FDA broadens the age range of Gardasil 9 to cover individuals 27 through 45 years old

The US Food and Drugs Administration (FDA) extended the use of Merck’s cervical cancer vaccine Gardasil 9 to include men and women aged 27 through 45 years.

"Today's approval represents an important opportunity to help prevent HPV-related diseases and cancers in a broader age range," Peter Marks, MD, Ph.D., director of the FDA's Center for Biologics Evaluation and Research, says in a news release.

"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," Marks says.

 "The CDC has made increasing HPV vaccination rates a public health priority,” said Jacques Cholat, M.D., president, Merck Vaccines, “and today’s recommendation for GARDASIL 9 is an important milestone in the shared effort to help further reduce the burden of HPV-related cancers and diseases.”

According to CDC, every year about 14 million Americans become infected with HPV; about 12,000 women are diagnosed with, and about 4,000 women die from cervical cancer caused by certain HPV viruses. Additionally, HPV viruses are associated with several other forms of cancer affecting men and women. 

FDA first approved Gardasil in 2006, to prevent certain cancers and diseases caused by HPV Types 6, 11, 16, and 18. Gardasil is no longer available in the US. Gardasil 9 received approval in 2014 for use in girls and women 9 through 26 years of age and boys 9 through 15 years of age for the prevention of the cancers and precancerous lesions of cervix, vulva, vagina, and anus caused by HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58.

The approval is based on results of a study involving 3,200 women, aged 27 through 45 years, 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.

"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," the FDA said.

Similarly, in men aged 27 through 45 years of age, vaccine effectiveness was inferred based on data described above in women, along with efficacy data of Gardasil 9 in younger men aged 16 through 25 years, 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.

In all the safety and efficacy of Gardasil 9 was evaluated in a total of 13,000 males and females, the most commonly reported side effect being injection site pain, swelling, redness, and headaches.

The FDA granted the Gardasil 9 application priority review status. This program facilitates and expedites the review of medical products that address a serious or life-threatening condition.

Important Information about GARDASIL 9 (Human Papillomavirus 9-Valent Vaccine, Recombinant)

GARDASIL 9 does not eliminate the necessity for women to continue to undergo recommended cervical cancer screening.

Recipients of GARDASIL 9 should not discontinue anal cancer screening if it has been recommended by a health care provider.

GARDASIL 9 has not been demonstrated to protect against disease from vaccine HPV types to which a person has previously been exposed through sexual activity.

GARDASIL 9 has not been demonstrated to protect against diseases due to HPV types other than 6, 11, 16, 18, 31, 33, 45, 52, and 58.

GARDASIL 9 is not a treatment for external genital lesions; cervical, vulvar, vaginal, and anal cancers; or cervical intraepithelial neoplasia (CIN), vulvar intraepithelial neoplasia (VIN), vaginal intraepithelial neoplasia (VaIN), or anal intraepithelial neoplasia (AIN).

Not all vulvar, vaginal, and anal cancers are caused by HPV, and GARDASIL 9 protects only against those vulvar, vaginal, and anal cancers caused by HPV 16, 18, 31, 33, 45, 52 and 58.

Vaccination with GARDASIL 9 may not result in protection in all vaccine recipients.

FDA press release

Merck news release

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Important Policy Updates from American Society of Clinical Oncology (ASCO) supporting HPV Vaccination.

American Society of Clinical Oncology is  the leading professional body committed to decrease the burden of cancer and hence promote any underutilized intervention that have potential to save millions of lives by preventing cancer incidences.

An extremely important policy statement from the American Society of Clinical Oncology (ASCO), published ahead of print on April 11, 2016 regarding the HPV Vaccination

ASCO states that more than 10% of cancers worldwide (more than million cases per year) are caused by viruses with HPV contributing about 600,000 to the pool.

In addition to cervical cancer, HPV is also responsible for causing anal cancer, vaginal cancer, and vulvar cancers, and increasingly of oropharyngeal cancer. It is estimated that HPV is responsible for 60% of all oropharyngeal cancer, 90% of which are caused by HPV 16.

HPV is the cause of nearly all cervical cancers with 70% cases caused by genotype 16 and 18.

HPV additionally causes of 91% of anal cancers, 75% of vaginal cancers, 69% of vulvar cancers, and 63% of penile cancers, with HPV 16 being the predominant oncogenic genotype.

Thus HPV causes cancers in both sexes and oropharyngeal cancer is 3-5 times more common in men.

“With safe and effective vaccines readily available, no young person today should have to face the devastating diagnosis of a preventable cancer like cervical cancer. But unless we rapidly increase vaccination rates for boys and girls, many of them will,” said ASCO President Julie M. Vose, MD, MBA, FASCO.

Vaccination against the HPV virus is incredible preventive strategy, because once the HPV virus becomes incorporated into cells lining the cervix, anus or oropharynx it is impossible to eradicate it and it will remain there for life.

A 2011 National immunization survey reported that only 36% of girls 14% of boys have received the full schedule of immunization needed to protect against the virus.  A study in the same year also showed that some of the states with highest rates of HPV related cancers have the lowest rate of immunization.

Therefore, The ASCO recommendations for increasing vaccination awareness and use are summarized here.

1. Education and raising the awareness among health care providers, public health professionals, policy makers and patients about HPV vaccine and the cancers it causes.
2. Increasing the vaccination rates in society by combining it with other vaccines like eg, Tdap and meningococcal virus) for young adolescents. Distribution of educational pamplets, reminders by e-messaging or mailing should also be considered to bring on increase contacts among Drs and patients.
3. ASCO strongly urges the policy makers and insurance company to increase the vaccination coverage, thereby decreasing out of pocket expenses because vaccination rates are strongly related to these factors.  
4. Addressing critical knowledge gaps through research and development, making vaccinations safe and effective.
5. ASCO strongly believed that oncologists can play a very important role in increasing patients compliance for vaccination. They should keep abreast the recent advances by CDC and WHO regarding vaccination and interact with internists, gynecologists and primary care physicians to raise their awareness and interaction. Play a role in policy making in the society so that leaders can understand the critical role played by vaccines in avoiding cancers.

Bivalent (Cervarix), quadrivalent (Gardasil), and, more recently, nonavalent (nine-valent) vaccines against HPV genotypes (targeting those most commonly causing cancer globally) are approved in the United States and other countries for primary prevention of HPV infections 

The current Advisory Committee for Immunization Practices (ACIP)  Vaccine Recommendations are: 

 Usual Adult Dose for Human Papillomavirus Prophylaxis

Gardasil - women and men:
Cervical, vulvar, vaginal, and anal cancer caused by HPV and genital warts (condyloma acuminata) caused by HPV:
9 years through 26 years: one dose (0.5 mL) intramuscularly once. Repeat dose in 2 months and 6 months for a total of 3 doses.
Cervarix - women:
9 years through 25 years: one dose (0.5 mL) intramuscularly at 0, 1, and 6 months.

Usual Pediatric Dose for Human Papillomavirus Prophylaxis

Gardasil - girls and boys:
9 years or older: one dose (0.5 mL) intramuscularly once. Repeat dose in 2 months and 6 months for a total of 3 doses.
Cervarix - girls:
9 years or older: one dose (0.5 mL) intramuscularly at 0, 1, and 6 months.

Vaccine is usually initiated at 11 to 12 years old; optimally, vaccination should be completed prior to onset of sexual activity.

References.

Bailey HH, Chang LT, DuPont NC, et al: American Society of Clinical Oncology statement: Human papillomavirus vaccination for cancer prevention. J Clin Oncol. April 11, 2016 (early release online).

http://jco.ascopubs.org/content/early/2016/04/07/JCO.2016.67.2014.full#sec-11

http://www.ascopost.com/News/39503

http://www.ascopost.com/issues/april-25-2016/asco-urges-aggressive-efforts-to-increase-hpv-vaccination-and-prevent-cancer/?platform=hootsuite

Kish JK, Rolin AI, Zou Z, et al: Prioritizing US cervical cancer prevention with results from a geospatial model. J Global Oncol. April 11, 2016 (early release online).