- FDA licenses and authorizes updated mRNA COVID-19 vaccines to better protect against currently circulating variants
- FDA changes schedule for GSK MenB (Bexsero): now same schedule as Pfizer MenB (Trumenba) with 2 doses 6 months apart or 3 doses given at 0, 1–2, and 6 months
- Immunize.org updates “Ask the Experts: Influenza” web section for the 2024–25 influenza season
- Immunize.org adds new PCV21 to “Ask the Experts: Pneumococcal” web section
- “National Vaccination Coverage among Adolescents Aged 13–17 Years—National Immunization Survey-Teen, United States, 2023” published in MMWR
- “Human Papillomavirus Vaccination Coverage among Adolescent Girls Aged 13–17 Years—U.S.-Affiliated Pacific Islands, 2013–2023” published in MMWR
- Immunize.org adds new vaccines to popular resource “Before You Vaccinate Adults, Consider Their ‘H-A-L-O’!”
- Immunize.org updates “Vaccines with Diluents: How to Use Them” resource
- Watch and share the latest installment in Immunize.org’s Orientation Video Series: Introducing VIS and VIS Translations
- Journalists interview Immunize.org experts
- Vaccines in the news
- Spotlight on the website: This season’s influenza VISs and access to translations
- Recap: Immunize.org introduces standing orders template for RSV vaccination of adults age 60 years and older
- Recap: Immunize.org updates the screening checklists for contraindications to injectable and live attenuated influenza vaccines for the 2024–25 season
- Recap: Immunize.org updates “Administering Vaccines: Dose, Route, Site, and Needle Size” and companion version for adults
- Recap: Immunize.org updates “Notification of Immunization Letter Template” to include newly recommended vaccines
On August 22, the FDA licensed and granted emergency use authorization (EUA) for updated mRNA COVID-19 vaccines (2024–2025 Formula) to include a single component that corresponds to the Omicron variant KP.2 strain of SARS-CoV-2. Comirnaty (Pfizer) and Spikevax (Moderna) are licensed for routine use in people age 12 years or older. The Pfizer and Moderna vaccines are authorized for emergency use (requiring use of EUA fact sheets) in children younger than age 12 years.
At its June 2024 meeting, ACIP voted in advance to approve the use of new 2024–2025 Formula COVID-19 vaccines in the manner licensed or authorized by FDA. Therefore, clinicians may begin using these vaccines as indicated by FDA as soon as they receive them. A portion of the FDA press release appears below.
What You Need to Know
- Unvaccinated individuals 6 months through 4 years of age are eligible to receive three doses of the updated, authorized Pfizer-BioNTech COVID-19 Vaccine or two doses of the updated, authorized Moderna COVID-19 Vaccine.
- Individuals 6 months through 4 years of age who have previously been vaccinated against COVID-19 are eligible to receive one or two doses of the updated, authorized Moderna or Pfizer-BioNTech COVID-19 vaccines (timing and number of doses to administer depends on the previous COVID-19 vaccine received).
- Individuals 5 years through 11 years of age regardless of previous vaccination are eligible to receive a single dose of the updated, authorized Moderna or Pfizer-BioNTech COVID-19 vaccines; if previously vaccinated, the dose is administered at least 2 months after the last dose of any COVID-19 vaccine.
- Individuals 12 years of age and older are eligible to receive a single dose of the updated, approved Comirnaty or the updated, approved Spikevax; if previously vaccinated, the dose is administered at least 2 months since the last dose of any COVID-19 vaccine.
- Additional doses are authorized for certain immunocompromised individuals ages 6 months through 11 years of age as described in the Moderna COVID-19 Vaccine and Pfizer-BioNTech COVID-19 Vaccine fact sheets.
On August 23, CDC posted 2024–2025 Formula COVID-19 vaccine guidance on its website regarding interim clinical considerations for the use of COVID-19 vaccines. Based upon that guidance, Immunize.org will revise our COVID-19 content. Watch for document and website revisions coming soon, including new standing orders templates from CDC for the use of 2024–2025 mRNA COVID-19 vaccines. These updates will be reflected in new versions of Immunize.org’s Checklist of Current Versions of U.S. COVID-19 Vaccination Guidance and Clinic Support Tools.
Do not administer any remaining dose of any 2023–2024 Formula COVID-19 vaccine; remove them from storage units and dispose of them or return them as appropriate. All doses of the protein-based 2023–2024 Formula Novavax COVID-19 vaccine expired earlier in the summer, and the 2024–2025 Formula Novavax COVID-19 vaccine is not yet authorized by FDA.
CDC will post updated interim clinical considerations for the use of 2024–2025 Formula Novavax COVID-19 vaccine after FDA reaches decisions about it; Immunize.org will revise our content at that time.
Related Links
- FDA: FDA Approves and Authorizes Updated mRNA COVID-19 Vaccines to Better Protect against Currently Circulating Variants (8/22/24)
- FDA: Comirnaty (COVID-19 Vaccine, mRNA) (2024–2025 Formula)
- FDA: Spikevax (COVID-19 Vaccine, mRNA) (2024–2025 Formula)
- FDA: Moderna COVID-19 Vaccine (2024–2025 Formula)
- FDA: Pfizer-BioNTech COVID-19 Vaccine (2024–2025 Formula)
- CDC: Use of COVID-19 Vaccines in the United States: Interim Clinical Considerations
On August 19, FDA approved a new dosing schedule for GSK meningococcal B (MenB) vaccine (Bexsero) that matches the schedule for Pfizer MenB vaccine (Trumenba), with 2 doses given 6 months apart or 3 doses given at 0, 1–2, and 6-month intervals. Bexsero’s original 2-dose schedule, with a 1-month interval between the two doses, is no longer licensed.
ACIP is expected to review the new schedule at its October 2024 meeting. Questions about recipients of the previously approved 2-dose (1-month interval) Bexsero schedule are likely to be discussed by ACIP at that time. In the interim, healthcare providers should refer to the updated Bexsero package insert for the currently approved schedule.
Related Links
- FDA: Bexsero product information web page
- CDC: Meningococcal Vaccine Recommendations web page
- Immunize.org: Vaccines A–Z: Meningococcal B
Immunize.org updated all the questions and answers on its popular Ask the Experts: Influenza web page. Clinical content now reflects 2024–25 influenza season recommendations. Changes include:
- References to the 2024–25 trivalent vaccines (containing two influenza A and one influenza B virus vaccine antigen) following removal of the B/Yamagata virus from the vaccine because it is no longer circulating
- Unless necessary for understanding, references to the number of strains in vaccines (also called “valency”) were removed
- ACIP affirmation that everyone age 6 months and older who has an egg allergy may receive any age-appropriate influenza vaccine without special precautions
- ACIP allowance for off-label use of high-dose (HD-IIV, Fluzone High Dose, Sanofi) or adjuvanted influenza vaccine (aIIV, Fluad, CSL Seqirus) as an option for solid organ transplant recipients age 18 through 64 years who are on immunosuppressive medication regimens, without a preference over any other age-appropriate injectable influenza vaccine
- Updated hyperlinks, as needed
Immunize.org’s Ask the Experts main page leads you to 30 web pages on various topics with more than 1,300 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; Iyabode Beysolow, MD, MPH; and Jane R. Zucker, MD, MPH.
Related Links
- Immunize.org: Ask the Experts main page with more than 1,300 questions and answers
- Immunize.org: Ask the Experts: Influenza web section
Immunize.org updated all the questions and answers on its popular Ask the Experts: Pneumococcal web page. The clinical content now reflects updated recommendations for PCV21 vaccine (Capvaxive, Merck) as an option for adults age 18 years or older who are recommended to receive a pneumococcal conjugate vaccine. Hyperlinks were also updated as needed.
Immunize.org’s Ask the Experts main page leads you to 30 web pages on various topics with more than 1,300 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; Iyabode Beysolow, MD, MPH; and Jane R. Zucker, MD, MPH.
Related Links
- Immunize.org: Ask the Experts main page with more than 1,300 questions and answers
- Immunize.org: Ask the Experts: Pneumococcal web section
CDC published National Vaccination Coverage among Adolescents Aged 13–17 Years—National Immunization Survey-Teen, United States, 2023 on August 22 in MMWR. A portion of the summary appears below.
Vaccinations are the best defense to protect persons and communities from serious vaccine-preventable diseases. Three vaccines are routinely recommended for adolescents. The Vaccines for Children (VFC) program provides recommended vaccines at no cost to eligible children and adolescents. . . .
Overall, vaccination coverage among VFC-eligible adolescents remained stable across recent birth years, except for a decline in human papillomavirus vaccine up-to-date coverage by age 13 years among those born in 2010 compared with those born in 2007. . . .
Health care providers should make strong recommendations for all routine vaccines and verify if adolescents, particularly those eligible for the VFC program, are up to date with all recommended vaccines.
Access the MMWR article in HTML or PDF.
Related Link
- CDC: MMWR main page providing access to the MMWR family of publications
CDC published Human Papillomavirus Vaccination Coverage among Adolescent Girls Aged 13–17 Years—U.S.-Affiliated Pacific Islands, 2013–2023 on August 22 in MMWR. A portion of the summary appears below.
Cervical cancer is the fourth most common cancer among women worldwide, and the World Health Organization Western Pacific Region, where the U.S.-affiliated Pacific Islands (USAPI) are located, accounts for one quarter of all estimated cases. Human papillomavirus (HPV) vaccines prevent most cervical cancers and are recommended for girls at age 11–12 years. . . .
This is the first comprehensive report of trends in HPV vaccination coverage among adolescent girls since the vaccines were introduced in USAPI jurisdictions [Northern Mariana Islands and American Samoa, but not four others]. Coverage with HPV vaccine is on track to meet 2030 goals in two jurisdictions, but disparities need to be addressed. . . .
Adolescent vaccination coverage assessment identifies progress toward regional goals. To target increased vaccine access and coverage, this assessment identifies populations and areas with low coverage.
Access the MMWR article in HTML or PDF.
Related Links
- CDC: MMWR main page providing access to the MMWR family of publications
- Immunize.org: Vaccines A–Z: Human Papillomavirus
Immunize.org recently updated its resource for healthcare professionals titled Before You Vaccinate Adults, Consider Their “H-A-L-O”!
H-A-L-O refers to four factors:
- Health condition
- Age
- Lifestyle
- Occupation
The document now includes mpox vaccine and updated polio (IPV) vaccination recommendations for previously unvaccinated adults. The RSV vaccine section was revised to match the June 2024 ACIP recommendations for routine vaccination of adults age 75 years and older, and risk-based vaccination of adults age 60 through 74 years.
Related Links
- Immunize.org: Clinic Tools: Vaccine Recommendations web page
- Immunize.org: Clinical Resources A–Z main page, where you can filter by topic, vaccine, language, or other criteria
Immunize.org recently added Penbraya (MenABCWY, Pfizer) to its Vaccines with Diluents: How to Use Them and updated the resource to specify the formulation of Pfizer-BioNTech COVID-19 vaccine that requires dilution.
Related Links
- Immunize.org: Clinical Resources: Storage & Handling main page
- Immunize.org: Clinical Resources A–Z main page, where you can filter by topic, vaccine, language, or other criteria
Immunize.org is pleased to share the latest installment in the Orientation Video Series, a 3-minute video introducing our VIS and VIS translations. This is one of the most popular sections of the Immunize.org website, featuring hundreds of VIS translations.
Available now on our YouTube channel, this is the third in our new Orientation Video Series. These videos will help both new and experienced users get the most out of all the online resources we offer. Horizontal versions of these videos, like the one below, orient viewers to the desktop format of the website. Vertical versions feature the mobile view displayed for smartphone users.
Please share this video with anyone who needs to learn how to get the most out of Immunize.org’s website to support effective immunization practices.
Like, follow, and share Immunize.org’s social media accounts and encourage colleagues and others interested in vaccination to do likewise.
- Facebook at ImmunizeOrg
- Instagram at ImmunizeOrg
- LinkedIn at ImmunizeOrg
- YouTube at ImmunizeOrg
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.
- Wall Street Journal: The FDA Approved New COVID Vaccines. Should You Get One? (8/23/24)
- NPR: FDA Approves Two Updated COVID Vaccines (8/22/24)
These recent articles convey the potential risks of vaccine-preventable diseases and the importance of vaccination.
- New York Times: Why Mpox Vaccines Aren’t Flowing to Africans in Desperate Need (8/23/24)
- New York Times: Whooping Cough Is Coming Back (8/22/24)
As facilities prepare for influenza vaccination season, several readers asked if the August 6, 2021, versions of influenza (inactivated or recombinant) and influenza (live, intranasal) VISs are the ones to use this season. The answer is yes! Unlike the vaccine products themselves, influenza VISs are not necessarily revised each year.
Find current influenza VISs and available translations at Immunize.org by clicking the "Vaccines & VISs" tab at the top of any page. Select “VISs” in the left column to display the menu of VIS pages. There are separate links labeled Influenza (inactivated or recombinant) and Influenza (live, intranasal). Each individual VIS web page lists all available translations of that VIS.
If you prefer to access all the VISs available in a particular language, select the "VIS Translations" option in the left column of the main menu. On the VIS translations page, select your language of interest from the "Choose Language" dropdown list.
Immunize.org offers a new, 3-page resource that allows users to scan a QR code for instant digital access to an injectable influenza vaccine VIS in any available language: QR Code Links to Vaccine Information Statement (VIS) Translations: Influenza (Flu) Vaccine (Inactivated or Recombinant).
Scan any QR code with your smartphone to open a translation in a specific language. Spanish and English QR codes are on the front page, followed by an alphabetical list of all available translations. Under each QR code, the title of the VIS is included in that language.
Related Links
- Immunize.org: Influenza (Inactivated or Recombinant) VIS web page
- Immunize.org: Influenza (Live Intranasal) VIS web page
- Immunize.org: VIS Translations web page
- Immunize.org: QR Codes Links to Vaccine Information Statement (VIS) Translations: Influenza (Flu) Vaccine (Inactivated or Recombinant)
- CDC: About VISs web page
- CDC: Current VISs web page
A new template, Standing Orders for Administering Respiratory Syncytial Virus Vaccine (RSV) to Adults Age 60 Years and Older, is available from Immunize.org. This template reflects current ACIP recommendations for any of the three licensed RSV vaccines: Abrysvo (Pfizer), Arexvy (GSK), and mResvia (Moderna).
In June 2024, ACIP recommended routine RSV vaccination of two groups:
- All unvaccinated adults age 75 years and older
- Unvaccinated adults age 60–74 years who experience health or living conditions that increase their risk of serious RSV disease
ACIP no longer recommends the use of shared clinical decision-making for RSV vaccination of adults age 60–74 years who are not at increased risk for serious RSV disease. People who previously received RSV vaccine should not be revaccinated this season.
Standing orders templates help vaccine providers establish protocols to streamline routine immunization without requiring individual patient orders.
Immunize.org also offers other standing orders templates for RSV prevention:
- Standing Orders for Administering Nirsevimab RSV Preventive Antibody (Beyfortus, by Sanofi) to Infants
- Standing Orders for Administering Pfizer Respiratory Syncytial Virus (RSV) Vaccine (Abrysvo) during Pregnancy
Immunize.org provides general information about the use of standing orders templates at Using Standing Orders for Administering Vaccines: What You Should Know.
Immunize.org updated its screening checklists for the 2024–25 influenza season to remove references to the number of strains contained in influenza vaccine products. All vaccines for this season contain three strains, following the removal of the B/Yamagata strain that is no longer detected anywhere in the world. The checklists are:
- Screening Checklist for Contraindications to Injectable Influenza Vaccination
- Screening Checklist for Contraindications to Live Attenuated Intranasal Influenza Vaccination
Immunize.org recently updated two clinical resources:
- Administering Vaccines: Dose, Route, Site, and Needle Size
- Administering Vaccines to Adults: Dose, Route, Site, and Needle Size
Updates to both documents include the following:
- The volume for Fluzone High-Dose (HD-IIV, Sanofi) vaccine changed from 0.7 mL to 0.5 mL for the 2024–25 season
- References were removed for the specific number of strains in influenza vaccines
- A footnote now indicates that 2024–25 HD-IIV and adjuvanted IIV (Fluad, CSL Seqirus) are options for administration to people age 18–64 years who are solid organ transplant recipients on an immunosuppressive medication regimen
- The mpox (Jynneos, Bavarian Nordic) footnote was updated to state that subcutaneous administration is preferred over intradermal administration
- Readers are directed to the latest COVID-19 vaccine information in Immunize.org's frequently updated Checklist of Current Versions of U.S. COVID-19 Vaccination Guidance and Clinic Support Tools
- MenABCWY (Penbraya, Pfizer) was added
Immunize.org recently updated its Notification of Immunization Letter Template to incorporate the new pneumococcal conjugate vaccine, PCV21 (Capvaxive, Merck), the new mRNA RSV vaccine (mResvia, Moderna), MenABCWY (Penbraya, Pfizer), and mpox vaccine (Jynneos, Bavarian Nordic).
HHS launched a national campaign, Risk Less. Do More., that aims to increase awareness of vaccines that reduce serious illness from influenza, COVID-19, and RSV. The campaign will provide resources to facilitate provider conversations with patients about vaccines against these viruses.
Related Links
- HHS: Risk Less. Do More. campaign web page
- HHS: HHS Launches National Public Education Campaign Ahead of Respiratory Virus Season (8/19/24)
Resources to ease children’s fears about vaccines—from Daniel Tiger to Immunize.org’s clinical resources on improving the vaccination experience
The University of Pittsburgh Medical Center (UPMC) Health Plan partnered with Fred Rogers Productions to create two 4-minute Daniel Tiger’s Neighborhood audio stories to help young ones prepare for their vaccinations. The stories follow Daniel Tiger’s journey from the moment he learns he is getting a shot to talking with Dr. Anna about what it will be like and why it’s important. This is part of a PBS series on children and fear.
Access the audio stories by prompting your Amazon Alexa or Google Assistant device to “Ask UPMC Health Plan for a Daniel Tiger story.”
Also related to easing children’s fears, Immunize.org offers a suite of resources to help vaccination providers, recipients, caregivers, and companions effectively address vaccination pain and anxiety. Specific guidance is available for infants and toddlers or older children, including a short video for parents. All Immunize.org’s print and video resources are available in one convenient location on our Clinical Resources: Improving the Vaccination Experience web page. Links to additional resources from trusted partner organizations are also provided.
Related Links
- Pittsburgh Magazine: Who Better than Daniel Tiger to Calm Children’s Fears about Vaccines? (1/3/23)
- PBS: Fred Rogers Timeless Wisdom: Children and Fears
- PBS: It's Time for Daniel's Shot | Daniel Tiger's Neighborhood video
- PBS: Why Do I Need to Get a Shot? | Daniel Tiger's Neighborhood video
- Immunize.org: Improving the Vaccination Experience main page
- Immunize.org: Improving the Vaccination Experience Video Series on YouTube
The Society of Infectious Diseases Pharmacists will present a 1-hour webinar titled Update Your Vaccination Toolbox: When and How to Use the Vaccine for Mpox beginning at 1:00 p.m. (ET) on September 19. The webinar will include a presentation by an expert faculty, active learning engagement questions throughout, and a live question and answer session.
Free continuing pharmacy education credits will be offered for the live event.
Register for the webinar.