IZ Express #1,692: FDA approves first RSV vaccine for adults age 60+, and more

According to CDC, each year in the United States respiratory syncytial virus (RSV) leads to approximately 60,000–120,000 hospitalizations and 6,000–10,000 deaths among adults age 65 and older. Like influenza, RSV is a seasonal virus, with peak activity typically occurring each fall or winter. On May 30, FDA approved the first vaccine to prevent RSV, to be distributed with the brand name Arexvy (manufactured by GSK). Arexvy is approved for preventing lower respiratory tract disease (LRTD) caused by RSV in individuals age 60 and older. The next step on the vaccine’s path to clinical implementation is for CDC's Advisory Committee on Immunization Practices (ACIP) to consider recommendations for the vaccine's use at its next meeting. A portion of the FDA press release appears below.

The safety and effectiveness of Arexvy is based on the FDA’s analysis of data from an ongoing, randomized, placebo-controlled clinical study conducted in the U.S. and internationally in individuals 60 years of age and older. The main clinical study of Arexvy was designed to assess the safety and effectiveness of a single dose administered to individuals 60 years of age and older. Participants will remain in the study through three RSV seasons to assess the duration of effectiveness and the safety and effectiveness of repeat vaccination. Data for a single dose of Arexvy from the first RSV season of the study were available for the FDA’s analysis. . . .

Among the participants who have received Arexvy and the participants who have received a placebo, the vaccine significantly reduced the risk of developing RSV-associated LRTD by 82.6% and reduced the risk of developing severe RSV-associated LRTD by 94.1%. . . . the most commonly reported side effects by individuals who received Arexvy were injection site pain, fatigue, muscle pain, headache and joint stiffness/pain.

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Immunize.org updates its "Checklist of Current Versions of U.S. COVID-19 Vaccination Guidance and Clinic Support Tools"

Immunize.org reviews and updates the Checklist of Current Versions of U.S. COVID-19 Vaccination Guidance and Clinic Support Tools every month, prominently indicating when it was last updated at the top of the page. In accordance with recent CDC and FDA changes to COVID-19 vaccine use and availability, the checklist has been modified as follows:

All references to monovalent mRNA (Pfizer-BioNTech and Moderna) vaccine formulations have been removed, including all FDA and CDC materials for monovalent products
Links to CDC clinical materials have been updated as they were available at the time of the checklist’s publication. Updates to a few clinical materials are still in process.
Janssen COVID-19 Vaccine (Johnson & Johnson) is no longer included on the checklist. All remaining doses of this vaccine have expired.

All COVID-19 vaccination providers should review the checklist regularly. The checklist is posted on Immunize.org's Vaccines: COVID-19 main page to help practices stay up to date.

Related Links

Immunize.org: Checklist of Current Versions of U.S. COVID-19 Vaccination Guidance and Clinic Support Tools (PDF)
Immunize.org: Vaccines: COVID-19 main page
Immunize.org: Ask the Experts: COVID-19 web page
CDC: Interim Clinical Considerations main page summarizing use of COVID-19 vaccines in the United States

Mother’s Day is May 14; thanks to all the moms who give babies a healthy start with recommended vaccinations

Mother's Day is Sunday, May 14, this year. Immunize.org celebrates mothers and mothers-to-be and all they do to give their children a healthy start in life. Protecting babies through vaccination begins during pregnancy. Receiving influenza, Tdap, and COVID-19 vaccines during pregnancy protects the mother and delivers protective antibodies through the placenta from mom to baby, providing protection through the first few months of life. CDC, the American College of Obstetrics and Gynecology (ACOG) and other experts recommend these three vaccines during pregnancy.

Tdap is needed during each pregnancy, preferably between 27 and 36 weeks of gestation. Tdap helps protect against whooping cough (pertussis), which can be life-threatening for newborns, as well as neonatal tetanus and diphtheria.

People who get influenza or COVID-19 infections while pregnant face an increased risk of hospitalization and complications, compared to their nonpregnant peers. Getting influenza vaccine during each pregnancy helps protect mother and baby from influenza. COVID-19 vaccination should be given during pregnancy whenever it is due. Both vaccines are well-studied and safe at any stage of pregnancy. Vaccines given during pregnancy help protect mother and baby from serious complications and death.

Thank you to all the moms who work hard to safeguard the health and well-being of their children every day. Immunize.org wishes all mothers a happy Mother's Day!

Related Links

CDC: Pregnancy and Vaccination main page
CHOP VEC: Vaccines and Your Baby booklet (view in Spanish)
Immunize.org: Handouts: Pregnancy and Vaccines main page
Immunize.org: Screening Checklists about Vaccine Contraindications and Precautions main page
Immunize.org: CDC Schedules main page

2023 Dr. Maurice R. Hilleman Essay Contest: Encourage students in grades 6–12 to enter

The Vaccine Makers Project, the classroom-based program of the Vaccine Education Center (VEC) at Children’s Hospital of Philadelphia, invites submissions for the 2023 Maurice R. Hilleman Essay Contest. Students in grades 6 through 12 are encouraged to learn about Dr. Hilleman’s life and accomplishments and submit a 500- to 600-word essay by June 9, 2023. This year's writing prompt is "Preparedness is an important component of science as demonstrated by Maurice Hilleman when he identified the 1957 influenza pandemic. How is preparedness critical in science today?"

This year VEC partnered with Public Health Association of British Columbia, Kids Boost Immunity, and Frontline Immunity to open the Maurice R. Hilleman Essay Contest to Canadian students.

Details and the entry form are available at HillemanFilm.com/contest. This year there will be three winners. The winners will each receive $500, a certificate, and recognition at a virtual award event this fall. Please share this information with eligible students or with teachers who may be interested in sharing with their students.

Related Links

The Vaccine Makers Project website
VEC: Hilleman Film website

Immunize.org's Influenza Vaccination Honor Roll recognizes facilities that take a stand for patient safety by implementing policies for mandatory healthcare personnel influenza vaccination. There are now 1,300 organizations enrolled. Since February 8, 2023, Immunize.org welcomed two additional healthcare organizations.

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.

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.

It helps your patients when you provide vaccine information in the language your patient prefers. Seven translations of Immunize.org's handouts "Vaccinations for Preteens and Teens" and "Vaccinations for Adults" were updated and are now available for healthcare providers to print and use with patients whose preferred language is not English.

Vaccinations for Preteens and Teens languages include:

Immunize.org recently updated "Vaccinations for Preteens and Teens" to categorize vaccines routinely administered in early childhood as “maybe needed”; this flags preteens and teens who may have missed out on routine vaccinations earlier in life. Also, a QR code linking to the online version of the document was added.

Vaccinations for Adults languages include:

Immunize.org's most recent update to "Vaccinations for Adults" incorporates the latest vaccination recommendations for COVID-19, universal hepatitis B, new pneumococcal conjugates, and routine zoster vaccination for immunocompromised adults.

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Infectious IDeas, a podcast series from the National Foundation for Infectious Diseases (NFID), brings leading experts together for thought-provoking conversations. The latest entry in the series, Championing Global Health Equity, features Katherine L. O’Brien, MD, MPH. A description from the web page appears below.

An international leader who played a key role in shaping the global COVID-19 vaccine strategy, Katherine L. O’Brien, MD, MPH, is now focused on bringing communities around the world up to date on immunizations and creating an accord to improve the global response to the next pandemic.

Voices for Vaccines (VFV) posted a new entry in its Vax Talk podcast series: Anti-vaxxers Are Litigious featuring Dorit Reiss, LLB, PhD. A description from the VFV web page appears below.

It feels like anti-vaxxers are bringing public health to court in droves. Does this spell the doom of people who don’t like getting measles and polio?

To explain why we shouldn’t panic and how this litigiousness works, we invite our friend Dorit Reiss, legal scholar and all-around good person.

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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.

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 [email protected].

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Immunize.org's personal immunization record cards, printed on rip-proof, smudge-proof, water-proof paper, are designed to last a lifetime. They fit in a wallet when folded. The record cards are for you to give to your patients as a permanent personal vaccination record and are sold in boxes of 250.

Make bulk purchases and receive quantity discounts. For quotes on larger quantities or customizing, or to request sample cards, call 651-647-9009 or email [email protected].

CDC published COVID-19 Mortality Update—United States, 2022 on May 5 in MMWR. A portion of the summary appears below.

COVID-19 was associated with approximately 244,000 deaths in the United States during January–December 2022. . . .

The age-adjusted COVID-19 death rate declined 47% compared with 2021. As in 2020 and 2021, most COVID-19 deaths occurred in a hospital inpatient setting, but an increasing percentage occurred in the decedent’s home or a nursing home or long-term care facility. . . .

Provisional death estimates provide an early signal about shifts in COVID-19 mortality trends. Timely and actionable data can guide public health policies and interventions for populations experiencing higher COVID-19–associated mortality.

The National Foundation of Infectious Diseases (NFID) will host a webinar titled Shingles Prevention through Vaccination, 12:00–1:00 p.m. (ET) on May 17. The interactive panel will discuss the importance of herpes zoster vaccination to help prevent shingles.

There is no fee to participate in this activity, but pre-registration is required.

Register for the webinar.

An on-demand recording of the webinar will be available on May 18.