Who Should Get the HPV Vaccine? FDA Updates Approval Ages

What you need to know about the HPV Vaccine: Gardasil 9 if you are living with HIV

Last week, the U.S. Food and Drug Administration (FDA) expanded the age range for approved use of the Gardasil 9 (Human Papillomavirus (HPV) 9-valent Vaccine, Recombinant) to include women and men aged 27 through 45 years.

Previously, the vaccine was only approved for men and women aged 9 through 26 years. And it’s possible you may already have received the vaccine, but you should check with your physician immediately.

What is Gardasil 9?

Gardasil 9, the vaccine for HPV, prevents certain cancers and diseases caused by the nine HPV types. Gardasil 9 replaced an earlier HPV vaccine, Gardasil, which only prevented 4 types of the virus.

“[Last week’s] approval represents an important opportunity to help prevent HPV-related diseases and cancers in a broader age range,” said Peter Marks, M.D., Ph.D., director of the FDA’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 percent of these cancers, or 31,200 cases every year, from ever developing.”

About 14 million Americans each year contract HPV. This includes nearly 12,000 women who are diagnosed with HPV and almost 4,000 women die from cervical cancer caused by certain HPV viruses. HPV is associated with several other forms of cancer affecting both men and women.

How Effective is Gardasil 9?

The effectiveness of Gardasil 9 is similar to the previously approved Gardasil vaccine approved in 2009 which demonstrated in a clinical study of approximately 3,200 women 27 through 45 years of age, followed for an average of 3.5 years, Gardasil was 88 percent effective in the prevention of a combined endpoint of persistent infection, genital warts, vulvar and vaginal precancerous lesions, cervical precancerous lesions, and cervical cancer related to HPV types covered by the vaccine, according the FDA release.

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.

Should Men Get the HPV Vaccine?

Although there was never a specific study for men  for this specific HPV vaccine, the effectiveness of Gardasil 9 in men 27 through 45 years of age is inferred from the data described above in women 27 through 45 years of age, as well as efficacy data from Gardasil in younger men (16 through 26 years of age) and immunogenicity data from a clinical trial in which 150 men, 27 through 45 years of age, received a 3-dose regimen of Gardasil over 6 months.

Is this HPV Vaccine Safe?

The term safe is hard to confirm, as with all vaccines, there may be risks of side effects that may vary from person to person and their body’s immune response. However, according to the FDA, “The safety of Gardasil 9 was evaluated in about a total of 13,000 males and females. The most commonly reported adverse reactions were injection site pain, swelling, redness and headaches.”

What About Any Considerations for Those With HIV?

Although in April 2018, a major HIV publication published a ‘click-bait worthy’ article saying it is not effective in those living with HIV, the article seems to contradict its own title by providing data it may infect protect individuals. Imstilljosh.com had off the record conversations with the FDA (where the article may have been reviewed hypothetically), and afterwhich this publication could not find any special population considerations, guidance, or support against the vaccine—demonstrating no real recommendations or special considerations exist. The label actually encourages the approved use, obviously.

Which Pharmaceutical Company Gained Approval for the HPV Vaccine?

The FDA granted the Gardasil 9 application priority review status to Merck, Sharp & Dohme Corp. a subsidiary of Merck & Co., Inc.