Major Developments in Gardasil® Trial

Gardasil has been under fire since consumers, parents, and health care professionals raised concerns about the safety of this human papillomavirus (HPV) vaccine.

Gardasil®  has been under fire since consumers, parents, and health care professionals raised concerns about the safety of this human papillomavirus (HPV) vaccine.

A recent lawsuit on behalf of a 19-year-old woman alleging the company misled the FDA and the public on its hazardous ingredients. They were accused of presenting misleading data to the FDA, to gain approval in 2006. 

In 2013, Merck & Co., the manufacturer of Gardasil®, initiated a voluntary recall because a limited number of units were in storage at the wrong temperature during shipment by a third-party delivery service. 

There are over 90 Gardasil® cases pending in the U.S. Court of Claims, and the cases will continue to grow as more consumers experience or learn about any serious long-term side effects. Let’s review the vaccine, the start of the Gardasil® trial and developments in the Gardasil® timeline.

What Is Gardasil®?

In 2006, the FDA approved the manufacturer Merck & Co. for the Gardasil® vaccine. The purpose is to protect against Human papillomavirus (HPV), a common sexually transmitted infection (STI) that could lead to cervical cancer. Cervical cancer happens in the lowest part of the uterus and affects approximately 12,000 women in the U.S. every year.

According to Gardasil®, the following applies:

  • Gardasil® is an injection into a muscle in your arm or thigh.
  • It is safe for both females and males. 
  • They recommend vaccinating children at age 11 or 12 years old. However, children as young as nine years old can also receive it.
  • Anyone severely allergic to yeast should not take the vaccine.
  • Side effects can include swelling, pain, redness, itching, bruising, bleeding, or a lump in the area of the shot.
  • Only a doctor or health care professional can administer the vaccine.

Gardasil® Complications

Some parents cited safety concerns, and a study from 2015 to 2018 reveals that the parents who opted out of giving their children the Gardasi®l vaccine were due to safety concerns. 

Similarly, on August 19, 2020, a national law firm filed a lawsuit against Merck. They filed this Gardasil® lawsuit on behalf of a woman from Rhode Island, Julia Balasco, claiming the company misled the public on the safety and effectiveness of Gardasil®. The lawsuit claims Merck was not forthcoming about the ingredients and potentially dangerous DNA particles. 

Plaintiff (Julia Balasco) claims she experienced severe side effects immediately after the first injection and still suffers from permanent physical injuries. Symptoms started with headaches, ear issues, and tinnitus leading to more intense complications after the second dose,   including an autoimmune disease after several more injections. 

Vaccines, like any medicine, can have side effects, but her case brings attention to the public regarding the severe complications from Gardasil®, which she claims drastically changed her life. According to data from the Vaccine Adverse Event Reporting System (VAERS), more than 64,000 case reports of adverse events have been reported after individuals received the Gardasil® vaccine. 

Common side effects stated by Gardasil® include:

  • Injection site reactions (pain, swelling, redness, bruising, or itching),
  • Dizziness
  • Tiredness
  • Fever
  • Headache
  • Nausea
  • Sleep problems (insomnia)
  • Vomiting
  • Diarrhea
  • Runny or stuffy nose,
  • Tooth pain
  • Sore throat
  • Cough
  • Joint or muscle pain

Serious Side Effects Claims:

Although Merck provides its common side effects of Gardasil® as stated above, there are other claims of more dangerous side effects such as:

  • Postural orthostatic tachycardia syndrome (POTS)
  • Postural orthostatic tachycardia syndrome
  • Neurologic injuries
  • Guillain–Barré syndrome
  • Chronic inflammatory demyelinating polyneuropathy
  • Dysautonomia
  • Multiple sclerosis
  • Fibromyalgia
  • Chronic regional pain syndrome 
  • Joint pain
  • Premature ovarian failure
  • Chronic fatigue syndrome
  • Brain fog
  • Other serious complications

Developments in Gardasil® Trial Timeline

The start of Gardasil® trial in preadolescents and adolescents began in October 2003 with the enrollment of 1781 girls ages 9-18 years old and was completed by November 2005. During the trial period, some participants received Gardasil® while others received a placebo. All the adolescents and preadolescents in the trial period study were healthy with no prior sexual history or a compromised immune system. 

After the trial, the vaccine, produced by Merck & Co., was approved in only six months. Jesse Goodman, director of the FDA Center for Biologics Evaluation and Research, said the vaccine was the first of its type and justified a rushed review and approval.

The lawsuit against Merck Gardasil® reveals shocking allegations regarding those who receive the active medication versus those who receive a placebo in the clinical trials. The complaint alleges they did not use a real placebo. Instead, the company used a spiked vaccine with other misleading additives. As a result, the vaccine and placebo groups suffered adverse reactions and medical conditions, including symptoms of certain autoimmune diseases.

Arguments suggest that the Gardasil® vaccine clinical trials were too short to determine its effectiveness in preventing cervical cancer, unlike other vaccine trial periods that typically last decades. In addition, consumers want to know why the Gardasil® vaccine was evaluated and approved in six months under the FDA's priority review process.

Review of the Gardasil® Trial 

There are more than 64,000 cases of adverse side effects reported after users received the Gardasil® vaccine, according to data from the Vaccine Adverse Event Reporting System (VAERS). However,  only 1% percent of those cases are allegedly reported. 

In addition, Gardasil® is quite costly. Two doses of Gardasil® 9 are about $450, plus the cost of two doctor visits, making this vaccine one the most expensive on the market. Vaccines make pharmaceutical companies a lucrative business. In 2018, Merck garnered $2.2 billion in sales from Gardasil® in in the United States. In 2019, they made $3.7 billion worldwide from Gardasil® sales. Therefore, it’s worth noting that the Julia Balasco Lawsuit alleges Merck willingly put Gardasil®’s profits before patient safety. 

What Can I Do If I Think I Was A Victim?

If you or your child believe you are a victim of adverse effects from the Gardasil® vaccine, tortx™ is here to provide you with a path to justice. We serve as a resource to connect you with highly skilled attorneys so you will receive the compensation you deserve. Not all lawyers can defeat big-name pharmaceutical businesses in court, but we know who can. 

Our team conducts tons of research to find ways to make justice more accessible to help you receive compensation from Merck. With over ten years of experience, 200+ mass tort campaigns, and 100+, trusted legal partners, our goal is give you justice through filing claims against class action lawsuits.

It is important to note that, while there is currently a great deal of controversy surrounding vaccines, our company is not against vaccines and feels it is your choice to make the best decisions for your health. Vaccines have the potential to eradicate diseases and save millions of lives. In legal situations where an individual can become a victim of a pharmaceutical or medical device class action lawsuit, this is where we come in.

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