Drugs Q & A

Why Was Gardasil Discontinued?

What is Gardasil?

Gardasil 9 is an HPV vaccine approved by the U.S. Food and Drug Administration and can be used for both girls and boys. This vaccine can prevent most cases of cervical cancer if the vaccine is given before girls or women are exposed to the virus. This vaccine can also prevent vaginal and vulvar cancer. In addition, the vaccine can prevent genital warts, anal cancers, and mouth, throat, head, and neck cancers in women and men.

In theory, vaccinating boys against the types of HPV associated with cervical cancer might also help protect girls from the virus by possibly decreasing transmission. HPV is a virus that can cause very serious conditions such as cervical, vulvar, vaginal, anal, and certain head and neck cancers. It can also cause precancerous spots to form in those areas. In addition to cancer and precancerous spots, HPV can also cause genital warts.

The Food and Drug Administration (FDA) has approved Gardasil 9 to protect against disease caused by the following HPV strains: types 6, 11, 16, 18, 31, 33, 45, 52, and 58.

These HPV strains are known to cause specific cancers or conditions.

Gardasil 9 is FDA-approved to prevent the following conditions that are caused by HPV in females:*

•          cervical precancer or cancer

•          vulvar precancer or cancer

•          vaginal precancer or cancer

•          anal precancer or cancer

•          certain head and neck cancers

•          genital warts.

Gardasil 9 is also FDA-approved to prevent the following conditions that are caused by HPV in males:*

•          anal precancer or cancer

•          certain head and neck cancers

•          genital warts.

Why was there a recall of the Gardasil HPV vaccine?

On December 16, 2013, CDC was informed by Merck that the company planned to implement a voluntary recall of one lot (lot J007354) of Gardasil [Human Papillomavirus Quadrivalent (Types 6, 11, 16, and 18) Vaccine, Recombinant], due to the potential for a small number of vials to contain glass particles as a result of breakage during the manufacturing process. These vials were distributed between August 20, 2013, and October 9, 2013. No other lots were affected.

Why Was Gardasil Discontinued?

Gardasil administration has been halted in many countries including Japan due to questions about its efficacy and safety. More than twenty women who received the Gardasil vaccine have died, but these deaths have not been causally connected to the shot, as correlation does not imply causation.

In 2012, a published case study of two deaths after HPV vaccination suggests that HPV vaccines containing HPV-16L1 antigens “pose an inherent risk for triggering potentially fatal autoimmune vasculopathies.”

Also in 2012, Dr. Sin Hang Lee, a research scientist and board-certified pathologist published a case study examining the sudden death of a teenage girl six months after receiving the final of her three shots of Gardasil. Dr. Lee found HPV-16 gene DNA in blood and spleen tissue samples similar to HPV-16 gene DNA fragments he found in Gardasil. The HPV-16 LI gene DNA was bound to what Merck describes as its proprietary aluminum adjuvant used in Gardasil 4 and Gardasil 9. This binding protected the DNA fragments from degradation.

According to Dr. Lee:

“Viral DNA molecules, as those found in Gardasil, when transfected with the aluminum adjuvant into the macrophages after intramuscular injection, are now known to stimulate release of many immune molecules some of which, such as the tumor necrosis factor-α, are potent myocardial depressants. Tumor necrosis factor is capable of causing hypotension and even death in experimental animals and in humans.”

But according to the CDC, over 15 years of monitoring and research during the vaccination program have continued to show that HPV vaccination is safe. Gardasil® 9 was studied in clinical trials with more than 15,000 females and males. Gardasil® was studied in clinical trials with more than 29,000 females and males.

Gardasil was voluntarily discontinued in the United States (for reasons other than those related to safety or efficacy). Since late 2016, Gardasil® 9 has been the only HPV vaccine available for use in the United States.

As with all approved vaccines, CDC and FDA closely monitor the safety of HPV vaccines. Any detected safety concerns are reported to health officials, healthcare professionals, and the public.

More than 135 million doses of HPV vaccines have been distributed since they were licensed. Data continue to show the vaccines are safe and effective.

Possible side effects

Vaccines, like any medicine, can have side effects. Common side effects from HPV shots are mild and get better within a day or two. These include:

•          Pain, redness, or swelling in the arm where the shot was given

•          Fever

•          Dizziness or fainting (fainting after any vaccine, including HPV vaccine, is more common among adolescents than others)

•          Nausea

•          Headache or feeling tired

•          Muscle or joint pain.

To prevent fainting and injuries from fainting, adolescents should be seated or lying down during vaccination and for 15 minutes after getting the shot.

Tell the doctor or nurse if your child has any severe allergies, like an allergy to latex or yeast.


Dr. Oche Otorkpa PG Cert, MPH, PhD

Dr. Oche is a seasoned Public Health specialist who holds a post graduate certificate in Pharmacology and Therapeutics, an MPH, and a PhD both from Texila American University. He is a member of the International Society of Substance Use Professionals and a Fellow of the Royal Society for Public Health in the UK. He authored two books: "The Unseen Terrorist," published by AuthorHouse UK, and "The Night Before I Killed Addiction."
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