Check out this answer from Consensus:
The body of evidence from multiple studies consistently supports the safety of HPV vaccines, including the bivalent, quadrivalent, and nonavalent formulations. While injection-site reactions are common, serious adverse events are rare, and the overall risk-benefit profile remains highly favorable. These findings underscore the importance of HPV vaccination in preventing HPV-related diseases.
Human papillomavirus (HPV) vaccines have been a significant advancement in the prevention of HPV-related diseases, including cervical cancer. Despite their proven efficacy, concerns about the safety of these vaccines persist. This article aims to provide a comprehensive review of the safety profile of various HPV vaccines based on recent research findings.
Immunogenicity and Safety in Males
A study evaluating the HPV-16/18 AS04-adjuvanted vaccine (Cervarix) in healthy boys aged 10-18 years demonstrated that the vaccine is both immunogenic and well-tolerated. All subjects seroconverted for HPV-16 and 18, with antibody levels significantly higher than those observed in females. The reactogenicity profile was similar to that of the hepatitis B virus (HBV) control vaccine, with pain and swelling at the injection site being more common but not affecting compliance1.
Safety Profile of the 9-Valent HPV Vaccine
The 9-valent HPV (9vHPV) vaccine has been evaluated across seven Phase III clinical trials involving over 15,000 subjects. The most common adverse events (AEs) were injection-site reactions and mild-to-moderate systemic symptoms such as headache and fever. Serious adverse events were rare, and no deaths were considered vaccine-related. The safety profile of the 9vHPV vaccine was comparable to that of the quadrivalent HPV (qHPV) vaccine, supporting its widespread use2.
Safety in Females Previously Vaccinated with qHPV
In females aged 12-26 years who had previously received the qHPV vaccine, the 9vHPV vaccine was found to be highly immunogenic and generally well-tolerated. Injection-site reactions were more frequent in the 9vHPV group compared to the placebo group, but systemic adverse events were comparable between the two groups. The study concluded that the 9vHPV vaccine is safe for use in this population3.
Updated Safety Review
An updated review of HPV vaccine safety, including the 9vHPV vaccine, reaffirmed the acceptable safety profile of these vaccines. The review included data from over 2.5 million vaccinated individuals and found no consistent evidence of increased risk for adverse events of special interest, such as neurological conditions or autoimmune diseases. Injection-site reactions were slightly more common with the 9vHPV vaccine compared to the 4vHPV vaccine4.
Long-term Safety and Efficacy
A long-term study of the HPV-16/18 AS04-adjuvanted vaccine in young adult women showed sustained efficacy and immunogenicity up to 7.3 years post-vaccination. No cases of HPV-16/18 infection or associated lesions were observed, and the safety profile remained similar to that of the placebo5. Another study in adolescent girls aged 10-14 years confirmed the long-term safety and immunogenicity of the AS04-HPV-16/18 vaccine over a 10-year period9.
Comparative Safety in Adolescents
A comparative study of the HPV-16/18 AS04-adjuvanted vaccine and the HPV-6/11/16/18 vaccine in girls aged 9-14 years found that the former elicited superior antibody responses. The safety profiles of both vaccines were consistent with known data, with no significant differences in the incidence of adverse events6.
Community-based Safety Data
A community-randomized study in Finland involving over 32,000 adolescents found that the AS04-HPV-16/18 vaccine had an acceptable safety profile. The incidence of new-onset autoimmune diseases and pregnancy outcomes were similar between the HPV vaccine and control groups, with no specific safety signals identified7.
Novel HPV Vaccine
A novel Escherichia coli-produced bivalent HPV-16/18 vaccine was found to be well-tolerated and highly efficacious in a phase 3 clinical trial. The vaccine induced robust antibody responses and had a favorable safety profile, with no vaccine-related serious adverse events reported8.
Is the HPV vaccine safe?
Jo Waller has answered Near Certain
An expert from University College London in Public Health
This recent review concluded: ‘Our review has identified robust scientific evidence that supports the safety of the HPV vaccine.’ https://www.ncbi.nlm.nih.gov/pubmed/29280070.
The current WHO position paper on HPV vaccination (published May 2017) is similarly reassuring with regards to safety: http://apps.who.int/iris/bitstream/handle/10665/255354/WER9219-241-268.pdf?sequence=1&isAllowed=y
Over 80 million doses of the vaccine have been administered around the world and safety has been closely monitored by a number of organisations. All have concluded that the HPV vaccine is safe.
Is the HPV vaccine safe?
Gregory D Zimet has answered Near Certain
An expert from Indiana University School of Medicine in Psychology, Public Health
The safety of HPV vaccination has been widely and closely monitored by multiple systems since development. There have been several very large-scale studies that have shown no differences in serious adverse events (including deaths) between vaccinated and unvaccinated persons.
One study from Denmark and Sweden, for instance, compared over 3 million unvaccinated females to almost 800,000 vaccinated females and failed to find any differences in rates of multiple sclerosis or other demyelinating diseases (Scheller et al. Quadrivalent HPV vaccination and risk of multiple sclerosis and other demyelnating diseases of the central nervous system. JAMA 2014;313:54-61).
Minor side-effects of HPV vaccination (as with any vaccine) include pain and swelling at the injection site, mild fever, and, rarely, fainting. The evidence on safety is quite clearly summarized in the recently published Cochrane Systematic Review (Arbyn et al. Prophylactic vaccination against human papillomaviruses to prevent cervical cancer and its precursors. Cochrane Database of Systematic Reviews 2018, Issue 5. Art. No.: CD009069). HPV vaccination is not 100% safe, but no activity in life is 100% safe, even getting out of bed in the morning. However, we can say with 100% certainty that getting vaccinated against HPV is safer than not getting vaccinated and that vaccinating a child against HPV is safer, for example, than having a child ride in a car wearing a seatbelt.
Is the HPV vaccine safe?
Aldo Venuti has answered Near Certain
An expert from Regina Elena National Cancer Institute in Virology, Oncology
I don’t know a single scientific and validated evidence that HPV vaccine is UNsafe
Is the HPV vaccine safe?
Gaurav Gupta has answered Near Certain
An expert from Oxford University in Virology, Immunology, Vaccinology
The HPV vaccines commercialised so far are using inactively produced VLPs in recombinant hosts like yeast cells or mammalian cells. Which are known be safe since decades after introduction of several vaccines and bio therapeutics similarly that has been given to millions without safety concern.
Is the HPV vaccine safe?
Manuel Martínez-Lavín has answered Likely
An expert from National Institute of Cardiology Mexico in Rheumatology
Is HPV vaccine linked with chronic fatigue syndrome?
What is chronic fatigue syndrome?
Chronic fatigue syndrome, also known as “myalgic encephalomyelitis/chronic fatigue syndrome” (ME/CFS) is an illness characterized by extreme fatigue resulting in significant functional impairment. Several diagnostic criteria for ME/CFS have been developed and used in both clinical practice and research. The Canadian Criteria defines ME/CFS as a condition lasting at least 6 months characterized by fatigue, post-exertion malaise, pain, and disordered sleep accompanied by neurologic, autonomic, neuro-endocrine, and immune dysfunction. In 2015 The Institute of Medicine renamed ME/CFS as “Systemic Exertion Intolerance Disease,” defined as a condition characterized by impaired day-to-day function, post-exertional malaise, and unrefreshing sleep, coupled with cognitive impairment and/or orthostatic tolerance with symptoms at least half the time for 6 months or more. The recent re-definition of ME/CFS as “systemic exertion intolerance disease” highlights its dysautonomia component
ME/CFS overlaps with other autonomic dysfunction syndromes such as postural orthostatic tachycardia syndrome (POTS) and fibromyalgia, among others. Current linear-reduccionist medical model appears unable to explain ME/CFS and similar maladies. Many physicians deny ME/CFS existence, others simply don’t care about this issue. Therefore, the reported incidence and notification of ME/CFS to the health authorities vary widely.
HPV vaccination adverse events and chronic fatigue syndrome.
Independent clinicians from different parts of the world have described the rare occurrence of a patterned illness of chronic neuropathic pain, chronic fatigue and pervasive autonomic dysfunction developing soon after HPV vaccination. This post- HPV vaccination illness has been labeled with different diagnoses such as ME/CFS, POTS, complex regional pain syndrome and/or fibromyalgia.
In contrast to these independent case-series reports, retrospective case-control studies have found no increased incidence of ME/CFS in the post-HPV vaccination cohorts. There are tentative explanations for this latter finding. ME/CFS is a difficult to diagnose entity. ME/CFS overlaps with other autonomic nervous system dysfunction syndromes, so the final diagnosis may be another autonomic dysfunction illness. Many physicians snub ME/CFS existence. Retrospective case-control studies showed a great variation in the background ME/CFS yearly frequency. These features endanger valid comparisons between pre and post HPV vaccination ME/CFS frequency.
HPV vaccine additional safety concerns.
In-depth analysis of the pre-licensure HPV vaccine randomized double-blind studies raise additional safety concerns. Two of the largest randomized trials found significantly more severe adverse events in the tested HPV vaccine arm of the study. Compared to 2871 women receiving aluminum placebo, the group of 2881 women injected with the bivalent HPV vaccine had more deaths on follow-up (14 vs. 3, p = 0.012). Compared to 7078 girls injected with the 4-valent HPV vaccine, 7071 girls receiving the 9-valent dose had more serious systemic adverse events (3.3 vs. 2.6%, p = 0.01). Nevertheless, the study investigators (and reviewers) overlooked or disregarded these crucial safety differences.
The overwhelming majority of HPV vaccine trials did not use a valid inert placebo, they used an adjuvant aluminum placebo. Aluminum adjuvants were designed to chronically stimulate the immune system. Therefore, an adjuvanted substance cannot serve as real placebo. An adjuvanted placebo can theoretically hide the active substance adverse effects.
Conclusion
Independent clinicians from different countries have described a similar severe illness of persistent pain and chronic fatigue developing after HPV vaccination. Case-control studies have not found evidence of increased fatigue illnesses after HPV vaccination. Most HPV vaccine randomized trials did not use valid inert placebo as comparator. Serious adverse events were overlooked in the pivotal pre-licensure HPV vaccine trials.
These data raise doubts on HPV vaccine safety.