|ACIP Updates Its Guidance on the Use of HPV, PCV13, HepA, HPV, and MenB Vaccines at June 26–27 Meeting|
|Published July 2019|
|The Advisory Committee on Immunization Practices (ACIP) met in Atlanta on June 26–27, 2019.
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).
*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” 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:
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:
ACIP discussed vaccine availability and updated guidance for the 2019–2020 influenza season and unanimously approved the following recommendation:
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.
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