The controversial HPV vaccine does not cause chronic pain or dizziness, despite reports from patients’ families complaining of those side effects, European regulators said Thursday after an extensive review.
The European Medicines Agency began its review in July after families complained that girls who were vaccinated suffered complex regional pain syndrome, or CRPS, a chronic pain that affects limbs. Other families said the vaccines caused postural orthostatic tachycardia syndrome, or POTS, which causes dizziness and fainting.
“The available evidence does not support a link” between the vaccines and the syndromes, said Enrica Alteri, who heads human medicines evaluation at the agency, during a press briefing. “There is no reason to change the way the vaccines are used.”
Public health officials say the vaccines can effectively thwart human papillomavirus, or HPV, which can lead to cervical cancer. The virus is responsible for about 5 percent of cancer cases globally, Alteri noted.
So far, about 80 million girls and women worldwide have been vaccinated against different HPV strains linked to cervical cancer and genital warts. There are two vaccines: Merck sells Gardasil and GlaxoSmithKline markets Cervarix.
But the vaccines — especially Gardasil, which was the first to be approved for use — have generated considerable controversy. Some parents objected to the cost of the treatment, which requires three shots. Others expressed concerns that getting an HPV vaccine may lead teenage girls to think it’s safer to have casual sex. (A study last fall from Canada found no evidence that the vaccine increased risky sexual behavior.)
Those anxieties were initially fueled by a surreptitious Merck marketing campaign. Before Gardasil won regulatory approval more than a decade ago, the drug maker tried to persuade lawmakers to require school districts to make vaccination mandatory.
“There is no reason to change the way the vaccines are used.”
Enrica Alteri, European Medicines Agency
Over the years, there have been persistent reports in the US, Europe, and elsewhere linking the vaccination to other ailments. Last summer, hundreds of vaccinated girls in Colombia reportedly experienced unexplained side effects following vaccination. And a recent documentary aired in Denmark suggested the vaccine was causing the syndromes that were reviewed by the European Medicines Agency.
As a result, vaccination rates have been low. Last year, 39.7 percent of those eligible for vaccination received the recommended three doses, up from 36.8 percent in 2013, according to the US Centers for Disease Control and Prevention. CDC officials have lamented that rates should be higher.
Physicians, too, have apparently been affected by the criticisms of the vaccine. A study out last month, based on a survey of 776 US doctors, found that a quarter did not strongly endorse the need for HPV vaccination with parents of 11- and 12-year-olds under their care. Nearly 60 percent were more likely to recommend vaccination for adolescents they thought were at higher risk of becoming infected with HPV.