Advisory Committee on Immunization Practices June 2018 Meeting Update
Jun 28, 2018
The Advisory Committee on Immunization Practices (ACIP) held their second of three annual meetings at the Centers for Disease Control and Prevention (CDC) in Atlanta, GA last week. ECBT staff took advantage of the opportunity to view the meeting via webcast, and strongly encourage members of the public to take advantage of this technology in order to gain a better understanding of the deliberations that take place to ensure the ongoing safety and effectiveness of the vaccines licensed for use in the U.S.
The CDC sets the recommended immunization schedules for people of all ages in the U.S. based on recommendations from the ACIP. The ACIP establishes, updates and continually evaluates all the vaccine recommendations that are made in the United States for infants, adolescents and adults. These guidelines are considered the gold standard among healthcare providers. The ACIP consists of 15 voting members, 8 ex officio members and 30 non-voting representatives who participate voluntarily. In addition to the three meetings per year, which are open to the public, ACIP members serve on various work groups that are active throughout the year. Work groups review the latest studies on specific vaccines (including safety and efficacy reports), in order to provide recommendations to the larger committee.
Last week the ACIP voted on recommendations for influenza (flu) and anthrax vaccinations, and discussed HPV, mumps, shingles (herpes zoster), Japanese encephalitis, and pneumococcal vaccines. Votes and highlights from the discussions are detailed below.
Influenza (Flu) Vaccination Discussion and Vote
It will come as no surprise to our readers that the flu virus hit a brutal blow to people of all ages during the very severe 2017-18 flu season in the U.S., striking at nearly the same time nationwide.
Influenza A (H3N2) was the predominant circulating strain and this year the effectiveness of the vaccine against this strain was approximately 24% (similar to the previous flu season). Effectiveness against the influenza A (H1N1) strain was 65% and 49% against the influenza B (Yamagata) strain.
Now the good news – vaccination reduced flu-related visits to healthcare providers (outpatient) by 40% among all people ages 6 months and older. Among adults, the vaccine reduced outpatient visits and hospitalizations by 22%.
The ACIP listened to vaccine safety reports provided by representatives from the Food and Drug Administration (FDA), vaccine manufacturers, and the vaccine safety surveillance systems in the U.S. – the Vaccine Adverse Event Reporting System (VAERS) and Vaccine Safety Datalink (VSD) which is a collaboration between CDC and nine healthcare organizations that began in 1990 and analyzes up to 10 million immunization records per year to ensure ongoing safety. After an extensive review of the safety of this season’s flu vaccines, the ACIP confirmed that there were no vaccine safety signals of concern including anaphylaxis, narcolepsy and Guillian-Barre Syndrome, each of which received increased scrutiny due to a number of news and anecdotal reports in recent years.
The ACIP approved the following influenza recommendations for the 2018-19 season:
Everyone 6 months of age and older should be vaccinated with any licensed, age-appropriate influenza vaccine (IIV, recombinant influenza vaccine [RIV], or LAIV), as indicated. No preference is given for any one vaccine over another. In its February meeting, the ACIP once again recommended LAIV (the nasal spray vaccine known as FluMist) for healthy, non-pregnant people 2 through 49 years old during the 2018-19 season. This recommendation was made after ACIP reviewed effectiveness data presented by the manufacturers of FluMist.
Of Note: The Redbook Committee of the American Academy of Pediatrics, who typically endorses the recommendations of the ACIP, have stated a preference for the flu shot (IIV or RIV) over the nasal spray vaccine (LAIV), recommending that pediatricians only give the nasal spray as a last resort. This decision by the AAP is not without controversy as it may lead to confusion among parents and their providers. ECBT Board Member Dr. Paul Offit recently created a Medscape video explaining why he agrees with the ACIP’s decision to recommend the use of FluMist in children based on the effectiveness data.
Pneumococcal Vaccination Discussion
Two pneumococcal vaccines are currently recommended for all adults over the age of 65 – one dose of pneumococcal conjugate vaccine (PCV13) with a booster dose of pneumococcal polysaccharide vaccine (PPSV). ACIP is re-examining whether PCV13 should be routinely recommended for otherwise healthy older adults. Some experts believe the childhood recommendations for routine vaccination with PCV13 is sufficiently lowering the disease burden in adults by reducing the circulation of the disease in communities. In data presented to the ACIP, however, it seems there are persistent disparities in the rate of pneumococcal disease and vaccine uptake
among minority populations and those in poverty, which puts into question whether it would be wise to eliminate the vaccine recommendation for adults. The ACIP will continue to deliberate the data and have continued discussions into 2019.
Anthrax Vaccination Discussion and Vote
The anthrax vaccine is currently approved for use by the FDA for 18-65 year olds, and is usually given to select populations of adults (i.e. military). As the Department of Health and Human Services (HHS) and CDC review their plans for responding to an anthrax “mass event”, they have asked ACIP to offer guidance on how best to use the vaccine in the event of emergency. Specifically, they asked ACIP whether the anthrax vaccine would be equally effective and safe if they had to administer the vaccine in fewer or smaller doses to ensure there was enough vaccine for everyone affected. Also under consideration was the utilization of different types of needles to be used in the event of a needle shortage. The current vaccine is given subcutaneously, not intramuscularly, like typical vaccines. Intramuscular needles are therefore more readily available.
After reviewing the data, the ACIP agreed unanimously that reduced dosing would still save lives, as would offering the vaccine intramuscularly instead of subcutaneously. There was no data, however, on whether reduced doses given intramuscularly would be equally effective. The Committee also offered their recommendations on the duration of antimicrobial treatment following vaccination. There is a new intramuscular anthrax vaccine on the horizon which may help federal agencies better plan for a possible emergency situation.
The ACIP made the following recommendations:
The intramuscular route of administration may be used if the subcutaneous route presents clinical, operational, or logistical challenges that may delay or prevent effective vaccination.
- Should there be an inadequate supply of anthrax vaccine available for Post Exposure Prophylaxis (PEP), either 2 full doses or 3 half doses of AVA may be used to expand vaccine coverage.
- In immunocompetent individuals 18-65 years of age, antimicrobials given in conjunction with vaccine may be discontinued at 42 days after the first vaccine dose or 2 weeks after the last vaccine dose, whichever comes later.
Japanese Encephalitis Vaccination Discussion
The cell culture-derived Japanese encephalitis vaccine (JE-VC) is both safe and effective, but given how few U.S. travelers contract the disease, ACIP is re-evaluating their recommendations. They are in the midst of re-evaluating the cost effectiveness of the vaccine and whether their recommendations should be more targeted. ACIP will continue deliberations at a future meeting.
Mumps Vaccination Discussion
Mumps outbreaks continue to crop up throughout the nation. From late 2016 through 2017, there were 56 outbreaks, which included 3,914 cases, and in 2018, there have already been 30 outbreaks, including 1,415 cases. The ACIP previously recommended the use of a 3rd dose of mumps virus-containing vaccine (MMR) for people identified at increased risk during a mumps outbreak. During the June, 2018 ACIP meeting, the CDC provided guidance for public health officials to assist them on the use of a 3rd dose of MMR vaccine during an outbreak, including identifying groups of people at risk for acquiring mumps during an outbreak; assessing transmission in the settings to determine if groups are at increased risk; and how to implement a 3rd dose recommendation.
Shingles (Herpes Zoster) Vaccination Discussion
In October 2017, ACIP made recommendations for a new recombinant zoster vaccine (RZV) called Shingrix. The vaccine is recommended for the prevention of shingles and related complications for adults 50 years of age and older. It is also recommended for adults 50 and older who previously received zoster vaccine live (ZVL), and it is preferred over ZVL for the prevention of shingles and related complications.
GSK, the manufacturer of Shingrix, reported to the Committee that it is increasing the number of doses available due to high demand and shipping delays. They are also continuing to study the safety and effectiveness of the vaccine. The CDC also continues to monitor shingles vaccine coverage and vaccine supply. As it does with all vaccines, the CDC is using U.S. safety surveillance systems – VAERS and VSD – to monitor the shingles vaccine (RZV). VAERS is a passive system that is not designed to determine if a vaccine caused a health problem, but does help to detect unusual or unexpected patterns of adverse events that might indicate a possible safety problem with a vaccine. The CDC reported that were 680 reports to VAERS between October 20, 2017 and April 27, 2018, and the majority concerned females. There were no unusual patterns or unexpected adverse events. 48 (7%) of reports involved co-administration with 1 or more other vaccines, and the most commonly reported side effects from RZV were injection site pain and pyrexia (fever).
The CDC also reported to ACIP about VSD monitoring of the shingles vaccine. The staff of the VSD conducted vaccine safety studies based on questions and concerns raised from the medical literature and reports to VAERS. As of May 31, 2018, 37,303 total doses of RZV were administered at the participating VSD sites. The VSD monitoring for RZV includes high priority short-term outcomes (GBS, anaphylaxis, and acute myocardial infarction); lower priority short-term outcomes for descriptive analysis (gout, local and systematic reactions); and longer-term outcomes (potential immune-mediated diseases). Evidence of safety and effectiveness of shingles vaccine in immunocompromised is currently being reviewed.
The CDC has created a number of resources for RZV. For providers, the CDC developed a report published in MMWR on vaccine administrative errors, a Continuing Medical Education program (CME) called “You Call the Shots”, a Medscape video, web pages, webinars/conferences and fact sheets. For the public, the CDC created a vaccine information statement (VIS) on the RZV, web pages and a fact sheet.
Human Papillomavirus (HPV) Vaccination Discussion
In October 2018, the FDA is expected to complete a review of scientific studies to determine whether 9-valent HPV vaccine (GARDASIL®9) is safe and effective for use in adults ages 27 to 45. The vaccine will continue to serve as a prophylactic to prevent new infections, and is not expected to prevent progression of the disease among those who already have a HPV infection. The ACIP is also simultaneously reviewing the evidence that has been sent to the FDA and will determine whether to recommend the vaccine if and when the FDA approves the vaccine for use among mid-aged adults. Factoring into the ACIP decision will be the fact that the overall population-level benefit will be lower among mid-aged adults than among younger populations. This is due to the fact that this
population may have already been exposed to HPV and thus already have an infection, or have immunity against some strains of the disease. In addition they tend to have fewer new sex partners and have several other factors that will make the vaccine less beneficial (but not without merit) for this older group than for those ages 11-12, who can be vaccinated prior to exposure.
The ACIP’s HPV work group is also continuing to review data in consideration of “harmonizing” the schedule for males and females so that both populations would be recommended up to the age of 26 instead of up to age 21 for males and up to age 26 for females and will report back to the full ACIP at a future meeting.
ECBT will keep you informed on this and other deliberations of this important committee.
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