Gardasil Reactions: HPV Vaccine Safety Questioned, Watchdog Groups Call for Investigation
As reports of Gardasil reactions and deaths of adolescent girls following Gardasil injections increase, the HPV vaccine safety debate continues.
Gardasil is a relatively new vaccination that, if administered before exposure, prevents strains of the sexually transmitted Human Papillomavirus (HPV) that can lead to cervical cancer. Hailed by supporters as a public health breakthrough, the world’s best selling vaccine, and the first vaccine marketed as cancer-preventative in the US, Gardasil was fast-tracked through the approval process by the US Food and Drug Administration (FDA) in 2006 and is now among the Centers for Disease Control and Prevention (CDC) recommended vaccines for girls and women ages 9-26.
But parents of many young girls receiving Gardasil injections say the vaccine caused their daughters serious complications such as seizures, strokes, heart problems, blood clots and deaths. Physicians and experts agree, and say more testing of the drug is needed before Gardasil safety can be known.
At least 32 deaths and nearly 12,000 adverse reactions following Gardasil injections have been reported in the US through the Vaccine Adverse Event Reporting System (VAERS), an FDA and CDC voluntary program. It’s unknown how many additional HPV vaccine reactions and Gardasil deaths have gone unreported to the VAERS. Other countries are seeing Gardasil reactions as well.
In February 2009, Spanish health authorities removed close to 76,000 doses of the vaccine from the market after two teens became seriously ill and were hospitalized in intensive care. The girls each received a Gardasil injection hours earlier under a government vaccine program for adolescents. Both girls recovered, and task of vaccinating adolescents resumed about a week after removing one batch of the vaccine considered suspect.
Of the reported Gardasil reactions in the US, at least 700 involved hospitalization, life-threatening illnesses or death. Among these serious Gardasil reactions were cases of Guillain-Barré Syndrome, a rare disorder causing muscle weakness; blood clots in the heart, lungs and legs; and unexplained deaths. Stating that a common pattern in the adverse HPV vaccine reactions has yet to be discovered, the FDA and CDC has refused to change their position on Gardasil safety.
Watchdog Groups Question Gardasil Safety
The National Vaccine Information Center, a US vaccine watchdog group, is calling for an investigation into deaths and serious injuries believed to be Gardasil reactions. The group is currently gathering signatures in a petition to President Barack Obama and Congress.
National government watchdog organization Judicial Watch published a special Gardasil report in June of 2008 that examines FDA records on the HPV vaccine and questions Gardasil safety. Among points made in the report were:
Gardasil is still in the testing stages. The HPV vaccine will not be considered fully evaluated by Merck until September 2009.
Gardasil has only been tested with one other vaccine for interactions. The CDC recommends 10 different vaccines for adolescents.
Long term effects of Gardasil are unknown.
Gardasil could make HPV symptoms worse when someone already infected is given a Gardasil injection. According to the report, some girls suffered outbreaks of genital warts as well as warts on the face, hands and feet after inoculation.
In addition to questioning Gardasil safety for the general public, the report raises doubt about Merck’s testing methods.
With much of FDA-approved research being outsourced to other countries and manufacturers conducting clinical trials of their own products, it’s not surprising that drug testing methods would be questioned. The FDA approved Gardasil in just six months, although Merck agreed to perform additional safety studies and research after approval.
Merck & Company aggressively lobbied US states for mandates regarding Gardasil injections, and many states may soon require the HPV vaccine before girls enter sixth grade. A majority of states have introduced legislation in a move towards such a mandate, and, as of August 2008, Gardasil is listed among required vaccines for immigrant young girls ages 11-26 who want to become a US citizen.
The company hopes this new drug will replace profits loss when another Merck product, Vioxx, which was also fast tracked through FDA approval, was pulled from the market in 2004 due to safety concerns about it causing an increased risk of heart attacks and strokes. A multitude of Vioxx lawsuits followed and continue to be filed.
In addition to the US, several other countries have initiated Gardasil vaccination programs for adolescent girls, and Merck has now requested FDA approval to vaccinate boys and men as well. Merck is also seeking approval for use of the HPV vaccine in women over the age of 26.
The CDC recommends giving Gardasil injections in a series of three shots during a six-month period at age 11-12, although it can be administered as early as 9 years old. Females aged 13-26 who haven’t received the vaccine are recommended to do so, too. Common Gardasil reactions include fever, pain and swelling at the injection site, fainting, nausea and headaches.