Europe Again Says HPV Vax Safe, but Petition in Spain

Zosia Chustecka

November 20, 2015

Europe has again proclaimed that vaccination against the human papilloma virus (HPV) is safe and that the available evidence does not support a causal link between the vaccines and development of two syndromes, complex regional pain syndrome (CRPS) and postural orthostatic tachycardia syndrome (POTS).

The latest pronouncement was made today by the European Medicines Agency's (EMA's) Committee for Medicinal Products for Human Use (CHMP) and follows an earlier review carried out by the Pharmacovigilance Risk Assessment Committee (PRAC).

Yet at the same time, a public health professor in Spain is spearheading a petition that calls for a halt to HPV vaccination there, and says the vaccine is "not necessary or effective, and it's not even safe."

In Denmark, more than 1300 girls and young women who experienced chronic symptoms after undergoing HPV vaccination are being treated at specialist centers. The Danish government is funding an independent investigation after Danish researchers said the European conclusions are "not valid."

Next week, Japan is holding a symposium entitled, Problems With the HPV Vaccine. Japan stopped recommending HPV vaccination in 2013 and has also established specialized centers to treat affected girls. However, the Japanese government continues to provide the vaccination.

Latest European Pronouncement

The latest European pronouncement was made today in a press release. The EMA said that it has now completed its review of the evidence surrounding reports of two syndromes, CRPS and POTS, in young women given HPV vaccines.

"In line with its initial recommendations, EMA confirms that the evidence does not support a causal link between the vaccines (Cervarix, Gardasil/Silgard and Gardasil 9) and development of CRPS or POTS. Therefore there is no reason to change the way the vaccines are used or amend the current product information," the agency says.

The agency's review included published research, data from clinical trials, and reports of suspected side effects from patients and healthcare professionals, as well as data supplied by EU member states. The initial review was carried out by the PRAC, which announced its findings 2 weeks ago. "In reaching its recommendations, it consulted a group of leading experts in the field, and took into account detailed information received from a number of patient groups that also highlighted the impact these syndromes can have on patients and families," the EMA notes.

The findings of the PRAC were passed to the CHMP along with further representations from patient groups. The CHMP concurred that the available evidence does not support the view that CRPS and POTS are caused by HPV vaccines. It therefore did not recommend any changes to the terms of licensing or the product information for these medicines, the EMA explains.

"The CHMP's position will now be passed to the European Commission for a legally binding decision. The assessment report containing the evidence supporting the Agency's review will be published shortly on EMA's website," the press release states.

Petition Against HPV Vaccination in Spain

In Spain, Carlos Alvarez-Dardet, MD, professor of public health at the University of Alicante, who is also a past president of the European Public Health Association and the Spanish Society of Public Health and Health Administration, has launched a petition against HPV vaccination.

Dr Alvarez-Dardet highlights adverse events that have been reported after HPV vaccination, including reports of death, permanent disability due to nervous system disease, autoimmune disorders, pulmonary embolisms, Guillain-Barré syndrome, seizures, fainting, tremors, syncope, dizziness, pancreatitis, lupus, and others. He questions the efficacy of the vaccine, noting that it protects against only some strains of HPV and that that protection lasts only a few years.

"The height of absurdity is that in Spain the incidence of cervical cancer is very low, of the smallest in Europe, which already is low (90% of deaths occur in developing countries where women do not undergo gynecological controls)," he writes, so "vaccinating our small mass makes no sense!"

He points out that when the national scheme for HPV vaccination was launched in Spain in 2007, more than 10,000 healthcare professionals (including more than half of the professors of preventive medicine and health public of Spain) and several scientific associations expressed "disagreement in the manifesto 'Reasons for a Moratorium on the Use of the HPV Vaccine in Spain,' a professional unprecedented move," he writes.

"However, that was not enough," he says, citing the "powerful pharmaceutical lobby."

So now he is using the Internet to publicize a petition against the HPV vaccine. It currently has more than 35,000 signatures.

Last year, there was also a petition in France about HPV vaccination. Now closed, it was signed by more than 700 doctors and 300 midwives and says that "the ball is now in the court of policy makers." That petition called for the establishment of a parliamentary mission on HPV vaccination and said that its effectiveness remains to be proven, noting that it was tested against a placebo fake (inasmuch as the placebo contained aluminium), that serious side effects have been reported, and that the vaccines are expensive.

Both petitions raise issues beyond the safety of the vaccines, questioning effectiveness and whether they are really necessary. The main aim of HPV vaccination is to offer protection against cervical cancer, but there is already a well-established method for achieving that ― screening with Pap smears, as several Medscape readers have pointed out in comments to previous stories. Even women who have been vaccinated need to undergo regular screening with smears, and the vaccine does not change that.

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