Canadian Health Officials Call for Only One Gardasil HPV Vaccine Injection for Children

Male and female patients reacted differently to Gardasil injections, with women reporting a higher number of adverse health events.

Amid continuing concerns about the side effects of Gardasil and a number of lawsuits being pursued in the United States, involving allegations that the HPV vaccine caused severe and debilitating autoimmune disorders, Canadian health officials now indicate that children only need one dose to help prevent infections and cervical cancer.

Gardasil was introduced in 2006, as the first vaccination against the development of human papillomavirus (HPV), which can be sexually transmitted and lead to the later development of cervical cancer. The injection has been widely used among both young girls and boys, before sexual activity, typically involving a series of two or three shots several months apart.

Last week, Canada’s National Advisory Committee on Immunization (NACI) issued new guidelines on HPV immunization, indicating that multiple doses of the vaccine are only needed for patients who are 21 years of age and older. Those between the ages of 9 and 20 only need to receive one injection to be adequately protected from the human papillomavirus (HPV) and decrease their risks of cervical cancer, the committee determined.

Concerns About Gardasil Injections

The updated recommendations come as new evidence continues to emerge about Merck’s widespread over promotion of Gardasil, which may have encouraged wider user of the vaccination than is necessary and failed to disclose serous risks that some users experience.

Merck currently faces several hundred Gardasil vaccine lawsuits in the United States, each raising similar allegations that teens and young adults have been left with severe and debilitating complications after receiving multiple injections, including postural orthostatic tachycardia syndrome (POTS), neurological problems, premature ovarian failure, idiopathic thrombocyteopenic purpora (ITP), chronic pain, brain fog, fatigue, headaches, nerve damage and other injuries.

The NACI HPV vaccine guidance now provides updated recommendations for doctors in Canada, indicating that while the committee continues to strongly recommend vaccination for all individuals 9 to 26-years-old, those between the ages of 9 and 20 only require one injection to be protected, while those ages 21 to 26 years old should get two.

Canada has two approved HPV vaccines, including Merck’s Gardasil, and GlaxoSmithKline’s Cervarix. Currently, NACI recommends the use of Gardasil, due to its wider range of protections against various versions of the virus.

According to NACI’s clinical data, the most common side effects from Gardasil injections were injection-site reactions, headaches and fevers for both sexes, and nausea for women. Women reported higher frequency of adverse events after receiving their third dose of Gardasil. The one exception was for pain; the highest reports of which came after women received a second dose of the vaccine.

The researchers found that men reacted differently, with injection site reactions being similar regardless to whether they were receiving their first, second or third dose. Among men, systemic reactions were higher following the first dose, and then decreased with each additional dose after.

Overall, Canadian researchers indicate the nation received 1,003 adverse event reports related to HPV vaccines from January 1, 2018, to September 14, 2023, with 906 of those involving Gardasil. While injection site reactions were the most commonly reported side effects, NACI indicates that 48 reports were serious, including 22 allergic reactions and five local reactions. The study does not mention finding any risks of autoimmune disorders or neurological damage.

August 2024 Gardasil Lawsuits Update

In the U.S., given common questions of fact and law presented in more than 200 Gardasil injection lawsuits now being pursued against Merck nationwide, the litigation has been centralized for pretrial proceedings in the U.S. District Court for the Western District of North Carolina, where the parties are currently working to prepare a group of Gardasil cases for trial.

However, injury lawyers are continuing to investigate and file new lawsuits for individuals who experienced a variety of complications from the HPV vaccine, including:

• Autoimmune Diseases
• POTS (Postural Orthostatic Tachycardia Syndrome)
• Premature Ovarian Failure
• Premature Menopause
• Polycystic Ovary Syndrome (PCOS)
• Idiopathic Thrombocytopenic Purpura (ITP)
• Irregular Heartbeat/Tachycardia
• Lupus
• Neurologic Disorder
• Brain Fog or Chronic Inability to Concentrate
• Chronic Fatigue
• Chronic Pain
• Severe Headaches
• Difficulty Sleeping
• Fibromyalgia
• Nerve Damage
• Menstrual Disorders/Problems
• Gastrointestinal Issues (food intolerances, nausea, vomiting)

Following coordinated discovery and any bellwether trials in the federal litigation, if the parties fail to reach Gardasil settlements or another resolution for the litigation, Judge Conrad may later establish a process to begin remanding each individual claim back to U.S. District Courts nationwide for individual trial dates in the future.