Published January 26, 2017
Clinical trials for a new Lyme disease vaccine will be conducted in the U.S. and Belgium after the U.S. Food...
— William Wilberforce
A handful of countries, like Denmark and Japan, remain skeptical about human papillomavirus (HPV) vaccines, even though the European Medicines Agency’s (EMA) Pharmacovigilance Risk Assessment Committee’s (PRAC) safety review in 2015 did not change the agency’s position that the benefits of HPV vaccinations outweigh the risks.
In July 2015, the PRAC in Europe launched a probe to investigate the safety of the three HPV vaccines available both in the United States and to countries in the European Union—Merck and Co.’s Gardasil and Gardasil 9 and GlaxoSmithKline’s Cervarix.
Continuing reports of several HPV-related adverse events prompted the investigation. The review focused on two inflammatory autoimmune conditions in particular: complex regional pain syndrome (CRPS),1 which causes sensory and motor dysfunction, including severe skin and bone pain; and postural orthostatic tachycardia syndrome (POTS)2 which increases heart rate abnormally and causes dizziness, fainting, chest pain, headache and weakness.
During routine vaccine safety monitoring, the PRAC had previously recorded reports of these two conditions in girls and women who had received HPV vaccines. Denmark specifically requested that the PRAC determine if there is a casual link between POTS and CRPS and HPV vaccinations.3
After interviewing HPV vaccine experts and evaluating published research, data from clinical trials, patient/provider reports and data supplied by Member States of the European Union, the PRAC concluded that the “available evidence does not support that CRPS and POTS are caused by HPV vaccines” and “therefore there is no reason to change the way the vaccines are used or amend the current product information.”
It is estimated that approximately 150 females aged 10 to 19 years out of every million may develop CRPS and/or POTS annually. Based on its review, the PRAC said the rates found among vaccinated females were consistent with the expected rates within this age group and noted that symptoms of CRPS and POTS overlap with other conditions, such as chronic fatigue syndrome.
The Committee for Medicinal Products for Human Use will consider the PRAC’s recommendation that government health officials make no change to the current HPV vaccine policy of giving all healthy girls and women a series of HPV vaccinations. The decision will eventually be adopted as the EMA’s final position.4
It was Denmark that initially requested the EMA review, and prominent physicians in that country are not convinced by the EMA’s conclusion that there should be no change to HPV vaccination policy. As a result, Denmark conducted and announced the results of its own independent investigation.
Dr. Jesper Mehlsen from Frederiksberg Hospital in Denmark explained that the EMA review was based on register studies with a focus on POTS and CRPS. Dr. Mehlsen pointed out that in some countries, POTS is not registered as a diagnosis.
Dr. Mehlsen, along with an independent researcher, Dr. Karsten Juhl Jorgensen, separately noted that many of the HPV vaccine adverse event reports come from the vaccine manufacturers themselves or those with substantial conflicts of interest, citing the potential for heavy bias. In fact, some of the EMA reviewers of HPV vaccine safety had been involved in the original HPV vaccine clinical trials and investigations. Therefore, they were, in effect, providing oversight on and judging themselves.
Denmark’s skepticism is backed by a number of case reports. Approximately 1,300 females have been referred to five specialist centers in Denmark with symptoms of CRPS or POTS. In particular, the Syncope Unit at Frederiksberg Hospital in Denmark reported 250 women and girls reporting these chronic symptoms within two months of vaccination.
Denmark’s Ministry of Health has awarded approximately $1 million for research by independent specialists treating girls with CRPS or POTS symptoms following HPV vaccinations. Results of the research are expected to be published during the first half of 2016.5
Other countries in Europe also are faced with addressing continuing reports of HPV vaccine injuries among their residents. In Spain, there had been 737 reports of HPV vaccine reactions, including three associated deaths, through January 2012. The creation of the Association of People Affected by HPV Vaccine (AAVP) was intended to address the issue of financial assistance for those suffering from HPV vaccine injury through lawsuits or government compensation.
The AAVP even requested that the Spanish Health Ministry ban HPV vaccines from the official vaccination schedule for the country.6 7 More recently, a public health inspector in Spain has launched a petition against the HPV vaccine that has accrued 35,000 signatures so far.
In 2014, France sent a similar petition to policymakers demanding further investigation into the safety of HPV vaccines with hundreds of thousands of signatures, including those from more than 700 doctors and 300 midwives.8
In early 2015, the United Kingdom established the Association of HPV Vaccine Injured Daughters (AHVID). In a survey among 94 AHVID members, 27 girls reported same-day reactions to the HPV vaccine, while 22 girls reported reactions within 7 days and 16 girls reported reactions with 30 days. Eight girls have a confirmed diagnosis of CRPS.9
After recording 1,968 adverse reactions—358 events deemed as serious—since the country began offering Gardasil vaccine to girls, Japan’s Vaccine Adverse Reactions Review Committee announced a moratorium on HPV vaccine use in June 2013. The Committee concluded that HPV vaccine should not be recommended for girls aged 12 to 16 years until safety concerns were fully addressed.10
Japan is considering overturning the decision for a moratorium on HPV vaccination, but is not yet convinced the vaccine is safe. In 2015, Japan’s Health Ministry surveyed 1,739 patients who received the HPV vaccine, revealing that 186 of them reported side effects, such as headaches, fatigue and muscle weakness. Further, 135 cases were severe enough to interfere with their daily activities.11 The government health agency determined an “undeniable causal relationship” for 11 of the cases and pay approximately $300 per month in government compensation is paid to each of the 11 HPV vaccine injured girls.12
In November, the private medical supply supervisory group, Medwatcher Japan, hosted a symposium titled, “Problems with the HPV Vaccine,” to further address reports that HPV vaccines are causing severe brain and immune system problems like POTS and CRPS.13
In the United States, there have been continuing reports since Gardasil was licensed in 200614 that girls and women who get federally recommended HPV shots are having disabling reactions and some are dying following HPV vaccination.15 As of Oct. 14, 2015, there have been more than 41,000 Gardasil and Cervarix vaccine-related reactions, hospitalizations and injuries reported to the federally operated vaccine Adverse Events Reporting System (VAERS), including 226 deaths.16
The U.S. Centers for Disease Control (CDC) continues to maintain that HPV vaccines are safe.
1 Goebel A, Blaes F. Complex regional pain syndrome, prototype of a novel kind of autoimmune disease. Autoimmunity Review 2013; 12(6): 682-686.
2 Hongliang L, Xichon Y et al. Autoimmune basis for postural tachycardia syndrome. J Am Heart Assoc 2014; 3(1).
3 European Medicines Agency. EMA to further clarify safety profile of human papillomavirus (HPV) vaccines. Press Release July 13, 2015.
4 European Medicines Agency. Review concludes evidence does not support that HPV vaccines cause CRPS or POTS. Press Release Nov. 5, 2015.
5 Chustecka Z. Chronic Symptoms After HPV Vaccination: Danes Start Study. Medscape Nov. 13, 2015.
6 Capilla A. AAVP asks Spanish Health Ministry to Ban HPV Vaccines. SaneVax Inc. Aug. 29, 2014.
7 Administration. Spain: AAVP responds to EMA conclusion on HPV vaccine safety. SaneVax Inc. Nov. 7, 2015.
8 Chustecka Z. Europe Again Says HPV Vax Safe, but Petition in Spain. Medscape Nov. 20, 2015.
9 See Footnote 3.
10 Judicial Watch. Japan Halts HPV Shot for Girls over Safety Issues. The Judicial Watch Blog Corruption Chronicles Oct. 1, 2013.
11 Kyodo Jiji. 10% of those harmed by cervical cancer vaccines failing to recover. The Japan Times Sept. 18, 2015.
12 Fifield A. The science doesn’t support them, but Japanese anti-vaxxers are winning on HPV. The Washington Post Nov. 10, 2015.
13 Symposium “Problems with the HPV Vaccine.” Medwatcher Japan Oct. 22, 2015.
14 NVIC. Merck’s Gardasil Not Proven Safe for Little Girls. June 26, 2006.
15 Gardasil and Unexplained Deaths.