A summary of presentations from the weekly Summit partner webinars
January 27, 2022 – The latest Summit summary
- Zoster Vaccine ACIP Recommendations Update – Kathleen Dooling (CDC)
- Flu Claims Update – Julian Ritchey (Sanofi Pasteur)
Zoster Vaccine ACIP Recommendations Update – Kathleen Dooling (CDC)
Kathleen Dooling, MD, MPH, Team Lead, Mumps/Varicella/Zoster Team, Division of Viral Diseases, CDC, gave a presentation on the new zoster vaccine ACIP recommendations.
There are new ACIP/CDC recommendations for the use of recombinant zoster vaccine (RZV, Shingrix) in immunocompromised adults age 19 and older. The policy note was published in MMWR: Use of Recombinant Zoster Vaccine in Immunocompromised Adults Aged ≥19 Years: Recommendations of the Advisory Committee on Immunization Practices—United States, 2022.
RZV is the first herpes zoster (HZ) vaccine recommended for use in immunocompromised people. When RZV first came on the market in 2018, it was recommended for immunocompetent people age 50 and older. Zostavax, the live shingles vaccine, is contraindicated for immunocompromised people.
CDC now recommends that 2 doses of RZV may be given for the prevention of HZ and related complications in adults age ≥19 who are or will be immunodeficient or immunosuppressed because of disease or therapy. Immunocompromised persons include:
- Hematopoietic cell transplant (HCT) recipients
- Patients with hematologic malignancies (HM)
- Renal or other solid organ transplant (SOT) recipients
- Patients with solid tumor malignancies (STM)
- People living with HIV
- Patients with primary immunodeficiencies, autoimmune and inflammatory conditions, and taking immunosuppressive medications/therapies
Data to support the recommendation:
Individuals who are immunocompromised are at a substantially higher risk for HZ compared to immunocompetent adults age 50 and older. For people who have HIV, solid tumors, solid organ transplant, blood cancer, and stem cell transplant, the incidence of HZ increases; the incidence of HZ also increases with increasing age.
In patients who develop postherpetic neuralgia (PHN) from HZ, about 6-10% are immunocompromised and only about 4% are immunocompetent. About 3% of immunocompromised individuals develop disseminated HZ; however, it’s exceedingly uncommon in healthy individuals. It’s been shown (source 1, source 2) that transplant patients with HZ have a higher mortality rate (10–17%) from disseminated HZ.
Around 8% of stem cell transplant recipients with HZ will experience hospitalization while less than 1% of the overall Medicare beneficiaries will go on to be hospitalized with HZ.
In a study evaluating the risk of zoster in autoimmune and inflammatory disease, authors determined that there is about 2–4 fold higher risk of zoster among individuals with autoimmune disease compared with healthy individuals, and the risk varied across age groups. The highest rates were found in patients with systemic lupus erythematosus (SLE), inflammatory bowel disease (IBD), and rheumatoid arthritis (RA).
According to the National Health Interview Survey, there are around 7 million adults with self-reported immunocompromise. The prevalence was found to be highest in people in their 50s, and higher in women than men. There are about 3 million people who have who have HIV, solid tumors, solid organ transplant, blood cancer, and stem cell transplant. There are around 22 million people with autoimmune conditions or inflammatory conditions, however this is self-reported and the conditions diverse––some not truly autoimmune or inflammatory conditions.
Summary of the GRADE analysis (outcomes considered preventable and potential harm of serious adverse event following immunization) presented to ACIP:
- Five randomized clinical trials found that the vaccine efficacy (VE) ranged from about 68% in stem cell transplant patients, 80% in blood cancer patients, and 90% in those age 50 and older who have an autoimmune condition but who are not taking immunosuppressants
- Observational studies showed slightly lower vaccine efficacy (VE) in both immunocompromised patients as well as autoimmune populations
- Information from seven randomized controlled trials showed no difference between serious adverse events from the placebo group versus the vaccine recipient group
The ACIP also took into consideration the current state of zoster vaccines. The demand and interest for the zoster vaccine is high for adults, and interest in RZV is increasing: 6.7% in 2008, 34.5% in 2018, 41.2% in 2019.
The series completion rates are high among Medicare enrollees, 78% of which received both doses by six months and 86% by 12 months. IQVIA data, which captures completion rates for individuals age 50–64 who might not have entered Medicare shows that 70% completed the series by 6 months and 80% by 12 months.
Physician recommendation was already high before the ACIP recommendation. Most physicians said that they strongly recommended vaccination for people age 50 and older with compromised immune systems. The recommendation was lower for people age 50 and older who are on chemo or receiving bone marrow or organ transplant. In that case, physicians prefer to defer to a sub-specialist to make the recommendation for the vaccine.
In summary, despite the lack of ACIP/CDC recommendation prior to 2022, many physicians were already recommending RZV to their immunocompromised patients. The ACIP workgroup determined the estimated economic value from the cost-effectiveness analysis to be favorable for bone marrow transplants. The workgroup also noted identifying immunocompromised patients who are recommended for HZ vaccination and the coordination of care may be challenging. There were mitigating suggestions made:
- Clinical decision support guidance will be helpful
- Physicians should look to promote best practices. Information available at Immunization Information Systems (IIS) | CDC
- Encourage providers to upload and update RZV vaccination information in jurisdictions’ immunization information systems.
CDC: ACIP Evidence to Recommendations Framework for Use of Recombinant Zoster Vaccine in Immunocompromised Adults Aged ≥19 Years
Recommendations for RZV for persons 50 years and older and new recommendations for Immunocompromised adults age 19 and over:
- The second dose of RZV should be given 2–6 months after the first, however, the series does not need to be restarted if more than 6 months have passed after the first dose.
- New for immunocompromised patients: For persons who are or will be immunodeficient or immunosuppressed and who would benefit from completing the series in a shorter period, the second dose can be administered 1–2 months after the first.
Timing of the Vaccination:
- RZV may be administered to patients who previously received varicella vaccine
- People who previously received zoster vaccine live should receive RZV
- RZV is not a live virus vaccine; therefore, RZV may be administered while patients are taking antiviral medications
- New for immunocompromised patients: When possible, patients should be vaccinated before becoming immunosuppressed. If not possible, providers should consider timing vaccination when the immune response is most likely to be robust.
Coadministration with Other Vaccines:
- CDC’s general best practice guidelines for immunization advise that recombinant and adjuvanted vaccines, such as RZV, can be administered concomitantly, at different anatomic sites, with other adult vaccines
Counseling for Reactogenicity:
- Before vaccination with RZV, providers should counsel patients about expected local and systemic reactogenicity
For additional guidance, including for patients with selected immunocompromising conditions, please see: Clinical Considerations for Use of Recombinant Zoster Vaccine (RZV, Shingrix) in Immunocompromised Adults Aged ≥19 Years | CDC
Pregnancy – There is currently no ACIP recommendation for RZV use in pregnancy or pregnancy testing prior to vaccination. Providers should consider delaying this vaccine until after pregnancy.
Breastfeeding – Recombinant vaccines such as RZV pose no known risk for mothers who are breastfeeding or to their infants.
The new recommendation states that clinicians may consider vaccination without regard to breastfeeding status if RZV is otherwise indicated.
Persons with a History of Zoster – If a patient has a history of shingles, they should still receive RZV, as shingles can recur.
Persons with no documented history of varicella, varicella vaccination, or herpes zoster please see the following guidance:
Clinical Considerations for Use of Recombinant Zoster Vaccine (RZV, Shingrix) in Immunocompromised Adults Aged ≥19 Years | CDC
If younger immunocompromised patients do not have documentation of vaccination or history of varicella disease, should serology testing be done before considering RZV?
First, you want to look for any record that the patient has received the varicella vaccine at some point in their childhood. Second, look for a history of clinical varicella/zoster. If you can’t find evidence that they have encountered the vaccine or wild VZV, then the next step would be serological testing.
The problem with the testing is that it might not be adequately sensitive to detect whether or not the patient has had the vaccine. If all roads point to the patient as VZV naive, then ACIP recommendation states that a primary dose of the varicella vaccine should be administered.
Those over age 50 most likely have had exposure to wild VZV, so Shingrix should be administered for the older population.
Is the RZV guidance for adults 50 years and older the same as it was before this addition of recommendations for immunocompromised people?
The guidance otherwise has not been changed.
Can you elaborate on the guidance on vaccination after shingles?
The acute infection (rash) should be resolved before the shingles vaccination is administered. If the patient is feeling well, they may be vaccinated.
Flu Claims Update – Julian Ritchey (Sanofi Pasteur)
Julian Ritchey, VP, Head of Public Affairs and Patient Advocacy, US Vaccines, Sanofi Pasteur, gave an updated presentation on influenza vaccination insurance claims.
Influenza activity continues despite declines over the last two weeks and there have been five pediatric deaths due to the flu this season so far.
The claims data represents around 50% of the doses in the market. The cumulative claims remain behind prior years’, however, weekly claims remain above the same week of the year compared to the prior two seasons.
The year got off to a later start with influenza vaccination compared with last year, however, still higher than the 2019–2020 season. The cumulative claims data this season shows a 17% drop from last season and a 6% drop from the prior season. The vaccination season seems to have peaked and vaccination rates are declining, as has been seen in previous years where vaccination drops off in December.
As late season vaccination continues, all age groups are behind in vaccination claims compared to last season. Claims are approaching the 2019–20 season levels for adults with the largest gap in pediatric vaccinations. There has been a significant decrease in flu vaccination claims this year in the 0–17 age group compared to the 2019–2020 season, which is very concerning.
During a 38-year period, CDC data shows that flu activity most often peaked in February, followed by December, January, and March, respectively. There is still time to immunize patients this season as flu activity continues and as we approach the historical peak flu virus activity in February. The data shows that late-season vaccination needs to continue as does messaging.
The low seasonal flu incidence has challenged this season’s coverage rates. This season, it has been tougher to motivate people to get vaccinated and to get vaccinated early in the season. It’s also important to start thinking about messaging for the next flu season.
How to plan for next year:
- Look at what messaging worked and what messaging should be improved. What went well this year?
- Find the best resources and messaging
- Encourage connectivity between organizations and align organization with the best information
- Determine what made people get vaccinated last season and not this season. What is the best way to reach those people?
- Challenge yourself/your organization to begin next year’s planning
1. Immunize.org has introduced a new patient handout to assist providers with influenza vaccination uptake: Not Sure If You Can Get an Influenza Vaccine? This handout, ideally printed as a two-sided, single page, addresses a variety of concerns (e.g., egg allergy, history of Guillain-Barre syndrome, pregnancy, and a weakened immune system).
2. IAC is now Immunize.org. You will find the new look of Immunize.org on its social media pages and in coming months, you’ll also see the new look on a redesigned website with improved searchability to keep accurate, up-to-date resources at the fingertips of vaccinators and the public. Immunize.org looks forward to increasing our visibility and expanding our reach to serve even more frontline vaccinators through these changes planned for 2022.
3. Immunize.org, with funding support from Seqirus, is offering a limited quantity of FREE Flu vaccine and COVID-19 vaccine buttons and stickers. To receive these supplies at no cost, please order now.
- Order the free flu buttons and stickers (in Spanish).
- Order the free COVID-19 buttons and stickers (in English and Spanish).
4. Immunize.org hosted two influenza webinars in September that can now be viewed online.
- The Continued Threat of Influenza and How to Sustain Influenza Vaccination Efforts
- Translating COVID-19 Strategies to Improve Influenza Seasonal Flu Vaccination Efforts
5. We would welcome having even more NAIIS member organizations to add their support to the Call to Action on adult immunization. Access the call to actionand click on the top righthand button to add your organization.
6. If you are not getting NAIIS emails, please add firstname.lastname@example.org (sender: NAIIS) to your list of email contacts to keep receiving the NAIIS emails.
7. There is new zoom login information this year. Please check your emails with the call agendas from NAIIS for the new zoom link and password information.