FDA Move Widens Approved Use of Human Papillomavirus Vaccine
By Rebecca Bowers
EXECUTIVE SUMMARY
The Food and Drug Administration has approved the use of the nine-valent human papillomavirus (HPV) vaccine in women and men ages 27-45. The Advisory Committee on Immunization Practices (ACIP) is scheduled to review further information at its February 2019 meeting, with a potential vote at that time. Insurance reimbursement often is based on ACIP guidance.
- Current recommendations call for administering two doses of HPV vaccine for people who start the immunization series before their 15th birthday. For people who start the vaccine series on or after their 15th birthday, three doses of HPV vaccine are recommended. The same three-dose recommendation applies to people with certain immunocompromising conditions.
- Routine immunization is recommended for children at age 11 or 12, but the series can be started at 9 years of age. Immunization also is recommended through age 26 for females and through age 21 for males. Males ages 22-26 may be immunized.
The Food and Drug Administration (FDA) has approved the use of the nine-valent human papillomavirus (HPV) vaccine in women and men ages 27 through 45. What are the next steps in implementing immunization for this expanded age range?
The October 2018 approval represents an “important opportunity” to aid in the prevention of HPV-related diseases and cancers in a broader age range, says Peter Marks, MD, PhD, director of the agency’s Center for Biologics Evaluation and Research.
“The Centers for Disease Control and Prevention has stated that HPV vaccination prior to becoming infected with the HPV types covered by the vaccine has the potential to prevent more than 90% of these cancers, or 31,200 cases every year, from ever developing,” said Marks in a press statement.
The nine-valent vaccine was approved for use in 2014. In October 2016, updated HPV immunization recommendations were issued regarding dosing schedules. The Centers for Disease Control and Prevention (CDC) currently recommends two doses of HPV vaccine for people starting the immunization series before their 15th birthday. The agency recommends the administration of three doses of HPV vaccine for people starting the series on or after their 15th birthday, as well as for people with certain immunocompromising conditions.
The CDC recommends routine immunization for children 11 or 12 years of age, but the series can be initiated at 9 years of age. Immunization also is recommended through age 26 for females and through age 21 for males. Males ages 22-26 may be immunized.1
In a practice advisory to its members, the American College of Obstetricians and Gynecologists states that it is working with the CDC to determine appropriate changes in clinical guidance and recommendations.2 Until changes are approved, clinicians should continue to follow current guidance. Providers are encouraged to welcome conversations with women older than age 26 who are interested in receiving the HPV vaccine, the advisory states. Decisions to be immunized should be made using shared decision-making and clinical judgment based on individual patient circumstances, preferences, and concerns. Research indicates the vaccine is safe and effective in preventing new HPV infections in women in the age 27-45 category.3
More Data to Be Presented in February
Should the upper age for HPV catch-up vaccination be expanded beyond the current recommendation? A work group of the Advisory Committee on Immunization Practices (ACIP) still is reviewing results from health economic analyses, as well as other data related to this policy question. The committee is scheduled to review further information and economic analyses at its February 2019 meeting, with a potential vote at that time.
Although the FDA approval of an expanded age range is important, many insurance companies look to ACIP recommendations when determining whether to extend coverage. Coverage may not be available until such recommendations are issued.
According to information presented at the October 2018 ACIP meeting, HPV vaccines have been licensed through age 45 or older in other countries. However, no country has a public health HPV vaccination program targeting mid-adults, which is the term public health officials now are using for the 26-45 age category.
The FDA summary basis for its regulatory action centered around research looking at use of the vaccine in both women and men.3-7 These studies include additional follow-up of patients enrolled in studies of the four-valent vaccine and observational studies lasting up to 10 years. Understanding the potential benefit of vaccination in adults is complex; HPV is common, with infection occurring soon after initiation of sexual activity, said Lauri Markowitz, MD, HPV team leader in the CDC’s Division of Viral Diseases at the October 2018 ACIP meeting. There are challenges in studies of HPV incidence, since HPV detection cannot distinguish between new or persistent infections and redetection of infection, she noted.
New infections do occur in adults, and sex with a new partner is a risk factor, said Markowitz. The percentage of adults with a new partner in the past year decreases in older age groups. Contributing to the complexity of the issue is that not all infected individuals develop antibodies, she stated.
The work group will continue to conduct a further review of the health economic analyses, summarize values and acceptability in the expanded age group, review data for special populations, discuss policy options, and complete evidence reviews in preparation for a potential vote at the February 2019 meeting, said Markowitz.
REFERENCES
- Meites E, Kempe A, Markowitz LE. Use of a 2-dose schedule for human papillomavirus vaccination - updated recommendations of the Advisory Committee on Immunization Practices. MMWR Morb Mortal Wkly Rep 2016;65:1405-1408.
- American College of Obstetricians and Gynecologists. Practice advisory: FDA approval of 9-valent HPV vaccine for use in women and men age 27-45. Available at https://bit.ly/2Rh7TQR. Accessed Nov. 20, 2018.
- Luna J, Plata M, Gonzalez M, et al. Long-term follow-up observation of the safety, immunogenicity, and effectiveness of Gardasil™ in adult women. PLoS One 2013;8:e83431.
- Giuliano AR, Palefsky JM, Goldstone S, et al. Efficacy of quadrivalent HPV vaccine against HPV infection and disease in males. N Engl J Med 2011;364:401-411.
- Castellsagué X, Giuliano AR, Goldstone S, et al. Immunogenicity and safety of the 9-valent HPV vaccine in men. Vaccine 2015;33:6892-6901.
- Muñoz N, Manalastas R Jr, Pitisuttithum P, et al. Safety, immunogenicity, and efficacy of quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine in women aged 24-45 years: A randomised, double-blind trial. Lancet 2009;373:1949-1957.
- Castellsagué X, Muñoz N, Pitisuttithum P, et al. End-of-study safety, immunogenicity, and efficacy of quadrivalent HPV (types 6, 11, 16, 18) recombinant vaccine in adult women 24-45 years of age. Br J Cancer 2011;105:28-37.
The Food and Drug Administration has approved the use of the nine-valent human papillomavirus (HPV) vaccine in women and men ages 27-45. The Advisory Committee on Immunization Practices (ACIP) is scheduled to review further information at its February 2019 meeting, with a potential vote at that time. Insurance reimbursement often is based on ACIP guidance.
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