Comments on the Proposed Vaccine Information Materials for HPV (Human Papillomavirus) Gardasil®-9 Vaccine

 

December 21, 2015

Suzanne Johnson-DeLeon
National Center for Immunization and Respiratory Diseases
Centers for Disease Control and Prevention
Mailstop A-19
1600 Clifton Road NE
Atlanta, GA 30329

Comments of members of the Patient, Consumer, and Public Health Coalition on the “Proposed Vaccine Information Materials for HPV (Human Papillomavirus) Gardasil®-9 Vaccine” [Docket No. CDC-2015-0089]

Members of the Patient, Consumer, and Public Health Coalition, a coalition of nonprofit organizations representing the interests of patients, consumers, health-care professionals, scientists, and public health experts, appreciate the opportunity to comment on the proposed vaccine information materials for HPV (human papillomavirus) Gardasil®-9 vaccine.

We have reviewed the vaccine information statement and we have suggested revisions for the wording and content of the Vaccine Information Statement (see blue text below):

Section 1: Why get vaccinated?

Paragraph 3, sentence 1: We recommend putting the risk information into context for the patient so they can better understand their risk. For example: In the US, about 1 in XXXXX women get cervical cancer every year, and about 1 in XXXXX women die from it.

Paragraph 4, sentence 1: HPV infection usually comes from sexual contact, and most people will become infected with the virus at some point in their life.

Paragraph 4, sentence 3:  Many Most infections will go away and not cause serious problems.

Paragraph 4, sentence 4: We rewrote this sentence to make the risk information easier to understand.   But thousands of women and men get cancer and diseases from HPV. The risk of getting cancer and disease from HPV is 1 in xxxx for women and 1 in yyyy for men.

Section 2: HPV vaccine

We recommend adding the following statement to this section to emphasize that maintenance of immunity beyond 2 years has not been established:  It is not known how long GARDASIL 9 will protect the patient from HPV.  In studies conducted by the company, it works for at least 2 years.  For this reason, it is not known when or if the child would need an additional vaccination as a “booster” shot to continue being protected against HPV.

Paragraph 1, sentence 3: It is routinely given at 11 or 12 years of age, but it may be given beginning at as early as age 9 years and through as late as age 26 years for girls and boys.

Paragraph 2 at the end add this sentence: You will need a total of 3 doses of the vaccine to be completely protected.

Paragraph 3, sentence 3:  Starting at age 21, women should still get regular Pap tests, according to the Centers for Disease Control and Prevention. We recommend emphasizing this point by giving it a prominent location on the handout.

Section 3: Some people should not get this vaccine

Paragraph 2: Anyone who has a severe (life threatening) allergy allergic reaction to any component of HPV vaccine should not get the vaccine.

Add a new paragraph at the end of paragraph 3, after “Tell your doctor if you have any severe allergies that you know of, including a severe allergy to yeast.” It would state:

Tell your health professional: if you or your child has an immune problem such as HIV or cancer; or if you or your child take medicines that affect the immune system.

Paragraph 4, sentence 3: At the beginning of the sentence, add the word “However,” before “any woman who learns she was pregnant…”

Section 4: Risks of vaccine reaction

Paragraph 7 states that “some people get severe pain in the shoulder…”  We recommend adding information that tells people what to do if these problems (severe shoulder pain and difficulty moving their arm) happen to them.

Conclusion

We urge you to include our above revisions in the final HPV (Human Papillomavirus) Gardasil®-9 vaccine information statement.  It is important that the statement concisely describe the benefits and risks associated with the vaccine.  But it is equally important that the statement provide all the essential information about the vaccine. It should include that it is for girls and boys, that maintenance of immunity beyond two years has not been established, and that patients should tell their health professional if they suffer from any immune problems (HIV or cancer).

Jacobs Institute of Women’s Health

National Center for Health Research

Our Bodies Ourselves

For additional information, contact Tracy A. Rupp, PharmD, MPH, RD Director of Public Health Policy Initiatives National Center for Health Research at (202) 223-4000 or at tr@center4research.org.