FDA licenses second respiratory syncytial virus (RSV) vaccine for people age 60 and older; ACIP will consider recommendations for use at its June meeting
According to CDC, each year in the United States respiratory syncytial virus (RSV) leads to 60,000–120,000 hospitalizations and 6,000–10,000 deaths among adults age 65 years and older. Like influenza, RSV is a seasonal virus, with peak activity typically occurring each fall or winter.
On May 31, FDA licensed the second vaccine to prevent RSV in adults, known as Abrysvo (uh-BREEZ-voh) and manufactured by Pfizer. Abrysvo is licensed for preventing lower respiratory tract disease (LRTD) caused by RSV in people age 60 years and older. The next step is for Advisory Committee on Immunization Practices (ACIP) to consider recommendations for the vaccine's use at its June meeting. A portion of the FDA announcement appears below.
In an ongoing clinical trial, approximately 17,000 individuals have received Abrysvo and approximately 17,000 individuals have received a placebo. Data from the first RSV season of the study were available for the FDA’s analysis. Abrysvo reduced the risk of developing RSV-associated LRTD with two or more symptoms by 66.7% and with three or more symptoms by 85.7%. Among a subset of clinical trial participants, the most commonly reported side effects were fatigue, headache, pain at the injection site and muscle pain. Guillain-Barré syndrome was reported 7 days after receipt of Abrysvo in one participant and Miller Fisher syndrome (a variant form of Guillain-Barré syndrome), was reported 8 days after receipt of Abrysvo in one participant. Atrial fibrillation within 30 days after vaccination was reported in 10 participants who received Abrysvo and 4 participants who received placebo.
"Estimates of SARS-CoV-2 Seroprevalence and Incidence of Primary SARS-CoV-2 Infections among Blood Donors, by COVID-19 Vaccination Status—United States, April 2021–September 2022" published in MMWR
CDC published Estimates of SARS-CoV-2 Seroprevalence and Incidence of Primary SARS-CoV-2 Infections among Blood Donors, by COVID-19 Vaccination Status—United States, April 2021–September 2022 on June 2 in MMWR. A portion of the summary appears below.
SARS-CoV-2 hybrid immunity (immunity derived from both previous infection and vaccination) has been reported to provide better protection than that from infection or vaccination alone. . . .
By the third quarter of 2022, an estimated 96.4% of persons aged ≥16 years in a longitudinal blood donor cohort had SARS-CoV-2 antibodies from previous infection or vaccination, including 22.6% from infection alone and 26.1% from vaccination alone; 47.7% had hybrid immunity. Hybrid immunity prevalence was lowest among adults aged ≥65 years. . . .
Low prevalence of infection-induced and hybrid immunity among older adults, who are at increased risk for severe disease if infected, reflects the success of public health infection prevention efforts while also highlighting the importance of this group staying up to date with recommended COVID-19 vaccination, including at least 1 bivalent dose.
Access the MMWR article in HTML or PDF.
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Check out our latest Ask the Experts video on Facebook, LinkedIn, Twitter, YouTube, and Instagram. Follow us and share our posts featuring Ask the Experts and our clinical resources.
Immunize.org's social media program highlights our educational resources for a new audience of vaccinators. Our latest short video, “Can COVID-19 Vaccination Lead to Fertility Problems?” is available now on our YouTube channel, along with all of our Ask the Experts videos. Our social media channels now feature our most popular printable resources and Ask the Experts questions and answers, as well as announcements important to frontline vaccinators.
Like, follow, and share Immunize.org’s social media accounts and encourage colleagues and others interested in vaccination to do likewise:
Floods, hurricanes, tornadoes, disasters: it’s the season to exercise your emergency plan
Power outages can create emergency conditions that damage your valuable vaccine inventory. For this reason, every site that stocks vaccines needs an emergency plan. Every Vaccines for Children (VFC) site is required to have one. Follow CDC’s Vaccine Storage and Handling Toolkit to create an emergency plan for your clinic and then practice your plan this month. Build redundancy, flexibility, and communication into your plan. Consider:
- Equipment backup options
- Alternate storage options
- Vaccine transport plans
Your plan should include at least one facility that is willing to receive and properly store your vaccine inventory if it must be relocated. CDC’s guide provides detailed instructions on monitoring temperatures during a power outage and what to do once proper storage is restored. Print out your plan before the power goes out!
Prevent avoidable vaccine waste by training your staff on emergency procedures, including after-hours roles and responsibilities. Then run an exercise to check understanding.
Spotlight: Immunize.org resources that focus on vaccine products and manufacturers
In this week's Spotlight, we summarize resources at Immunize.org that focus on specific vaccine products.
Package Inserts and FDA Product Approvals main page provides up-to-date product information links and links to FDA vaccine approval web pages for all vaccines licensed for use in the United States.
Vaccine Manufacturers main page provides links to the websites of the vaccine manufacturers in the United States, as well as providing contact information such as telephone numbers and email addresses. In addition, the vaccine products for each of the companies are listed.
Vaccines main page links to information about 24 vaccines and the diseases they prevent. For each vaccine, access the latest recommendations, information, and resources from Immunize.org and CDC.
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 one 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
Recap: Immunize.org updated these clinic resources in April and May
IZ Express regularly summarizes Immunize.org’s new and updated educational materials. All Immunize.org materials are free to distribute. In recent weeks, Immunize.org updated these helpful materials:
Immunize.org Web Pages
Immunize.org Printable Materials for Patients
Immunize.org Materials for Clinicians
- Top 10 Reasons to Protect Your Child by Vaccinating
- After the Shots . . . What to Do If Your Child has Discomfort with translations in Spanish, Arabic, Chinese-Simplified (corrected), French, Korean, Russian, Vietnamese
- Questions Parents Ask About Vaccinations for Babies
- Vaccinations for Preteens and Teens with translations in Spanish, Arabic, Chinese-Simplified, French, Korean, Russian, Vietnamese
- Vaccinations for Adults with translations in Spanish, Arabic, Chinese-Simplified, French, Korean, Russian, Vietnamese
- Tips for Locating Old Immunization Records
- Pneumococcus: Questions and Answers
- Protect Yourself from Hepatitis A and Hepatitis B with translation in Spanish
- Shingles (Zoster): Questions and Answers
- MMR Vaccine Does Not Cause Autism
- 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 eight 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
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Vaccine Information Statements
Recap: Two new interim Vaccine Information Statements released in May
IZ Express regularly provides readers with information about new and updated Vaccine Information Statements (VISs) and their translations.
In response, Immunize.org updated two handouts related to VISs:
On May 12, CDC released two new interim VISs:
AAP offers new podcast episode from Pediatrics on Call
discussing vaccine hesitancy
American Academy of Pediatrics (AAP) posted a new entry in its Pediatrics On Call podcast series: Drowning Prevention, Vaccine Hesitancy (33 minutes). A description from the podcast web page appears below.
In the first full episode, hosts Joanna Parga-Belinkie, MD, FAAP and David Hill, MD, FAAP share why they became pediatricians and introduce listeners to the new podcast from the American Academy of Pediatrics. Guest interviews address two of the biggest issues facing children’s health today: drowning and vaccine hesitancy.
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 vaccine outreach 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 update 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.
Laminated versions of CDC’s 2023 immunization schedules are going fast. Get yours before they're gone!
Immunize.org's laminated versions of the 2023 U.S. child and adolescent immunization schedule and the 2023 U.S. adult immunization schedule are still available. Order while supplies last. Once sold out, we will not print more until 2024.
While the schedules are available online from CDC at no cost, Immunize.org’s laminated schedules are ideal for use in any busy healthcare setting. Their tough coating can be wiped down, and they’re durable enough to stand up to a year of use.
- Length: Each schedule with appendices is 12 pages
- Size: Standard 8.5” X 11” booklet format
- Full Color: With color coding for easy reading, our laminated schedules replicate the original CDC formatting, including the essential tables and notes
- Bonus: The adult schedule includes Immunize.org’s popular 1-page handout summarizing the dose, route, and needle length recommendations for all vaccines and recipients
Pricing for Each Schedule
$10.00: 1 copy
$ 9.50 each: 2–4 copies
$ 8.50 each: 5–19 copies
$ 7.50 each: 20–99 copies
$ 6.00 each: 100–499 copies
$ 5.00 each: 500–999 copies
$ 4.00 each: 1,000–1,999 copies
$ 3.25 each: 2,000+ copies
Visit Shop Immunize.org: Laminated Schedules to view images of each page and order today!
For additional information, call 651-647-9009 or email firstname.lastname@example.org.
“Safety of COVID-19 mRNA Vaccination among Young Children in the Vaccine Safety Datalink” published in Pediatrics
In the June 6 issue, Pediatrics published Safety of COVID-19 mRNA Vaccination among Young Children in the Vaccine Safety Datalink. The media summary appears below.
Researchers reviewed more than 245,000 COVID-19 mRNA vaccine doses (135,005 doses of Pfizer-BioNTech COVID-19 vaccine to children 4 years and younger and 112,006 doses of Moderna COVID-19 vaccine to children 5 years and younger) given over nine months and found no cause for concern during the 21 days after vaccination. Notably, the study did not identify any cases of myocarditis or pericarditis following any dose of vaccine [in these young children]. While one case of hemorrhagic stroke and one case of pulmonary embolism were identified after vaccination, chart review found each outcome was unrelated to vaccination as both children had congenital abnormalities. In descriptive analyses, one case of anaphylaxis was found also to be unrelated to vaccination (due to food allergy). Authors of the study expressed confidence in the findings based on the diverse population surveyed, weekly analyses, and a robust capture of outcome and vaccination data. They say the results should provide reassurance to clinicians, parents, and policymakers.
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"Targeted Vaccine Messaging to Promote COVID-19 Vaccines for Children and Youth" published in Pediatrics
In the May 5 issue, Pediatrics published Targeted Vaccine Messaging to Promote COVID-19 Vaccines for Children and Youth. The conclusions section appears below.
Messages that focus on trusted parents choosing to vaccinate their children were more effective at promoting parents’ COVID-19 vaccination intentions for their children than alternative messages. These findings have implications for public health messaging and pediatric providers’ communications with parents.
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"Trends in Reasons for Human Papillomavirus Vaccine Hesitancy: 2010–2020" published in Pediatrics
In the May 23 issue, Pediatrics published Trends in Reasons for Human Papillomavirus Vaccine Hesitancy: 2010–2020. The conclusions section appears below.
Parents who cited vaccine safety as a reason for not intending to vaccinate their adolescent children against HPV increased over time. Findings support efforts to address parental safety concerns surrounding HPV vaccination.
Virtual: Moderna offers five-part webinar series High-Risk Populations – Protecting Patients at High Risk of Severe COVID-19
Moderna is offering a free, five-part webinar series High-Risk Populations – Protecting Patients at High-Risk of Severe COVID-19 in June. This five-part webinar series will discuss the continued risks and consequences of COVID-19 infections in high-risk populations. Each event will focus on a different high-risk population. Courses include:
- TODAY: June 7 at 3:00 p.m. (ET): "Older Adults (65+)"
- June 13 at 1:00 p.m. (ET): "Patients with Chronic Diseases"
- June 15 at 1:00 p.m. (ET): "Immunocompromised Patients"
- June 22 at 1:00 p.m. (ET): "Patients with Cardiovascular Diseases"
- June 28 at 1:30 p.m. (ET): "Patients with Respiratory Diseases"
Registration is required for each event separately.
Register for the free webinars.
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Virtual: Watch June 15–16 National Vaccine Advisory Committee meeting
The National Vaccine Advisory Committee (NVAC) will hold its next meeting June 15–16, starting at 9 a.m. (ET). NVAC will hear presentations on vaccine safety, antimicrobial resistance, pandemic preparedness, and routine vaccination.
Attendance is open to the public on a first-come, first-served basis by registration. Registration is now available online.
Virtual: Watch June 21–23 ACIP meeting. Topics include RSV, polio, influenza, pneumococcal, dengue, chikungunya, mpox, meningococcal, and COVID-19 vaccines.
CDC will convene an extended, 3-day meeting of the Advisory Committee on Immunization Practices (ACIP), June 21–23, starting at 8 a.m. (ET). ACIP will discuss vaccination recommendations for respiratory syncytial virus (RSV), polio, influenza, pneumococcal, dengue, chikungunya, mpox, meningococcal, and COVID-19 vaccines.
No registration is required to watch webcasts of live ACIP meetings or listen via telephone. Opportunities for public comment are described on the website.
View the agenda.
- ACIP main page for access to webcast, agendas
- ACIP: Meeting Information for presentation slides, content from previous meetings, and information about future meetings