HPV Vaccine Controversy

Madelyne, 20, and Olivia, 19, are suing Merck, the makers of Gardasil, saying the vaccine caused their ovaries to stop producing eggs, a condition known as premature ovarian failure.

"We were robbed of our womanhood," Madelyne says. "And now, wherever I go, I always see the pregnant lady, and knowing that might not be an option for me, [leaves me] just devastated."

Almost all cervical cancers are caused by HPV, a common virus that can be passed from one person to another during sex, according to the Centers for Disease Control and Prevention. There are many types of HPV. Some HPV types can cause changes on a woman’s cervix that can lead to cervical cancer over time, while other types can cause genital or skin warts. 

"If you weigh the costs and the benefits of the [HPV] vaccination, they clearly come down on the side of the benefit.  I don't think there's really any doubt about that," says Dr. Joel Palefsky, Infectious Disease Specialist, UCSF School of Medicine. 

Dr. Palefsky is an Infectious Disease Specialist at the University of California San Francisco School of Medicine, as well as the Chair of the HPV Working Group of the AMC and is the head of the AMC HPV Virology Core Lab. He has extensive experience in studying the biology of HPV infection, HPV infection in HIV-positive men and women, HPV vaccines and in the design and implementation of clinical research trials of HPV-related disease. He has published over 250 papers.

• Click here to read the official statement from Merck — the manufacturer of Gardasil.

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Cervical cancer facts
• Each year in the United States, an estimated 26,000 new cancers are attributable to HPV.
◊ Female cases: 18,000. Cervical cancers: 11,500.
◊ Male cases: 8,000. Oropharyngeal (a cancer that forms on the middle part of the throat): 5,900.

• The CDC estimates 14,100,000 new cases of HPV per year.  

• The American Cancer Society estimates there will be 12,340 new cases of invasive cervical cancer in the United States in 2013. 

• They estimate that 4,030 women will die from cervical cancer. 

• Order of those most likely to get cervical cancer: Hispanic women, followed by African-Americans, Asian-Americans, Pacific Islanders and whites. 

• American Indians and Alaskan natives are least likely to get it.

HPV facts 
• Approximately 79 million Americans are infected with HPV.

• Approximately 14 million people become infected each year.

• Genital HPV is the most commonly sexually transmitted infection (STI).

• There are more than 40 types of HPV that can infect the genital area of both males and females. They can also infect the mouth and throat.

• Anyone who has ever had sex is at risk, even if it has been with only one partner.

• Nearly all sexually active men and women get it at some point in their lives.

Vaccine facts
• The Food and Drug Administration has licensed two vaccines shown to effectively prevent HPV infection.
◊ Gardasil offers protection against cervical cancer, cervical dysplasias, vulvar or vaginal dysplasias and genital warts associated with HPV types 6, 11, 16 and 18.
◊ Cervarix offers protection against cervical cancer and cervical dysplasia associated with HPV types 16 and 18.

• Studies show that both vaccines are nearly 100 percent effective in protecting women who haven't already been exposed to the types of HPV covered by the vaccine.

• Vaccination prior to the onset of sexual activity has been found to most-effectively prevent cervical cancer later in life.

Gardasil facts 
• Approved for use in women ages 9 to 26.

• Three injections are given over a six-month period. The first dose is given at a time selected by the patient and doctor. The second is given two months later, and the third is given six months after the first dose.

• The vaccine is given in the muscle of the upper arm or thigh.

• Most common side effects:
◊ Pain; swelling; itching; bruising and redness at the injection site.
◊ Headache; fever; nausea; dizziness; vomiting; fainting

• Signs of an allergic reaction:
◊ Difficulty breathing; wheezing; hives; rash

• Inform your doctor if your child has:
◊ Swollen glands (neck, armpit or groin); joint pain; unusual tiredness, weakness or confusion; chills; generally feeling unwell; leg pain; shortness of breath; chest pain; aching muscles; muscle weakness; seizures; bad stomach ache; bleeding or bruising more easily; skin infection

• Gardasil should not be given if:
◊ The patient has an allergic reaction after getting a dose of the drug.
◊ The patient has a severe allergic reaction to yeast, 
amorphous aluminum hydroxyphosphate sulfate or Polysorbate 80.

Vaccine safety
• In 2006, a safety study was required by the FDA and the European Medicines Agency. 
◊ The study involved about 190,000 women, who received at least one dose of the HPV vaccine. At least 44,000 women received all three doses.
◊ Researchers looked at emergency room visits and hospitalizations for 60 days following each dose of the vaccine.
◊ Two hundred categories of illnesses were reviewed. Most were found to have existed before the vaccine was administered. Fourteen deaths recorded were not linked to the vaccine. No increased risk of autoimmune diseases were found.

• The Vaccine Adverse Effect Reporting System (VAERS):
◊ Requires health providers to report harm that comes to patients within a specific time period after vaccination.
◊ From 2006 to 2013, approximately 57 million doses of HPV vaccines were distributed, and VAERS received approximately 22,000 adverse event reports occurring in girls and women who received HPV vaccines. Of those, 92 percent were classified as "non-serious."
◊ The CDC and the FDA looked at the first 12,424 reports to VAERS. They noted only two cases of unusual neurological symptoms. They also studied the increase in potentially dangerous blood clots and found 90 percent of those patients had a separate risk factor for clots. Many effects were likely a result of the shot itself, as some people have adverse reactions to common vaccine components.

Safety monitoring
• Vaccines continue to be monitored for safety after they are licensed.

• The CDC and the FDA primarily use three systems:
◊ The Vaccine Safety Datalink (VSD): a collaboration between the CDC and several healthcare organizations:
  1. In 2011, the VSD studied 600,000 receivers of Gardasil. The adverse events were compared to other vaccines. None of the adverse events were found to be any more common after the HPV vaccine.
  ◊ The Clinical Immunization Safety Assessment (CISA) Project, a collaboration between the CDC and several medical research centers.

HPV vaccine for pre-teens
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