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IAC summarizes September 29 ACIP meeting on zoster, pneumococcal, and hepatitis B vaccination and other diseases

The Advisory Committee on Immunization Practices (ACIP) met on September 29, 2021, to review information on vaccines to prevent tick-borne encephalitis (TBE), zoster, pneumococcal disease, hepatitis B, and orthopoxvirus diseases. With the exception of TBE, the Committee reviewed each vaccine using its Evidence to Recommendations (EtR) framework to prepare for potential votes during future meetings. No votes were held at this meeting. Presentation slides are available online, and highlights of the meeting are provided below. Tick-borne encephalitis (TBE) vaccine – Information was presented on the safety and immunogenicity of TBE vaccine (Ticovac, Pfizer) licensed by FDA on August 13, 2021, as a 3-dose primary series (with a booster, if needed, after 3 years) administered intramuscularly to individuals age 1 year or older. TBE does not occur naturally in the Americas; however, this vaccine and similar vaccines have been in use in endemic countries for decades with high levels of effectiveness against TBE reported. ACIP is considering recommendations for U.S. adults and children at risk of exposure to infected ticks while traveling in endemic regions of Europe and Asia and workers at risk of exposure to TBE virus in a laboratory setting. Because the disease is rare, the vaccine has been approved based on its immunogenicity, with protective antibody levels detected in at least 94% of vaccine recipients after 3 years. Available data identified no major safety issues and few systemic or severe local reactions reported. A vote is proposed for the February 2022 ACIP meeting.
 
Zoster vaccine – ACIP discussed policy options and evidence to support the use of recombinant shingles vaccine (Shingrix, GSK) as a 2-dose series in immunocompromised people age 19 years and older. Because Shingrix is already recommended for immunocompetent adults age 50 years and older and licensed for all adults age 50 and older, there was little specific discussion of this age group. The benefit of vaccination varies widely due to the different degrees of risk of shingles and its complications among people with different types of immunocompromising conditions. However, adults age 19 through 49 with common autoimmune conditions, such as psoriasis, remain at 2- to 4-fold higher risk than the healthy people age 50 or older currently recommended for vaccination. Due to this variability, the work group endorsed support for a simple, broad ACIP recommendation. A vote is anticipated at a future ACIP meeting.
 
Pneumococcal vaccine – ACIP reviewed policy options for the use of two new pneumococcal conjugate vaccines licensed by FDA during summer 2021: a 15-valent pneumococcal conjugate vaccine (PCV15, Merck) and a 20-valent PCV (PCV20, Pfizer). They compared each vaccine separately against current pneumococcal vaccine recommendations. They did not compare the two new vaccines against each other. The work group had settled on a list of possible policies. For PCV20, they evaluated the evidence to support recommending PCV20 for all adults beginning at either age 50 years or age 65 years, and they also evaluated PCV20 for younger adults beginning at age 19 years who have chronic medical conditions or immunocompromise. For PCV15, the work group considered it only if used in combination with the current 23-valent pneumococcal polysaccharide vaccine (PPSV23), beginning at 65 and older for all or beginning at age 19 years for people with chronic medical conditions or immunocompromise. Economically, the PCV20 recommendations were more favorable than the PCV15+PPSV23 options; however, it is possible for the ACIP to recommend both. Discussion focused on the complexity of the pneumococcal vaccination schedule and hopes for a simpler set of recommendations. A vote is anticipated at the upcoming October 20–21 meeting.
 
Hepatitis B vaccine (HepB) – ACIP reviewed evidence to support a potential recommendation for HepB vaccination of all unvaccinated adults, replacing the current recommendations that limit HepB vaccination to those who report risk factors or who request it. Such an expansion would address persistent rates of acute hepatitis B infection among adults, especially those age 30 to 50 years without reported risk factors. There are federal public health goals to reduce acute hepatitis B infections by 90% by 2030, but adult vaccination rates remain low. In addition to the policy discussion, a large, observational safety study was presented comparing the risk of an acute myocardial infarction after vaccination with either 3-dose hepatitis B vaccine (Engerix-B, GSK) or 2-dose hepatitis B vaccine (Heplisav-B, Dynavax) showing no evidence of any difference in risk of acute myocardial infarction by type of hepatitis B vaccine given. After receiving the work group’s conclusion to recommend the expansion, the committee discussed the relative value of a universal vaccination policy compared to the current risk-based recommendations. A vote is anticipated for the upcoming October 20–21 ACIP meeting.
 
Orthopoxvirus vaccines – The committee ended its day with a discussion of proposed recommendations for the use of a non-replicating vaccine (Jynneos, Bavarian Nordic) against orthopoxviruses (a family of viruses that includes monkeypox, vaccinia, and smallpox). Jynneos is approved as a 2-dose series (0, 4 weeks) administered subcutaneously and available only through the federal Strategic National Stockpile (SNS) to designated recipients. The vaccine is being considered by ACIP only for research and clinical laboratory personnel performing diagnostic testing for orthopoxviruses and for designated response teams at risk of occupational exposure. Booster doses are being considered every 2 years for individuals at ongoing risk of exposure to high virulence orthopoxviruses (i.e., monkeypox, smallpox) and every 10 years for individuals at ongoing risk of exposure to lower virulence orthopoxviruses (e.g., cowpox, vaccinia). Jynneos is being considered as an alternative to the current live vaccinia vaccine, ACAM2000 (Emergent BioSolutions), which is based on the traditional smallpox vaccine and administered by scarification of the skin. As a non-replicating vaccine, Jynneos has a lower risk of serious adverse events and fewer contraindications than ACAM2000. A vote is proposed for the October 20–21 meeting.

Future ACIP Meetings
The next regularly scheduled ACIP meeting will be held on October 20–21. However, in the interim, ACIP may call additional meetings to address updated recommendations for use of any FDA-authorized COVID-19 vaccine(s). Information about past and future ACIP meetings may be found on the ACIP website.