Gardasil Now FDA Approved for Individuals 27 to 45 Years Old
According to the CDC
The 9-valent HPV vaccine protects against nine HPV types, including seven types that can cause cancer. Of the 32,500 cancers that HPV has caused every year, 30,000 are caused by strains that could have been prevented by the 9-valent HPV vaccine.
Previously, Gardasil 9 was approved for males and females ages 9 to 26
Based on current research, the FDA has now extended approval to include individuals ages 27 to 45
The Gardasil 9 age extension was approved using ‘priority review status’, which is an expedited review of medical products that address a serious or life-threatening condition
ACOG has responded with a Practice Advisory (October 2019) that addresses the following considerations
Further review of data, including cost-effectiveness is still necessary
CDC and ACIP are reviewing the data, in conjunction with ACOG
Current guidelines “remain in effect” and ObGyns and other health professionals are “encouraged” to discuss the vaccine with women who are >26 years and are interested in vaccination
In women 27 to 45 years, decisions regarding vaccination should
Involve shared decision making
Include clinical judgement
The original Gardasil vaccine was approved in 2006 and covered 4 HPV types but is no longer distributed in the US
Gardasil 9 (Human Papillomavirus (HPV) 9-valent Vaccine, Recombinant) was approved in 2014 and includes the original 4 HPV types plus another 5 pathogenic types
Gardasil studies were considered ‘relevant’ for Gardasil 9 review because both vaccines are manufactured similarly and cover 4 common HPV types
In one study, 3,200 women 27 through 45 years of age were followed for an average of 3.5 years
Gardasil was 88 percent effective in the prevention of a combined endpoint of HPV related lesions and cancer (persistent infection, genital warts, vulvar and vaginal precancerous lesions, cervical precancerous lesions, and cervical cancer)
“The FDA’s approval of Gardasil 9 in women 27 through 45 years of age is based on these results and new data on long term follow-up from this study”
Males age 27 through 45 years
Effectiveness: ‘Inferred’ from the above data
Efficacy: Derived from Gardasil data in males age 16 through 26 years
Immunogenicity: Derived from a clinical trial in which 150 men, 27 through 45 years of age, received a 3-dose regimen of Gardasil over 6 months
Gardasil 9 was evaluated in approximately 13,000 males and females
Lipkind et al. (Obstet Gynecol., 2017) evaluated the impact of administering quadrivalent human papillomavirus vaccine (4vHPV) during the periconception and perinatal time periods on maternal and fetal outcomes
Retrospective, observational cohort study (2007-2013)
Periconception (2 weeks before and 2 weeks after after LMP)
Both of the above
4-18 months before their last menstrual period
Hypertensive disorders of pregnancy
Major structural birth defects in offspring
720 received vaccine during periconceptional period, 698 received vaccine during pregnancy and 8196 controls received vaccine
4vHPV administered during pregnancy was not associated with increased risk for adverse obstetric events or birth outcomes
When comparing vaccine exposure during pregnancy to controls
There was no evidence of increased preterm birth (adjusted relative risk [aRR] 0.97; 95% CI 0.72-1.3)
There was no evidence of increased major structural birth defects (2.0% vs 1.8%)
Results were similar for 4vHPV exposure during periconceptional period
Administering 4vHPV during pregnancy or periconceptional period was not associated with adverse pregnancy or birth outcomes
HPV Vaccine Recommendations Including Guidance for Ages 27 to 45
The most recent evidence-based HPV vaccine recommendations address when to administer the vaccine and dosing. One area that has elicited more recent guidance focuses on whether to offer the HPV vaccine to individuals over the age of 26.
The FDA (October 2018) extended approval of HPV vaccine to individuals age 27-45 years
ACIP (June 2019) voted to
Expand routine and catch-up HPV vaccination in males through 26 years of age who are inadequately vaccinated
Offer HPV vaccine to individuals age 27-45 years who have not been adequately vaccinated based on shared clinical decision making
ACIP published their final recommendations (August 2019) in the CDC’s Morbidity and Mortality Weekly Report
Children and adults aged 9 through 26 years: HPV vaccination is routinely recommended at age 11 or 12 years; vaccination can be given starting at age 9 years. Catch-up HPV vaccination is recommended for all persons through age 26 years who are not adequately vaccinated.
Adults aged >26 years: Catch-up HPV vaccination is not recommended for all adults aged >26 years. Instead, shared clinical decision-making regarding HPV vaccination is recommended for some adults aged 27 through 45 years who are not adequately vaccinated. HPV vaccines are not licensed for use in adults aged >45 years.
These recommendations for children and adults aged 9 through 26 years and for adults aged >26 years apply to all persons, regardless of behavioral or medical risk factors for HPV infection or disease.
For persons who are pregnant, HPV vaccination should be delayed until after pregnancy; however, pregnancy testing is not needed before vaccination.
Persons who are breastfeeding or lactating can receive HPV vaccine. Recommendations regarding HPV vaccination during pregnancy or lactation have not changed.
ACIP suggests considering the following points for shared-decision making with adults who are 27 to 45 years of age
HPV is very common, usually transient and asymptomatic
Although typically acquired in young adulthood, some adults are at risk for acquiring new HPV infection
A new sex partner is a risk factor, while those in long-term, mutually monogamous partnerships are not likely to acquire a new HPV infection
HPV types: Sexually active adults will likely have been exposed to some HPV types, but not all HPV types are vaccine targets
There is no antibody test to determine immunity
HPV vaccine has high efficacy in young persons not yet exposed to vaccine-type HPV
Lower vaccine effectiveness may be expected in those with HPV risk factors
Multiple lifetime sex partners | Previous infection with vaccine-type HPV | immunocompromising conditions
HPV vaccines are prophylactic only and can’t prevent infection progression, improve time to clearance or treat HPV-related disease
In summary, the CDC states
For adults aged 27 years and older, clinicians can consider discussing HPV vaccination with people who are most likely to benefit. HPV vaccination does not need to be discussed with most adults over age 26 years
Updated ACOG HPV vaccine recommendations
Routine HPV vaccination is recommended for females and males
Target age is 11-12 years but can be given through age 26
Can be given from age of 9
Do not test for HPV DNA prior to vaccination
Vaccinate even if patient was tested and is HPV DNA positive
If not vaccinated between 11-12 years
Vaccinate between 13–26 years (catch up period)
Women 27–45 years and not previously unvaccinated
Use shared clinical decision making
ACOG “does not recommend that an individual who received the quadrivalent HPV vaccine be revaccinated with 9-valent HPV vaccine, including those aged 27–45 years who previously completed some, but not all, of the vaccine series when they were younger”
HPV vaccine is not recommended during pregnancy
Pregnancy testing prior to HPV vaccination not recommended
If vaccination schedule is interrupted by pregnancy, resume postpartum with the next dose
HPV vaccine can and should be given to breastfeeding women ≤ 26 who have not been vaccinated
Counsel to expect mild local discomfort and that this is not a cause for concern
Watch adolescents for at least 15 minutes following vaccination due to risk of fainting in this population
AAP HPV Vaccine Implementation Guidance 2017
The AAP has also endorsed the CDC HPV recommendations and provides the following guidance
The AAP and the ACIP of the CDC recommend HPV vaccination with any available vaccine for routine immunization of females at 11 or 12 years of age, and recommend either 9vHPV or 4vHPV** for routine immunization of males 11 or 12 years of age. The vaccination series can be started as young as 9 years of age, and in the case of a child who has been the victim of sexual abuse, HPV vaccination is recommended beginning at 9 years of age.
AAP recommends that physicians frame their HPV discussions with families as an opportunity to prevent HPV-related cancer deaths rather than as an STI vaccine
The ACS endorses ACIP CDC guidance regarding HPV guidance except for the approach to take with individuals who are 27 to 45 years and not adequately vaccinated
The ACS does not endorse the 2019 Advisory Committee on Immunization Practices recommendation for shared clinical decision making for some adults aged 27 through 45 years who are not adequately vaccinated because of the low effectiveness and low cancer prevention potential of vaccination in this age group, the burden of decision making on patients and clinicians, and the lack of sufficient guidance on the selection of individuals who might benefit
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