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Immunize.org summarizes ACIP’s September 1 meeting recommending bivalent mRNA COVID-19 vaccines for fall booster doses The Advisory Committee on Immunization Practices (ACIP) met on September 1, 2022, to discuss FDA’s August 31 Emergency Use Authorizations (EUAs) of new bivalent formulations of Pfizer-BioNTech and Moderna mRNA COVID-19 vaccines as a booster dose. The ACIP recommendations represent a fundamental reset of the COVID-19 vaccination schedule for every person age 12 years and older.
Background: Bivalent mRNA COVID-19 vaccines help the immune system target the spike protein of the ancestral (original) strain of SARS-CoV-2 and the spike protein found on the Omicron BA.4 and 5 variants. All previous COVID-19 vaccines in use in the United States were monovalent COVID-19 vaccines targeting only the original virus strain. The addition of the BA 4/5 component is intended to broaden and enhance the immune response to newer strains of the Omicron variant expected to continue to circulate through the fall and winter months.
Following a thorough review using its “Evidence to Recommendation” process, ACIP voted to:
- Recommend that a single booster dose of bivalent Pfizer-BioNTech COVID-19 Vaccine (for individuals age 12 years and older) or bivalent Moderna COVID-19 Vaccine (for individuals age 18 years and older) be given at least 2 months after completion of a monovalent primary series or any prior monovalent booster dose of COVID-19 vaccine.
- Repeal its previous recommendations for use of monovalent vaccines as booster doses for all people age 12 years and older.
[Note: at this time, there is no change to the monovalent vaccine schedules for children age 6 months through 11 years.]
ACIP members discussed that, while the FDA-authorized interval of 2 months between the completion of a primary series or the most recent booster is acceptable, longer intervals of 3–6 months may be preferred depending upon individual circumstances. Factors influencing timing include recent recovery from COVID-19 infection, risks related to travel or work, or the patient’s risk of serious complications of COVID-19 infection due to age or health status. Evidence suggests longer intervals produce a stronger immune response, as well as a reduced risk of myocarditis in individuals at increased risk for myocarditis after vaccination (e.g., adolescent and adult males under 40). Individuals recently recovered from COVID-19 may wait up to 90 days after illness before bivalent booster vaccination. ACIP members noted that CDC should carefully outline these issues for healthcare providers in its updated interim clinical considerations guidance.
Clinical Considerations
All healthcare professionals who administer COVID-19 vaccines should carefully review CDC’s updated Vaccines & Immunizations: Use of COVID-19 Vaccines in the U.S. summarizing interim clinical considerations for use of COVID-19 vaccines currently approved or authorized in the United States for specific guidance on appropriate use of these newly recommended boosters. A few important highlights include:
- People must first complete at least a primary series with the original monovalent vaccine before receiving a single bivalent booster at least 2 months later.
- People may receive either brand of bivalent vaccine that is age-appropriate; there is no preference and no need to match the brand of the primary series.
- The bivalent booster recommendation replaces previous booster recommendations only for people age 12 years and older. At this time, people age 5 through 11 years who have received a Pfizer-BioNTech primary series should continue to receive one monovalent booster dose.
- The new recommended schedule for all people age 12 years and older is now simplified. Healthcare providers no longer need to consider the previous number of booster doses received; all people age 12 years and older who have completed a primary series should receive one bivalent booster dose, as long as it has been at least 2 months since their most recent dose. (Note: timing considerations are outlined in detail at CDC’s Clinical Considerations web page).
- This recommendation is for a one-time booster. ACIP does not anticipate recommendations for frequent (e.g., every few months) booster doses of bivalent vaccine.
- COVID-19 vaccines may be co-administered with all other routinely recommended vaccines, including influenza vaccine. Special situation: individuals vaccinated against monkeypox, particularly adolescent or young adult males, may consider waiting 4 weeks after receiving monkeypox vaccine before receiving a COVID-19 vaccine. See Coadministration of COVID-19 Vaccines with Other Vaccines subsection in "Timing, Spacing, and Interchangeability of COVID-19 Vaccines" for additional guidance.
- Evusheld (AstraZeneca) is a combination of long-acting antibodies recommended to be administered every 6 months to people with moderate or severe immunocompromise, as a supplement to vaccination. Individuals eligible for Evusheld should wait at least 2 weeks after the first COVID-19 vaccination before receiving the first dose of Evusheld. There is no minimum interval after Evusheld to administer a subsequent COVID-19 vaccination; however, it is recommended to wait at least 2 weeks to administer Evusheld after any subsequent COVID-19 vaccination.
Operational and Administration Considerations
- Storage and handling considerations for bivalent Pfizer BioNTech and Moderna COVID-19 vaccines are identical to the previously available vaccines from each manufacturer.
- Vaccine identification: providers must carefully check carton and vial labels before administering any vaccine. The risk of inadvertent administration error is high if vaccinators do not adhere to standard good vaccination practices, including checking the label at least three times to ensure the correct product and dose is administered to the recipient.
- Pfizer-BioNTech – The only packaging difference between the monovalent product for primary vaccination for age 12 years and older and the bivalent product for booster dosing is the wording on the vial and carton labels. Both products have gray vial caps and gray label borders. The monovalent vaccine label states “Pfizer-BioNTech COVID19 Vaccine” while the bivalent vaccine is labeled as “Pfizer-BioNTech COVID-19 Vaccine, Bivalent, Original and Omicron BA.4/BA.5.”
- Moderna – Moderna’s bivalent product has a dark blue cap and gray vial label border and is clearly labeled “Booster Doses Only.” However, take care to avoid confusing the bivalent product with the monovalent Moderna product for children age 6 through 11 years, which has a dark blue cap and a purple label border, and incorrectly includes label wording indicating it is also for booster doses.
- Administration errors: Vaccine administration errors, including administration of any monovalent vaccine as a booster dose to any person age 12 years or older, or administration of any bivalent vaccine as a primary series dose, should be reported to VAERS. However, CDC does not recommend revaccination following inadvertent administration of a monovalent COVID-19 vaccine when a bivalent is recommended, or vice versa.
Benefits of COVID-19 Vaccine Boosters
As immunity conferred by past doses wanes, studies of hospitalization and mortality rates have made the importance of receiving the recommended bivalent boosters clear. A recent publication presented during the ACIP meeting projects that a fall-winter (September 2022 through March 2023) vaccination campaign with expanded eligibility for bivalent boosters and high booster coverage could avert 100,000 to 160,000 deaths and 1 to 1.7 million hospitalizations in the coming months.
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Immunize.org’s 2022–2023 standing orders for administering influenza vaccine to adults and to children and teens now available for healthcare providers Immunize.org recently posted its updated 2022–2023 Standing Orders for Administering Influenza Vaccine to Children and Teens and Standing Orders for Administering Influenza Vaccine to Adults.
The document for children and teens now includes information on the co-administration of influenza and other vaccines.
The document for adults now includes information on the following:
- The new recommendation that adults age 65 and older receive one of three preferred higher dose (Fluzone HD or Flublok, Sanofi) or adjuvanted (Fluad, Seqirus) influenza vaccine products
- Co-administration of influenza and other vaccines
- The option of administering the intramuscular (IM) injection in the anterolateral thigh muscle, rather than the deltoid muscle
 
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Immunize.org’s 2022–2023 recipient screening forms for contraindications and precautions to influenza vaccination now available for healthcare providers
"National Vaccination Coverage among Adolescents Aged 13–17 Years—National Immunization Survey-Teen, United States, 2021" published in MMWRCDC published National Vaccination Coverage among Adolescents Aged 13–17 Years—National Immunization Survey-Teen, United States, 2021 on September 2 in MMWR. A portion of the summary appears below.
Among adolescents aged 13–17 years in 2021, HPV vaccination coverage (≥1 dose and HPV vaccine up to date) increased. Coverage with ≥1-dose Tdap and ≥1-dose MenACWY remained high. Among age-eligible adolescents, MenACWY booster dose coverage increased. Analyses of the potential COVID-19 pandemic effect among adolescents born in 2008 show a concerning decrease in ≥1 MenACWY and ≥1 Tdap dose coverage....
As more adolescents who were due for routine vaccinations during the pandemic age into the NIS-Teen sample, the full impact of the pandemic can be assessed. Providers should review vaccination records to ensure that adolescents are current with all recommended vaccinations.
Access the MMWR article in HTML or PDF.
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"COVID-19 mRNA Vaccine Safety among Children Aged 6 Months–5 Years—United States, June 18, 2022–August 21, 2022" published in MMWRCDC published COVID-19 mRNA Vaccine Safety among Children Aged 6 Months–5 Years—United States, June 18, 2022–August 21, 2022 on December 31 on September 2 in MMWR. A portion of the summary appears below.
COVID-19 vaccines have been recommended for children aged 6 months–5 years since June 2022; approximately one million doses were administered to persons in this age group during June–August 2022....
Local and systemic reactions after vaccination with either BNT162b2 (Pfizer-BioNTech) or mRNA-1273 (Moderna) COVID-19 vaccines were reported for children aged 6 months–4 years and 6 months–5 years, respectively, to v-safe and VAERS safety monitoring systems. Serious adverse events were rarely reported....
Initial vaccine safety data indicate that among young children, local and systemic reactions are expected after COVID-19 vaccination and serious adverse events are rare.
Access the MMWR article in HTML or PDF.
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Spotlight: Immunize.org resources grouped by age cohorts In this week's Immunize.org spotlight, we summarize resources at Immunize.org grouped by age cohorts.
Our CDC Schedules main page provides printable PDFs of the recommended immunization schedules for children and adolescents and for adults.
Our Schedules for Patients main page contains links to informational sheets on vaccines recommended for people with varying needs based on their age and/or underlying medical conditions.
Within our Handouts: Topic Index we feature:
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 selection of our recent citations.
These recent articles convey the potential risks of vaccine-preventable diseases and the importance of vaccination.
Immunize.org Pages and Handouts
Immunize.org posts eight printable resources to help you kick off a successful 2022–2023 influenza vaccination season. All now have QR codes for easy access to electronic versions on mobile devices. In addition to its very popular standing orders templates and screening checklists for contraindications, Immunize.org has posted eight additional influenza vaccination season resources reviewed and updated, as needed, for the 202–2023 season. On each document, you will now find a QR code in the footer that can be scanned to access the document on your mobile devices. In the future, these QR codes will bring you to the most current online version of the document every time.
All of these resources are designed to support your efforts to ensure high rates of influenza vaccination this season and protect the public from the seasonal epidemic threat of influenza.
The updated resources include:
Understanding contraindications and precautions
Other influenza-related resources
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Recap: These updated Immunize.org educational materials and web pages for clinicians were released during July and August
IZ Express regularly provides readers with information about Immunize.org’s new and updated educational materials and web pages. All Immunize.org materials are free to distribute.
In case you missed them during recent weeks, updates were made to these helpful materials:
Updated Printable Materials for Clinicians
Updated Web Pages
Updated Printable Materials for Patients
Related Links
- Immunize.org: Handouts main page to see educational materials sorted by category
- Immunize.org: Ask the Experts main page to access more than 1,200 questions answered by Immunize.org experts
- Immunize.org: Clinic Tools main page and its nine subtopics
- Immunize.org: Educational Materials for Patients and Staff—an alphabetical list of more than 230 ready-to-print staff educational materials and patient handouts
Vaccine Information Statements
Recap: These new VISs and VIS translations were released during July and August
IZ Express regularly provides readers with information about new and updated Vaccine Information Statements (VISs) and their translations.
In August, CDC released an update to the Smallpox/Monkeypox vaccine VIS.
Here are recent VIS translations posted during July and August:
- Influenza (inactive) vaccine VIS – Armenian, Hindi, Hmong, Japanese, Khmer, Korean, Punjabi, Tagalog, Thai
- Influenza (live) vaccine VIS – Armenian, Hindi, Hmong, Japanese, Khmer, Korean, Punjabi, Tagalog, Thai
- MMR vaccine VIS - Armenian, Hindi, Hmong, Japanese, Khmer, Korean, Punjabi, Tagalog, Thai
- Multi-vaccine (pediatric) vaccine VIS – Haitian Creole and Portuguese
- Smallpox/Monkeypox vaccine VIS – Haitian Creole, Portuguese
- Tdap vaccine VIS - Armenian, Hindi, Hmong, Japanese, Khmer, Korean, Punjabi, Tagalog, Thai
Additionally, two handouts related to VISs were updated:
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Featured Resources
Help Immunize.org reach more vaccinators through your social media networks. Follow us and share our posts featuring Ask the Experts questions and our clinical resources on Facebook, Twitter, and Instagram! Immunize.org launched a new social media program to highlight our educational resources for a new audience of vaccinators. Our social media channels now feature our most popular printable resources and Ask the Experts questions, as well as announcements important to frontline vaccinators. Our Instagram account is new and we need your support to build our following!
Like, follow, and share Immunize.org’s social media accounts and encourage colleagues and others interested in vaccination to do likewise:
Each additional follower extends the reach of our work to help healthcare professionals deliver quality vaccination services to people of all ages.
Campus COVID-19 Vaccine and Mitigation Initiative offers resources and toolkits to combat misinformation and increase vaccine confidence on college campuses The Campus COVID-19 Vaccination and Mitigation Initiative (CoVAC), an initiative of the American College Health Association in collaboration with CDC, aims to increase vaccine confidence and combat vaccine misinformation on college campuses. To do this, CoVAC provides students and other campus stakeholders relevant, credible, accurate information on the importance of getting vaccinated, vaccine safety, and where to get vaccinated.
The program offers various resources, including:
- Student Ambassador Toolkit – encourages peer-to-peer education by providing materials for students to become involved in COVID-19 messaging on their campus
- VaxForward Toolkit – offers a variety of digital tools for educating members of campus about COVID-19
- COVID in Focus newsletter – provides timely insights, talking points, and sample social media posts to share with campus communities
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Explore the www.Give2MenACWY.org website to increase coverage for the MenACWY booster and other adolescent vaccinations Immunize.org's www.Give2MenACWY.org website promotes the importance of adolescent vaccination, including the recommended MenACWY vaccine booster dose at age 16. Many teens are behind on vaccines because of the pandemic, so vaccination is more important than ever.
Materials on this colorful website for healthcare professionals incorporate the 2020 ACIP meningococcal vaccine recommendations and coverage statistics from CDC’s National Immunization Survey–Teen (NIS–Teen). One particularly popular resource on the site is the updated Algorithm for MenACWY Immunization in Adolescents 11 through 18 Years of Age.
The website is divided into five easy-to-access sections:
The site also categorizes materials according to whether they are primarily of interest to providers, to adolescents, or to parents.
Visit Give2MenACWY.org and enjoy browsing (and deploying) its bountiful resources.
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Notable Publications
"Parental Intentions and Perceptions toward COVID-19 Vaccination among Children Aged 4 Months to 4 Years—PROTECT Cohort, Four States, July 2021–May 2022" published in MMWRCDC published Parental Intentions and Perceptions toward COVID-19 Vaccination among Children Aged 4 Months to 4 Years—PROTECT Cohort, Four States, July 2021–May 2022 on September 2 in MMWR. A portion of the summary appears below.
In June 2022, COVID-19 vaccines were authorized for use in children aged 6 months–5 years. Intent to vaccinate and vaccination rates in children have been low....
During July 2021–May 2022, in a longitudinal cohort of 393 children aged <5 years in four states, parental intent to vaccinate children against COVID-19 and perception of COVID-19 vaccine safety and effectiveness declined over a 3-month period, but intent to vaccinate and perceptions of vaccine safety returned to baseline after 6 months....
Identifying and addressing barriers to COVID-19 vaccination in children aged <5 years and educating parents about COVID-19 vaccine effectiveness and safety in young children are critical to increasing pediatric COVID-19 vaccination coverage.
Access the MMWR article in HTML or PDF.
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"Booster COVID-19 Vaccinations among Persons Aged ≥5 Years and Second Booster COVID-19 Vaccinations among Persons Aged ≥50 Years—United States, August 13, 2021–August 5, 2022" published in MMWRCDC published Booster COVID-19 Vaccinations among Persons Aged ≥5 Years and Second Booster COVID-19 Vaccinations among Persons Aged ≥50 Years—United States, August 13, 2021–August 5, 2022 on September 2 in MMWR. A portion of the summary appears below.
A COVID-19 vaccine booster dose provides enhanced protection against SARS-CoV-2 infection, COVID-19–associated emergency department visits, hospitalization, and death....
Among 214 million eligible persons aged ≥5 years, approximately one half received a booster dose. Among 55 million eligible persons aged ≥50 years, approximately one third received a second booster dose. Booster and second booster dose coverage rates were lower among the youngest age groups; males; non-Hispanic Black or African American, Hispanic or Latino, and multiracial persons; residents of rural counties; and Janssen (Johnson & Johnson) primary series recipients....
Focused interventions to improve vaccine equity and effectiveness of outreach to populations with low booster and second booster dose coverage should be developed and implemented.
Access the MMWR article in HTML or PDF.
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“Prevalence of Human Papillomavirus Infection among Women Born in the 1990s vs the 1980s and Association with HPV Vaccination in the U.S.” published in JAMAIn the August 19 issue, JAMA published Prevalence of Human Papillomavirus Infection among Women Born in the 1990s vs the 1980s and Association with HPV Vaccination in the U.S. The discussion section appears below.
These study findings suggest that HPV vaccination was associated with a reduction in HPV-16/18 infection prevalence among a recent birth cohort of vaccinated and unvaccinated 18- to 26-year-old women. A larger decline in the prevalence of HPV-16/18 infection among 18- to 20-year-old women during the 2015−2016 time period may reflect greater direct and herd protection from broader HPV vaccination coverage.
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Upcoming Events
Virtual: North Dakota State University offers webinar “COVID-19 and Vaccines: Science vs. Antiscience” on September 26 North Dakota State University's (NDSU) Center for Immunization Research and Education (CIRE) will host a webinar titled COVID-19 and Vaccines: Science vs. Antiscience at 12:00 p.m. (CT) on September 26. The webinar will feature Peter J. Hotez, MD, PhD, discussing COVID-19 vaccine diplomacy and the impact of antivaccine sentiment and activities.
Free continuing education credits (CME) will be available for the live event. A webinar recording will not be available following the event.
Register for the webinar.
On-demand: CDC’s “The Pink Book” chapter webinars on vaccine-preventable diseases and best practices roll out weekly. Polio and Hib chapters now available, with CE. CDC continues its 19-part pre-recorded webinar series to provide a chapter-by-chapter overview of the 14th edition of Epidemiology and Prevention of Vaccine-Preventable Diseases (also known as "The Pink Book").
Webinar #11, "Polio and Hib" was released on September 6. Additional webinars will be released weekly, concluding on November 1, 2022.
No registration is required to view the sessions. Information and program details are available on CDC's Pink Book Webinars series web page.
CME, CNE, CPE, and CEU credits are available for each event. Questions about the material can be submitted to nipinfo@cdc.gov.
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