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Issue 1,563:
April 28, 2021
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| Top Stories |
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Featured Resources
Journal Articles and Newsletters
Education and Training
Immunization PSAs from the Archive
Top Stories
CDC and FDA adopt ACIP
recommendation to lift pause on Janssen COVID-19 Vaccine (Johnson & Johnson); CDC updates clinical
guidance
The Advisory Committee
on Immunization Practices (ACIP) met on
April 23 to review information on the safety of Janssen
COVID-19 Vaccine (Johnson & Johnson). Following this review, the Committee voted to recommend lifting the 10-day pause on administration of the
Janssen vaccine. Less than 2 hours later, CDC and FDA adopted the recommendation.
As reported in
IAC Express #1,561, the vaccination pause was called by FDA and CDC on April 13 due to reports of six women who
developed a rare and severe type of blood clot (cerebral venous sinus thrombosis [CVST]) occurring in combination with low levels of platelets
(thrombocytopenia) after receiving the Janssen vaccine. At its April 14 meeting, ACIP members requested the pause be extended while additional safety
data was collected and analyzed.
At the April 23 review, CDC reported on a total of 15 confirmed cases (including the previously reported 6 cases) of thrombosis with thrombocytopenia
syndrome (TTS) diagnosed typically 1–2 weeks after vaccination among the 7 million individuals vaccinated with Janssen vaccine in the U.S before
the pause. All 15 patients were women: thirteen were age 18–49 years and 2 were age 50–64 years. The incidence of TTS among Janssen
vaccine recipients was 7 cases per million vaccinated women age 18–49 years and less than 1 per million vaccinated women age 50 years and
older. No apparent links with typical risk factors for thrombosis (e.g., obesity, oral contraceptive use) were observed.
ACIP also evaluated the benefits of the Janssen vaccine, including its high level of protection against circulating COVID-19 variants and the logistical
advantages of a single-dose vaccine stored at routine refrigerated temperatures. In particular, ACIP reviewed models indicating that, in the context of
current rates of COVID-19 infection in the U.S., continued use of the Janssen vaccine could result in 26–45 cases of TTS in people age 18 and
older, while preventing up to 1,400 deaths and 3,500 ICU admissions from COVID-19.
Following extensive discussion, ACIP voted to reaffirm its original recommendation: “The Janssen COVID-19 vaccine is recommended for persons
18 years of age and older in the U.S. population under the FDA’s Emergency Use Authorization [EUA].” The vote was ten in favor, four
opposed, and one abstention. A minority view held that the ACIP recommendation should specifically include the need to inform women under 50 years of
age about the risk of TTS and the option to choose a different COVID-19 vaccine without that risk. The majority believed inclusion of information in the
EUA Fact Sheets provided to
vaccination providers and
recipients and caregivers, plus CDC clinical guidance and patient education materials, would be sufficient.
ACIP members emphasized the importance of education for medical providers and the general public about TTS in association with Janssen COVID-19 Vaccine. On Tuesday, April 27, CDC issued a MMWR titled Updated Recommendations from the Advisory Committee on Immunization Practices for Use of the Janssen (Johnson & Johnson) COVID-19 Vaccine After Reports of Thrombosis with Thrombocytopenia Syndrome Among Vaccine Recipients—United States, April 2021, and updated its webpage on Interim Clinical Considerations for Use of COVID-19 Vaccines Currently Authorized in the U.S., including a summary document. On the same day, CDC held a Clinician Outreach and Communication (COCA) clinician update teleconference. Appropriate materials also have been updated on the CDC’s Janssen COVID-19 Vaccine (Johnson & Johnson) product page.
TTS has not been reported following administration of more than 190 million doses of the mRNA-based Pfizer-BioNTech and Moderna vaccines. The
underlying cause of TTS syndrome remains under investigation, having been associated with both Oxford/AstraZeneca and Janssen adenovirus-vector
vaccines. Healthcare providers (HCPs) are urged to maintain a high index of suspicion for TTS symptoms, including severe headache, backache, new
neurologic symptoms, severe abdominal pain, shortness of breath, leg swelling, petechiae (tiny red spots on the skin), or new and easy bruising, with
typical onset 1–2 weeks post-vaccination. TTS symptoms appear later than the common vaccine side effects (e.g., headache) that typically occur
1–3 days after vaccination and resolve spontaneously. Suspected TTS should not be treated with heparin. The American Society of
Hematology has published considerations relevant to the diagnosis and treatment of TTS following the
Janssen COVID-19 Vaccine. Possible cases of TTS should be reported immediately to the Vaccine Adverse Events Reporting System.
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“Postvaccination SARS-CoV-2 Infections among Skilled Nursing Facility Residents and Staff
Members—Chicago, Illinois, December 2020–March 2021” published in MMWR
CDC published Postvaccination SARS-CoV-2 Infections among Skilled Nursing Facility Residents and Staff
Members—Chicago, Illinois, December 2020–March 2021 in MMWR on April 21. Portions of the summary
appear below.
...Twenty-two possible breakthrough SARS-CoV-2 infections occurred among fully vaccinated persons ≥14 days after their second dose of
COVID-19 vaccine. Two thirds of persons were asymptomatic. A minority of persons with breakthrough infection experienced mild to moderate COVID-
19–like symptoms; two COVID-19–related hospitalizations and one death occurred. No facility-associated secondary transmission was
identified.…
The results in this report highlight the importance of COVID-19 vaccination in high-risk congregate settings such as SNFs; most fully vaccinated persons
were not infected, did not have COVID-19–like symptoms, and did not have severe illness.…
[Skilled nursing facilities] (SNFs) should prioritize vaccination and follow recommended COVID-19 infection prevention and control practices,
including following work restrictions, isolation, quarantine, testing of residents and staff members, and use of personal protective equipment.
Access the MMWR article in HTML format or in PDF format.
Related Link
- MMWR's
gateway page provides access to MMWR Weekly, MMWR Recommendations and Reports, MMWR
Surveillance Summaries, and MMWR Supplements
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“COVID-19 Outbreak Associated
with a SARS-CoV-2 R.1 Lineage Variant in a Skilled Nursing Facility after Vaccination Program—Kentucky, March 2021” published in
MMWR
CDC published COVID-19 Outbreak Associated with a SARS-CoV-2 R.1 Lineage Variant in a Skilled Nursing Facility after
Vaccination Program—Kentucky, March 2021 in MMWR on April 21. Despite exposure to a variant, vaccinated skilled
nursing facility residents and workers were much less likely to have symptomatic COVID-19 infection. Portions of the summary appear below.
...In a COVID-19 outbreak at a Kentucky [skilled nursing facility] SNF involving a newly introduced variant to the region, unvaccinated residents and
health care personnel (HCP) had 3.0 and 4.1 times the risk of infection as did vaccinated residents and HCP. Vaccine was 86.5% protective against
symptomatic illness among residents and 87.1% protective among HCP.
Vaccination of SNF residents and HCP is essential to reduce the risk for symptomatic COVID-19, as is continued focus on infection prevention and
control practices.
Access the MMWR article in HTML format or in PDF format.
Related Link
- MMWR's
gateway page provides access to MMWR Weekly, MMWR Recommendations and Reports, MMWR Surveillance
Summaries, and MMWR Supplements
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Institute for Safe Medication Practices publishes
Medication Safety Alert outlining frequently reported COVID-19 vaccination errors
The Institute for Safe Medication Practices has published a report titled,
Any New
Process Poses a Risk for Errors: Learning from 4 Months of COVID-19 Vaccinations in the April 22 issue of Medication Safety Alert.
ISMP categorizes more than 160 error reports as follows:
- General errors: Wrong dose (20% of reports), wrong age (17%), wrong technique (8%), wasted vaccine (5%), incorrect storage and
handling (4%), contraindicated coadministration (2%)
- Errors specific to mRNA vaccines: Mixed vaccine series (11%), wrong time interval (9%)
- Dilution errors specific to Pfizer-BioNTech vaccine: Wrong volume of diluent (11%), no diluent (3%), wrong diluent (3%)
- Errors specific to Janssen (J&J) vaccine: Two-dose record card shipped with single-dose vaccine (1%)
Graphic appearing in referenced Institute for Safe Medication Practice report.
ISMP offers specific safe-practice recommendations in these categories:
- Staff competency verification
- Patient scheduling and check-in processes
- Product preparation
- Dose administration
- Response to error recognition
Access the full article and use their safe-practice recommendations for staff training: Any New Process Poses a Risk for Errors: Learning from 4 Months of COVID-19 Vaccinations.
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New! Order IAC’s “I Got My COVID-19 Vaccine” buttons and
stickers
IAC now offers “I Got My COVID-19 Vaccine” buttons and stickers for purchase. Place them on lab coats, uniforms, jackets,
lanyards, ID badges, or backpacks to show your confidence in COVID-19 vaccination.
Buttons: Wear them to reassure your patients and remind those around you to protect themselves from COVID-19.
 
Stickers: Give away to COVID-19 vaccine recipients or vaccinated clinic staff!
- Description: Bright yellow stickers on a roll with an easy-peel-off back and perforations between stickers to make them easy to tear off and
share
- Packaging: Roll of 200 stickers
- Dimension: 1.5" across
- To order: See Shop IAC: COVID-19 Vaccine Buttons and Stickers for quantity and pricing options
Please note: Through a separate program supported by CDC, public health departments and selected CDC nonprofit Vaccinate with Confidence campaign partners have been notified about how to receive limited supplies of these items at no cost.
For questions, call 651-647-9009 or email
admininfo@immunize.org.
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60 U.S. hospitals team up to promote COVID-19 vaccination in “Get the
Vaccine to Save Lives” campaign
A campaign led by Cleveland Clinic and Mayo Clinic, with support from 60 top hospitals and health care institutions, will encourage adults to get
vaccinated against COVID-19. The Get the Vaccine to Save Lives campaign is designed to reassure the public that vaccines are safe, effective, and necessary to
achieve herd immunity and return to normal activities. A paragraph from the press release appears below.
The campaign hopes to reach adults who are hesitant to receive a vaccine, including racial and minority ethnic groups and people living in rural
communities. According to a Kaiser Family Foundation survey published March 30, 17% of the public say they will take a wait-and-see approach before
getting it themselves, and another 20% say they will never get a vaccine or will only get it if required to do so for work, school or other activities. This
leaves a significant portion of the population at risk of going unvaccinated.
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It’s National Infant Immunization Week! Use CDC's 2021 digital media
toolkit to spread the word.
National Infant Immunization Week (NIIW), April 24–May 1, highlights the importance of protecting infants from vaccine-
preventable diseases and celebrates the achievements of immunization partners. This year, because of the pandemic, it’s critical to ensure that
families stay on track for their children’s routine checkups.
Since 1994, hundreds of U.S. communities have joined together during NIIW to celebrate the critical role vaccination plays in protecting our children,
communities, and public health. Giving babies and toddlers the recommended vaccinations by age two is the best way to protect them from 14 serious
childhood diseases.
Save time by using CDC's 2021 NIIW Digital Media Toolkit to plan and implement your organization's
NIIW activities. The toolkit includes updated logos, sample social media content, social graphics, and key messages. Please share them, using the
hashtag #ivax2protect.
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The Vaccine Makers Project of the Vaccine Education Center at CHOP invites essays from students in grades 6
through 12 for 2021 Dr. Maurice Hilleman essay contest
The Vaccine Makers
Project, the classroom-based program of the Vaccine Education Center (VEC) at Children's Hospital of Philadelphia, is currently inviting essays
for the 2021 Maurice R. Hilleman Essay Contest. Students in grades 6 through 12 are encouraged to learn about Dr. Hilleman’s life and
accomplishments and submit a 500- to 600-word essay that answers the question, “How do Dr. Hilleman’s accomplishments demonstrate the
importance of creativity in science?” Entries will be accepted through June 4, 2021.
Details and entry form are available at HillemanFilm.com/contest. Three winners will each receive $1,000, a certificate, a VEC prize bag, and recognition at a virtual award event
this fall. Please feel free to share this information with eligible students or with teachers who might be interested in sharing with their students.
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Voices for Vaccines releases new podcast with
Chelsea Clinton to talk about her work on global health and immunization issues
Voices for Vaccines (VFV) has posted a new entry in its Vax Talk podcast series: It’s
Chelsea Clinton! A description from their web page appears below.
Chelsea Clinton comes from a background of public service, so why is she working so hard on global health right now? And why is she willing to
take a stand for vaccines?
Voices for Vaccines is a national organization of parents and others who are dedicated to raising the level of the voices of immunization supporters.
VFV invites everyone who values vaccines to become a member, use VFV tools in their own community, and sign up for
VFV’s free newsletter. Please spread the word to your friends and colleagues to join VFV!
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Ready to ship! Order IAC’s laminated
versions of CDC’s 2021 immunization schedules today!
IAC's laminated versions of the 2021 U.S. child/adolescent immunization schedule and the 2021 U.S. adult immunization schedule are available for order.
These schedules are ideal for use in any busy healthcare setting where vaccinations are given. Their tough coating can be wiped down, and
they’re durable enough to stand up to a year's worth of use.
The child/adolescent schedule is eight pages (i.e., four double-sided pages) and the adult schedule is six pages (i.e., three double-sided pages), but both
schedules fold down to a convenient 8.5" x 11" size.
 
With color coding for easy reading, our laminated schedules replicate the original CDC formatting, including the essential tables and notes.
PRICING
1–4 copies: $7.50 each
5–19 copies: $5.50 each
20–99 copies: $4.50 each
100–499 copies: $4.00 each
500–999 copies: $3.50 each
For quotes on customizing or placing orders of 1,000 copies or more, call 651-647-9009 or email admininfo@immunize.org.
Visit the Shop IAC: Laminated Schedules web page for more information on the schedules, to view images of all the pages, and to download
the order form today!
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IAC Spotlight! IAC's "Mandates and Exemptions" gateway
page compiles information about state mandates on immunization and vaccine-preventable diseases
IAC's Mandates
and Exemptions gateway page contains links to state-specific situations in three ways, accessed from the upper left corner:
- Vaccine-
Specific Requirements leads to “State Laws and Mandates by Vaccine,” which links to 15 subordinate pages with details by age
and vaccine type
- Exemptions by State, linking to discussions of the rationale for requirements and policy statements from medical organizations endorsing
these requirements and describing the risks of personal belief and non-medical exemptions
- State Immunization Websites, linking to websites for 50 states and the District of Columbia.
You can locate this content via State Laws and Mandates within the Favorites tab in the blue bar across the top of any immunize.org web page.
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IAC experts called on by news media
With vaccines in the news so much lately, journalists have sought out IAC experts to communicate the intricacies of running a quality vaccination
program. Our insights have helped explain vaccines to the public and policy makers. We want to help them understand the complex work vaccinators do.
We've reached mass markets and local stations, across the U.S. and overseas, via print, radio, television, blogs, and more. Here is a selection of
our recent citations:
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Not-to-miss immunization articles in the news
These recent articles convey the potential risks of vaccine-preventable diseases and the importance of vaccination.
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Featured Resources
In
IAC’s “Video of the Week,” a wise grandmother convinces her family to get vaccinated against COVID-19
Vaccinated against COVID-19? Encourage friends
to follow your lead by adding IAC’s “I Got My COVID-19 Vaccine” Facebook profile photo frame!
Share your excitement about COVID-19 vaccination and inspire your friends! When you have received your COVID-19 vaccine, add IAC's new
"I Got My COVID-19 Vaccine" Facebook photo frame to liven up your profile picture!
You can obtain the frame in two ways:
Together we can end the COVID-19 pandemic!
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IAC's MenB Vaccination Honor Roll adds three
new colleges that protect their students
The Immunization Action Coalition (IAC) is pleased to announce that three new post-secondary institutions have been enrolled into its MenB Vaccination
Honor Roll for requiring or recommending meningococcal serogroup B vaccine for students.
The newly added institutions are listed below. Clicking on the institutions' names brings you to the place on the school's website that details their
vaccine requirements and recommendations.
Currently, there are 270 honorees, with 40 colleges and universities requiring MenB vaccination for their students and 230 recommending it.
IAC launched the MenB Vaccination Honor Roll to recognize exemplary institutions that have taken the lead in establishing policies requiring or recommending
meningococcal serogroup B (MenB) vaccination to protect their students.
Please help us to grow the honor roll by notifying us of colleges or universities that require or recommend MenB vaccination for their students. Colleges
and universities may apply for the honor roll or you can alert us at menB@immunize.org.
Please visit the MenB Vaccination Honor Roll web page to find resources such as news stories about meningitis B outbreaks, personal stories from families
affected by meningitis B, journal articles, and links to organizations that work to prevent meningitis.
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IAC's website Mass-
Vaccination-Resources.org can help you excel at mass vaccination clinics
The Immunization Action Coalition’s website www.Mass-Vaccination-Resources.org assists you in finding ideas for developing your
own mass vaccination clinics. Mass vaccination efforts will continue to be useful for expediting COVID-19 vaccination now, as well as other vaccinations in
the future.
Many of the documents were written in the pre-pandemic era and will need modification to ensure that additional protections, such as social distancing
and personal protective equipment, help safeguard against COVID-19 transmission.
In addition, IAC's archived, full-length webinar (1 h. 46 min.) highlighting best practices and offering practical information for conducting a
successful mass vaccination clinic, Mass Vaccination Clinics: Challenges and Best Practices, can be viewed on www.Mass-
Vaccination-Resources.org.
If you have a resource to suggest for the website, please send a message to info@mass-vaccination-resources.org.
The webinar and the new website are supported by a medical education grant from Seqirus.
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Use IAC's expanded
"Repository of Resources for Maintaining Immunization during the COVID-19 Pandemic" for catch-up initiatives
IAC now offers 287 items in its Repository of Resources for Maintaining Immunization during the COVID-19
Pandemic gateway page to assist in maintaining routine immunization rates during the COVID-19 pandemic. Located on the website of
the National
Network of Immunization Coalitions, a project of IAC, this repository includes links to both national and state-level policies and guidance; advocacy
materials, including talking points, webinars, press releases, articles, and social media posts; and telehealth resources.
If you have a resource to suggest for the repository, please send a message to info@immunizationcoalitions.org.
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Journal Articles and Newsletters
CHOP's Vaccine Education Center publishes April issue of Vaccine Update newsletter
The Vaccine Education Center (VEC) at Children's Hospital of Philadelphia (CHOP) publishes a
monthly immunization-focused newsletter titled Vaccine Update. The April issue includes the
following articles:
Additional resources, including information booklets for patients, are available in the full newsletter.
Access the sign-up form to subscribe to Vaccine Update.
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“Effectiveness of Influenza
Vaccination in Preventing Hospitalisation Due to Influenza in Children: A Systematic Review and Meta-Analysis” published in Clinical
Infectious Diseases
In the March 27 issue, Clinical Infectious Diseases published Effectiveness of Influenza Vaccination in Preventing Hospitalisation Due to Influenza in Children: A Systematic Review and Meta-Analysis. A
portion of the abstract appears below.
This systematic review assesses the literature for estimates of influenza vaccine effectiveness (IVE) against laboratory-confirmed influenza-
associated hospitalisation in children....
...A random-effects meta-analysis of 37 studies that used a test-negative design gave a pooled seasonal IVE against hospitalisation of 53.3% (47.2-58.8)
for any influenza. IVE was higher against influenza A/H1N1pdm09 (68.7%, 56.9-77.2) and lowest against influenza A/H3N2 (35.8%, 23.4-46.3). Estimates
by vaccine type ranged from 44.3% (30.1-55.7) for LAIV to 68.9% (53.6-79.2) for inactivated vaccines. IVE estimates were higher in seasons when the
circulating influenza strains were antigenically matched to vaccine strains (59.3%, 48.3-68.0).
Influenza vaccination gives moderate overall protection against influenza-associated hospitalisation in children supporting annual vaccination. IVE varies
by influenza subtype and vaccine type.
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"Preliminary Findings of mRNA
COVID-19 Vaccine Safety in Pregnant Persons" published in New England Journal of Medicine
In the April 21 issue, the New England Journal of Medicine published Preliminary Findings of mRNA COVID-19 Vaccine Safety in Pregnant
Persons. Portions of the abstract sections appear below.
Methods
From December 14, 2020, to February 28, 2021, we used data from the “v-safe after vaccination health checker” surveillance system,
the v-safe pregnancy registry, and the Vaccine Adverse Event Reporting System (VAERS) to characterize the initial safety of mRNA Covid-19 vaccines in
pregnant persons.
Results
A total of 35,691 v-safe participants 16 to 54 years of age identified as pregnant. Injection-site pain was reported more frequently among pregnant
persons than among nonpregnant women, whereas headache, myalgia, chills, and fever were reported less frequently. Among 3958 participants enrolled
in the v-safe pregnancy registry, 827 had a completed pregnancy, of which 115 (13.9%) resulted in a pregnancy loss and 712 (86.1%) resulted in a live
birth (mostly among participants with vaccination in the third trimester). Adverse neonatal outcomes included preterm birth (in 9.4%) and small size for
gestational age (in 3.2%); no neonatal deaths were reported. Although not directly comparable, calculated proportions of adverse pregnancy and neonatal
outcomes in persons vaccinated against Covid-19 who had a completed pregnancy were similar to incidences reported in studies involving pregnant
women that were conducted before the Covid-19 pandemic. Among 221 pregnancy-related adverse events reported to the VAERS, the most frequently
reported event was spontaneous abortion (46 cases).
Conclusions
Preliminary findings did not show obvious safety signals among pregnant persons who received mRNA Covid-19 vaccines. However, more
longitudinal follow-up, including follow-up of large numbers of women vaccinated earlier in pregnancy, is necessary to inform maternal, pregnancy, and
infant outcomes.
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Education and Training
CDC offers webinar archive for clinicians titled “Johnson & Johnson/Janssen COVID-19 Vaccine and Thrombosis with
Thrombocytopenia Syndrome (TTS): Update for Clinicians”
National Academies of Sciences, Engineering, and Medicine host “COVID-19 Vaccines: Building Confidence
& Explaining Efficacy” webinar on May 4 at 3:00 p.m. (ET)
The National Academies of Sciences, Engineering, and Medicine will present a webinar titled COVID-19 Vaccines: Building Confidence & Explaining Efficacy on
May 4 from
3:00–4:00 p.m. (ET). The webinar will cover public engagement and communications strategies public officials can use to
promote vaccination, build vaccine confidence, and overcome confusing messages about vaccine efficacy.
Register for the webinar.
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Indiana Immunization Coalition hosts
“COVID-19 Vaccines: Considerations in Practice” webinar featuring Dr. Samina Bhumbra on May 20 at 3:00 p.m. (ET); CE
available
The Indiana Immunization Coalition will host a webinar titled COVID-19 Vaccines: Considerations in Practice from 3:00–4:00 p.m. (ET) on May 20. This presentation will
identify the various COVID-19 vaccine options and present current guidance for providers related to vaccine components, mechanisms of action,
and considerations for administration in various age groups. The presenter is Samina Bhumbra, MD. Dr. Bhumbra is an assistant professor
of clinical pediatrics at the Indiana University School of Medicine. CME, CNE, and CPE will be offered.
Register for the webinar.
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Immunization PSAs from the Archive
In this somber PSA from 1999 by the Pennsylvania Department of Health, vaccine-preventable diseases are
contrasted with extinct animals
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