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IZ Express #1,643: “Vaccines: COVID-19” page updated with new CDC and FDA resources for vaccination of young children, and more
| From | Immunize.org <[email protected]> |
| Subject | IZ Express #1,643: “Vaccines: COVID-19” page updated with new CDC and FDA resources for vaccination of young children, and more |
| Date | July 20, 2022 11:15 AM |
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Issue 1,643: July 20, 2022
Top Stories
* Immunize.org’s “Vaccines: COVID-19” main page updated to include the latest CDC and FDA resources for use of both mRNA vaccines in children age 6 months through 17 years
* WHO and UNICEF report global vaccination coverage continued to decline in 2021, with 25 million infants missing out on lifesaving vaccines
* FDA issues EUA for Novavax COVID-19 Vaccine as a primary series; ACIP convened to review and vote on July 19
* Immunize.org posts ten new translations of four Vaccine Information Statements (VISs) updated in August 2021
* FDA expands licensure of Comirnaty (Pfizer-BioNTech) vaccine for adolescents age 12 through 15 years as a two-dose primary series; vaccine recommendations remain unchanged
* Influenza Vaccination Honor Roll for mandatory healthcare worker vaccination now features 1,291 organizations
* Spotlight: Review of resources at Immunize.org focused on the history of vaccines
* Journalists interview Immunize.org experts
* Vaccines in the news
Immunize.org Pages and Handouts
* Immunize.org updates standing orders for administering human papillomavirus vaccine to children and teens
Featured Resources
* Experts offer vaccination resources for the ongoing monkeypox outbreak; CDC announces increased nationwide testing capacity
Notable Publications
* “Safety Monitoring of COVID-19 mRNA Vaccine First Booster Doses among Persons Aged ≥12 Years with Presumed Immunocompromise Status—United States, January 12, 2022–March 28, 2022” published in MMWR
* “How Ready Was the U.S. Vaccination Infrastructure and Network of Immunization Information Systems for COVID-19 Vaccination Campaigns: Recommendations to Strengthen the Routine Vaccination Program and Prepare for the Next Pandemic” published in Human Vaccines & Immunotherapeutics
* “Maternal Vaccination and Risk of Hospitalization for COVID-19 among Infants” published in New England Journal of Medicine
* “Evaluation of Acute Adverse Events after COVID-19 Vaccination during Pregnancy” published in New England Journal of Medicine
Upcoming Events
* CDC’s recorded webinars on principles of vaccination and general best practice guidelines, as well as other segments in “The Pink Book,” now rolling out weekly
Editorial Information
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Top Stories
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Immunize.org’s “Vaccines: COVID-19” main page updated to include the latest CDC and FDA resources for use of both mRNA vaccines in children age 6 months through 17 years
Immunize.org updated the comprehensive list of CDC and FDA resources found on its Vaccines: COVID-19 ([link removed]) main page. The revised list now incorporates information on recently authorized formulations of mRNA vaccines for children age 6 months through 4 years (Pfizer-BioNTech) or 5 years (Moderna), and the use of Moderna vaccines for children and teens age 6 through 17 years. The new resources from CDC and FDA include fact sheets, clinical considerations, vaccine administration tools, and storage and handling guidance. This page also includes a link to Immunize.org’s regularly updated print-ready checklist for current versions of U.S. COVID-19 vaccination guidance and clinic support tools ([link removed]).
Be sure to bookmark this page for quick access to links to key COVID-19 vaccine resource pages from Immunize.org, CDC, and other partners. As guidelines for COVID-19 vaccines are updated and new CDC materials are released, the page will continue to be updated.
------------------------------------------------------------
WHO and UNICEF report global vaccination coverage continued to decline in 2021, with 25 million infants missing out on lifesaving vaccines
On July 15, WHO and UNICEF issued a joint press release titled COVID-19 Pandemic Fuels Largest Continued Backslide in Vaccinations in Three Decades ([link removed]), sounding the alarm regarding the largest sustained decline in childhood vaccinations since 2008. A portion of the press release appears below.
The percentage of children who received three doses of the vaccine against diphtheria, tetanus and pertussis (DTP3) – a marker for immunization coverage within and across countries – fell 5 percentage points between 2019 and 2021 to 81 per cent.
As a result, 25 million children missed out on one or more doses of DTP through routine immunization services in 2021 alone. This is 2 million more than those who missed out in 2020 and 6 million more than in 2019, highlighting the growing number of children at risk from devastating but preventable diseases...
“This is a red alert for child health. We are witnessing the largest sustained drop in childhood immunization in a generation. The consequences will be measured in lives,” said Catherine Russell, UNICEF Executive Director. “While a pandemic hangover was expected last year as a result of COVID-19 disruptions and lockdowns, what we are seeing now is a continued decline. COVID-19 is not an excuse. We need immunization catch-ups for the missing millions or we will inevitably witness more outbreaks, more sick children and greater pressure on already strained health systems.”
Related Links
* UNICEF: Immunization dataset overview ([link removed]) page including full datasets, data visualization, and county profiles
* WHO: Immunization Analysis and Insights dataset information ([link removed]) page including a global dashboard and full datasets
* WHO: Vaccines and Immunization social media ([link removed]) main page
* WHO: Immunization Coverage ([link removed]) fact sheet
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FDA issues EUA for Novavax COVID-19 Vaccine as a primary series; ACIP convened to review and vote on July 19
On July 13, the FDA issued an Emergency Use Authorization (EUA) ([link removed]) for the Novavax COVID-19 Vaccine, Adjuvanted ([link removed]) to help prevent disease caused by SARS-CoV-2 virus in people 18 years of age and older.
FDA’s action follows the unanimous recommendation of its Vaccines and Related Biological Products Advisory Committee ([link removed]) (VRBPAC), which determined on June 7 that the benefits of vaccination with the Novavax COVID-19 Vaccine outweigh any potential risks for use in people age 18 years or older.
The Advisory Committee on Immunization Practices (ACIP) convened on July 19 ([link removed]) to discuss and vote on the use of Novavax COVID-19 Vaccine in adults age 18 years and older. The results of the meeting were not available at press time and will be summarized in next week’s issue of IZ Express. Presentations and the agenda from the July 19 ACIP meeting are available on CDC's website ([link removed]).
Below, find links to technical and supportive documents related to this vaccine and the EUA. Most relevant to vaccinators are the Fact Sheet for Recipients and Caregivers ([link removed]) and the Fact Sheet for Healthcare Providers Administering Vaccine ([link removed]). The second 26-page document includes the product’s prescribing information.
Related Links
* Novavax COVID-19 Vaccine, Adjuvanted, EUA Fact Sheet for Recipients and Caregivers ([link removed]) (7 pages)
* Novavax COVID-19 Vaccine, Adjuvanted, EUA Fact Sheet for Healthcare Providers Administering Vaccine ([link removed]) (26 pages)
* FDA: Letter of EUA Authorization ([link removed]) for Novavax COVID-19 Vaccine, Adjuvanted
* CDC: ACIP Meeting Information ([link removed])
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Immunize.org posts ten new translations of four Vaccine Information Statements (VISs) updated in August 2021
Immunize.org posted ten new translations of four Vaccine Information Statements ([link removed]) (VISs) issued by CDC on August 6, 2021. These translations were generously donated by the California Department of Public Health Immunization Program.
All translations are available in print-ready PDF format.
Influenza, Inactivated VIS view in English ([link removed]):
* Armenian ([link removed])
* Farsi ([link removed])
* Hindi ([link removed])
* Hmong ([link removed])
* Japanese ([link removed])
* Khmer (Cambodian) ([link removed])
* Korean ([link removed])
* Punjabi ([link removed])
* Tagalog ([link removed])
* Thai ([link removed])
Influenza, Live Intranasal VIS view in English ([link removed]):
* Armenian ([link removed])
* Farsi ([link removed])
* Hindi ([link removed])
* Hmong ([link removed])
* Japanese ([link removed])
* Khmer (Cambodian) ([link removed])
* Korean ([link removed])
* Punjabi ([link removed])
* Tagalog ([link removed])
* Thai ([link removed])
Measles-Mumps-Rubella (MMR) VIS view in English ([link removed]):
* Armenian ([link removed])
* Farsi ([link removed])
* Hindi ([link removed])
* Hmong ([link removed])
* Japanese ([link removed])
* Khmer (Cambodian) ([link removed])
* Korean ([link removed])
* Punjabi ([link removed])
* Tagalog ([link removed])
* Thai ([link removed])
Tetanus-diphtheria-acellular pertussis (Tdap) VIS view in English ([link removed]):
* Armenian ([link removed])
* Farsi ([link removed])
* Hindi ([link removed])
* Hmong ([link removed])
* Japanese ([link removed])
* Khmer (Cambodian) ([link removed])
* Korean ([link removed])
* Punjabi ([link removed])
* Tagalog ([link removed])
* Thai ([link removed])
Related Links
* Immunize.org: Vaccine Information Statement ([link removed]) main page for VISs in 47 languages ([link removed])
* Immunize.org: Dates of Current Vaccine Information Statements ([link removed]) (PDF)
* CDC: What's New with VISs ([link removed]) web page
* CDC: Current VISs ([link removed]) web page
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FDA expands licensure of Comirnaty (Pfizer-BioNTech) vaccine for adolescents age 12 through 15 years as a two-dose primary series; vaccine recommendations remain unchanged
On July 8, the FDA licensed Pfizer-BioNTech’s COVID-19 vaccine, Comirnaty ([link removed]), for the prevention of COVID-19 caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals age 12 through 15 years.
The expansion of the license means that the emergency use authorization for use of this vaccine in this age group no longer applies; however, it does not change the ACIP recommendations for use of this vaccine in this age group.
Related Links
* FDA: Comirnaty product approval letter ([link removed]) (7/8/22)
* FDA: Comirnaty ([link removed]) web page
* Immunize.org: Package Inserts and FDA Product Approvals ([link removed]) main page
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Influenza Vaccination Honor Roll for mandatory healthcare worker vaccination now features 1,291 organizations
Immunize.org's Influenza Vaccination Honor Roll ([link removed]) recognizes facilities that take a stand for patient safety by implementing policies for mandatory healthcare personnel influenza vaccination. There are now 1,291 organizations enrolled. Since June 15, 2022, seven additional healthcare organizations have been recognized.
* St. Joseph’s Center, Scranton, PA
* AFC Urgent Care Grand Junction, Grand Junction, CO
* AFC Urgent Care Cortez, Cortez, CO
* AFC Urgent Care Garden City, Garden City, ID
* AFC Urgent Care Nampa, Nampa, ID
* AFC Urgent Care Meridian, Meridian, ID
* AFC Urgent Care Farmington, Farmington, NM
Eligibility:
* Eligible organizations: Hospitals, long-term care facilities, medical practices, pharmacies, professional organizations, health departments, and other government entities
* Requirements:
+ Your policy must require influenza vaccination for all staff
+ The application ([link removed]) must describe measures to prevent transmission of influenza from unvaccinated personnel to patients (e.g., masking for the entire work shift)
Related Links
* Immunize.org: List of Influenza Vaccination Honorees, all healthcare settings ([link removed]), by state
* Immunize.org: Long-Term Care/Assisted Living Influenza Vaccination Honorees ([link removed]) by state
* Immunize.org: Influenza Vaccination Honor Roll program ([link removed]), including:
+ Position statements ([link removed]) from professional societies and leading healthcare organizations in support of mandatory influenza vaccination
+ Application form for Influenza Vaccination Honor Roll ([link removed])
* Immunize.org: Honor Roll for Patient Safety ([link removed]) web page
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Spotlight: Review of resources at Immunize.org focused on the history of vaccines
Here are Immunize.org resources that focus on the history of vaccines.
Our Vaccine Timeline ([link removed]) main page lists historic dates and events related to vaccines and immunization. From Edward Jenner's first smallpox vaccination in 1796 to COVID-19 vaccines, this chart highlights scientific discoveries and technologies that led to rapid advances in virology, molecular biology, and vaccinology.
Our YouTube channel ([link removed]) containing public service announcements (PSAs) encouraging vaccination, compiled by vaccine expert Capt. William L. Atkinson, MD, MPH, USPHS (retired), is a collection that spans more than 50 years.
Our History through Film ([link removed]) main page overviews the Protecting Health: Saving Lives documentary, which covers the history of the Immunization Action Coalition from 1990 to 2020. Hosted by Sam Waterston, the 30-minute film was produced by Visionaries, Inc. for broadcast during its 24th season on more than 100 local PBS stations nationwide.
Our Publications Archive ([link removed]) links to past issues of various Immunize.org publications, describing the contemporary vaccine-practice issues of the time: Needle Tips, Vaccinate Adults, Vaccinate Women, and IZ Express (and its IAC Express predecessor).
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Journalists interview Immunize.org experts
Journalists seek out Immunize.org 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.
* Salon: Omicron-Targeted Boosters Could Be Here by Fall. Here’s What We Know ([link removed]) (7/6/22)
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Vaccines in the news
These recent articles convey the potential risks of vaccine-preventable diseases and the importance of vaccination.
* NPR: A New Dominant Omicron Strain in the U.S. Is Driving Up Cases—and Reinfections ([link removed]) (7/11/22)
* Gavi: COVID Vaccines and Pregnancy: A Review of the Evidence Shows They Are Safe ([link removed]) (7/11/22)
* American Heart Association: Being Vaccinated May Lower Stroke Risk in Adults with Flu-Like Illnesses ([link removed]) (7/11/22)
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Immunize.org Pages and Handouts
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Immunize.org updates standing orders for administering human papillomavirus vaccine to children and teens
Immunize.org issued its updated Standing Orders for Human Papillomavirus Vaccine to Children and Teens ([link removed]) template to note that vaccination may begin at age 9 years.
Related Links
* Immunize.org: Standing Orders for Human Papillomavirus Vaccine to Children and Teens ([link removed]) (PDF)
* Immunize.org: Vaccines: Human Papillomavirus ([link removed]) main page
* Immunize.org: Handouts: Standing Orders Templates for Administering Vaccines ([link removed]) main page
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Featured Resources
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Experts offer vaccination resources for the ongoing monkeypox outbreak; CDC announces increased nationwide testing capacity
CDC is closely tracking cases of monkeypox detected in the United States during the 2022 monkeypox outbreak ([link removed]). Anyone who has been in close contact with someone who has monkeypox is at risk. To date, gay, bisexual, and other men who have sex with men make up a high number of cases. CDC posted Considerations for Monkeypox Vaccination ([link removed]) and multiple other resources for health professionals ([link removed]).
Two vaccines (Jynneos [Bavarian Nordic, Smallpox and Monkeypox Vaccine, Live, Nonreplicating], and ACAM2000 [Emergent Biosolutions, Smallpox Vaccine, Live]) are available through the Strategic National Stockpile to public health authorities for use as post-exposure prophylaxis (PEP) for at-risk contacts of cases or, in certain circumstances, as pre-exposure prophylaxis (PrEP).
At this time, CDC does not recommend widespread vaccination against monkeypox. However, vaccination may be recommended for people who:
* Are in close personal contact with people who have monkeypox
* May have been exposed to the virus
* May have an increased risk of being exposed to the virus, such as people who perform laboratory testing to diagnose monkeypox
CDC recommendations and clinical considerations for vaccination against monkeypox will be updated as the outbreak evolves and as Jynneos vaccine supplies increase.
Several commercial laboratories are now able to perform diagnostic tests for monkeypox. Testing requires a swab taken from a suspicious lesion. Monkeypox testing capacity will continue to increase throughout July.
Bavarian Nordic, the manufacturer of Jynneos (Smallpox and Monkeypox Vaccine, Live, Nonreplicating), issued a letter to the CDC updating the cold-chain tolerances of this vaccine. Notably, unopen vials of Jynneos may be stored at 2 to 8°C for up to 8 weeks after thawing ([link removed]), longer than described in the Jynneos package insert.
The Association of State and Territorial Health Officials (ASTHO) released two educational podcasts: Podcast 197: Preparing for Monkeypox ([link removed]) and Podcast 211: Monkeypox Response ([link removed]).
The Council of State and Territorial Epidemiologists (CSTE) issued Position Statement 22-ID-10: Public Health Reporting and National Notification for Monkeypox Virus Infection ([link removed]).
CDC urges healthcare professionals to be alert for patients with a rash consistent with monkeypox regardless of their specific risk factors for monkeypox. Use these CDC resources to familiarize yourself with this disease and how it appears.
* 2022 U.S. Monkeypox Outbreak: information for healthcare professionals ([link removed])
* Considerations for monkeypox vaccination ([link removed])
* Monkeypox: Signs and Symptoms ([link removed])
* Monkeypox: How It Spreads ([link removed])
* Monkeypox: Prevention ([link removed])
* Monkeypox: Infection Control in Healthcare Settings ([link removed])
Related Links
* CDC: Monkeypox: Vaccines ([link removed]) web page
* Immunize.org: Smallpox/Monkeypox VIS ([link removed]) main page
* Bavarian Nordic: BN-CDC-ASPR Jynneos Stability Letter ([link removed]) (6/14/22)
* Association of State and Territorial Health Officials (ASTHO): Podcast 197: Preparing for Monkeypox ([link removed]) and Podcast 211: Monkeypox Response ([link removed])
* Council of State and Territorial Epidemiologists (CSTE): Position Statement 22-ID-10: Public Health Reporting and National Notification for Monkeypox Virus Infection ([link removed])
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Notable Publications
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“Safety Monitoring of COVID-19 mRNA Vaccine First Booster Doses among Persons Aged ≥12 Years with Presumed Immunocompromise Status—United States, January 12, 2022–March 28, 2022” published in MMWR
CDC published Safety Monitoring of COVID-19 mRNA Vaccine First Booster Doses among Persons Aged ≥12 Years with Presumed Immunocompromise Status—United States, January 12, 2022–March 28, 2022 ([link removed]) on July 15 in MMWR ([link removed]). A portion of the summary appears below.
Additional doses of COVID-19 vaccine are recommended for immunocompromised persons, and 518,113 fourth doses were presumed administered to this population during January–March, 2022….
Among presumed immunocompromised persons aged ≥12 years, local and systemic reactions were less frequently reported to v-safe after mRNA booster (dose 4) than after primary series dose 3. Only 17 serious adverse events were reported to VAERS….
Serious adverse events after mRNA booster (dose 4) are rare. Immunocompromised persons aged ≥12 years should receive a first booster ≥3 months after a 3-dose primary COVID-19 vaccination series and a second booster ≥4 months after the first booster.
Access the MMWR article in HTML ([link removed]) or PDF ([link removed]).
Related Link
* MMWR's main page ([link removed]) provides access to MMWR Weekly and its companion publications
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“How Ready Was the U.S. Vaccination Infrastructure and Network of Immunization Information Systems for COVID-19 Vaccination Campaigns: Recommendations to Strengthen the Routine Vaccination Program and Prepare for the Next Pandemic” published in Human Vaccines & Immunotherapeutics
On July 5, Human Vaccines & Immunotherapeutics published How Ready was the U.S. Vaccination Infrastructure and Network of Immunization Information Systems for COVID-19 Vaccination Campaigns: Recommendations to Strengthen the Routine Vaccination Program and Prepare for the Next Pandemic ([link removed]), featuring work by Immunize.org’s Angela K. Shen, ScD, MPH. The abstract appears below.
Coronavirus disease 2019 (COVID-19) pandemic vaccination campaigns globally have been unlike any effort in history. In the United States, the success of these efforts, in part, has hinged on the timely capture and reporting of an unprecedented amount of data from a significantly greater number of administering providers than for routine vaccinations. The pandemic response has highlighted the need to explore the status and value of vaccination data as the critical glue that connects all aspects of the upstream US vaccine development and downstream vaccination delivery system. In this review, we examine immunization information systems and the role that data and staffing play in pandemic responses. We offer three strategic recommendations—regarding funding, expanded provider enrollment, and data reporting—informed by a literature review, a survey and focus group from a convenience sample of 22 immunization jurisdictions, and the vision for enhanced data flow to improve future pandemic responses and routine vaccination.
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“Maternal Vaccination and Risk of Hospitalization for COVID-19 among Infants” published in New England Journal of Medicine
On July 14, New England Journal of Medicine published Maternal Vaccination and Risk of Hospitalization for COVID-19 among Infants ([link removed]). A portion of the article appears below.
Infants younger than 6 months of age are at high risk for complications of coronavirus disease 2019 (COVID-19) and are not eligible for vaccination. Transplacental transfer of antibodies against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) after maternal COVID-19 vaccination may confer protection against COVID-19 in infants….
Maternal vaccination with two doses of mRNA vaccine was associated with a reduced risk of hospitalization for COVID-19, including for critical illness, among infants younger than 6 months of age.
An accompanying editorial ([link removed]) notes:
The results of the study by Halasa et al. provide compelling evidence that maternal vaccination is effective in reducing the risk of Covid-19–related hospitalization in infants younger than 6 months of age, a finding that further supports recommendations for Covid-19 vaccination during pregnancy. Such infants have a higher risk of severe illness and hospitalization than older children and cannot be vaccinated now or in the near future.
Related Link
* NEJM: COVID-19 Vaccination during Pregnancy—Two for the Price of One ([link removed]) (7/14/22)
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“Evaluation of Acute Adverse Events after COVID-19 Vaccination during Pregnancy” published in New England Journal of Medicine
On July 14, New England Journal of Medicine published Evaluation of Acute Adverse Events after COVID-19 Vaccination during Pregnancy ([link removed]). A portion of the article appears below.
Pregnant women with symptomatic coronavirus disease 2019 (COVID-19) have a higher risk of adverse outcomes than do women who are not pregnant. In part because of these findings, COVID-19 vaccination has been recommended for pregnant women. However, uptake has been lower in pregnant women than among women who are not pregnant….
Medically attended acute adverse events after COVID-19 vaccination immediately preceding or during pregnancy were uncommon. COVID-19 vaccines were not associated with an increased risk of the clinically serious acute adverse events that were evaluated. The present data add to the growing literature supporting the safety of COVID-19 vaccination during pregnancy.
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Upcoming Events
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CDC’s recorded webinars on principles of vaccination and general best practice guidelines, as well as other segments in “The Pink Book,” now rolling out weekly
CDC continues its 19-part pre-recorded webinar series ([link removed]) to provide a chapter-by-chapter overview of the 14th edition of Epidemiology and Prevention of Vaccine-Preventable Diseases ([link removed]) (also known as "The Pink Book"). The series discusses vaccination principles, general best practices, vaccination strategies, and specific information about vaccine-preventable diseases and the vaccines that prevent them. Each broadcast includes updated information from the Advisory Committee on Immunization Practices (ACIP).
The third webinar, on general best practices (part 2) and vaccine safety, was released on July 19; no registration is required. Additional webinars will be released weekly, concluding on November 1, 2022.
Videos of the first two 1-hour webinars are available online now.
Information and program details are available on CDC's Pink Book Webinars series ([link removed]) web page.
Continuing education credits are available for each event. Questions about the material can be submitted to [email protected].
All the sections of "The Pink Book" (i.e., chapters, appendices, front matter) are available to download at no charge at www.cdc.gov/vaccines/pubs/pinkbook/index.html. You also can order this resource from the Public Health Foundation for $50 plus shipping and handling.
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For more upcoming events, visit our Calendar of Events ([link removed]).
Editorial Information
Editor-in-Chief
Kelly L. Moore, MD, MPH
Managing Editor
John D. Grabenstein, RPh, PhD
Associate Editor
Sharon G. Humiston, MD, MPH
Writer/Publication Coordinator
Taryn Chapman, MS
Courtnay Londo, MA
Style and Copy Editor
Marian Deegan, JD
Web Edition Managers
Arkady Shakhnovich
Jermaine Royes
Contributing Writer
Laurel H. Wood, MPA
Technical Reviewer
Robin VanOss
About IZ Express
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Issue 1,643: July 20, 2022
Top Stories
* Immunize.org’s “Vaccines: COVID-19” main page updated to include the latest CDC and FDA resources for use of both mRNA vaccines in children age 6 months through 17 years
* WHO and UNICEF report global vaccination coverage continued to decline in 2021, with 25 million infants missing out on lifesaving vaccines
* FDA issues EUA for Novavax COVID-19 Vaccine as a primary series; ACIP convened to review and vote on July 19
* Immunize.org posts ten new translations of four Vaccine Information Statements (VISs) updated in August 2021
* FDA expands licensure of Comirnaty (Pfizer-BioNTech) vaccine for adolescents age 12 through 15 years as a two-dose primary series; vaccine recommendations remain unchanged
* Influenza Vaccination Honor Roll for mandatory healthcare worker vaccination now features 1,291 organizations
* Spotlight: Review of resources at Immunize.org focused on the history of vaccines
* Journalists interview Immunize.org experts
* Vaccines in the news
Immunize.org Pages and Handouts
* Immunize.org updates standing orders for administering human papillomavirus vaccine to children and teens
Featured Resources
* Experts offer vaccination resources for the ongoing monkeypox outbreak; CDC announces increased nationwide testing capacity
Notable Publications
* “Safety Monitoring of COVID-19 mRNA Vaccine First Booster Doses among Persons Aged ≥12 Years with Presumed Immunocompromise Status—United States, January 12, 2022–March 28, 2022” published in MMWR
* “How Ready Was the U.S. Vaccination Infrastructure and Network of Immunization Information Systems for COVID-19 Vaccination Campaigns: Recommendations to Strengthen the Routine Vaccination Program and Prepare for the Next Pandemic” published in Human Vaccines & Immunotherapeutics
* “Maternal Vaccination and Risk of Hospitalization for COVID-19 among Infants” published in New England Journal of Medicine
* “Evaluation of Acute Adverse Events after COVID-19 Vaccination during Pregnancy” published in New England Journal of Medicine
Upcoming Events
* CDC’s recorded webinars on principles of vaccination and general best practice guidelines, as well as other segments in “The Pink Book,” now rolling out weekly
Editorial Information
------------------------------------------------------------
Top Stories
------------------------------------------------------------
Immunize.org’s “Vaccines: COVID-19” main page updated to include the latest CDC and FDA resources for use of both mRNA vaccines in children age 6 months through 17 years
Immunize.org updated the comprehensive list of CDC and FDA resources found on its Vaccines: COVID-19 ([link removed]) main page. The revised list now incorporates information on recently authorized formulations of mRNA vaccines for children age 6 months through 4 years (Pfizer-BioNTech) or 5 years (Moderna), and the use of Moderna vaccines for children and teens age 6 through 17 years. The new resources from CDC and FDA include fact sheets, clinical considerations, vaccine administration tools, and storage and handling guidance. This page also includes a link to Immunize.org’s regularly updated print-ready checklist for current versions of U.S. COVID-19 vaccination guidance and clinic support tools ([link removed]).
Be sure to bookmark this page for quick access to links to key COVID-19 vaccine resource pages from Immunize.org, CDC, and other partners. As guidelines for COVID-19 vaccines are updated and new CDC materials are released, the page will continue to be updated.
------------------------------------------------------------
WHO and UNICEF report global vaccination coverage continued to decline in 2021, with 25 million infants missing out on lifesaving vaccines
On July 15, WHO and UNICEF issued a joint press release titled COVID-19 Pandemic Fuels Largest Continued Backslide in Vaccinations in Three Decades ([link removed]), sounding the alarm regarding the largest sustained decline in childhood vaccinations since 2008. A portion of the press release appears below.
The percentage of children who received three doses of the vaccine against diphtheria, tetanus and pertussis (DTP3) – a marker for immunization coverage within and across countries – fell 5 percentage points between 2019 and 2021 to 81 per cent.
As a result, 25 million children missed out on one or more doses of DTP through routine immunization services in 2021 alone. This is 2 million more than those who missed out in 2020 and 6 million more than in 2019, highlighting the growing number of children at risk from devastating but preventable diseases...
“This is a red alert for child health. We are witnessing the largest sustained drop in childhood immunization in a generation. The consequences will be measured in lives,” said Catherine Russell, UNICEF Executive Director. “While a pandemic hangover was expected last year as a result of COVID-19 disruptions and lockdowns, what we are seeing now is a continued decline. COVID-19 is not an excuse. We need immunization catch-ups for the missing millions or we will inevitably witness more outbreaks, more sick children and greater pressure on already strained health systems.”
Related Links
* UNICEF: Immunization dataset overview ([link removed]) page including full datasets, data visualization, and county profiles
* WHO: Immunization Analysis and Insights dataset information ([link removed]) page including a global dashboard and full datasets
* WHO: Vaccines and Immunization social media ([link removed]) main page
* WHO: Immunization Coverage ([link removed]) fact sheet
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FDA issues EUA for Novavax COVID-19 Vaccine as a primary series; ACIP convened to review and vote on July 19
On July 13, the FDA issued an Emergency Use Authorization (EUA) ([link removed]) for the Novavax COVID-19 Vaccine, Adjuvanted ([link removed]) to help prevent disease caused by SARS-CoV-2 virus in people 18 years of age and older.
FDA’s action follows the unanimous recommendation of its Vaccines and Related Biological Products Advisory Committee ([link removed]) (VRBPAC), which determined on June 7 that the benefits of vaccination with the Novavax COVID-19 Vaccine outweigh any potential risks for use in people age 18 years or older.
The Advisory Committee on Immunization Practices (ACIP) convened on July 19 ([link removed]) to discuss and vote on the use of Novavax COVID-19 Vaccine in adults age 18 years and older. The results of the meeting were not available at press time and will be summarized in next week’s issue of IZ Express. Presentations and the agenda from the July 19 ACIP meeting are available on CDC's website ([link removed]).
Below, find links to technical and supportive documents related to this vaccine and the EUA. Most relevant to vaccinators are the Fact Sheet for Recipients and Caregivers ([link removed]) and the Fact Sheet for Healthcare Providers Administering Vaccine ([link removed]). The second 26-page document includes the product’s prescribing information.
Related Links
* Novavax COVID-19 Vaccine, Adjuvanted, EUA Fact Sheet for Recipients and Caregivers ([link removed]) (7 pages)
* Novavax COVID-19 Vaccine, Adjuvanted, EUA Fact Sheet for Healthcare Providers Administering Vaccine ([link removed]) (26 pages)
* FDA: Letter of EUA Authorization ([link removed]) for Novavax COVID-19 Vaccine, Adjuvanted
* CDC: ACIP Meeting Information ([link removed])
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Immunize.org posts ten new translations of four Vaccine Information Statements (VISs) updated in August 2021
Immunize.org posted ten new translations of four Vaccine Information Statements ([link removed]) (VISs) issued by CDC on August 6, 2021. These translations were generously donated by the California Department of Public Health Immunization Program.
All translations are available in print-ready PDF format.
Influenza, Inactivated VIS view in English ([link removed]):
* Armenian ([link removed])
* Farsi ([link removed])
* Hindi ([link removed])
* Hmong ([link removed])
* Japanese ([link removed])
* Khmer (Cambodian) ([link removed])
* Korean ([link removed])
* Punjabi ([link removed])
* Tagalog ([link removed])
* Thai ([link removed])
Influenza, Live Intranasal VIS view in English ([link removed]):
* Armenian ([link removed])
* Farsi ([link removed])
* Hindi ([link removed])
* Hmong ([link removed])
* Japanese ([link removed])
* Khmer (Cambodian) ([link removed])
* Korean ([link removed])
* Punjabi ([link removed])
* Tagalog ([link removed])
* Thai ([link removed])
Measles-Mumps-Rubella (MMR) VIS view in English ([link removed]):
* Armenian ([link removed])
* Farsi ([link removed])
* Hindi ([link removed])
* Hmong ([link removed])
* Japanese ([link removed])
* Khmer (Cambodian) ([link removed])
* Korean ([link removed])
* Punjabi ([link removed])
* Tagalog ([link removed])
* Thai ([link removed])
Tetanus-diphtheria-acellular pertussis (Tdap) VIS view in English ([link removed]):
* Armenian ([link removed])
* Farsi ([link removed])
* Hindi ([link removed])
* Hmong ([link removed])
* Japanese ([link removed])
* Khmer (Cambodian) ([link removed])
* Korean ([link removed])
* Punjabi ([link removed])
* Tagalog ([link removed])
* Thai ([link removed])
Related Links
* Immunize.org: Vaccine Information Statement ([link removed]) main page for VISs in 47 languages ([link removed])
* Immunize.org: Dates of Current Vaccine Information Statements ([link removed]) (PDF)
* CDC: What's New with VISs ([link removed]) web page
* CDC: Current VISs ([link removed]) web page
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FDA expands licensure of Comirnaty (Pfizer-BioNTech) vaccine for adolescents age 12 through 15 years as a two-dose primary series; vaccine recommendations remain unchanged
On July 8, the FDA licensed Pfizer-BioNTech’s COVID-19 vaccine, Comirnaty ([link removed]), for the prevention of COVID-19 caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals age 12 through 15 years.
The expansion of the license means that the emergency use authorization for use of this vaccine in this age group no longer applies; however, it does not change the ACIP recommendations for use of this vaccine in this age group.
Related Links
* FDA: Comirnaty product approval letter ([link removed]) (7/8/22)
* FDA: Comirnaty ([link removed]) web page
* Immunize.org: Package Inserts and FDA Product Approvals ([link removed]) main page
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Influenza Vaccination Honor Roll for mandatory healthcare worker vaccination now features 1,291 organizations
Immunize.org's Influenza Vaccination Honor Roll ([link removed]) recognizes facilities that take a stand for patient safety by implementing policies for mandatory healthcare personnel influenza vaccination. There are now 1,291 organizations enrolled. Since June 15, 2022, seven additional healthcare organizations have been recognized.
* St. Joseph’s Center, Scranton, PA
* AFC Urgent Care Grand Junction, Grand Junction, CO
* AFC Urgent Care Cortez, Cortez, CO
* AFC Urgent Care Garden City, Garden City, ID
* AFC Urgent Care Nampa, Nampa, ID
* AFC Urgent Care Meridian, Meridian, ID
* AFC Urgent Care Farmington, Farmington, NM
Eligibility:
* Eligible organizations: Hospitals, long-term care facilities, medical practices, pharmacies, professional organizations, health departments, and other government entities
* Requirements:
+ Your policy must require influenza vaccination for all staff
+ The application ([link removed]) must describe measures to prevent transmission of influenza from unvaccinated personnel to patients (e.g., masking for the entire work shift)
Related Links
* Immunize.org: List of Influenza Vaccination Honorees, all healthcare settings ([link removed]), by state
* Immunize.org: Long-Term Care/Assisted Living Influenza Vaccination Honorees ([link removed]) by state
* Immunize.org: Influenza Vaccination Honor Roll program ([link removed]), including:
+ Position statements ([link removed]) from professional societies and leading healthcare organizations in support of mandatory influenza vaccination
+ Application form for Influenza Vaccination Honor Roll ([link removed])
* Immunize.org: Honor Roll for Patient Safety ([link removed]) web page
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Spotlight: Review of resources at Immunize.org focused on the history of vaccines
Here are Immunize.org resources that focus on the history of vaccines.
Our Vaccine Timeline ([link removed]) main page lists historic dates and events related to vaccines and immunization. From Edward Jenner's first smallpox vaccination in 1796 to COVID-19 vaccines, this chart highlights scientific discoveries and technologies that led to rapid advances in virology, molecular biology, and vaccinology.
Our YouTube channel ([link removed]) containing public service announcements (PSAs) encouraging vaccination, compiled by vaccine expert Capt. William L. Atkinson, MD, MPH, USPHS (retired), is a collection that spans more than 50 years.
Our History through Film ([link removed]) main page overviews the Protecting Health: Saving Lives documentary, which covers the history of the Immunization Action Coalition from 1990 to 2020. Hosted by Sam Waterston, the 30-minute film was produced by Visionaries, Inc. for broadcast during its 24th season on more than 100 local PBS stations nationwide.
Our Publications Archive ([link removed]) links to past issues of various Immunize.org publications, describing the contemporary vaccine-practice issues of the time: Needle Tips, Vaccinate Adults, Vaccinate Women, and IZ Express (and its IAC Express predecessor).
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Journalists interview Immunize.org experts
Journalists seek out Immunize.org 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.
* Salon: Omicron-Targeted Boosters Could Be Here by Fall. Here’s What We Know ([link removed]) (7/6/22)
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Vaccines in the news
These recent articles convey the potential risks of vaccine-preventable diseases and the importance of vaccination.
* NPR: A New Dominant Omicron Strain in the U.S. Is Driving Up Cases—and Reinfections ([link removed]) (7/11/22)
* Gavi: COVID Vaccines and Pregnancy: A Review of the Evidence Shows They Are Safe ([link removed]) (7/11/22)
* American Heart Association: Being Vaccinated May Lower Stroke Risk in Adults with Flu-Like Illnesses ([link removed]) (7/11/22)
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Immunize.org Pages and Handouts
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Immunize.org updates standing orders for administering human papillomavirus vaccine to children and teens
Immunize.org issued its updated Standing Orders for Human Papillomavirus Vaccine to Children and Teens ([link removed]) template to note that vaccination may begin at age 9 years.
Related Links
* Immunize.org: Standing Orders for Human Papillomavirus Vaccine to Children and Teens ([link removed]) (PDF)
* Immunize.org: Vaccines: Human Papillomavirus ([link removed]) main page
* Immunize.org: Handouts: Standing Orders Templates for Administering Vaccines ([link removed]) main page
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Featured Resources
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Experts offer vaccination resources for the ongoing monkeypox outbreak; CDC announces increased nationwide testing capacity
CDC is closely tracking cases of monkeypox detected in the United States during the 2022 monkeypox outbreak ([link removed]). Anyone who has been in close contact with someone who has monkeypox is at risk. To date, gay, bisexual, and other men who have sex with men make up a high number of cases. CDC posted Considerations for Monkeypox Vaccination ([link removed]) and multiple other resources for health professionals ([link removed]).
Two vaccines (Jynneos [Bavarian Nordic, Smallpox and Monkeypox Vaccine, Live, Nonreplicating], and ACAM2000 [Emergent Biosolutions, Smallpox Vaccine, Live]) are available through the Strategic National Stockpile to public health authorities for use as post-exposure prophylaxis (PEP) for at-risk contacts of cases or, in certain circumstances, as pre-exposure prophylaxis (PrEP).
At this time, CDC does not recommend widespread vaccination against monkeypox. However, vaccination may be recommended for people who:
* Are in close personal contact with people who have monkeypox
* May have been exposed to the virus
* May have an increased risk of being exposed to the virus, such as people who perform laboratory testing to diagnose monkeypox
CDC recommendations and clinical considerations for vaccination against monkeypox will be updated as the outbreak evolves and as Jynneos vaccine supplies increase.
Several commercial laboratories are now able to perform diagnostic tests for monkeypox. Testing requires a swab taken from a suspicious lesion. Monkeypox testing capacity will continue to increase throughout July.
Bavarian Nordic, the manufacturer of Jynneos (Smallpox and Monkeypox Vaccine, Live, Nonreplicating), issued a letter to the CDC updating the cold-chain tolerances of this vaccine. Notably, unopen vials of Jynneos may be stored at 2 to 8°C for up to 8 weeks after thawing ([link removed]), longer than described in the Jynneos package insert.
The Association of State and Territorial Health Officials (ASTHO) released two educational podcasts: Podcast 197: Preparing for Monkeypox ([link removed]) and Podcast 211: Monkeypox Response ([link removed]).
The Council of State and Territorial Epidemiologists (CSTE) issued Position Statement 22-ID-10: Public Health Reporting and National Notification for Monkeypox Virus Infection ([link removed]).
CDC urges healthcare professionals to be alert for patients with a rash consistent with monkeypox regardless of their specific risk factors for monkeypox. Use these CDC resources to familiarize yourself with this disease and how it appears.
* 2022 U.S. Monkeypox Outbreak: information for healthcare professionals ([link removed])
* Considerations for monkeypox vaccination ([link removed])
* Monkeypox: Signs and Symptoms ([link removed])
* Monkeypox: How It Spreads ([link removed])
* Monkeypox: Prevention ([link removed])
* Monkeypox: Infection Control in Healthcare Settings ([link removed])
Related Links
* CDC: Monkeypox: Vaccines ([link removed]) web page
* Immunize.org: Smallpox/Monkeypox VIS ([link removed]) main page
* Bavarian Nordic: BN-CDC-ASPR Jynneos Stability Letter ([link removed]) (6/14/22)
* Association of State and Territorial Health Officials (ASTHO): Podcast 197: Preparing for Monkeypox ([link removed]) and Podcast 211: Monkeypox Response ([link removed])
* Council of State and Territorial Epidemiologists (CSTE): Position Statement 22-ID-10: Public Health Reporting and National Notification for Monkeypox Virus Infection ([link removed])
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Notable Publications
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“Safety Monitoring of COVID-19 mRNA Vaccine First Booster Doses among Persons Aged ≥12 Years with Presumed Immunocompromise Status—United States, January 12, 2022–March 28, 2022” published in MMWR
CDC published Safety Monitoring of COVID-19 mRNA Vaccine First Booster Doses among Persons Aged ≥12 Years with Presumed Immunocompromise Status—United States, January 12, 2022–March 28, 2022 ([link removed]) on July 15 in MMWR ([link removed]). A portion of the summary appears below.
Additional doses of COVID-19 vaccine are recommended for immunocompromised persons, and 518,113 fourth doses were presumed administered to this population during January–March, 2022….
Among presumed immunocompromised persons aged ≥12 years, local and systemic reactions were less frequently reported to v-safe after mRNA booster (dose 4) than after primary series dose 3. Only 17 serious adverse events were reported to VAERS….
Serious adverse events after mRNA booster (dose 4) are rare. Immunocompromised persons aged ≥12 years should receive a first booster ≥3 months after a 3-dose primary COVID-19 vaccination series and a second booster ≥4 months after the first booster.
Access the MMWR article in HTML ([link removed]) or PDF ([link removed]).
Related Link
* MMWR's main page ([link removed]) provides access to MMWR Weekly and its companion publications
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“How Ready Was the U.S. Vaccination Infrastructure and Network of Immunization Information Systems for COVID-19 Vaccination Campaigns: Recommendations to Strengthen the Routine Vaccination Program and Prepare for the Next Pandemic” published in Human Vaccines & Immunotherapeutics
On July 5, Human Vaccines & Immunotherapeutics published How Ready was the U.S. Vaccination Infrastructure and Network of Immunization Information Systems for COVID-19 Vaccination Campaigns: Recommendations to Strengthen the Routine Vaccination Program and Prepare for the Next Pandemic ([link removed]), featuring work by Immunize.org’s Angela K. Shen, ScD, MPH. The abstract appears below.
Coronavirus disease 2019 (COVID-19) pandemic vaccination campaigns globally have been unlike any effort in history. In the United States, the success of these efforts, in part, has hinged on the timely capture and reporting of an unprecedented amount of data from a significantly greater number of administering providers than for routine vaccinations. The pandemic response has highlighted the need to explore the status and value of vaccination data as the critical glue that connects all aspects of the upstream US vaccine development and downstream vaccination delivery system. In this review, we examine immunization information systems and the role that data and staffing play in pandemic responses. We offer three strategic recommendations—regarding funding, expanded provider enrollment, and data reporting—informed by a literature review, a survey and focus group from a convenience sample of 22 immunization jurisdictions, and the vision for enhanced data flow to improve future pandemic responses and routine vaccination.
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“Maternal Vaccination and Risk of Hospitalization for COVID-19 among Infants” published in New England Journal of Medicine
On July 14, New England Journal of Medicine published Maternal Vaccination and Risk of Hospitalization for COVID-19 among Infants ([link removed]). A portion of the article appears below.
Infants younger than 6 months of age are at high risk for complications of coronavirus disease 2019 (COVID-19) and are not eligible for vaccination. Transplacental transfer of antibodies against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) after maternal COVID-19 vaccination may confer protection against COVID-19 in infants….
Maternal vaccination with two doses of mRNA vaccine was associated with a reduced risk of hospitalization for COVID-19, including for critical illness, among infants younger than 6 months of age.
An accompanying editorial ([link removed]) notes:
The results of the study by Halasa et al. provide compelling evidence that maternal vaccination is effective in reducing the risk of Covid-19–related hospitalization in infants younger than 6 months of age, a finding that further supports recommendations for Covid-19 vaccination during pregnancy. Such infants have a higher risk of severe illness and hospitalization than older children and cannot be vaccinated now or in the near future.
Related Link
* NEJM: COVID-19 Vaccination during Pregnancy—Two for the Price of One ([link removed]) (7/14/22)
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“Evaluation of Acute Adverse Events after COVID-19 Vaccination during Pregnancy” published in New England Journal of Medicine
On July 14, New England Journal of Medicine published Evaluation of Acute Adverse Events after COVID-19 Vaccination during Pregnancy ([link removed]). A portion of the article appears below.
Pregnant women with symptomatic coronavirus disease 2019 (COVID-19) have a higher risk of adverse outcomes than do women who are not pregnant. In part because of these findings, COVID-19 vaccination has been recommended for pregnant women. However, uptake has been lower in pregnant women than among women who are not pregnant….
Medically attended acute adverse events after COVID-19 vaccination immediately preceding or during pregnancy were uncommon. COVID-19 vaccines were not associated with an increased risk of the clinically serious acute adverse events that were evaluated. The present data add to the growing literature supporting the safety of COVID-19 vaccination during pregnancy.
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Upcoming Events
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CDC’s recorded webinars on principles of vaccination and general best practice guidelines, as well as other segments in “The Pink Book,” now rolling out weekly
CDC continues its 19-part pre-recorded webinar series ([link removed]) to provide a chapter-by-chapter overview of the 14th edition of Epidemiology and Prevention of Vaccine-Preventable Diseases ([link removed]) (also known as "The Pink Book"). The series discusses vaccination principles, general best practices, vaccination strategies, and specific information about vaccine-preventable diseases and the vaccines that prevent them. Each broadcast includes updated information from the Advisory Committee on Immunization Practices (ACIP).
The third webinar, on general best practices (part 2) and vaccine safety, was released on July 19; no registration is required. Additional webinars will be released weekly, concluding on November 1, 2022.
Videos of the first two 1-hour webinars are available online now.
Information and program details are available on CDC's Pink Book Webinars series ([link removed]) web page.
Continuing education credits are available for each event. Questions about the material can be submitted to [email protected].
All the sections of "The Pink Book" (i.e., chapters, appendices, front matter) are available to download at no charge at www.cdc.gov/vaccines/pubs/pinkbook/index.html. You also can order this resource from the Public Health Foundation for $50 plus shipping and handling.
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For more upcoming events, visit our Calendar of Events ([link removed]).
Editorial Information
Editor-in-Chief
Kelly L. Moore, MD, MPH
Managing Editor
John D. Grabenstein, RPh, PhD
Associate Editor
Sharon G. Humiston, MD, MPH
Writer/Publication Coordinator
Taryn Chapman, MS
Courtnay Londo, MA
Style and Copy Editor
Marian Deegan, JD
Web Edition Managers
Arkady Shakhnovich
Jermaine Royes
Contributing Writer
Laurel H. Wood, MPA
Technical Reviewer
Robin VanOss
About IZ Express
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