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ACIP updates recommendations on HPV, HepB, MenB vaccines :

October 20, 2016

Adolescents under age 15 years need only two doses of human papillomavirus (HPV) vaccine instead of three under a new recommendation from a Centers for Disease Control and Prevention (CDC) committee.

The CDC’s Advisory Committee on Immunization Practices (ACIP) said a two-dose schedule could improve lagging completion rates, while still providing protection against the infection.

The group also made changes to hepatitis B and meningococcal B (MenB) vaccine recommendations during Wednesday’s meeting.

ACIP’s recommendations will be reviewed by the CDC director. Those that are approved will be published as official recommendations in the Morbidity and Mortality Weekly Report (MMWR). The Academy will review the CDC’s changes and make official policy recommendations of its own. Yvonne A. Maldonado, M.D., FAAP, vice chair of the AAP Committee on Infectious Diseases who represented the Academy at the meeting, recommends pediatricians follow existing AAP guidance for now but prepare for the potential changes.

HPV

To protect against HPV-related cancers, the Academy and CDC recommend HPV vaccine as part of routine immunization for males and females at age 11 or 12 years, although it can be started as early as 9 years.

The vaccine, now available as the 9-valent Gardasil 9, traditionally has been given in a three-dose series, but the Food and Drug Administration (FDA) recently approved a two-dose series for children ages 9-14.

After reviewing the data, ACIP members followed suit. They recommended a two-dose schedule for children younger than 15 years of age who are starting vaccination, with the second dose administered six to 12 months after the first dose. Those starting vaccination at age 15-26 should receive three doses. ACIP continues to recommend routine vaccination at age 11-12, though the vaccine can be given as early as 9 years of age.

Dr. Maldonado applauded the change.

“We want to make sure children are up to date on their vaccines and ... the two-dose HPV schedule is certainly much easier and should hopefully lead to more compliance,” she said.

Only about 42% of teen girls and 28% of teen boys receive all three doses, according to the CDC.

Adolescents under 15 who have received two doses that were less than six months apart will need a third dose.

The 9-valent vaccine may be used to complete a series started with a quadrivalent or bivalent vaccine, and a schedule that has been interrupted does not need to be restarted. ACIP currently does not have a recommendation as to whether those who were fully vaccinated with one of those two types should receive additional vaccination with the 9-valent vaccine, and the Academy will work closely with the CDC to determine if such guidance can be forthcoming.

CDC Director Tom Frieden, M.D., M.P.H., quickly approved ACIP’s HPV recommendations.

“Safe, effective, and long-lasting protection against HPV cancers with two visits instead of three means more Americans will be protected from cancer,” Dr. Frieden said in a news release. “This recommendation will make it simpler for parents to get their children protected in time.”

Hepatitis B

ACIP also took steps Wednesday to stress the importance of vaccinating infants against hepatitis B as soon as possible after birth.

Hepatitis B is a liver infection transmitted through blood or body fluids and can be passed from a mother to her infant. The CDC estimates 90% of infected infants develop chronic infection.

ACIP recommended Wednesday that infants be immunized within 24 hours of birth and removed policy language allowing a delay in some circumstances.

“The earlier the better,” Dr. Maldonado said. “Once infants are discharged home after birth, there is a risk they might miss their first well-child appointment and their first hepatitis B vaccine dose. If the infant’s mother is infected with hepatitis B, there would be a very high risk of becoming infected themselves.”

Pediatricians should continue to be vigilant about vaccinating infants who did not receive a dose at birth.

MenB

The Academy and CDC currently recommend routine MenB vaccination for those 10 and older who are at increased risk of MenB, including those with persistent complement component deficiencies, anatomic or functional asplenia, and people living in an outbreak area. They do not express a preference for the two licensed vaccines — MenB-4C (Bexsero) and MenB-FHbp (Trumenba) — but the same product must be used for the entire series.

In April, the FDA approved a label change giving MenB-FHbp a flexible three-dose schedule of zero, one to two months and six months and a two-dose schedule of zero and six months. ACIP members on Wednesday recommended when using MenB-FHbp to vaccinate people at increased risk of MenB, the three-dose schedule should be used.

That schedule will “provide early protection and maximize immune response,” said Jessica MacNeil, M.P.H., a CDC epidemiologist.

For healthy people ages 16-23 years who are not at increased risk of MenB disease, ACIP has a permissive recommendation that allows use of one of the MenB vaccines should the patient desire to be immunized. If an adolescent so chooses and MenB-FHbp is selected, ACIP recommended a two-dose schedule.

If a patient receives a second dose of MenB-FHbp less than six months after the first dose, a third dose should be given at least six months after the first.

Pertussis

Experts also reviewed new research regarding the safety of tetanus diphtheria acellular pertussis (Tdap) vaccine during pregnancy.

CDC epidemiologist Jennifer Liang, D.V.M., M.P.V.M., said data “continue to be reassuring.”

“Studies of over 50,000 women receiving Tdap during pregnancy … show no increased risk of adverse maternal or infant health outcomes,” she said.

In 2012, ACIP began recommending Tdap during every pregnancy. While it can be given at any time, the CDC considers 27-36 weeks’ gestation to be optimal. The CDC now is working on new language to emphasize vaccination in the early part of that window when it is believed to be most beneficial.

Next steps

AAP News will continue to update members when recommendations have been approved by the CDC director and published in the MMWR, as well as when the Academy makes official policy recommendations on these vaccinations.

The CDC will hold webinar on the HPV recommendations from 12 p.m. to 1 p.m. Eastern on Oct. 26. To register, visit https://www2.cdc.gov/vaccines/ed/hpvreg/. After the event, the presentation will be posted at https://www.cdc.gov/vaccines/ed/ciinc/index.html.

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