CDC’s ACIP recommends preferred use of new herpes zoster vaccine

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CDC’s Advisory Committee on Immunization Practices (ACIP) met on October 25–26 in Atlanta to discuss the latest information on vaccines and immunization practices. ACIP voted on vaccination recommendations for herpes zoster (HZ) vaccines and mumps-containing vaccines. ACIP also voted to approve the 2018 immunization schedules and discussed updates on many other vaccine-related issues.

Following is a summary of the discussions; complete minutes of the meeting will be published on CDC’s website. ACIP’s next meeting is scheduled for February 21–22, 2018.

Preference for HZ/su vaccine over ZVL vaccine

ACIP voted to recommend the recently approved Shingrix (GlaxoSmithKline) vaccine, also known as herpes zoster subunit (HZ/su), for adults aged 50 years and older and to recommend revaccination for those who previously received the Zostavax (Merck) vaccine, also known as zoster vaccine live (ZVL). ACIP voted to recommend a preference for HZ/su vaccine over the ZVL vaccine.

In discussions of the currently available HZ vaccines, ACIP addressed three policy questions:

  • 1. Should ACIP recommend HZ/su for vaccination of immunocompetent adults aged 50 years and older?

    Based on studies and GRADE assessments (Grading of Recommendations, Assessment, Development and Evaluation), the workgroup determined that HZ/su is safe and efficacious and noted that there is a slight increase in local reactions compared with the ZVL vaccine. But the majority of the workgroup members said HZ/su should be recommended for individuals aged 50 years and older because 21% percent of HZ disease occurs in those aged 50–59 years.

  • 2. Should individuals previously vaccinated with ZVL receive HZ/su?

    Based on studies showing higher efficacy, significant waning of protection with ZVL, and minimal adverse reactions following vaccination of previously vaccinated individuals, the workgroup said revaccination with HZ/su should be recommended for those who previously received ZVL.

  • 3. Should ACIP recommend a preference for HZ/su over ZVL?

Since all assumptions have demonstrated a better efficacy, duration of protection, and cost-effectiveness, most of the workgroup recommended a preference for the HZ/su vaccine.

Cost-effectiveness models were presented for HZ/su, as well as comparisons of both HZ/su and ZVL with placebo among five age groups. The model assumed that HZ/su duration of protection was 20 years; however, because only 4 years of data are available, predictions of duration are difficult to make. The ZVL model assumed a 10-year duration of protection. The models projected higher rates of protection by HZ/su compared with ZVL and placebo based on several studies of vaccine effectiveness. The cost per quality-adjusted life year (QALY) for HZ/su was estimated to be $26,000– $30,000 for adults aged 50 years and older compared with $55,000–$67,000 for ZVL. It was noted that these models have many limitations, mainly because of unknown estimated variables.

Based on available efficacy, safety, and cost-effectiveness data, ACIP voted unanimously to recommend HZ/su for adults aged 50 years and older (15 yes votes) and to revaccinate those who have previously received the ZVL vaccine (12 yes, 3 no votes). The vote for a preference of HZ/su over ZVL was very close (8 yes, 7 no votes). Even with this narrow margin, the recommendation passed.

Approval for third dose of MMR during mumps outbreaks

ACIP voted to approve a recommendation for use of a third dose of measles–mumps–rubella (MMR) vaccine during a mumps outbreak, on the basis of the available data.

Epidemiology of mumps cases was presented, and it was noted that mumps cases have increased yearly throughout the United States since 2013. A total of 6,366 cases were reported in 2016, and 4,677 cases were reported in 2017 through October. The highest incidence was in those aged 18–22 years, and 75% of this group had been vaccinated with two doses of the MMR vaccine. Since January 2016, 150 outbreaks have occurred, mostly in school and community settings. Thirteen percent of the outbreaks included more than 50 cases, accounting for 80% of all cases reported. The workgroup determined that this increase was not due to antigenic differences between the Jeryl Lynn vaccine strain and the circulating wild strains. Mumps complications, mostly orchitis, were seen in 2.9% (270) of all cases.

Unlabelled Image Opens large imageA GRADE analysis was presented on use of a third dose of MMR for outbreaks. The range of vaccine effectiveness for the third dose in three outbreaks was 61%–88%, although evidence was weak. There were no reports of serious adverse effects resulting from addition of a dose. This intervention appears to be effective, although again, the evidence is weak. A vaccine effectiveness of 88% has been established for the two-dose series, and antibodies wane over time.

Approval for 2018 immunization schedules

The 2018 adult immunization schedule was presented. Updates will include the changes passed at this meeting, including the preferred use of HZ/su and the MMR third dose during outbreaks.

Other changes this year include HPV dose changes and removal of polysaccharide meningococcal vaccine (MPSV4), along with footnote changes.

Unlabelled Image Opens large image

The schedule was approved and is projected to be published in early February 2018.

The 2018 childhood/adolescent schedule was presented for approval. Changes included removal of Men-Hibrix (Hib-MenCY) because it is no longer available, a new table listing vaccines and their brand names and abbreviations, an orange-colored box indicating precautions, and footnote changes. ACIP voted to approve the schedule.

Resources on vaccine safety: Shoulder injury after vaccination

Shoulder Injury Related to Vaccine Administration (SIRVA) increasingly is being reported. There were 2,189 Vaccine Adverse Event Reporting System (VAERS) reports of SIRVA between 2010 and 2016, of which CDC determined that 1,006 were plausible. Reports across various immunization providers indicate additional outreach be conducted. The most commonly reported cause is injection of a vaccine too high in the shoulder, with other causes listed as improper or poor administration technique, uneven position between vaccinator and patient, needle too long, and past history of shoulder pain.

CDC has developed a handout to help educate providers on correct administration of injections, as well as other resources (available at www.cdc.gov/vaccines/hcp/admin/admin-protocols.html).

Updates on influenza vaccines

The 2017 influenza recommendations were published on August 27, 2017. Since publication, one update is a licensing change for Afluria Quadrivalent (Seqirus), which lowered the approval age to 5 years and older.

The predominant influenza virus that circulated last year, which currently is circulating in the Southern Hemisphere, is A(H3N2). Minimal virus is circulating at this time in the United States, and most of the cases are the A(H3N2) viruses, which are a good match for the recommended vaccine strains. The new recommendation for the Southern Hemisphere vaccine for 2018 changed the A(H3N2) vaccine strain. This change was made not because of antigenic drift but because a vaccine strain that better matches the circulating strain was identified.

Vaccination coverage rates also were discussed. Data from multiple databases showed that coverage among children (69%) and adults (41.3%) increased only slightly over last year’s coverage. A slight increase was also seen in adults older than 65 years (65.3%), but the rate was still lower than in some previous years. Coverage among pregnant women was 53.6%, and overall coverage for health care providers was 78.6%. The rate for pharmacists (93.7%) was second only to that for physicians (95.8%).

Updates on hepatitis B and A vaccines

An investigational hepatitis B vaccination (Heplisav-B—Dynavax) has been submitted to FDA for evaluation. The vaccine is an adjuvanted, recombinant hepatitis B surface antigen vaccine that is administered in two doses over a 1-month period. The adjuvant mimics natural innate immune responses to bacterial and viral DNA, which activate both B and T cell responses.

The vaccine induced higher sero-protection rates compared with the Engerix-B (GlaxoSmithKline) vaccine. It also has shown superior protection rates in all age groups, as well as in patients with diabetes, patients who are obese, and smokers. Adverse effects were similar, except that a higher incidence of myocardial infarction occurred in one of the Phase II studies; this was not seen in other studies. Overall, this vaccine appears to provide a higher rate of protection with fewer doses.

The ACIP statement “Prevention of Hepatitis A through Active or Passive Immunization: Recommendation of the Advisory Committee on Immunization Practices,” along with other hepatitis A guidance documents, are being updated.

It was noted that five large outbreaks of hepatitis A, with approximately 1,600 cases, have occurred since July 1, 2016. California is experiencing the largest number of outbreaks, mostly in the homeless population.

Stephan L. Foster, PharmD, FAPhA, APhA liaison to ACIP; professor (Ret.), College of Pharmacy, University of Tennessee Health Science Center; CAPT (Ret.), U.S. Public Health Service

Source: http://www.pharmacytoday.org/article/S1042-0991(17)31807-8/fulltext