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Issue 1,584:
August 18, 2021
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Immunize.org Pages and Handouts
Vaccine Information Statements
Featured Resources
Notable Publications
Global News
Immunization PSAs from the Archive
Top Stories
IAC summarizes August 13 ACIP
meeting on new recommendation for additional dose of mRNA COVID-19 vaccine for people with moderate to severe
immunocompromise
On August 13, the Advisory Committee on Immunization Practices (ACIP) met to review the
FDA’s August 12 modifications to its Emergency Use Authorizations (EUAs) for the Pfizer-BioNTech and Moderna
mRNA COVID-19 vaccines. ACIP members unanimously recommended administration of an additional dose of mRNA vaccine for moderately to
severely immunocompromised people who have completed either 2-dose mRNA COVID-19 vaccine series. This recommendation does not apply
to immunocompromised people who received Janssen COVID-19 Vaccine (Johnson & Johnson). Presentation slides from the meeting are available online, and details of this recommendation are provided below.
Background: Approximately 7 million people (2.7% of the population) in the United States are immunocompromised. These individuals
are more likely to get severely ill from SARS-CoV-2 infection and shed the virus for prolonged periods. Small studies indicate that, when compared
to non-immunocompromised people, immunocompromised people are more likely to have serious breakthrough infection; 40–44% of fully
vaccinated individuals hospitalized with breakthrough infection have been immunocompromised. A blood test showing detectable neutralizing
antibodies after vaccination is a simple but imperfect estimate of a person’s protection from COVID-19 illness. Among immunocompromised people
with no detectable antibody response to a 2-dose mRNA vaccine series, 33–50% developed a detectable antibody response after a third
dose.
Available evidence supports the conclusion that an additional dose is safe in immunocompromised people. Public health authorities in other countries,
including France, Israel, Germany, and the United Kingdom, have recommended an additional dose of COVID-19 vaccine be given to
immunocompromised people.
CDC presenters emphasized the difference between an additional dose in this context and a booster dose. An “additional”
dose of vaccine is a dose administered when the immune response to a standard primary vaccine series is likely not to be protective. A
“booster” dose of vaccine is a dose administered to restore protection after the effectiveness of protection from the
primary series has declined. ACIP does not recommend booster doses at this time.
Implementation and Clinical Considerations: Following approval of the ACIP recommendation, CDC updated its Interim Clinical Considerations for Use of COVID-19 Vaccines Currently Authorized in the United States.
COVID-19 vaccine providers should review this CDC document carefully for complete information. Highlights of key aspects of implementation guidance
for this recommendation are provided below.
Moderately to Severely Immunocompromised People: The ACIP recommendation applies to people with moderate to severe
immunocompromise due to a medical condition or immunosuppressive treatment. According to CDC, these conditions and treatments include but are not
limited to:
- Active treatment for solid tumor and hematologic malignancies
- Receipt of solid-organ transplant and taking immunosuppressive therapy
- Receipt of CAR-T-cell or hematopoietic stem cell transplant (within 2 years of transplantation or taking immunosuppressive therapy)
- Moderate or severe primary immunodeficiency (e.g., DiGeorge syndrome, Wiskott-Aldrich syndrome)
- Advanced or untreated HIV infection
- Active treatment with high-dose corticosteroids (i.e., 20 mg or more prednisone or equivalent per day), alkylating agents,
antimetabolites, transplant-related immunosuppressive drugs, cancer chemotherapeutic agents classified as severely immunosuppressive, tumor-necrosis
[factor] (TNF) blockers, and other biologic agents that are immunosuppressive or immunomodulatory.
The ACIP recommendation does not require vaccine providers to obtain a prescription or medical verification of a person’s condition; patients may
simply attest to their immunocompromised status.
Vaccine Type:
- The recommendation applies only to people who have completed a mRNA vaccine series.
- When possible, the additional dose should be the same mRNA vaccine as the primary series. However, the other mRNA vaccine may be
used if the primary series product is not available.
Vaccination Timing: The additional dose of mRNA COVID-19 vaccine should be administered at least 28 days after the second
dose.
Age Range: Age groups authorized to receive the additional dose:
- Pfizer-BioNTech COVID-19 Vaccine: age 12 years and older
- Moderna COVID-19 Vaccine: age 18 years and older
Patient Counseling: Immunocompromised people should continue to practice the same COVID-19 infection prevention measures as
unvaccinated people (e.g., mask wearing, social distancing, and avoiding crowds or poorly ventilated indoor spaces) because they may not be adequately
protected from breakthrough illness even after receiving an additional dose.
Serologic Testing: Post-vaccination serologic testing is not part of this recommendation. The FDA has not approved a test for this
purpose.
Action Step: Update EUA Fact Sheets used in your clinic to current versions (see links below).
Additional Presentations: Following the vote described above, CDC updated the ACIP on COVID-19 epidemiology and vaccine
effectiveness. Notably, as of August 2, among the more than 164 million fully vaccinated people in the U.S., there have been only 7,101 hospitalizations
and 1,507 COVID-related deaths. The majority (75%) of hospitalized or fatal breakthrough cases were in people age 65 years and
older.
The day’s final presentation included background information for future policy discussions on booster doses (see definition above) of COVID-19
vaccines for immunocompetent people who have completed a primary series.
Future ACIP Meetings: The next announced ACIP meetings are scheduled for August 24 (COVID-19 vaccines only), September
29–30 (catch-up on other vaccine-preventable diseases), and the regularly scheduled meeting on October 20–21. Additional meetings may
be announced; information about past and future ACIP meetings may be found on the ACIP website.
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CDC releases 14 updated Vaccine
Information Statements; translations in progress
On August 9, CDC posted 14 updated Vaccine Information Statements (VISs). Access these VISs on their respective IAC web pages by clicking on the links below.
- DTaP
(Diphtheria, Tetanus, Pertussis)
- Haemophilus influenzae type b (Hib)
- HPV
(Human Papillomavirus)
- Influenza, inactivated or recombinant
- Influenza, live intranasal
-
Meningococcal ACWY
- Meningococcal B
- MMR
(Measles, Mumps, and Rubella)
- MMRV (Measles, Mumps, Rubella, and Varicella)
- Pneumococcal Conjugate (PCV13)
- Polio
- Td
(Tetanus, Diphtheria)
- Tdap
(Tetanus, Diphtheria, Pertussis)
- Varicella (Chickenpox)
CDC encourages providers to begin using these VISs immediately; however, existing supplies of the previous editions may be used until exhausted.
IAC will produce translations of these new VISs and post them on Immunize.org as they become available over the next several weeks. Translations
of previous VIS versions may be used until new translations become available. CDC states that the corresponding up-to-date English-language VIS must
also be supplied when providing an out-of-date translation.
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CDC strengthens
recommendation for COVID-19 vaccination for people who are or may become pregnant, in light of reassuring safety data for vaccination in
all stages of pregnancy
On August 11, CDC released a statement on the safety of COVID-19 vaccines in
pregnant individuals and is strengthening the recommendation that all people 12 years of age and older get vaccinated against COVID-19. A portion of the
statement appears below.
A new CDC analysis of current data from the v-safe pregnancy registry assessed vaccination early in pregnancy and did not find an
increased risk of miscarriage among nearly 2,500 pregnant women who received an mRNA COVID-19 vaccine before 20 weeks of
pregnancy....
Previously, data from three safety monitoring systems did not find any safety concerns for pregnant
people who were vaccinated late in pregnancy or for their babies. Combined, these data and the known severe risks of COVID-19 during pregnancy
demonstrate that the benefits of receiving a COVID-19 vaccine for pregnant people outweigh any known or potential risks.
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"Use of COVID-19 Vaccines after Reports of Adverse Events among Adult
Recipients of Janssen (Johnson & Johnson) and mRNA COVID-19 Vaccines (Pfizer-BioNTech and Moderna): Update from the Advisory Committee
on Immunization Practices—United States, July 2021" published in MMWR Early Release
CDC published
Use of COVID-19 Vaccines after Reports of Adverse Events among Adult Recipients of Janssen (Johnson &
Johnson) and mRNA COVID-19 Vaccines (Pfizer-BioNTech and Moderna): Update from the Advisory Committee on Immunization
Practices—United States, July 2021 on August 10 as an MMWR Early Release. A portion of the summary appears
below.
Rare serious adverse events have been reported after COVID-19 vaccination, including Guillain-Barré syndrome (GBS) and thrombosis with
thrombocytopenia syndrome (TTS) after Janssen COVID-19 vaccination and myocarditis after mRNA (Pfizer-BioNTech and Moderna) COVID-19
vaccination....
On July 22, 2021, the Advisory Committee on Immunization Practices reviewed updated benefit-risk analyses after Janssen and mRNA
COVID-19 vaccination and concluded that the benefits outweigh the risks for rare serious adverse events after COVID-19 vaccination....
Continued COVID-19 vaccination will prevent COVID-19 morbidity and mortality far exceeding GBS, TTS, and myocarditis cases expected.
Information about rare adverse events should be disseminated to providers, vaccine recipients, and the public.
Access the MMWR Early Release article in HTML format or in PDF format.
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For National Immunization Awareness
Month, use the new “We Can Do This” social media posts and graphics to promote back-to-school vaccinations
August is National Immunization Awareness Month (NIAM). This annual observance highlights the efforts of healthcare professionals to protect
patients of all ages against vaccine-preventable diseases through on-time vaccination.
The Department of Health and Human Services' (HHS) We Can Do This campaign now offers social media graphic posts to promote COVID-19 vaccination
among students 12 years and older. Post them on your social media accounts to encourage students, parents, teachers, school staff, and others in our
communities to get vaccinated as they return to school.
Don't forget about promoting all other vaccinations during NIAM! CDC’s NIAM web page
includes two toolkits, one for reaching healthcare professionals and the other for reaching parents and patients. Each includes key messages, sample social media content, and educational resources. CDC
encourages its partners to share these messages and resources throughout August using the hashtag #ivax2protect. Stay tuned for more resources to be
released throughout the coming weeks.
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Multiple vaccine advocacy groups publish white paper describing challenges that prevent maternal immunization in the
United States
IAC and fifteen other professional societies and vaccine advocacy groups recently published a white paper titled Improving Maternal Immunization Status: Working toward Solutions to the Policy, Data, and
Implementation Challenges Driving Suboptimal U.S. Maternal Vaccination Rates. The document offers “an overview of the current
landscape, limitations, and impacts of challenges related to maternal immunization data collection/reporting and implementation.” It also details
potential solutions that could strengthen efforts in place to address longstanding barriers to vaccinations among pregnant individuals.
The white paper includes a discussion of:
- Background information
- Evolving data and implementation challenges in commercial and Medicaid contexts
- Longstanding barriers to maternal immunization
- Existing and proposed solutions, including
- High quality data collection, monitoring and reporting
- On-the-ground coordination and implementation
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IAC Spotlight! IAC’s Immunize.org website offers many useful navigation
features
In this week's IAC Spotlight, we summarize features of IAC's Immunize.org website that ease navigation to our many resources.
Our “Favorites” tab is left-most of the six blue tabs atop each Immunize.org web page. Clicking on the tab will take you to the Favorite Web
Sections gateway page, and then onward to 18 of the most highly visited gateway pages on IAC's content-rich website.
Our "Guide to Immunize.org" appears at the bottom of each Immunize.org web page with a light gray background. The alphabetized topics link
you directly to IAC's gateway pages.
Our Google search bar appears at the top right corner of each Immunize.org web page. The search function is limited to the Immunize.org website.
Our Handouts for
Patients and Staff gateway page contains all the handouts in a table sortable by title, language, data, and item number. To find it, hover over
"Handouts and Staff Materials," the second of the six blue tabs atop each Immunize.org web page. Click on “View All
Resources,” the first option in the drop-down menu; this will bring you to the sortable table. At the end of the 26 options, What’s New:
Handouts will take you to a list of our most recent additions and revisions.
At the top right of each page are three tabs.
- “For Healthcare Professionals” is the option for Immunize.org itself.
- “For the Public” leads to vaccineinformation.org, our website for easy-to-read content.
- “For Coalitions” takes you to the website for the Immunization Coalitions Network.
Each gateway page within the Immunize.org website has a treasure trove of resources listed. Please invest a few minutes to explore the Immunize.org
website. We believe it will save you time when you next need immunization information in a hurry.
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Journalists interview IAC experts
Journalists seek out IAC experts to help explain vaccines to the public and policy makers. We help the media understand and communicate the complex
work vaccinators do. Here is a recent citation:
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Vaccines in the news
These recent articles convey the potential risks of vaccine-preventable diseases and the importance of vaccination.
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Immunize.org Pages and Handouts
IAC updates "Vaccine with Diluents: How to Use Them"
handout for healthcare professionals
IAC recently updated its handout for healthcare professionals titled Vaccines with Diluents: How to Use Them to remove Zostavax and to add a box
referring those seeking information about COVID-19 vaccine diluents to a CDC site.
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Vaccine Information Statements
IAC updates "You Must Provide Patients with Vaccine
Information Statements (VISs) – It's the Law!" to reflect new VIS version dates
IAC recently updated the 2-page handout for healthcare providers You Must Provide Patients with Vaccine Information Statements (VISs) – It’s Federal
Law! to reflect updated Vaccine Information Statement (VIS) version dates.
 
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IAC revises "Dates of Current Vaccine Information Statements (VISs)" checklist to reflect new VIS
version dates
IAC recently updated its Dates of Current Vaccine Information Statements (VISs) 4-panel checklist to reflect the new Vaccine Information Statement (VIS) version
dates. Use this checklist to make sure your whole inventory is up to date.
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Featured Resources
National Governors Association Center for Best
Practices releases new publication, "State Strategies to Increase COVID-19 Vaccine Uptake in Rural Communities"
The National Governors Association Center for Best Practices (NGA Center) released a new publication, State Strategies to Increase COVID-19 Vaccine Uptake in Rural Communities. Access to health
care is a common challenge for rural and frontier communities due to provider shortages and insufficient broadband Internet availability. Additional challenges surfaced during the pandemic. The fast-paced nature of the pandemic spurred new and changing information with
misinformation spreading as quickly as reliable news, undercutting science and public policies, especially related to COVID-19 vaccines.
To address these issues, this publication compiles best practices for Governors, including building vaccine confidence through consistent,
transparent, and factual communication; establishing straightforward pathways for people to access vaccines; and developing sustainable systems to
distribute vaccines to rural and frontier populations.
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IAC’s gateway page “Vaccination and COVID-19” offers a collection of tools from many
organizations to sustain routine vaccination services during the pandemic
IAC’s Vaccination and COVID-19 gateway page assists healthcare professionals faced with challenges in providing routine and catch-up
vaccination during the pandemic. In this gateway page, IAC has assembled key links to help both new and experienced vaccinators deliver safe, effective
vaccination to people of all ages, applicable in typical and nontraditional vaccination settings.
The site facilitates access to key pandemic resource pages from major clinical and public health organizations involved in vaccination. We will update the
page as needed with new links and resources specific to catch-up vaccination, so be sure to check back regularly.
To easily locate this gateway page on Immunize.org, go to the light blue band of tabs across the top, and choose "Clinic Tools." You also can use the Guide to Immunize.org at the bottom of each web
page.
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Organizing a new vaccination
program? Use IAC's Vaccinating Adults: A Step-by-Step Guide—free to download by chapter or in its entirety
Download IAC's free 142-page book on adult vaccination to help build your program and train your team: Vaccinating Adults: A
Step-by-Step Guide (Guide).
This thorough "how to" guide on adult vaccination provides easy-to-use, practical information covering all essential activities. It helps vaccine
providers enhance their existing adult vaccination services or introduce them into any clinical setting.
The Guide is available to download/print either by chapter or in its entirety free at www.immunize.org/guide. The National Vaccine Program Office and CDC both
supported the development of the Guide and provided early technical review.
The Guide is a valuable resource to assist providers in increasing adult vaccination rates. Be sure to get a copy today!
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Encourage others to get vaccinated by ordering IAC's “Me Vacuné…” and
“I Got My COVID-19 Vaccine” buttons and stickers, now FREE to all organizations promoting or offering COVID-19 vaccination!
All organizations promoting or offering COVID-19 vaccination may order IAC’s FREE “Me Vacuné…” and “I
Got My COVID-19 Vaccine” buttons and stickers, provided with support from CDC. Access this order form to request the FREE buttons and stickers
for your outreach efforts while supplies last.
 
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Fall is right around the corner; so is
flu season! Stock up on IAC's flu vaccine buttons and stickers for staff and patients.
After you order your vaccine, don’t forget to order your buttons and stickers. IAC “FLU VACCINE” buttons and stickers are ready to
ship! Their bright red color helps broadcast your important message about the need for influenza vaccination. And the cost is reasonable.
“FLU VACCINE” BUTTONS
The button measures 1.25" across and carries a bold message! Pin on lab coats, uniforms, other clothing, tote bags, or backpacks to show support
for flu vaccine.
Buttons are delivered in bags of 10 buttons per bag.
Click here
for pricing and ordering information for "FLU VACCINE" buttons.
“FLU VACCINE” STICKERS
Measuring 1.5" across, these stickers adhere well to clothing and have an easy-peel-off backing.
Stickers are delivered to you cut individually (not on rolls)—available in bundles of 100.
Click here for pricing and ordering information for “FLU VACCINE” stickers.
Visit Shop IAC for additional
items, including "Vaccines Save Lives" enamel pins, patient record cards, and a vaccine administration training video.
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Notable Publications
“Randomized Trial of a Third Dose of mRNA-1273 Vaccine in Transplant Recipients” published in
NEJM
In the August 11 issue, NEJM published Randomized Trial of a Third Dose of mRNA-1273 [Moderna] Vaccine in Transplant
Recipients. A portion of the description of this double-blind, randomized, controlled trial, performed with 120 transplant recipients (median age of 66.6
years; median time from transplantation to the third dose was 3.16 years), appears below.
A third dose of mRNA vaccine in transplant recipients had substantially higher immunogenicity than placebo... This trial had short follow-up and was
not powered to detect differences in clinical outcomes. We also acknowledge that the cutoff value … for the
… antibody level is … not necessarily predictive of resistance to infection. A third dose was safe when risk versus benefit was
considered. We note that a small subgroup of patients who received placebo did have modest increases in antibody levels. This may reflect ongoing
mRNA vaccine-induced B-cell stimulation, as recently described, and highlights the importance of evaluating a control group. We conclude that a
third-dose booster Covid-19 vaccine should be considered, in conjunction with regulatory approval, for transplant recipients who have received two doses
of mRNA-1273.
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MMWR recap: Reduced risk of reinfection of COVID-19 after vaccination
CDC recently published an article first distributed as an MMWR Early Release:
- Reduced Risk of Reinfection with SARS-CoV-2 after COVID-19 Vaccination—Kentucky, May–June 2021 (MMWR,
August 13,
HTML format or PDF format)
Related Link
- MMWR gateway page provides access to MMWR Weekly and its companion publications
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“Pediatric Immunization Schedule: Best
Available Evidence for 2021” published in Clinical Advisor
In the August 9 issue, Clinical Advisor published
Pediatric
Immunization Schedule: Best Available Evidence for 2021, authored by IAC’s Mary Beth Koslap-Petraco, DNP. A portion of the article appears
below.
Routine pediatric immunization rates decreased in 2020–2021 due to the COVID-19 pandemic, making it even more important for nurse
practitioners (NP) and PAs to use the best available evidence to catch up on vaccines for children and keep them on track to receive all medically- and
age-appropriate vaccines....
All vaccines due or overdue should be administered according to the recommended ACIP schedules during that visit unless a specific contraindication
exists. Identify children who have missed well-child visits and/or recommended vaccinations and contact parents to schedule in-person appointments,
starting with newborns, infants, and children up to 24 months, young children, and extending through adolescence.
If vaccines for pregnant people (tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis [Tdap] and influenza) have been delayed
because of reduced or deferred in-person prenatal care visits, schedule patients for follow-up and administer vaccinations during the next in-person
appointment. Provide protection as soon as possible. Giving vaccines during regularly scheduled follow-up visits will reduce the number of health care
visits needed to complete vaccination.
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“Evaluation of mRNA-1273 SARS-CoV-2
Vaccine in Adolescents” published in NEJM
In the August 9 issue, NEJM published
Evaluation of mRNA-1273 SARS-CoV-2 Vaccine in Adolescents. The discussion section of the abstract
appears below.
The mRNA-1273 vaccine had an acceptable safety profile in adolescents. The immune response was similar to that in young adults, and the vaccine
was efficacious in preventing Covid-19.
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Global News
“The CAPACITI Decision-Support Tool for National Immunization Programs” published in Value in
Health
In the August issue, Value in Health published The CAPACITI Decision-Support Tool for National Immunization
Programs. IAC’s Kelly L. Moore, MD, MPH, is one of the coauthors.
This tool was developed by the World Health Organization in collaboration with national immunization program decision makers in low-income and middle-
income countries (LMICs) to structure and document an evidence-based, context-specific process for prioritizing or selecting among multiple vaccination
products, services, or strategies. This is important as programs vie for limited resources and national immunization programs are forced to make choices
that are best suited to their setting. The authors report:
Pilot countries valued the CAPACITI decision-support tool as a means to consider multiple criteria and stakeholder
perspectives and to evaluate trade-offs and the impact of data quality. With use, it is expected that LMICs will tailor steps to their context and streamline
the tool for decision making.
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Immunization PSAs from the Archive
In this upbeat 2003 PSA from Texas Department of Health, a doctor and mother explains why she recommends
vaccinations for her own children and patients
In this upbeat 2003 public service announcement (PSA) offered by the Texas Department of Health in both English and Spanish, a family
physician explains that the risks of not vaccinating far outweigh the small chance of a bad reaction from a vaccination. This PSA is part of a collection
curated by vaccine expert William L. Atkinson, MD, MPH, that spans a period of more than 50 years.
Previous PSAs featured in "Immunization PSAs from the Archive” are available when viewing this Vimeo video.
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