ACIP considers data on 9-valent HPV vaccine

The Advisory Committee on Immunization Practices heard data on an investigational 9-valent HPV vaccine being developed by Merck.

The vaccine demonstrated noninferior immunogenicity for HPV types 6, 7, 16 and 18 compared with the quadrivalent HPV vaccine (Gardasil, Merck) and offered 97% protection against the five additional HPV serotypes: 31, 33, 45, 52 and 58. In addition, the vaccine demonstrated noninferior immunogenicity in adolescents compared with adults.

Additional data presented indicate that 50% of high-grade cervical lesions are attributable to HPV types 16 and 18 and another 25% are attributable to the five additional serotypes in the 9-valent vaccine. Other data indicate that 62% of HPV-associated cancers are attributable to HPV types 16 and 18 and another 11% are attributable to the five additional serotypes.

According to Lauri Markowitz, MD, leader of the ACIP’s HPV Vaccine Working Group, depending on the upcoming data and FDA licensure, the ACIP may vote on the vaccine’s recommendations in the February 2015 meeting.

Markowitz also discussed other considerations being explored by the working group regarding the 9-valent vaccine, including considering recommendations for the vaccine in older females and males who were not vaccinated at the recommended age, the recommendation of routine vaccination at age 11 to 12 years and considering vaccination recommendations for people partially or fully vaccinated with the quadrivalent vaccine.

The working group also is considering data on reduced dose schedules for the HPV vaccine.

“There is global interest in simplified schedules because they will facilitate delivery and reduce some of the logistical challenges,” Markowitz said. “Some jurisdictions are using two-dose schedules in their national immunization programs around the world.”

The European Medicines Agency granted marketing authorization for Cervarix (GlaxoSmithKline) in a two-dose schedule, given at 0 and 6 months for girls aged 9 to 14 years. Merck also has made an application for a two-dose schedule for Gardasil, Markowitz said.

The committee also voted unanimously to accept an updated HPV vaccine statement, which consolidates recommendations for females and males, consolidates information and recommendations for bivalent and quadrivalent vaccines, harmonizes wording that differed slightly from policy notes and the original statement, and to update background information and data regarding immunogenicity, safety, efficacy, monitoring, etc.

“This overlaps with consideration of the 9-valent vaccine, but we believe this updated statement will help facilitate efforts to develop future policy if we have all of this information in one document,” Markowitz said.

The original statement was made in 2007, after the quadrivalent vaccine was licensed in females. There have been evolving recommendations since then, including the recommendation for routine vaccination with the bivalent vaccine or the quadrivalent vaccine in 2010 and the recommendation for routine vaccination in males in 2011, Markowitz said.

The Advisory Committee on Immunization Practices heard data on an investigational 9-valent HPV vaccine being developed by Merck.

The vaccine demonstrated noninferior immunogenicity for HPV types 6, 7, 16 and 18 compared with the quadrivalent HPV vaccine (Gardasil, Merck) and offered 97% protection against the five additional HPV serotypes: 31, 33, 45, 52 and 58. In addition, the vaccine demonstrated noninferior immunogenicity in adolescents compared with adults.

Additional data presented indicate that 50% of high-grade cervical lesions are attributable to HPV types 16 and 18 and another 25% are attributable to the five additional serotypes in the 9-valent vaccine. Other data indicate that 62% of HPV-associated cancers are attributable to HPV types 16 and 18 and another 11% are attributable to the five additional serotypes.

According to Lauri Markowitz, MD, leader of the ACIP’s HPV Vaccine Working Group, depending on the upcoming data and FDA licensure, the ACIP may vote on the vaccine’s recommendations in the February 2015 meeting.

Markowitz also discussed other considerations being explored by the working group regarding the 9-valent vaccine, including considering recommendations for the vaccine in older females and males who were not vaccinated at the recommended age, the recommendation of routine vaccination at age 11 to 12 years and considering vaccination recommendations for people partially or fully vaccinated with the quadrivalent vaccine.

The working group also is considering data on reduced dose schedules for the HPV vaccine.

“There is global interest in simplified schedules because they will facilitate delivery and reduce some of the logistical challenges,” Markowitz said. “Some jurisdictions are using two-dose schedules in their national immunization programs around the world.”

The European Medicines Agency granted marketing authorization for Cervarix (GlaxoSmithKline) in a two-dose schedule, given at 0 and 6 months for girls aged 9 to 14 years. Merck also has made an application for a two-dose schedule for Gardasil, Markowitz said.

The committee also voted unanimously to accept an updated HPV vaccine statement, which consolidates recommendations for females and males, consolidates information and recommendations for bivalent and quadrivalent vaccines, harmonizes wording that differed slightly from policy notes and the original statement, and to update background information and data regarding immunogenicity, safety, efficacy, monitoring, etc.

“This overlaps with consideration of the 9-valent vaccine, but we believe this updated statement will help facilitate efforts to develop future policy if we have all of this information in one document,” Markowitz said.

The original statement was made in 2007, after the quadrivalent vaccine was licensed in females. There have been evolving recommendations since then, including the recommendation for routine vaccination with the bivalent vaccine or the quadrivalent vaccine in 2010 and the recommendation for routine vaccination in males in 2011, Markowitz said.

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