Issue 1,541: December 23, 2020
Top Stories
Featured Resources
Journal Articles and Newsletters
On the Lighter Side
Top Stories
Happy holidays from all of us at IAC! We'll be back on January 6, 2021
All of us at the Immunization Action Coalition (IAC) wish you, our readers, a safe, happy, and healthy remainder of the holiday season. We do not plan to publish another issue of IAC Express until January 6, 2021. But we will stay alert in these turbulent times and will publish a special edition, if warranted.
The IAC office will be closed on December 24 and 25, as well as January 1.
Happy holidays!
Group photo taken pre-pandemic in February 2020.
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FDA issues EUA for Moderna mRNA vaccine after advisory committee vote; fact sheets published
On December 18, the Food and Drug Administration (FDA) issued the second Emergency Use Authorization (EUA) for a vaccine to help prevent COVID-19 caused by SARS-CoV-2 virus in people 18 years of age and older. The EUA allows the Moderna COVID-19 vaccine (also known as mRNA-1273) to be distributed in the United States.
FDA’s action aligns with the unanimous recommendation of its Vaccines and Related Biological Products Advisory Committee (VRBPAC), which determined on December 17 that the totality of scientific evidence available to date indicates that the benefits of vaccination with the Moderna COVID-19 vaccine outweigh the risks for use in people 18 years or older.
Below appear links to technical and supportive documents related to Moderna’s vaccine and the EUA. Most relevant to vaccinators are the Fact Sheet for Potential Recipients and Caregivers and the Fact Sheet for Vaccination Providers. That second 22-page document contains 7 pages of EUA information plus 15 pages of the product’s prescribing information.
Related Links
ACIP recommends second COVID-19 vaccine for use in U.S.; IAC summarizes December 19 meeting and highlights clinical considerations for use of mRNA vaccines
On December 19, the Advisory Committee on Immunization Practices (ACIP) voted to recommend the use of the Moderna COVID-19 vaccine for persons 18 years of age and older in the United States. This vote followed issuance of the FDA’s Emergency Use Authorization (EUA) for the vaccine on December 18 (see story above).
The ACIP recommendations and additional guidance for the vaccine’s use became official when they were adopted by CDC and published as ACIP’s Interim Recommendation for Use of Moderna COVID-19 Vaccine—U.S, December 2020 in the Morbidity and Mortality Weekly Report (MMWR) Early Release issued on December 20.
Prior to the vote, ACIP received an overview of the mRNA-1273 vaccine from Moderna representatives. The Committee also reviewed its Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) approach and assessed available vaccine information using its Evidence to Recommendation (EtR) framework.
ACIP also received an update on anaphylaxis incidents following receipt of the Pfizer-BioNTech mRNA vaccine in the United Kingdom and the United States. All cases occurred within several minutes and were promptly treated. The prescribing information for both the Pfizer-BioNTech and Moderna COVID-19 vaccines states that a severe allergic reaction (e.g., anaphylaxis) to any component of the vaccine is a contraindication to vaccination. While these anaphylactic occurrences have been rare, all vaccination sites should be prepared to respond appropriately. CDC has posted Interim Considerations: Preparing for the Potential Management of Anaphylaxis at COVID-19 Vaccination Sites to assist facilities in being prepared to recognize, respond, and report anaphylaxis. The guidance recommends that persons with a history of anaphylaxis (due to any cause) be observed for 30 minutes following vaccination. The recommended observation period for other persons is 15 minutes. Vaccination sites should prioritize the training of staff to recognize the early signs of anaphylaxis. Clinic personnel may refer to the CDC guidance for details about preparation for, assessment, and management of anaphylaxis.
CDC has posted Interim Clinical Considerations for Use of mRNA COVID-19 Vaccines Currently Authorized in the United States. Because the Pfizer-BioNTech and Moderna COVID-19 vaccines are both based on a mRNA platform, the clinical considerations for both vaccines are similar and have been incorporated on a single web page. Where appropriate, the page also notes the differences in the clinical considerations for the two vaccines. Consult the full web page for important details in vaccine administration with either vaccine. The key differences between the two products are highlighted below.
- Authorized age groups (under the Emergency Use Authorizations [EUAs])
- Pfizer-BioNTech: ages 16 years and older
- Moderna: ages 18 years and older
- Administration: The mRNA COVID-19 vaccine series consists of two doses administered intramuscularly:
- Pfizer-BioNTech (30 µg, 0.3 ml): three weeks (21 days) apart*
- Moderna (100 µg, 0.5 ml): one month (28 days) apart*
*Second doses administered within a grace period of no more than 4 days from the recommended date for the second dose are considered valid. However, doses administered earlier do not need to be repeated. The second dose should be administered as close to the recommended interval as possible. However, there is no maximum interval between the first and second dose for either vaccine. Do not restart the vaccination series.
- Interchangeability of COVID-19 vaccine products: ACIP did not state a preference for use of either mRNA vaccine. But the vaccines are NOT interchangeable, and care should be taken to ensure the same vaccine is used for both doses. However, if different mRNA vaccines are inadvertently administered, no additional doses of either vaccine are recommended at this time.
CDC is updating the COVID-19 information on its web pages frequently, with several key resources listed below.
Related Links
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ACIP provides interim recommendation for people who will be in Phases 1b and 1c of COVID-19 vaccination priority groups in the United States
During its meeting on December 20, the Advisory Committee on Immunization Practices (ACIP) approved a recommendation designating persons to include in Phases 1b and 1c of COVID-19 vaccination efforts during times of limited vaccine availability. This decision was an update to ACIP’s previous recommendation to include healthcare workers and residents of long-term care facilities in Phase 1a.
Specifically, the interim recommendation includes the following populations:
- Phase 1b: persons age 75 years and older and frontline essential workers*
- Phase 1c: persons age 65–74 years, persons age 16–64 years with high-risk medical conditions, and other essential workers*
* “Frontline essential workers” include workers who are in sectors essential to the functioning of society and who are at substantially higher risk for exposure to SARS-CoV-2 virus. Occupations in this group include first responders (e.g., firefighters, police), education staff (e.g., teachers, support staff, daycare), and persons working in food and agriculture, manufacturing, corrections, the U.S. Postal Service, and grocery stores.
In considering the age groups to include in each phase, ACIP noted that persons age 75 years and older comprise 8% of the U.S. population, but account for 25% of the country’s COVID-19 deaths.
In making these recommendations, ACIP members emphasized their efforts to balance the goals of preventing morbidity and mortality due to SARS-CoV-2 infection with the goal of preserving societal function. In addition, the group wished to provide a framework for decisions while allowing flexibility for state and local governments to prioritize their vaccine allocations based on priorities that might vary based on local circumstances.
At the outset of the meeting, Nancy Messonnier, MD, director of the National Center for Immunization and Respiratory Diseases, CDC, put the deliberations in context by noting that current projections suggest vaccine would be available to vaccinate 20 million people in December, another 30 million in January, and another 50 million in February. Although CDC and ACIP strongly support all persons in the U.S. being vaccinated, it is recognized that prioritization will be necessary until vaccine supplies are ample.
Read the The Advisory Committee on Immunization Practices’ Updated Interim Recommendation for Allocation of COVID-19 Vaccine—United States, December 2020.
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CDC updates web pages featuring practical materials for administration, storage, and handling of each authorized COVID-19 vaccine
CDC has refreshed its gateway pages leading to multiple practical web pages for each of the COVID-19 vaccines authorized for distribution in the United States. From the CDC’s COVID-19 Vaccination gateway page, viewers can seek information for either the Pfizer-BioNTech COVID-19 vaccine or the Moderna COVID-19 vaccine.
The following resources pertain to both mRNA vaccines:
Pfizer-BioNTech COVID-19 Vaccine Resources
Scrolling down the Pfizer-BioNTech COVID-19 Vaccine gateway page, one finds information within the page plus links to useful PDF documents:
- Administration Overview: how to thaw, prepare, dilute, and administer, plus standing orders and a screening form for contraindications and precautions
- Storage and Handling Overview: summary, beyond-use dating and labels, a delivery checklist, storage and handling labels, expiration date tracking tool, ultra-cold storage logger (Fahrenheit or Celsius), and dry ice safety
- CDC’s Pfizer-BioNTech COVID-19 Vaccine FAQs
Moderna COVID-19 Vaccine Resources
Scrolling down the Moderna COVID-19 vaccine gateway page, one finds similar information and useful PDF documents:
Related Links:
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MMWR Recap: CDC publishes recommendations for COVID-19 vaccines and phased allocation: Moderna’s vaccine in December 20 Early Release and Pfizer-BioNTech’s vaccine on December 18
CDC recently published several articles about specific COVID-19 vaccines, phased allocation, and ethical principles. Here is a recap:
- ACIP recommendations for Moderna COVID-19 vaccine (MMWR Early Release, December 20, HTML format or PDF format); anticipated for December 25 issue
- ACIP priorities for allocating subsequent supplies of COVID-19 vaccines, Phases 1b and 1c (MMWR Early Release, December 22, HTML format or PDF format); anticipated for December 25 issue
- ACIP recommendations for Pfizer-BioNTech COVID-19 vaccine (MMWR, December 18, HTML format or PDF format)
- ACIP priorities for allocating initial supplies of COVID-19 vaccines, Phase 1a (MMWR, December 11, HTML format or PDF format)
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CDC adds many more ready-to-use materials to its COVID-19 Vaccination Communication Toolkit for Medical Centers, Clinics, and Clinicians
CDC has released ready-to-use materials to help earn confidence about COVID-19 vaccination. CDC’s COVID-19 Vaccination Communication Toolkit for Medical Centers, Clinics, and Clinicians includes:
- A guide for building vaccine confidence within health systems, medical offices, and clinics
- Communications and Confidence Readiness Checklist
- COVID-19 Vaccine Confidence Conversation Starter
- Turn-key slide decks for immunization coordinators, the healthcare team, and other healthcare personnel with information about COVID-19 vaccines, tips for building vaccine confidence, and tips for having effective vaccine conversations with patients
- Posters to download, print, and hang in your health facility
- Fact sheets and FAQs
- Social media sample messages
- Printable buttons/stickers for staff to wear after vaccination
- A video describing how ACIP makes recommendations and advises CDC on the use of vaccines in our country
View CDC’s COVID-19 Vaccination Communication Toolkit for Medical Centers, Clinics, and Clinicians today!
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Becker's Hospital Review publishes "Influenza Vaccination Remains a Priority Even as We Begin Rolling Out a COVID-19 Vaccination Program" by IAC authors—find it on IAC’s mass-vaccination-resources.org website
On December 9, Becker's Hospital Review published Influenza Vaccination Remains a Priority Even as We Begin Rolling Out a COVID-19 Vaccination Program, written by IAC's Drs. Carolyn Bridges and L.J Tan. A portion of the article is reprinted below.
...The risk of influenza disease is still present, and we must continue to seek innovative ways to provide convenient and safe access to influenza vaccination. This includes the use of drive-through influenza vaccination clinics, curbside clinics, parking lot clinics, and other similar interventions. Best practices for implementing mass immunization clinics are documented on the Immunization Action Coalition’s new website “Resources for Developing Mass Vaccination Clinics.” Efforts in innovating new and broad access points for influenza vaccination will serve to prepare us for the large-scale roll out of COVID-19 vaccine in phase 2 of the United States’ COVID-19 vaccination program.
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Voices for Vaccines releases new podcast, "Dr. Offit Talks COVID-19 Vaccines," with answers to common COVID-19 questions
Voices for Vaccines (VFV) has posted a new entry in its Vax Talk podcast series: Dr. Offit Talks COVID-19 Vaccines. A description from their web page is reprinted below.
Everyone we know has said, “If Paul Offit says it’s safe to get the vaccine, I will get it.” So, we had him on our podcast and asked him that and so much more.
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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HRSA announces competition, with up to 70 cash prizes totaling $1 million, to address declining vaccination coverage and well-child visits
The Maternal and Child Health Bureau (MCHB) of the Health Resources & Services Administration (HRSA) launched the Promoting Pediatric Primary Prevention (P4) Challenge competition to respond to declining rates of childhood vaccination coverage and well-child visits due to the COVID-19 pandemic. CDC data show that these declines may leave young children and communities vulnerable to vaccine-preventable diseases such as measles.
The P4 Challenge will award a total of $1 million in prizes for innovative approaches to increase access to and utilization of well-child visits and/or vaccination services within primary care settings. Partnerships with state and local organizations are encouraged. Submissions must include a primary care provider who delivers health services to children.
MCHB expects to select up to 50 Phase 1 winners and up to 20 Phase 2 winners. Proposals may be submitted between January 19 and March 15, 2021. Visit the P4 Challenge website for more information.
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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 helped explain vaccines to the public and policy makers. We want to help everyone 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,” the Alliance for Aging Research acknowledges pandemic stress and the importance of getting vaccinated against COVID-19
In this 1-minute video, the Alliance for Aging Research shares how stressful this pandemic has been for all of us. When a vaccine becomes available, it will be important that we get vaccinated. Our Best Shot—Vaccine PSA reminds viewers that, in the meantime, it is important for everyone to stay up to date on all vaccines, including flu and, for some people, pneumonia vaccines as well.
Visit the VOTW archive.
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Journal Articles and Newsletters
CHOP's Vaccine Education Center publishes December 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 December 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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Watch this vintage PSA about IAC Express from 2006, created by CDC and aired many times on CDC’s “Immunization Update” satellite broadcasts
Take a nostalgic look back at IAC Express in this 14-year-old public service announcement (PSA) produced for CDC’s “Immunization Update” satellite broadcasts by vaccine expert William L. Atkinson, MD, MPH, and CDC’s audio/visual team. The PSA aired many times in those years— some of you may remember it. This is part of a PSA collection curated by Dr. Atkinson.
Previous PSAs featured in “On the Lighter Side” are available when viewing this Vimeo video.
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Video of the Week
Our Best Shot—Vaccine PSA: In this 1-minute video, the Alliance for Aging Research shares how stressful this pandemic has been for all of us. When a vaccine becomes available, it will be important that we get vaccinated. This PSA reminds us that in the meantime, it is important for everyone to stay up to date on all vaccines, including flu and, if you are older, pneumonia vaccines as well.
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Technically Speaking
Read Dr. Wexler's column for the Vaccine Education Center's monthly newsletter, Vaccine Update
Vaccinating Adults:
A Step-by-Step Guide
Calendar of Events
Conferences, meetings, and training opportunities
Patient Record Cards
Record cards for patients -- child & teen, adult, and lifetime -- are printed on durable paper and sized to fit in a wallet when folded
DVD: Immunization Techniques
Every practice should have this award winning, "how-to" training video
Protect Newborns Guidebook
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