ANTI HUMAN PAPILLOMA VIRUS BY MERCK
GARDASIL 9 is contraindicated in individuals with hypersensitivity, including severe allergic reactions to yeast, or after a previous dose of GARDASIL 9 or GARDASIL® [Human Papillomavirus Quadrivalent (Types 6, 11, 16, and 18) Vaccine, Recombinant].
Because vaccinees may develop syncope, sometimes resulting in falling with injury, observation for 15 minutes after administration is recommended. Syncope, sometimes associated with tonic-clonic movements and other seizure-like activity, has been reported following HPV vaccination. When syncope is associated with tonic-clonic movements, the activity is usually transient and typically responds to restoring cerebral perfusion.
Safety and effectiveness of GARDASIL 9 have not been established in pregnant women.
The most common (≥10%) local and systemic adverse reactions in females were injection-site pain, swelling, erythema, and headache. The most common (≥10%) local and systemic reactions in males were injection-site pain, swelling, and erythema.
The duration of immunity of GARDASIL 9 has not been established.
Information by World Health Organization
A large body of randomised controlled trial evidence comprising 72,835 subjects provided data upon which the rates of serious adverse events were calculated. In addition, several large cohort studies provided evidence for specific health outcomes, predominantly autoimmune diseases. The specific methodology, articles’ profiles and quality of evidence that compromise the systematic review can be accessed through http://www.who.int/vaccine_safety/HPV_vac cination_safety_report_AHTA_dec17.pdf
Adverse events Minor adverse events(See table 2) Local adverse events The 9v-HPV vaccine was well-tolerated, and most adverse events were injection siterelated pain, swelling, and erythema that were mild to moderate in intensity. The safety profiles were similar in 4v-HPV and 9v-HPV vaccinees.
Among females aged 9 through 26 years, 9vHPV recipients had more injectionsite adverse events, including swelling (40.3% in the 9vHPV group compared with 29.1% in the 4v-HPV group) and erythema (34.0% in the 9vHPV group compared with 25.8% in the 4v-HPV group).
Males had fewer injection site adverse events. In males aged 9 through 15 years, injection site swelling and erythema in 9vHPV recipients occurred in 26.9% and 24.9%, respectively. Rates of injection-site swelling and erythema both increased following each successive dose of 9vHPV. (See table 2) https://www.cdc.gov/mmwr/preview/mmwrh tml/mm6411a3.htm
Systemic adverse eventsIn clinical trials prior to licensure of the 4vHPV vaccine, systemic adverse events were monitored for the first 15 days post vaccination. The only adverse event reported that occurred in greater than 1% of vaccines and occurred more frequently than placebo was pyrexia (10.1 versus 8.4% according to EMEA CHMP (2006), respectively). A number of other systemic adverse events, of minor nature were reported, but these occurred with less than a 0.5% difference in the vaccinated group. Mild systemic adverse events possibly related to vaccination included headache, dizziness, myalgia, arthralgia, and gastrointestinal symptoms (nausea, vomiting abdominal pain). In a direct comparison of the 2v-HPV and 4v-HPV vaccines, systemic reactions were reported at comparable rates, with the exception of fatigue [49.8% (95% CI: 45.5-54.2) vs. 39.8% (35.6-44.1)] and myalgia [27.6% (95% CI: 23.8- 31.6) vs. 19.6% (16.3-23.3)], which were reported more frequently amongst recipients of the 2v-HPV vaccine. (See table 2)
Severe or serious adverse events– systematic review (See table 3) This comprehensive systematic review containing a large body of high-level evidence is very consistent in finding no evidence of severe or serious adverse events associated with difference in the rate of Serious Adverse Events (SAE) between people who have received either the 2v-HPV or 4v-HPVvaccines and people who received a placebo or a control vaccine. Good quality cohort studies of specific autoimmune and other SAEs also found no relationship between exposure to HPV vaccination and development of these outcomes.
2 The results of the analysis for the specific outcomes are summarised in the Summary of Findings Table using the Grading of Recommendations, Assessment, Development and Evaluation (GRADE) methodology http://www.gradeworkinggroup.org/. These outcomes included SAE, new onset chronic disease and medically significant conditions. A comparison of effects show that there is no absolute event rate difference for any of these conditions in those vaccinated with HPV vaccine (2v-HPV or 4v-HPV) and placebo (or those vaccinated with a control vaccine). For auto-immune disease, venous thromboembolism, multiple sclerosis and other demyelinating conditions safety data is available from high quality cohort studies which have not demonstrated differences in the rates of these conditions in those exposed or unexposed to the HPV vaccine.
Rare or very rare adverse events (such as auto-immunity) can only be evaluated for safety using post licensure surveillance studies because randomised controlled trials do not have adequate power to detect such events. The current estimated rate of anaphylaxis is 1.7 cases per million doses. This is consistent with the rate of anaphylaxis following other vaccines. The rates for anaphylaxis for other vaccines given to children and adolescents range from 0 to 3.5 per million doses in international studies which have used different case definitions for anaphylaxis.
Other vaccine safety issues Postural Orthostatic Tachycardia Syndrome (POTS), Chronic Regional Pain Syndrome (CRPS), Chronic Fatigue Syndrome (CFS). POTS, CRPS, and CFS are reported as adverse events following HPV immunization. These conditions most commonly occur independent of immunisation and and their pathogenesis is poorly understood. Their causal association with immunization is not established. However, it is plausible that CRPS may occur in a limb that has been the site of an injected vaccine as other causes of local trauma may trigger this condition. CRPS has been described, in case reports, to present soon after immunisation. The association between POTS and CRPS has been reviewed by the European Medicines Agency (EMA) who have concluded that there is no causal association between these conditions and HPV immunization. Death Deaths were reported in nearly every study, and the number of deaths was very low.
No death was considered vaccine related in the Gardasil studies, and two of the Cervarix studies reported the causes of death without commenting their causality
Syncope in adolescent girls. Post-marketing surveillance has documented a number of cases of syncope in adolescent girls. Possibly the rate of syncope is higher when the HPV vaccine is delivered as part of a school programme and vaccine providers should have measures in place to prevent syncope and syncope-related injury from occurring.
For other updated news on the effects of Gardasil consult “Vaccine Adverse Effect Reporting System” https://vaers.hhs.gov/data.html