Immunization Update and ACIP Highlights – October 2016

November 23, 2016

The Advisory Committee on Immunization Practices (ACIP) of the CDC met on October 19 and 20 to provide guidance on vaccines. Below are the key highlights.​

  • An updated recommendations statement was approved for Hepatitis B vaccine including a recommendation that the first dose be given within 24 hours of birth, a recommendation for  Hepatitis B vaccine in persons infected with Hepatitis C virus, and examples of chronic liver conditions
  •  An updated recommendations statement was approved for pertussis, tetanus and diphtheria vaccines with no new recommendations, but the committee discussed guidance to optimize maternal antibody production by providing Tdap earlier in the 27-36 gestation week timeframe
  • A 2-dose series for 9vHPV vaccine was approved with a 6-12 month dosing interval for healthy females and males who start the series prior to age 15 years
  • A 2-dose series with a 6 month dosing interval was approved when healthy adolescents opt to get Trumenba® MenB-FHbp. Meningococcal B vaccine is still a category B recommendation in a non-outbreak setting
  • The 2017 child/adolescent and adult immunization schedules were approved including a new High Risk Figure to accompany the child/adolescent schedule
  • Future: the committee reviewed more data regarding the HZ/su vaccine for the prevention of Herpes Zoster.
 
CURRENT RECOMMENDATIONS
 
Hepatitis B Vaccine
 
Various recommendations for infants, children, adults, diabetics, and healthcare personnel were combined into an updated Hepatitis B vaccine statement. Permissive language for delaying the birth dose was removed, and the recommendation for birth dose was harmonized with the WHO recommendation to administer the first dose of Hepatitis B vaccine within the first 24 hours of life to infants with a birth weight > 2000 g whose mothers are Hep B surface antigen negative. Infants with a birth weight < 2000 g whose mothers are Hep B surface antigen negative should be immunized by age 1 month or at hospital discharge. Infants whose mothers are Hep B surface antigen positive should still be immunized within 12 hours after birth.
 
Hepatitis B vaccine is recommended for individuals with chronic liver conditions. Examples of those conditions were added to the recommendations, including Hepatitis C infection, cirrhosis, fatty liver disease, alcoholic liver disease, autoimmune hepatitis, and liver function tests >2 times the upper limit of normal.
 
The rate of reported acute Hepatitis B infection has declined by 90.6% in the U.S. since vaccination was initiated in 1982. Most of the increase in locally contracted cases seen in recent years is due to injection drug use. Imported cases to the U.S. now constitute 95% of new cases.
 
Human Papilloma Virus Vaccine
 
The FDA approved a 2-dose schedule for HPV vaccine with a 6-12 month interval between doses, and a minimum interval of 5 months. The ACIP voted to approve this 2-dose schedule for healthy adolescent males and females ages 9 through 14 years due to evidence of non-inferiority with the 3-dose scheduled.
  • If the individual initiates the series at age 15 years or older, then 3 doses must be administered in the (0, 1-2, 6) month dosing schedule. Note: Number of doses is determined by the age of the person when the series is initiated.
  •  If there is not at least a 5 month separation between the first and second dose of the 2-dose series, a third dose will need to be administered. 
  • If the individual is immunocompromised then 3 doses will need to be administered.
There was some confusion about the minimum timing between the second and third dose, and it will be clarified when the recommendation is published by CDC.
 
Persons with prior vaccination:
  • Persons who initiated vaccine with 9vHPV, 4vHPV, or 2vHPV before their 15th birthday are adequately vaccinated if they received 2 or 3 doses at appropriate intervals
  •  Persons who initiated vaccine with 9vHPV, 4vHPV, or 2vHPV on or after their 15th birthday are adequately vaccinated if they received 3 doses at appropriate intervals
  • 9vHPV may be used to continue or complete a series started with 4vHPV or 2vHPV
  • If adequately vaccinated with 2vHPV or 4vHPV, no need to have additional 9vHPV doses
 Immunocompromised:
  • Immunocompromised males and females 9 through 26 years should have 3 doses (including those with reduced cell-mediated or humeral immunity, such as B lymphocyte antibody deficiencies, T lymphocyte complete or partial defects, HIV infection, malignant neoplasm, transplantation, autoimmune disease or immunosuppressive therapy), since immune response to vaccination may be attenuated.
 Meningococcal B Vaccine
 
In April 2016, the FDA approved a 2-dose series for Trumenba® (MenB-FHbp) with the second dose being administered at least 6 months after the first dose. ACIP voted to approve a 2-dose series of MenB-FHbp for healthy adolescents who are not at increased risk of disease who are choosing to receive Meningococcal B vaccine in the context of the Category B recommendation that was previously approved.
 
Decrease in carriage is the main way to create herd population protection. Male gender, smoking and social mixing (in bars) were shown to increase carriage of Men B, while antibiotic use has been shown to decrease carriage. Studies conducted on college campuses of oropharyngeal carriage of Men B show that Men B vaccine was not associated with reduction in carriage, and therefore is postulated not to provide herd immunity.
 
Good persistence and memory response were shown for MenB-Fhbp with either 2 or 3 doses when given at a separation of at least 6 months.  The 0, 6 months schedule had the highest percent of responders and GMTs that were the most similar to the 3-dose schedule. If the second dose is given at an interval of < 6 months, a third dose should be given at least 6 months after the first dose.
 
A 3-dose schedule is preferred for those who wish to maximize short-term protection such as in outbreaks, or for those who are at high-risk. For persons at increased risk for meningococcal disease and for use during serogroup B outbreaks, 3 doses of MenB-FHbp should be administered at 0, 1-2, 6 months.
 
There are two licensed Men B vaccines for persons ages 10-35 years. The ACIP states no vaccine preference.
 
 
FUTURE RECOMMENDATIONS
 
Evidence was presented in the ACIP meeting to inform the committee concerning future vaccine recommendations.
 
Herpes Zoster Vaccine
 
GSK plans to submit a biologics license application (BLA) to the FDA for approval of its adjuvanted candidate 2-dose zoster vaccine (HZ/su) before the end of 2016. Approval from the FDA and ACIP can take 1-2 years from that point.
Results of the ZOE-50 and ZOE-70 efficacy trials were presented to the ACIP. HZ/su is refrigerator stable, is >90% effective, and appears to have great persistence of protection. It has a high rate of local reactions. During the studies, vaccine compliance was 94.4-96.4% for receipt of second dose. 
Next steps:
Current ongoing studies of the HZ/su vaccine include a study in those who had a previous episode of shingles which found the vaccine to be safe and immunogenic (to be published soon), a revaccination study, a co-administration study, and a duration of protection study.
Merck is testing an inactivated from of zoster vaccine, a 4-dose series for ages 18+ years. GSK is evaluating their HZ/su product in ages 18+ years as well.
 If you have any questions regarding immunization, feel free to contact Tamara Sheffield, MD, MPA, MPH, Medical Director, Community Health and Prevention, Intermountain Healthcare, at (801) 442-3946.