The HPV Vaccine: Then and Now

Linda Brookes, MSc

Disclosures

August 01, 2016

In This Article

Safety Concerns an Issue

All guidelines issued by the government and by professional medical organizations stress the safety of currently available HPV vaccines. "The CDC's Immunization Safety Office, in collaboration with the FDA, is constantly monitoring the safety of vaccines, Dr Markowitz stresses. "It is one of the strengths of the US program that we have a robust infrastructure for safety monitoring," she explains. She acknowledges that the rumors and misinformation about HPV vaccine perpetuated online, especially on social media, are "a constant problem." However, concerns related to HPV vaccination have been raised in the medical literature, including descriptions of autoimmune-like reactions, complex regional pain syndrome (CRPS), postural orthostatic tachycardia syndrome (POTS), and chronic fatigue syndrome. Most of the reports of these adverse reactions come from high-income countries, notes Rebecca Chandler, MD, from the Uppsala Monitoring Centre (UMC) in Sweden, a WHO collaborating pharmacovigilance center.

At the request of Denmark, where reports of adverse effects suspected to be linked to the HPV vaccine began to emerge in 2013,[40,41,42] the European Medicines Agency (EMA) conducted a review of the evidence, eventually concluding that that there is no evidence of an association that between HPV vaccines and POTS or CRPS.[43,44] Shortly after that, the WHO Global Advisory Committee on Vaccine Safety issued a statement containing similar conclusions on POTS and CRPS, and concluding that the risk for an autoimmune reaction (Guillain–Barré syndrome), if it exists, is "very small.[45]"The findings of the EMA report were rejected by several investigators in Denmark, including the authors of the adverse-reaction reports.[46] Dr Chandler also has reservations about the EMA report, noting that the EMA drew their conclusions from an observed vs expected analysis which compares the observed number of reported cases to the background incidence of disease. This absence of reporting and discussion of all data available to EMA led to a poorer-quality publicly available assessment report. For example, only selected results from the UMC report were presented and discussed. "I was disappointed by the poor quality of the document," she tells Medscape.

Dr Chandler is concerned that there might be a large pool of girls with the same pattern of symptoms—dizziness, headache, and fatigue—after HPV vaccination who are not being diagnosed with POTS because it is a comparatively new diagnosis and the number of background cases is not known. "Whether this is caused by the HPV vaccine or not, we are not close to being able to hypothesize. We just know that we did not see POTS commonly reported in adolescent girls taking other medications or vaccines," she says. She notes that the effect of publicity in the Danish media about possible adverse effects related to the vaccine has led to a sharp fall in HPV vaccination in a country that 3 years ago had a 90% uptake. Another country that has reacted to reports of adverse events after HPV immunization is Japan, which in 2013 suspended all HPV vaccination, an action that appears, like the debate in Europe, to be having global repercussions.[47] All national and international organizations agree with the WHO that "continued pharmacovigilance will be important to ensure that concerns related to the use of HPV vaccines can be addressed with the best possible evidence."

Combating Underuse

The federal government and medical organizations have come together to increase HPV vaccination coverage in the United States.[33] In 2014, the President's Cancer Panel Report called for coordinated efforts to, for example, reduce missed opportunities to recommend and administer the HPV vaccine, increase the acceptance of HPV vaccine by parents and adolescents, and maximize access to HPV vaccination services.[48] The same year, the American Academy of Family Physicians, the American Academy of Pediatrics, the American College of Obstetricians and Gynecologists, the CDC, and the Immunization Action Coalition sent a letter to physicians asking them to "urge" their patients to get vaccinated against HPV.[49] In January this year, all 69 National Cancer Institute–designated cancer centers issued a joint statement urging young adults, parents, and healthcare providers to take action to increase HPV vaccination rates for cancer prevention.[50] "There is a lot of work going on around this issue," Dr Markowitz reports. "In the past year or two, a lot of funds have been going out to different states to try to understand how vaccination rates can be increased." She notes that "providers don't necessarily make a strong recommendation at the age when the vaccine should be given because parents often want to wait until their son or daughter is older. We try to emphasize that this is the age when kids are coming in for other vaccines and they need to get it before there would be any potential for being exposed to HPV."

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