ACIP Recommends Two-dose Regimen for HPV Vaccine

Group Offers Additional Recommendations for Hep B, MenB-FHbp, Tdap Vaccines

October 26, 2016 02:11 pm Chris Crawford

During the CDC's Advisory Committee on Immunization Practices (ACIP) meeting Oct. 19-20,(www.cdc.gov) members made specific recommendations on vaccines for HPV; hepatitis B (HepB); serogroup B meningococcal (MenB) disease; and tetanus, diphtheria and pertussis (Tdap).

[Teen boy getting vaccination from medical staff]

HPV Vaccine

Probably the biggest news out of this meeting was the ACIP's vote to recommend patients ages 11-12 receive two doses of the nine-valent HPV vaccine (HPV9; Gardasil 9) at least six months apart, rather than the previously recommended three doses, to protect against cancers caused by HPV infections.

Teens and young adults who start the series later, at ages 15-26, will continue to need three doses of HPV vaccine.

"Safe, effective and long-lasting protection against HPV cancers with two visits instead of three means more Americans will be protected from cancer," said CDC Director Tom Frieden, M.D., M.P.H., in a news release.(www.cdc.gov) "This recommendation will make it simpler for parents to get their children protected in time."

Adolescents ages 13-14 also are able to receive HPV vaccine on the new two-dose schedule.

Story highlights
  • During the CDC's Advisory Committee on Immunization Practices (ACIP) October meeting, members voted to recommend patients ages 11-12 receive two doses of the nine-valent HPV vaccine at least six months apart.
  • ACIP members also made new recommendations on vaccines for hepatitis B; serogroup B meningococcal disease; and tetanus, diphtheria and pertussis.
  • It was reported during the meeting that disease patterns for this year's flu season in the United States largely match those already seen in the Southern Hemisphere, which suggests a good match between strains in the vaccine and what is circulating in the environment.

The ACIP reviewed data from clinical trials showing two doses of HPV vaccine in younger adolescents (ages 9-14) produced an immune response similar to or higher than the response in young adults (ages 16-26) who received three doses.

It's worth noting that on Oct. 7, the FDA approved adding a two-dose schedule for HPV9 for adolescents ages 9-14.

AAFP liaison to the ACIP Margot Savoy, M.D., M.P.H., of Wilmington, Del., told AAFP News the HPV vaccine schedule change came as a direct result of this FDA approval. "Up until October, it wasn't FDA-approved to do a two-dose schedule of the nine-valent vaccine in the United States," she said. "The evidence (supporting the revised schedule) was the same evidence the ACIP has seen during the past year; they just didn't have the FDA approval to recommend it previously."

ACIP members also were notified during the meeting that Merck is phasing out its original four-valent HPV vaccine, with plans to distribute only the nine-valent vaccine in the United States starting in November. GlaxoSmithKline has also announced that it will no longer market its bivalent HPV vaccine, Cervarix, in the United States.

Additionally, Savoy said family physicians should know that if practices haven't transitioned to the nine-valent vaccine, they won't need to restart a series for a patient who has received one dose of the two- or four-valent vaccine -- they just need to complete the series with the nine-valent option.

Frieden approved the committee's recommendations shortly after the vote, which will become official agency guidance after publication in the CDC's Morbidity and Mortality Weekly Report (MMWR).

However, the agency encourages clinicians to begin implementing the two-dose schedule in their practices now.

Savoy said the upcoming MMWR guidance will clarify what to do with patients who have already received two doses of the two- or four-valent vaccine and how to determine whether they have been adequately immunized.

Hepatitis B Vaccine

For the HepB vaccine, the ACIP recommended a change to its birth dose recommendation to read "within 24 hours of birth" instead of the previous "at hospital discharge."

"This change (which is consistent with the World Health Organization's recommendation) reflects the importance of the dose being given early after birth and not waiting for the first office visit," Savoy said. "In addition, removal of 'hospital' clarifies that all birthing centers and locations should provide the birth dose."

The full recommendation reads: "For all medically stable infants weighing greater than or equal to 2,000 grams at birth and born to HBsAg (hepatitis B surface antigen)-negative mothers, the first dose should be administered within 24 hours of birth. Only single antigen HepB vaccine should be used for the birth dose."

The ACIP also clarified that HepB vaccine is recommended for patients with chronic liver disease, including patients with hepatitis C and those with fatty liver disease.

"So once you are diagnosed with hepatitis C, you are now qualified to get the hepatitis B vaccine," Savoy said. "Fatty liver disease hadn't previously been listed as a qualifier, but it is a huge, growing diagnosis. The fact that you have fat deposits in your liver creates a type of cirrhosis over time that creates end-stage liver disease complications. I previously wouldn't have thought to give these patients the hepatitis B vaccine."

MenB-FHbp Vaccine

The ACIP's updates for the MenB vaccine apply only to the MenB-FHbp (Trumenba) product and clarify when two doses are recommended rather than the original three-dose schedule.

The approved final language reads: "For patients at increased risk for meningococcal disease and for use during serogroup B outbreaks, three doses of MenB-FHbp should be administered at ages 0, 1-2 months and 6 months. When given to healthy adolescents who are not at increased risk for meningococcal disease, two doses of MenB-FHbp should be administered at 0 and 6 months. If the second dose is given at an interval of less than 6 months, a third dose should be given at least 6 months after the first dose."

Tdap in Pregnancy

Regarding updated guidance for the Tdap vaccine, "The pregnancy language was updated to reflect the new data that vaccinating earlier in the window improves the antibody transfer to the infant," Savoy said.

The updated portion of the recommendation reads: "Tdap should be administered between 27 and 36 weeks' gestation, although it may be given at any time during pregnancy. Currently available data suggest that vaccinating earlier in the 27 through 36 week window will maximize passive antibody transfer to the infant."

The recommendation still calls for administering Tdap vaccine immediately postpartum in women not previously vaccinated with Tdap during pregnancy.

Influenza Vaccine

Savoy noted that even though live attenuated influenza vaccine (LAIV; FluMist) was taken off the market this flu season in the United States, Canada and countries in Europe continue to use it.

"It's still not known why FluMist had such a bad efficacy, and why it got worse once it became a quadrivalent," she said. "Currently (FluMist manufacturer MedImmune) is drilling down to figure out the root causes of what went wrong, and they are working with the CDC and FDA in hopes of reintroducing the product -- but the timeline is unknown."

Fortunately, no shortage of flu vaccine is expected this season, said Savoy, even without LAIV.

Savoy also said it was reported during the meeting that disease patterns for this year's flu season in the United States largely match those already seen in the Southern Hemisphere, which suggests a good match between strains in the vaccine and what is circulating in the environment.

Finally, she reported that for the first time since the 2009-2010 H1N1 pandemic, the U.S. flu vaccine for the 2017-2018 season will include an updated H1N1 strain.

Up Next

The ACIP approved the 2017 child/adolescent and adult immunization schedules, which will be released in February. There are major formatting changes to the adult schedule that improve readability and usability (such as landscape formatting, cleaner graphics, use of abbreviations and reformatting to allow for larger font in the footnotes).

"In 2017, the ACIP will hold focus groups to update the adult schedule," Savoy noted. "They will review how people use the adult schedule, similarly to how they made changes to the pediatric schedule this past year."

For the Feb. 22-23 ACIP meeting, Savoy said she anticipates an update on the Zika virus vaccines that are being evaluated -- with four currently in phase 1 and one to be in phase 2 in 2017.

Related AAFP News Coverage
Study Finds LAIV, IIV Offer Comparable Community Protection
AAFP Still Backs CDC Recommendation Against LAIV Use

(8/24/2016)

ACIP Recommends MenACWY-D for HIV-infected Patients, Cholera Vaccine
(6/29/2016)


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