Two years ago, Merck & Co. got approval for its
Gardasil, the first cervical cancer vaccine to block four types of human
papilloma virus, a sexually transmitted virus, which can cause cervical cancer
and genital herpes. It was the first time a company succeeded to come up with
such a vaccine.
The vaccine was approved for use in girls and women aged 9
to 26 in order to prevent future infections.
Its approval was based on studies involving about 11,000
people who only experienced mild to moderate reactions, such as pain or
tenderness at the injection site.
One year later, the Centers for Disease Control and
Prevention added Gardasil to its childhood immunization schedule, which was
also good news.
Since its approval, more than 26 million doses of Gardasil
have been distributed globally, including nearly 16 million in the U.S., Merck
reported.
However, good news appears to head to an ending, as Gardasil’s
success is presently shadowed by some 7,802 reports of adverse events in people
who received it. The Vaccine Adverse Events Reporting System (VAERS), a system
of monitoring vaccines’ side effects belonging to the CDC and the Food and Drug
Administration, registered the reports between June 8, 2006 and April 30, 2008.
These reports include 15 deaths and 31 cases of
Guillain-Barre syndrome, a life-threatening condition in which the body’s
immune system attacks part of the nervous system, eventually leading to
paralysis.
Merck defended the vaccine in a statement reading that a
report of an adverse reaction “does not mean that a causal relationship between
and event and vaccination has been established – just that the event occurred after
vaccination,” CNN reported.
The reports are currently studied by the company, the CDC
and the FDA to establish if there was a direct link between the signaled
adverse effects and the vaccine.
Cervical cancer is the second most common cause of cancer
death in women worldwide, resulting in nearly a half-million diagnoses and
280,000 deaths each year. In 2007, there were an estimated 11,000 new cases of
cervical cancer and 3,600 deaths in the US.
Currently Gardasil is the only cervical cancer vaccine on
the market. It has racked up about $1 billion in sales since its June 2006 U.S.
launch.
After the reports were made public, Merck’s shares dropped
4.8 percent.