The debate has always been hot about the risk-benefit ratio of human papillomavirus (HPV) vaccines, ever since Merck’s Gardasil-4 vaccine was fast tracked to licensure by the U.S. Food and Drug Administration (FDA) in 2006 followed by persistent reports of young girls suffering serious health problems after vaccination.1 Now, new international investigations and reports of failure are hitting the headlines, prompting additional worries about severe reactions to HPV vaccines.
Europeans Launch Investigation Into HPV-Related Adverse Events
Three HPV vaccines are available both in the United States and the European Union. Merck and Co. makes two of them—Gardasil-4, the first FDA-approved HPV vaccine, and Gardasil-9, the newest licensed HPV vaccine—while GlaxoSmithKline Plc makes the third, Cervarix.
In July 2015, the European Medicines Agency (EMA) launched a probe to clarify the safety of the three HPV vaccines. The EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) will review available data with a focus on two conditions: complex regional pain syndrome (CRPS), which impacts the limbs, and postural orthostatic tachycardia syndrome (POTS) which increases heart rate abnormally and causes dizziness, fainting, chest pain, headache and weakness.
The PRAC has previously recorded reports of these conditions in female recipients of the HPV vaccines during routine safety monitoring, but Denmark requested a deeper investigation and for the PRAC to determine if there is a causal link between the incidents and the vaccines.2
A 2015 review published in Clinical Rheumatology describes a hypothesis for the development of CRPS and POTS following HPV vaccination.
“These are illnesses often difficult to diagnose that have overlapping clinical features,” suggesting that “small fiber neuropathy and dysautonomia could be the common underlying pathogenesis to the group of rare, but severe reactions that follow HPV vaccination.” The study author warned, “Clinicians should be aware of the possible association between HPV vaccination and the development of these difficult to diagnose painful dysautonomic syndromes.”3
While the EMA stressed that the review is not questioning if “the benefits of HPV vaccines outweigh their risks,” the results of the review could prompt the committee to recommend changes to product information.4
Japan has already taken an action against HPV vaccination. After recording 1,968 adverse reactions—358 events deemed as serious—since the country began offering Gardasil to girls, Japan’s Vaccine Adverse Reactions Review Committee announced in June 2013 that the HPV vaccine should not be recommended until safety concerns were addressed.5
U.S. Compensation Program Paid Some $6 Million to Victims
Between 2006, when Gardasil first received approval from the FDA, and August 14, 2015, there have been 36,855 Gardasil-4 adverse reactions reported to the FDA’s Vaccine Adverse Event Reporting System (VAERS). Specifically, 16,327 (44%) were serious events categorized as “life threatening” or requiring an emergency room visit or hospitalization. There have been 6,914 Gardasil-4 adverse event reports where the patient “did not recover” and 1,145 reports that resulted in permanent disability. There have been 208 Gardasil-4 death reports made to VAERS.
Judicial Watch reported that the National Vaccine Injury Compensation Program (VICP) had awarded at least $5.9 million to 49 victims for claims that the HPV vaccine either caused injury or death (2 claims) as of March 2013. There are still nearly 100 claims pending and still others that were dismissed. Judicial Watch had requested these documents and information from the Department of Health and Human Services as part of the agency’s compliance with the Freedom of Information Act.
“This new information from the government shows that the serious safety concerns about the use of Gardasil have been well-founded,” Judicial Watch President Tom Fitton argued.
However, the FDA and U.S. government stands by the vaccine’s safety and continues to promote its use.6
U.S. Federal Claims About Reactions Still Unresolved
In November 2013, two Wisconsin sisters filed a federal claim against Merck claiming that Gardasil led their ovaries to stop producing eggs, leaving them infertile and forcing them into premature menopause. Though there is still no decision in the case, this case represents the first one to reach a hearing alleging that Gardasil causes infertility.7
Madelyne Meylor, who is now in her 20s, began her menstrual periods at age 13 and received her first HPV dose a few months later. Her periods became irregular and by the third HPV dose at age 15, her periods stopped. At age 16, she was diagnosed with premature ovarian failure.
Olivia Meylor, who is also now in her 20s, received the three HPV doses before having her first period at age 15. At age 16, she was diagnosed with premature ovarian failure. Both women tested negative for genetic predispositions to the condition.8
There has also been a question as to the link between HPV vaccines and infertility. Infertility affected 10.9% of women aged 15 to 44 years in the United States from 2006 through 2010.9
According to Sanevax, a non-profit group providing independent monitoring of HPV vaccine safety, there has been a recent, substantial increase in reports of infertility in the U.S. with a 790% increase in the annual average of fertility problems beginning in 2007, shortly after HPV vaccines were introduced.10
Further, according to the VAERS databases, nearly 90% of infertility cases reported as a vaccine side effect were attributed to the HPV vaccines. There has also been a 276% increase in the number of “abortion/stillbirth” adverse events related to vaccines since 2006.11
Merck said its post-licensure reports of Gardasil effects and clinical trial evidence do not support a causal link between the vaccine and premature ovarian insufficiency.12
However, according to Merck’s package insert for Gardasil, the vaccine has not been evaluated for impairment of fertility in humans, only in female rates. These pre-clinical studies showed no effects on fertility.13
1 NVIC. Merck’s Gardasil Vaccine Not Proven Safe for Little Girls. June 27, 2006.
2 European Medicines Agency. EMA to further clarify safety profile of human papillomavirus (HPV) vaccines. Press Release July 13, 2015.
3 Martinez-Lavin M. Hypothesis: Human papillomavirus vaccination syndrome—small fiber neuropathy and dysautonomia could be its underlying pathogenesis. Clinical Rheumatology 2015;34:7:1165-69.
4 See Footnote #1.
5 Judicial Watch. Japan Halts HPV Shot for Girls over Safety Issues. The Judicial Watch Blog Corruption Chronicles Oct. 1, 2013.
6 Judicial Watch. JW Investigates HPV Injury Compensation Program. Press Release Mar. 20, 2013.
7 Wahlberg D. Still no ruling in Mount Horeb sisters’ HPV vaccine injury claim. Wisconsin State Journal Oct. 20, 2014.
8 Wahlberg D. Sisters’ HPV Vaccine injury claim heads to federal court. Wisconsin State Journal Nov. 7, 2013.
9 Centers for Disease Control and Prevention. Infertility. Updated Oct. 30, 2013.
10 Erickson N. How closely does the CDC monitor HPV vaccine safety? News Blog. SaneVax Inc. Jan. 5, 2014.
11 Erickson N. Chart on Abortion/Stillbirth from article How closely does the CDC monitor HPV vaccine safety? News Blog. SaneVax Inc. Jan. 5, 2014.
12 See Footnote #3.
13 U.S. Food and Drug Administration. Package Insert–Gardasil. Vaccines, Blood & Biologics. Updated Nov. 13, 2013.