ACIP Updates Its Guidance on the Use of HPV, PCV13, HepA, HPV, and MenB Vaccines at June 26–27 Meeting

During the meeting, several topics were discussed for informational purposes only. Specifically, the Committee received an update on the current measles outbreak in the United States, discussed updated safety data on recombinant zoster vaccine (Shingrix, GSK), considered future policy options for use of tetanus-diphtheria-pertussis (Tdap) vaccine, and reviewed dengue epidemiology and Dengvaxia (Sanofi) Phase III clinical trials.

In addition, ACIP broke a single-meeting record by taking 18 separate votes during the June meeting, encompassing 11 votes on five different vaccines and seven votes related to inclusion of specific vaccines into the Vaccines For Children (VFC) program. These individual votes are highlighted below.

Human Papillomavirus Vaccine (HPV)

ACIP approved two new recommendations for use of HPV vaccine (Gardasil-9, Merck).

• Harmonization of upper age limit for routine catch-up vaccination of males and females: The current HPV recommendation calls for routine catch-up vaccination of females through age 26 and males through age 21, though males with risk factors or who want to be protected may be vaccinated through age 26. ACIP voted unanimously to harmonize the routine catch-up vaccination schedule for both males and females through age 26.
• Shared clinical decision making* for vaccination of persons age 27 through 45 years: In a split (10 to 4) vote, ACIP approved vaccination of persons age 27–45 years based on “shared clinical decision making” between the patient and clinician. Members in support of the recommendation noted this option offers providers case-by-case flexibility and allows potential insurance coverage for HPV vaccine in this age group.

*Shared clinical decision making means the decision to vaccinate persons age 27 through 45 years should be based on a discussion of benefits and risks between the patient and the clinician.

Pneumococcal Conjugate Vaccine for Immunocompetent Older Adults

When the pneumococcal conjugate vaccine (PCV13, Prevnar 13, Pfizer) recommendation for adults age >65 years was initially passed in 2014, ACIP recommended that all immunocompetent adults in this age group receive a dose of PCV13, followed by a dose of pneumococcal polysaccharide vaccine (PPSV23, Pneumovax 23, Merck) at least one year later. At the time this was approved, Committee members requested the recommendation be revisited after several years to examine the indirect impact of childhood PCV13 immunization on the rates of invasive pneumococcal disease in adults. Due to high rates of childhood immunization resulting in decreased transmission of vaccine-containing serotypes, available data indicate the anticipated impact from continued PCV13 use in older adults is minimal.

ACIP took three separate votes in the process of agreeing on the final recommendation. After the majority of committee members failed to approve policy options to (1) continue the current recommendation of PCV13 followed by PPSV23 or (2) eliminate the PCV13 recommendation in this age group entirely, the committee approved (in a 13 to 1 vote) the following recommendation:

• Shared clinical decision making*: ACIP recommends PCV13 based on shared clinical decision making for adults 65 years and older who do not have an immunocompromising condition** and who have not previously received PCV13. All adults 65 years and older should receive a dose of PPSV23.

* Shared clinical decision making” means the decision to vaccinate persons age 65 years and older who are not at high risk for invasive pneumococcal diseases should be based on a discussion of benefits and risks between the patient and the clinician.

** Immunocompromising conditions are defined as chronic renal failure, nephrotic syndrome, immunodeficiency, iatrogenic immunosuppression, generalized malignancy, HIV, Hodgkin disease, leukemia, lymphoma, multiple myeloma, solid organ transplants, cochlear implants, CSF leaks, congenital or acquired asplenia, sickle cell disease, or other hemoglobinopathies.

Of note, the recommendations for vaccination of adults at high risk of invasive pneumococcal disease (MMWR, Vol. 61, No. 40, pages 816–819) have not changed.

Hepatitis A Vaccine

Unlike in the pre-vaccine era, when hepatitis A virus (HAV) transmission was most often associated with asymptomatic children, recent outbreaks have primarily affected adults. Although sporadic foodborne outbreaks occur, person-to-person spread is now the dominant mode of HAV transmission. In addition, persons with HIV are recognized to have increased HAV infection severity.

In recognition of this changing epidemiology, ACIP unanimously approved the following recommendations for use of hepatitis A vaccine:

• Catch-up vaccination of children and adolescents: ACIP recommends that all children and adolescents age 2 through 18 years who have not previously received hepatitis A vaccine be vaccinated at any age (i.e., children and adolescents are recommended for catch-up vaccination).
• Vaccination of persons with HIV infection: ACIP recommends that all persons with HIV age >1 year be vaccinated with hepatitis A vaccine.
• Updated hepatitis A vaccine recommendations to be published: ACIP affirms the updated statement “Prevention of Hepatitis A Virus Infection in the United States: Recommendations of the Advisory Committee on Immunization Practices.”

When the updated hepatitis A vaccine recommendations are published in Morbidity and Mortality Weekly Reports (MMWR), they will include guidance related to consideration of pre-vaccination testing for certain populations expected to have high rates of previous HAV infection (pre-vaccination testing is not recommended for the general population) and post-vaccination testing of persons whose subsequent clinical management depends on knowledge of their immune status, such as persons with HIV infection and other immunocompromised persons. The publication also will incorporate changes to the list of high-risk persons for hepatitis A infection, specifically (1) persons with clotting factor disorders will be removed from this listing (changes in clotting factor preparation practices and donor screening have greatly reduced the risk for hepatitis A for clotting factor recipients) and (2) pregnant women and persons with chronic liver disease will be added. Finally, the updated MMWR will contain guidance on handling interrupted schedules, minimum dosing intervals, and other immunization management issues and considerations.

Meningococcal B Vaccine (MenB)

When ACIP initially passed a recommendation for meningococcal B vaccine (MenB) for persons at increased risk of infection, the committee did not recommend booster doses for persons who remain at increased risk or who are at risk in an outbreak setting. Since that time, additional data has indicated waning immunity 1–2 years following primary MenB vaccination and a robust immune response following receipt of a booster dose. Armed with this new information, ACIP unanimously approved the following recommendations:

• Booster doses for persons at increased risk

• Persons with certain conditions and microbiologists: For persons >10 years with complement deficiency, complement inhibitor use, asplenia, or who are microbiologists, ACIP recommends a MenB booster dose 1 year following completion of a MenB primary series followed by MenB booster doses every 2–3 years thereafter, for as long as increased risk remains.
• During an outbreak: For persons age >10 years determined by public health officials to be at increased risk during an outbreak, ACIP recommends a one-time booster dose if it has been >1 year since completion of a MenB primary series. A booster dose interval of >6 months may be considered by public health officials depending on the specific outbreak, vaccination strategy, and projected duration of elevated risk.

• Updated MenB recommendations to be published: ACIP affirms the updated statement “Meningococcal Vaccination: Recommendations of the Advisory Committee on Immunization Practices.”

• When published, this updated statement will include the new booster recommendations and will incorporate all existing ACIP recommendations for MenACWY and MenB vaccines into a single document.
• An important change in wording will be included in the updated ACIP statement. Previous “Category B” language for MenB primary vaccination in adolescents will be modified to state “ACIP recommends a MenB primary series for individuals aged 16–23 years based on shared clinical decision making.” This distinction clarifies the importance of the provider and patient discussing and deciding together whether MenB vaccine should be given to the patient.
• A final change incorporated with the updated statement’s publication will be removal of the current appendices that provide guidance on chemoprophylaxis of close contacts and management of outbreaks.

Influenza Vaccine

ACIP discussed vaccine availability and updated guidance for the 2019–2020 influenza season and unanimously approved the following recommendation:

• Updated influenza vaccine statement to be published: ACIP affirms the updated statement “Prevention and Control of Seasonal Influenza with Vaccines: Recommendations of the Advisory Committee on Immunization Practices—United States, 2019–20 Influenza Season.”

The new statement will include information about vaccine licensure changes and a new table highlighting the dose volume differences between the four inactivated influenza vaccine preparations expected to be available for children age 6 through 35 months. In addition, updated guidance will outline optimal timing for vaccination, groups that should be the focus of efforts if vaccine supply is limited, clarification on the number of vaccine doses needed for 8-year-olds who have their ninth birthday before receipt of a recommended second dose of vaccine, and concomitant receipt of two vaccines containing novel adjuvants.

Vaccines For Children (VFC) Program Resolutions

ACIP unanimously approved 7 resolutions to include specific vaccines in the VFC program and to encompass updated ACIP recommendations. The resolutions do not alter the vaccine recommendations themselves.

• Combination Pediatric Hexavalent Vaccine (4 resolutions): Although Vaxelis (DTaP-IPV-Hib-HepB, Merck-Sanofi) is not expected to reach the U.S. market until 2021, ACIP is supportive of its inclusion as an available option in the VFC program. This required four separate resolutions for each vaccine component, i.e., DTaP, polio, Hib, and hepatitis B.
• Influenza: The purpose of this resolution is to update the table of inactivated influenza vaccines in the VFC Program.
• Hepatitis A: The purpose of this resolution is to streamline the Recommended Vaccination Schedule and Intervals section, update the language related to catch-up vaccination, add information about the accelerated Twinrix (HepA-HepB, GSK) schedule, clarify the timing of vaccine and immunoglobulin receipt, and remove pregnancy as a precaution.
• Meningococcal B: The purpose of this revision is to update the resolution to reflect (a) currently available meningococcal conjugate vaccines and (b) new recommendations for booster doses for serogroup B meningococcal vaccines. In addition, the language regarding the intervals for one of the serogroup B vaccines covered by the resolution has been updated to more closely reflect the current ACIP recommended language.

All recommendations approved by ACIP are provisional until they are approved by the CDC director and published in MMWR. Presentation slides from the June meeting are posted on the ACIP website.

CDC Additional Information

• Advisory Committee on Immunization Practices main page
• ACIP Meeting Information web page