What is HPV Vaccine?
There are three FDA licensed HPV vaccines, however only one, Gardasil 9, approved in 2014 and manufactured by Merck, is currently available in the United States. Initially, HPV vaccines were given as a series of three shots over 6 months to protect against HPV infection and the health problems that ongoing HPV infection can cause. In 2016 the CDC recommended a two dose series with second dose administration between 6 to 12 months from the first dose.1 Below is information on the HPV vaccines licensed in the U.S.
- Gardasil 9: FDA approved Gardasil 9 for use in 2014. The safety of Gardasil 9 was studied in clinical trials with more than 15,000 participants before it was licensed and continues to be monitored. According to Merck’s product insert, Gardasil 9 protects against HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58.
- Gardasil: FDA approved Gardasil for use in 2006. The safety of Gardasil was studied in clinical trials with more than 29,000 participants before it was licensed. According to Merck’s product insert, Gardasil protects against HPV types 6, 11, 16, and 18.
- Cervarix: FDA approved Cervarix for use in 2009. The safety of Cervarix was studied in clinical trials with more than 30,000 participants before it was licensed. According to GlaxoSmithKine’s product insert, Cervarix protects women and girls against HPV types 16 and 18.
Vaccines, like any medicine, can have side effects. Some people who get HPV vaccine have no side effects at all. Some people report having very mild side effects, like a sore arm from the shot. According to manufacturer product inserts,2 the most common side effects reported are usually mild and include:
- Pain, redness, or swelling in the arm where the shot was given
- Headache or feeling tired
- Muscle or joint pain
According to the Gardasil 9 product insert,3 brief fainting spells and related symptoms (such as jerking movements) can happen after any medical procedure, including vaccination. Sitting or lying down for about 15 minutes after a vaccination can help prevent fainting and injuries caused by falls.
On very rare occasions, severe (anaphylactic) allergic reactions can occur after vaccination. People with severe allergies to any component of a vaccine should not receive that vaccine.
Gardasil 94 is approved for use in girls and women ages 9 through 26 to prevent genital warts caused by Human Papillomavirus (HPV) types 6 and 11 and for the prevention of cervical, anal, vaginal, and vulvar cancers associated with HPV types 16, 18, 31, 33, 45, 52, and 58. Per the manufacturer’s product insert, Gardasil 9 also targets the following dysplastic and precancerous lesions associated with HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58:
- Cervical intraepithelial neoplasia (CIN) grade 1
- Cervical adenocarcinoma in situ (AIS) and cervical intraepithelial neoplasia (CIN) grade 2/3
- Anal intraepithelial neoplasia (AIN) grades 1, 2, and 3
- Vaginal intraepithelial neoplasia (VIN) grade 2 and 3
- Vulvar intraepithelial neoplasia (VIN) grade 2 and 3
Gardasil 9 is also approved for use in boys and men ages 9 through 26 to prevent genital warts caused by HPV types 6 and 11 and for the prevention of anal cancer associated with HPV types 16, 18, 31, 33, 45, 52, and 58. Per the manufacturer’s product insert, Gardasil 9 targets anal intraepithelial dysplasia (AIN) grades 1, 2, and 3 associated with HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58.
According to Merck’s product insert, Gardasil 9, Human Papillomavirus 9-valent Vaccine, Recombinant, is a non-infectious recombinant 9-valent vaccine approved by the FDA for intramuscular administration. This vaccine is produced from the purified virus-like particles (VLPs) of the major capsid (L1) protein of HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58. The L1 proteins are formed by separate fermentations using recombinant Saccharomyces cerevisiae and self-assembled into virus-like particles. The fermentation process necessitates the growth of S. cerevisiae on a chemically-defined fermentation media which include carbohydrates, mineral salts, vitamins, and amino acids. The virus-like particles are freed from the yeast cells by cell disruption and purified by a series of physical and chemical methods. The purified virus-like particles are adsorbed on preformed Amorphous Aluminum Hydroxyphosphate Sulfate (AAHS), an aluminum containing adjuvant. The 9-valent Human Papillomavirus VLP vaccine is a sterile liquid suspension that is prepared by combining the adsorbed virus-like particles of each HPV type as well as additional amounts of the aluminum-containing adjuvant, AAHS, and the final purification buffer.
Merck’s Gardasil 9 product inserts states that each 0.5-mL dose contains approximately 30 mcg of HPV Type 6 L1 protein, 40 mcg of HPV Type 11 L1 protein, 60 mcg of HPV Type 16 L1 protein, 40 mcg of HPV Type 18 L1 protein, 20 mcg of HPV Type 31 L1 protein, 20 mcg of HPV Type 33 L1 protein, 20 mcg of HPV Type 45 L1 protein, 20 mcg of HPV Type 52 L1 protein, and 20 mcg of HPV Type 58 L1 protein.
Each 0.5-mL dose of the vaccine also contains approximately 500 mcg of aluminum (in the form of Amorphous Aluminum Hydroxyphosphate Sulfate), 9.56 mg of sodium chloride, 0.78 mg of L-histidine, 50 mcg of polysorbate 80, 35 mcg of sodium borate, <7 mcg yeast protein, and water for injection.
The majority of pre-licensure clinical trials compared Gardasil 9 to Merck’s original Gardasil vaccine. In pre-licensure studies of the original Gardasil vaccine, Merck was permitted by the FDA to use Amorphous Aluminum Hydoxyphosphate Sulfate (AAHS), an aluminum adjuvant, in lieu of a saline placebo, as a control for nearly all of its trial participants.5 A reactive placebo, such as AAHS, has the ability to artificially increase the appearance of safety when used as a control in a clinical trial and neither the FDA nor Merck disclosed the amount of aluminum contained in the placebo. Both human and animal studies have shown that aluminum can enter the brain and that vaccine aluminum adjuvants can cause nerve cell death, as well as inflammation at the injection site leading to chronic muscle and joint pain and fatigue.6
IMPORTANT NOTE: NVIC encourages you to become fully informed about HPV and the HPV vaccine by reading all sections in the Table of Contents , which contain many links and resources such as the manufacturer product information inserts, and to speak with one or more trusted health care professionals before making a vaccination decision for yourself or your child. This information is for educational purposes only and is not intended as medical advice.
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1 Meites E., Kempe, A., Marowitz, LE. Use of 2-Dose Schedule for Human Papillomavirus Vaccination – Updates Recommendations of the Advisory Committee on Immunization Practices. MMWR. 2016;65:1405-1408. Dec. 16, 2016.
2 FDA. Human Papillomavirus Vaccine – Approved Products. Feb. 2, 2018.
3 FDA Gardasil 9 – Product insert. Feb. 9, 2018
4 FDA Gardasil 9 – Product insert. Feb. 9, 2018
5 FDA Gardasil – Product insert. Apr. 24, 2015
6 NVIC Merck’s Gardasil Vaccine Not Proven Safe for Little Girls. Press Release. Jun. 27, 2006