canada, told the Star.

---

BioSpace Temperature Poll
Will Hiring Heat Up in 2015? With companies as large as Biogen Idec and as small as ICON upping their hiring across the board, where do you think the biotech job market will go in 2015? BioSpace wants your opinion!