Doctors Push HPV Vaccine, Merck asks FDA to Expand Gardasil 9 Age Range

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HPV Vaccine

Doctors, national cancer organizations and 70 nationally recognized cancer centers banded together in June to increase HPV vaccinations and improve cervical cancer screening.

But they’re not the only ones pushing for more vaccinations.

HPV vaccine maker Merck requested the FDA expand the recommended age range for Gardasil 9. Gardasil 9 is currently the only HPV vaccination available in the U.S.

Nearly 80 million Americans get HPV infections each year. Of those people, about 32,500 get HPV-related cancers, according to the CDC.

Studies show the HPV vaccine is effective in protecting against the human papilloma virus. The virus can lead to several cancers. These include cervical, vaginal, vulvar, anal, penile or throat cancers.

HPV vaccination rates in the U.S. remain low. Doctors and cancer centers say low vaccination rates are a public health threat.

“HPV vaccination is cancer prevention,” Dr. Deanna Kepka, assistant professor in the University of Utah’s College of Nursing, said in a statement. “It is our best defense in stopping HPV infection in our youth and preventing HPV-related cancers in our communities.”

Doctor: HPV Vaccination Could Wipe Out Cervical Cancer Within 40 years

Right now, the vaccination rate among teens ages 13 to 17 is 60 percent. Doctors are pushing for an 80 percent HPV vaccination rate in pre-teen boys and girls.

Suffering from an HPV Vaccine related injury? Get a Free Case Review

“[Vaccination] combined with continued screening and treatment for cervical pre-cancers … could see the elimination of cervical cancer in the U.S. within 40 years,” Dr. Richard Wender, chief cancer control officer for the American Cancer Society, said in a news release. “No cancer has been eliminated yet, but we believe if these conditions are met, the elimination of cervical cancer is a very real possibility.”

Gardasil 9 requires two to three doses to be complete. Only 43 percent of teens get all required doses.

Studies show the vaccine is safe for most people. The most common side effects are headache, nausea, vomiting and fever.

But, the HPV vaccine may cause rare but serious side effects. The FDA’s Vaccine Adverse Event Reporting System has reports of autoimmune diseases, deaths and premature ovarian failure linked to the vaccine.

The National Vaccine Injury Compensation Program (VICP) has paid out millions to a few people who said the vaccine injured them.

Since 2006, VICP has paid out or settled 126 HPV claims and dismissed 157.

Merck Wants FDA to Expand Age Range for Gardasil 9

Current campaigns urge pre-teens and teens to get the HPV vaccine. Merck wants more adults to get the vaccine, too.

At the beginning of June, the FDA accepted Merck’s application to expand the age range for Gardasil 9. The agency granted it priority review.

The FDA originally approved Gardasil 9 for people ages 9 to 26. But Merck wants that age range expanded to include adults ages 27 to 45.

“Women and men ages 27 to 45 continue to be at risk for acquiring HPV, which can lead to cervical cancer and certain other HPV-related cancers and diseases,” Dr. Alain Luxembourg, Merck Laboratories’ director of clinical research, said in a statement.

HPV is a group of about 150 related viruses. Gardasil 9 protects against nine strains.
The FDA hopes to reach a decision on the application by Oct. 2, 2018.

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5 Cited Research Articles

  1. Miller, N.S. (2018, June 13). Doctors push for higher HPV vaccination rates. Retrieved from http://www.orlandosentinel.com/health/os-hpv-vaccination-quality-improvement-20180612-story.html
  2. Merck. (2018, June 13). FDA Grants Priority Review to Merck’s Supplemental Biologics License Application (sBLA) for GARDASIL®9 in Women and Men Ages 27 to 45 for the Prevention of Certain HPV-Related Cancers and Diseases. Retrieved from https://www.businesswire.com/news/home/20180613005477/en/FDA-Grants-Priority-Review-Merck%E2%80%99s-Supplemental-Biologics
  3. Huntsman Cancer Institute at the University of Utah. (2018, June 7). Huntsman Cancer Institute Partners with Nation’s Top Cancer Centers to Endorse Goal of Eliminating HPV Related Cancers in the United States. Retrieved from http://huntsmancancer.org/newsroom/2018/06/hci-hpv-statement.php
  4. CDC. (2018, April 20). HPV Vaccination Coverage Data. Retrieved from https://www.cdc.gov/hpv/hcp/vacc-coverage/index.html
  5. Health Resources & Services Administration. (2018, June 4). Data & Statistics. Retrieved from https://www.hrsa.gov/sites/default/files/hrsa/vaccine-compensation/data/monthly-stats-june-2018.pdf
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