VACCINE RESOURCE COMMITTEE

of the Edmonton Zone Medical Staff Association

View Full List of Vaccine Questions Here

Human Papillomavirus Vaccine Question #4:

Is the vaccine too new to be administered?

The vaccine was licensed in Canada in 2006; there is almost 20 years of data showing a favorable safety profile.

The vaccines are not new as there is now almost 20 years of safety monitoring showing that the HPV vaccine is safe with no evidence that it causes infertility, autoimmune diseases or other health problems. Many people have no side effects from vaccines. For those that do, they are usually mild and go away on their own within a few days. Serious side effects are very rare.

Side effects of the HPV vaccine can include:

  • Pain, redness, or swelling at the site where the vaccine was given

  • Fever

  • Dizziness or fainting

  • Nausea

  • Headache or feeling tired

  • Muscle or joint pain

Anaphylaxis is an extremely rare severe allergic reaction that may occur with any vaccination, usually in the first 15 minutes after vaccine administration.

HPV vaccines are safe‎

Findings from many vaccine safety monitoring systems and more than 160 studies have shown that HPV vaccines have a favorable safety profile—the body of scientific evidence overwhelmingly supports their safety.

Of the reports to the Vaccine Adverse Event Reporting System (VAERS) in the US, 6% were classified as "serious." Of the other reports to VAERS relating to HPV, about 22% of the reports were not related to health problems, but were reported for reasons such as improper vaccine storage or the vaccine being given to someone for whom it was not recommended.

Over 100 million doses of HPV vaccines were distributed in the United States from June 2006 through December 2017. To date, most of CDC’s HPV vaccine safety monitoring and research has focused on Gardasil because it has accounted for the majority of HPV vaccine doses distributed in the United States. These safety efforts continue, now focusing on Gardasil 9.

Gardasil 9, Gardasil and Cervarix

In November 2019, initial post-licensure safety monitoring of Gardasil 9 was published in Pediatrics. In two separate articles, analyses from the VAERS and the Vaccine Safety Datalink (VSD) were presented. Both included multiple years of data, and did not identify any unexpected safety problems with Gardasil 9. These findings support the favorable safety profile that was established in pre-licensure clinical trials.

In 2014, before Gardasil 9 was licensed by the FDA, its safety was evaluated across seven studies. The safety findings from these pre-licensure studies show that Gardasil 9 has a similar safety profile to Gardasil, an earlier version of the vaccine. The most common side effects were localized reactions, which may occur more often after Gardasil 9 than Gardasil.

Reports from prior HPV vaccines (Gardasil, Cervarix) showed 92-96% of reactions were non-serious.

HPV vaccines have not been associated with increased rates of:

  • Fainting

  • Analphylaxis

  • Guillain-Barré Syndrome

  • Postural orthostatic tachycardia syndrome (POTS)

  • Complex Regional Pain Syndrome (CRPS)

  • Myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS)

  • Death

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. To date, no adverse events related to this lot of HPV vaccine have been reported other than mild reactions such as redness and swelling at the injection site. It is not expected that delayed side effects will occur.

Reproductive concerns

HPV vaccines and primary ovarian insufficiency (POI), also known as "premature menopause," is a condition in which a woman's ovaries stop functioning before age 40. CDC and FDA have not found any proof that HPV vaccines cause reproductive problems in women, including POI. 

HPV vaccination prevents infection with the HPV types that most commonly cause cervical cancer. In some cases, women develop cervical cancer before starting or finish having children. Treatment for cervical cancer (removal of the cervix and uterus, chemotherapy, and/or radiation) can keep a woman from being able to become pregnant. Preventing cervical cancer through HPV vaccination reduces this risk.

CDC works closely with the American Academy of Pediatrics (AAP) and the American Academy of Family Physicians (AAFP) on HPV vaccination. Both organizations have information about HPV vaccine available on their websites. Also, the American College of Obstetrics and Gynecologists (ACOG) offers additional resources.

HPV vaccines are not approved or recommended for pregnant women. However, some pregnant women receive HPV vaccines because they don't know that they are pregnant at the time of vaccination. CDC and vaccine manufacturers have monitored and studied HPV vaccine safety in women who received the vaccine when they were pregnant. The manufacturers for each vaccine have established pregnancy registries to follow outcomes for those women who were vaccinated while pregnant. Close monitoring has not found any health concerns.  If a woman receives HPV vaccine and later learns that she is pregnant, there is no reason to be alarmed.

Any woman who learns she was pregnant at the time she received an HPV vaccine is encouraged to contact the vaccine manufacturer. This will help us learn how pregnant women respond to the vaccine.

If a pregnant woman receives a dose of Gardasil 9 no intervention is needed. If she found out she was pregnant when starting the vaccination series, the remainder of the 3-dose series should be delayed until completion of pregnancy. She may contact Merck at 1-877-888-4231 if she has questions related to getting the vaccine while pregnant.

Doctors should report Gardasil 9 vaccination during pregnancy as early in the pregnancy as possible using the Merck Pregnancy Registries or calling 1-800-986-8999.

Pregnant women who received Gardasil 9 and their physician can also report to local public health.

Sources:

Health Link BC: Human papillomavirus (HPV) vaccines
CDC: Vaccine Safety: Human Papillomavirus (HPV) Vaccine Safety