Immunize.org summarizes ACIP meeting on 2023–2024 COVID-19 vaccine recommendations
The Advisory Committee on Immunization Practices (ACIP) met on September 12 to review FDA’s September 11 action approving and authorizing the 2023–2024 formula (“updated”) mRNA COVID-19 vaccines. Bivalent COVID-19 vaccines are no longer authorized and should no longer be used; at this time, the recommendations for Novavax COVID-19 vaccine are unchanged. ACIP voted (13–1) to recommend use of the 2023–2024 (monovalent, XBB-containing) COVID-19 vaccines for all individuals age 6 months and older, in accordance with the terms of FDA licensure or emergency use authorization (EUA). Although this recommendation currently applies only to Pfizer-BioNTech and Moderna mRNA vaccines, it also will apply to a 2023–2024 updated Novavax COVID-19 vaccine if it receives FDA authorization.
from the meeting are available online, and meeting highlights are provided below. Following the meeting, the CDC director officially accepted the recommendations in a media statement
Expected vaccine effectiveness against emerging strains and safety
Current Epidemiology of SARS-CoV-2
More than 90% of currently circulating viruses in the United States are of XBB lineage, the strain selected in June for the 2023–2024 COVID-19 vaccine formulation. Recently, SARS-CoV-2 BA.2.86 lineage viruses also have been detected at low levels in the United States.
There are currently an estimated 17,000 or more COVID-related hospitalizations each week. Hospitalizations have increased in all age groups since mid-July, 2023, with highest rates seen in infants younger than age 6 months and older adults. While 4 out of 5 adults age 65 years and older hospitalized with COVID-19 had at least 3 underlying medical conditions, more than half of children younger than age 5 years hospitalized with COVID-19 in the first half of 2023 were in a normal state of health at baseline with no underlying medical conditions. Most children and adults hospitalized for COVID-19 during 2023 were unvaccinated or had not received an updated bivalent booster.
CDC presented updated information on the prevalence of post-COVID conditions (“Long COVID”) in previously infected individuals. A wide range of physical and mental health consequences may continue or develop at least 4 weeks after initial COVID-19 illness. The prevalence of ongoing symptoms lasting at least 3 months after COVID-19 varies by age, with between 2.3 and 4.7 percent of all adults in one nationally representative survey currently reporting symptoms consistent with Long COVID. Almost 1 in 4 adults with Long COVID reported significant activity limitations
. A growing body of evidence indicates that COVID-19 vaccination reduces the risk of Long COVID among children and adults.
Justification for universal recommendation
Evidence presented to ACIP demonstrated that people of any age and health status have some measurable risk of severe illness following SARS-CoV-2 infection; in addition, conditions that increase the risk of severe illness are widespread (e.g., 70% of U.S. adults are overweight or obese). The uncertain future of COVID-19 epidemiology combined with the well-understood, reassuring safety profile of available vaccines favor a cautious, broad recommendation for vaccination at this time, despite the relatively short (a few months) duration of enhanced protection from hospitalization. The risk-benefit balance favors vaccination for all age groups and the economic cost-benefit balance is in line with other routine vaccines in all groups.
ACIP recommended the use of 2023–2024 updated COVID-19 vaccines in accordance with their FDA licensure or emergency use authorization (EUA). By not specifying brands of 2023–2024 COVID-19 vaccines in its recommendation, this recommendation may apply to any 2023–2024 COVID-19 vaccine authorized or approved by FDA in the future (e.g., the 2023–2024 formulation of the Novavax adjuvanted protein subunit vaccine, which is currently under evaluation for an EUA by FDA). Additional information on each product is shown below under “Related Links.”
Age 12 years and older (vaccines have full FDA licensure)
||mL and mcg/dose
||0.3 mL/30 mcg
||0.5 mL/50 mcg
Age 6 months through 11 years (vaccines available under EUA)
Recommended schedule for updated 2023–2024 COVID-19 vaccines
Most individuals age 5 years and older
||mL and mcg/dose
6 mos through 4 y
||0.3 mL/3 mcg
|5 through 11 y
||0.3 mL/10 mcg
||0.25 mL/25 mcg
Most individuals age 6 months through 4 years
- All individuals age 5 years and older should receive 1 dose of any age-appropriate updated vaccine at least 2 months after their most recent dose of COVID-19 vaccine
- Only one dose is recommended regardless of vaccination history
- Those who have completed a 2-dose (Moderna) or 3-dose (Pfizer-BioNTech) primary series of COVID-19 vaccine should receive 1 dose of any age-appropriate formulation of an updated vaccine at least 2 months after their most recent dose of COVID-19 vaccine
- Those who have not completed a 2-dose (Moderna) or 3-dose (Pfizer-BioNTech) primary series of COVID-19 vaccine should complete the primary series (using the same brand for all primary series doses) with the updated COVID-19 vaccine
Individuals who are moderately to severely immunocompromised
- Those age 6 months and older who have completed a 3-dose primary series of COVID-19 vaccine should receive one dose of any age-appropriate brand and formulation of updated COVID-19 vaccine at least 2 months after their most recent dose. Additional doses may be given as deemed necessary by the individual’s clinical care team
- Those age 6 months and older who have not completed a 3-dose primary series, should complete a 3-dose primary series using the same brand for all doses. Use the age-appropriate formulation and brand of the updated COVID-19 vaccine to complete the series. Additional doses may be given as deemed necessary by the individual’s clinical care team.
CDC’s Interim Clinical Considerations for Use of COVID-19 Vaccines Currently Approved or Authorized in the United States
web page has been updated to reflect the new recommendations. Immunize.org advises all healthcare professionals recommending or administering COVID-19 vaccines review these updated considerations for specific vaccine guidance. Immunize.org resources, including Ask the Experts, the COVID-19 main page, and the Checklist of Current Versions of U.S. COVID-19 Vaccination Guidance and Clinic Support Tools
will be updated in coming weeks to reflect the new changes.
Representatives from Pfizer-BioNTech, Moderna, and Novavax presented available data on their updated 2023–2024 formulations of COVID-19 vaccine. Information from clinical trials or preclinical data indicate the updated vaccines are expected to provide cross-protection against the newer circulating SARS-CoV-2 viruses in the BA.2.86 lineage.
Extensive vaccine safety surveillance continues to indicate COVID-19 vaccines are safe and effective. Benefits continue to outweigh risk in the age groups for which risk of myocarditis is highest (males age 12 through 39 years). For example, the risk of adverse cardiac outcomes was 1.8–5.6 times higher after SARS-CoV-2 infection than after mRNA COVID-19 vaccination among males age 12 through 17 years. The strain change made in the 2023–2024 updated formulation is not expected to alter the safety profile of the vaccines.
Projected public interest in COVID-19 vaccination
A survey of more than 4,000 American adults conducted in August indicated approximately 42% definitely or probably would get the updated vaccine. Confidence in vaccine safety is higher for influenza and other routine adult vaccines than for COVID-19 vaccine. A survey conducted in June 2023 showed the impact of a healthcare provider’s recommendation: about 9 out of 10 adults who reported that their healthcare provider recommended COVID-19 vaccination had been vaccinated, while only about 2 out of 3 adults who reported that no healthcare provider had recommended COVID-19 vaccination to them had been vaccinated anyway.
Transition to routine vaccine purchase and billing
With the exception of uninsured adults, all other vaccine recipients will receive the 2023–2024 formulation of COVID-19 vaccines as they do other routine vaccines. The retail price of these vaccines is in the range of $120–$130/dose, but the cost will be fully covered by most private insurance plans, Medicaid and Medicare, and eligible children will have access through the Vaccines for Children (VFC) program. CPT codes have been updated for billing purposes.
CDC has established a temporary Bridge Access Program to cover the cost of vaccine for adults who are uninsured or underinsured. The Bridge Access Program will be available through the end of 2024 in designated pharmacies, federally qualified health centers, and public health departments. Information about dose availability, including availability of doses through the Bridge Access Program for uninsured and underinsured adults, is available at www.vaccines.gov
The next ACIP meeting will be held on Friday, September 22, when the committee will consider recommendations for the use of maternal RSV vaccine during pregnancy for the prevention of severe RSV disease in infants. Information about past and future ACIP meetings
may be found on the ACIP website.
FDA: Approval/authorization materials for Pfizer-BioNTech (2023–2024 formula)
FDA: Approval/authorization materials for Moderna (2023–2024 formula)
- Comirnaty (Pfizer-BioNTech) (for age 12 years and older)
- Emergency Use Authorization Fact Sheets: Pfizer-BioNTech (for age 6 months through 11 years)
- Dear Healthcare Provider letter (9/11/2023)
- Spikevax (Moderna) (for age 12 years and older)
- Emergency Use Authorization Fact Sheets: Moderna (for age 6 months through 11 years)
- Dear Healthcare Provider letter (9/11/2023)
Back to top
CDC updates clinical considerations for COVID-19 vaccines, including 2023–2024 recommendations
CDC updated their Interim Clinical Considerations for Use of COVID-19 Vaccines Currently Approved or Authorized in the United States on September 15. This guidance provides important details on use of COVID-19 vaccines. All healthcare professionals administering or counseling patients on COVID-19 vaccination should review all changes on the web page.
The revised Interim Clinical Considerations include:
- The ACIP recommendations adopted on September 12
- Updated guidance regarding myocarditis or pericarditis
- Updated guidance regarding multisystem inflammatory syndrome (MIS) in children (MIS-C) and in adults (MIS-A)
- Reorganization and consolidation of sections on contraindications and precautions, including allergic reactions to COVID-19 vaccines
View the CDC’s Interim Clinical Considerations for Use of COVID-19 Vaccines Currently Approved or Authorized in the United States web page.
HHS launches Bridge Access Program to provide COVID-19 vaccines at no cost for uninsured and underinsured adults
On September 14, CDC issued a press release announcing the launch of the federal Bridge Access Program, a program to sustain broad access to COVID-19 vaccines at no cost to millions of uninsured and underinsured adults. A portion of the press release appears below.
Administered through the Centers for Disease Control and Prevention, the more than $1 billion program will create a unique public-private partnership to help maintain uninsured individuals’ access to COVID-19 care at their local pharmacies, through existing public health infrastructure, and at their local health centers. Doses will be available in some locations this week, with distribution increasing in the coming weeks. . . .
The Bridge Access Program is temporary and scheduled to end in December 2024. A longer-term solution is the Vaccines for Adults (VFA) program, proposed in both the FY 2023 and 2024 Presidential Budgets, which would cover all recommended vaccinations at no cost for uninsured adults. This proposal has not yet been enacted into law.
COVID-19 vaccines remain free for most Americans through their health insurance plans—or through the Vaccines for Children (VFC) program, which provides recommended vaccines and immunizations at no cost to about half of the nation’s children. Vaccination remains the best available protection against the most severe outcomes of COVID-19, including hospitalization and death.
In addition to public health clinics and federally qualified health centers, most CVS and Walgreens locations will participate, as well as selected independent and other pharmacies under contract with eTrueNorth. To locate COVID-19 vaccines available through the Bridge Access Program in clinics near you, visit Vaccines.gov; information on participating pharmacies is being added to the site, but may not be available at the time of this publication.
Immunize.org updates its “Ask the Experts” web page on influenza for the 2023–24 season
Immunize.org's popular Ask the Experts: Influenza web page was updated for the 2023–24 influenza season. Answers have been updated with current information on the burden of influenza disease, current season vaccines, and information about routine vaccine administration for people with egg allergies.
CDC and ACIP consider egg allergy of any severity neither a contraindication nor a precaution to the routine use of any egg-based or non-egg-based influenza vaccine. No additional precautions are necessary for people with an egg allergy of any severity beyond those recommendations for safe administration of any vaccine.
Immunize.org’s Ask the Experts main page leads you to 30 web pages on various topics with more than 1,200 common or challenging questions and answers about vaccines and their administration. Immunize.org’s team of experts includes Kelly L. Moore, MD, MPH (team lead), Carolyn B. Bridges, MD, FACP, and Iyabode Beysolow, MD, MPH.
“MenACWY Given at Age 10. Revaccinate at 11, or Not?”: watch the 1-minute answer, part of the Ask the Experts Video Series
on Facebook, LinkedIn, X (Twitter), YouTube, and Instagram
Immunize.org's social media channels make it easy for you to learn a little more every day. This week, our featured episode from the Ask the Experts Video Series is MenACWY Given at Age 10. Revaccinate at 11, or Not? This is available on our YouTube channel, along with our full collection of quick video answers to popular Ask the Experts questions.
Like, follow, and share Immunize.org’s social media accounts and encourage colleagues and others interested in vaccination to do likewise:
Back to top
Spotlight: Immunize.org's resources focused on communication between healthcare personnel and patients or caregivers
The Talking about Vaccines web page provides healthcare professionals with 11 topical web pages to help them discuss vaccination with concerned parents or patients. Topics include, for example, adjuvants, alternative medicine, autism, religious concerns, and thimerosal.
The Unprotected People Stories web page features more than 100 real-life accounts of people who suffered or died from vaccine-preventable diseases.
Handouts for Patients and Staff leads to hundreds of resources that are free to download, print, copy, and distribute widely.
Vaccine Basics: Common Questions about Vaccines on Immunize.org’s public website, vaccineinformation.org, offers patients and caregivers timely and accurate information about vaccines and the diseases they prevent.
These recent articles convey the potential risks of vaccine-preventable diseases and the importance of vaccination.
Immunize.org Pages and Handouts
Immunize.org updates the 2023–24 influenza vaccination standing orders templates—one for adults and one for children and teens
Immunize.org revised the wording of the two current (2023–24) standing orders templates for influenza based upon questions from readers. The new wording is intended to make it more explicit that the ACIP and CDC do not consider egg allergy a contraindication or precaution to the use of any influenza vaccine. No additional safety measures are necessary when administering any influenza vaccine to a person with egg allergy of any severity beyond standard practices for safe vaccine administration. The note is now clearly placed under the subheading, “Not a contraindication or a precaution.”
In addition, the phrase, “live virus” was inadvertently missing from the statement on the routine 4-week interval recommended between live attenuated influenza vaccine and other injectable live virus vaccines not administered on the same day.
The two standing order templates include both injectable and intranasal influenza vaccines:
Please replace previous versions of these templates with the current versions.
Back to top
Immunize.org revises its clinical resource “Communicating the Benefits of Influenza Vaccination” for the 2023–24 season
Immunize.org revised its clinical resource, co-branded with Association of Immunization Managers (AIM), Communicating the Benefits of Influenza Vaccination. The influenza vaccination rates displayed on the top right were updated and the document acknowledges the potential need for immunization against other respiratory viruses, including COVID-19 and RSV. Use this resource to improve communications with patients.
Back to top
Immunize.org updates three handouts, “Notification of Immunization Letter Template,” “Hepatitis A is a Serious Liver Disease: Vaccination Can Protect You!,” and “Hepatitis A: Questions and Answers”
Immunize.org updated three handouts to include a QR code linking users to the PDF of the current document. Additional changes to the resources include:
Back to top
Immunize.org updates its “Vaccine Timeline” web page to include recent vaccine-related events
Immunize.org’s Vaccine Timeline main page was updated to include new events related to vaccines and immunization.
If you would like to suggest an event to add, contact us at email@example.com.
Vaccine Information Statements
Immunize.org posts 12 new translations of CDC’s recently updated multi-vaccine Vaccine Information Statement for infants
Immunize.org posted 12 translations of the multi-vaccine Vaccine Information Statement (VIS) titled Your Child’s First Vaccines VIS, which CDC updated on July 24, 2023. These translations join the Spanish (RTF) VIS. This VIS provides information on diphtheria, tetanus, pertussis, Hib, hepatitis B, pneumococcal, and poliovirus vaccines, including 20-valent pneumococcal conjugate vaccine (PCV20) as an option for vaccination.
All translations are available in print-ready PDF format.
Your Child’s First Vaccines (view in English):
Check the version dates of your office copies of newly updated translations. Translations of previous VIS versions should be discarded now that translations of the current version are available.
Back to top
Vaccinate Your Family launches its 2023–24 “Not ‘Just’ the Flu” campaign to raise awareness about the seriousness of influenza
Vaccinate Your Family launched its Not “Just” the Flu campaign to raise awareness about the seriousness of influenza and the importance of flu vaccination.
This campaign features key messages, social media graphics, pre-drafted posts, and downloadable videos from individual advocates affected by flu. Resources include:
The campaign will run for as long as influenza season lasts. Please share on your social platforms with the hashtag #NotJustFlu.
Feel free to co-brand materials. Please reach out to firstname.lastname@example.org
with your branding questions.
Back to top
Voices for Vaccines releases video “What is Community Immunity?” to share with patients and the public
Voices for Vaccines released an animated video with voice-over titled What is Community Immunity? (3:18 minutes). It is designed to explain how people build immunity to infectious diseases and why it's important to get vaccinated.
Download and share the video across social media and other platforms using the hashtag #VoicesForVaccines.
Organizing a new vaccination program? Use Immunize.org’s Vaccinating Adults: A Step-by-Step Guide
—free to download by chapter or in its entirety.
Download Immunize.org’s free 142-page book on adult vaccination to help build your program and train your team: Vaccinating Adults: A Step-by-Step Guide (Guide).
This thorough "how to" guide on adult vaccination provides easy-to-use, practical information covering all essential activities. It helps vaccine providers enhance their existing adult vaccination services or introduce them into any clinical setting.
The Guide is available to download/print either by chapter or in its entirety free at www.immunize.org/guide. The National Vaccine Program Office and CDC both supported the development of the Guide and provided early technical review.
The Guide is a valuable resource to assist providers in increasing adult vaccination rates. Be sure to get a copy today!
Please note: this guide was produced in 2017, before the COVID-19 era, and reflects the recommendations of that time.
“Interim Effectiveness Estimates of 2023 Southern Hemisphere Influenza Vaccines in Preventing Influenza-Associated Hospitalizations—REVELAC-I Network, March–July 2023” published in MMWR
CDC published Interim Effectiveness Estimates of 2023 Southern Hemisphere Influenza Vaccines in Preventing Influenza-Associated Hospitalizations—REVELAC-I Network, March–July 2023 in the September 15 issue of MMWR. A portion of the summary appears below.
Effectiveness of seasonal influenza vaccine varies by season and circulating virus type. . . .
The 2023 Southern Hemisphere seasonal influenza vaccine reduced the risk for influenza-associated hospitalizations by 52%. Circulating influenza viruses were genetically similar to those targeted by the 2023–24 Northern Hemisphere influenza vaccine formulation. This vaccine might offer similar protection if these viruses predominate during the coming Northern Hemisphere influenza season. . . .
Vaccination remains one of the most effective ways to protect against influenza-associated complications. In anticipation of Northern Hemisphere influenza virus circulation, CDC recommends that health authorities encourage U.S. healthcare providers to administer seasonal influenza vaccine to all eligible persons aged ≥6 months.
Access the MMWR article in HTML and PDF.
Virtual: Watch the ACIP discuss RSV vaccination during pregnancy on September 22 at 10:00 a.m. (ET)
CDC will convene its Advisory Committee on Immunization Practices (ACIP) on September 22, from 10:00 a.m.–5:00 p.m. (ET). The committee will discuss maternal respiratory syncytial virus (RSV) vaccination. In August, the U.S. Food and Drug Administration (FDA) licensed one RSV vaccine (Abrysvo, Pfizer) for use during pregnancy between 32—36 weeks gestation to prevent lower respiratory tract disease caused by RSV in infants from birth through 6 months of age.
No registration is required to watch webcasts of live ACIP meetings or listen via telephone. Opportunities for public comment are described at the website.
Virtual: NCIRD offers webinar “Clinical Guidance for Use of Products to Prevent RSV Disease in Infants” on September 27 at 12:00 p.m. (ET); CE available
The Immunization Services Division (ISD) in CDC's National Center for Immunization and Respiratory Diseases (NCIRD) will host a webinar in their Current Issues in Immunization Webinar (CIIW) Series titled Clinical Guidance for Use of Products to Prevent RSV Disease in Infants, 12:00–1:00 p.m. (ET) on September 27. The presentation will review the ACIP-recommended use of nirsevimab, a long-acting monoclonal antibody for the prevention of RSV in infants, as well as any recommendations made by ACIP on September 22 concerning the use of RSV vaccine during pregnancy.
Registration is not needed, but participation is limited. Continuing education credit is available.
A recording will be available following the webinar. View archived CIIW videos
Join the event directly
Back to top
Virtual: Moderna offers multiple informational briefings for clinical staff on the updated 2023–2024 Moderna COVID-19 vaccine formulation in September
Moderna will host several virtual informational briefings for clinical staff titled Understanding the Updated Moderna COVID-19 Vaccine (2023–2024 Formulation) through September 29. Briefings will feature 15-minute presentations, followed by live, 30-minute Q&A sessions. Topics will include: