FDA limits authorized use of Janssen (Johnson & Johnson) COVID-19 Vaccine to certain individuals
On May 5, FDA limited the use of the Janssen (Johnson & Johnson) COVID-19 Vaccine to two groups of individuals age 18 and older:
- Those for whom other authorized or approved COVID-19 vaccines are not accessible or are contraindicated, and
- Those who elect to receive the Janssen COVID-19 Vaccine because they would otherwise not receive a COVID-19 vaccine
A portion of the FDA’s announcement appears below.
The FDA and CDC have continuously monitored for and investigated all suspected cases of TTS [thrombosis with thrombocytopenia syndrome] reported to VAERS. In an updated analysis of TTS cases following administration of the Janssen COVID-19 Vaccine that were reported to VAERS through March 18, 2022, the FDA and CDC have identified 60 confirmed cases, including nine fatal cases. The FDA has determined that the reporting rate of TTS is 3.23 per million doses of vaccine administered and the reporting rate of TTS deaths is 0.48 per million doses of vaccine administered.
In making the determination to limit the authorized use of the Janssen COVID-19 Vaccine, the agency considered that reporting rates of TTS and TTS deaths following administration of the Janssen COVID-19 Vaccine are not appreciably lower than previously reported. Furthermore, the factors that put an individual at risk for TTS following administration of Janssen COVID-19 Vaccine remain unknown. The FDA also considered that individuals with TTS may rapidly deteriorate, despite prompt diagnosis and treatment, that TTS can lead to long-term and debilitating health consequences and that TTS has a high death rate. The agency also considered the availability of alternative authorized and approved COVID-19 vaccines which provide protection from COVID-19 and have not been shown to present a risk for TTS.
Examples of individuals who may still receive the Janssen COVID-19 Vaccine include: individuals who experienced an anaphylactic reaction after receipt of an mRNA COVID-19 vaccine, individuals who have personal concerns with receiving mRNA vaccines and would otherwise not receive a COVID-19 vaccine and individuals who would remain unvaccinated for COVID-19 due to limited access to mRNA COVID-19 vaccines.
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Immunize.org updates “Checklist of Current Versions of U.S. COVID-19 Vaccination Guidance and Clinic Support Tools”
Immunize.org offers a 2-page job aid, Checklist of Current Versions of U.S. COVID-19 Vaccination Guidance and Clinic Support Tools, to help you keep up with changes to COVID-19 vaccine guidance and resources. The checklist includes the most recent revision dates of CDC’s primary COVID-19 vaccination websites, as well as print-ready PDF documents from CDC and FDA. Each date is hyperlinked to the original document or web page. Immunize.org updates this list at least monthly, prominently indicating when it was last updated at the top of the page.
We encourage COVID-19 vaccination providers to review this list monthly to be sure your practices stay up to date. The most recent checklist update was May 4, 2022, at 5:00 p.m. (ET).
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“Use of a Modified Preexposure Prophylaxis Vaccination Schedule to Prevent Human Rabies: Recommendations of the Advisory Committee on Immunization Practices—United States, 2022” published in MMWR
May is Hepatitis Awareness Month; raise awareness of the new recommendation for hepatitis B vaccination of all adults through age 59 years with these resources
May is Hepatitis Awareness Month across the United States, and May 19 is designated as National Hepatitis Testing Day. Public health partners are working to shed light on the effect of viral hepatitis while encouraging testing and vaccination in accordance with CDC recommendations for adult vaccination issued in April 2022.
- Several viruses can cause hepatitis. The most common types are hepatitis A, hepatitis B, and hepatitis C.
- Chronic hepatitis B and hepatitis C are the leading causes of liver cancer in the United States
- Both hepatitis A and hepatitis B are preventable with safe and effective vaccines
CDC published Universal Hepatitis B Vaccination in Adults Aged 19–59 Years: Updated Recommendations of the Advisory Committee on Immunization Practices—United States, 2022 on April 1 in MMWR. Hepatitis B vaccination is now recommended by CDC as shown:
- All adults age 19 through 59 years and adults age 60 years and older with risk factors for hepatitis B infection should be vaccinated against hepatitis B
- Adults age 60 years and older without known risk factors may also receive HepB
Immunize.org updated its popular Ask the Experts: Hepatitis B web page to reflect the new adult recommendations in April.
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CDC continues to recommend hepatitis B vaccination for all infants and catch-up vaccination of children and teens younger than age 19 years.
Get the word out with graphics and posts on social media to promote Hepatitis Awareness Month and National Hepatitis Testing Day. CDC's social media toolkit can be found on its Hepatitis Awareness Month web page.
National Nurses Week celebrations continue until May 12; today we honor School Nurse Day
During this weeklong celebration of National Nurses Week, today, Wednesday, May 11, is set aside as School Nurse Day. We are proud to help the National Association of School Nurses (NASN) bring attention to the dedicated school nurses who help keep schools a safe and healthful learning environment for everyone. School nurses bridge health care and education, provide care coordination, and advocate for quality student-centered care, including vaccination.
Acknowledge and celebrate school nurses as critical educators and vaccination champions by spreading the word across your social media channels today by visiting www.nasn.org/advocacy/school-nurse-day and using the SND2022 logo, social media toolkit, and the hashtag #SND2022 with your posts.
Encourage students in grades 6 through 12 to enter now! 2022 Dr. Maurice R. Hilleman Essay Contest, sponsored by the Vaccine Education Center at CHOP, open for submissions.
The Vaccine Makers Project, the classroom-based program of the Vaccine Education Center (VEC) at Children’s Hospital of Philadelphia, invites submissions for the 2022 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 10, 2022. This year's writing prompt is "Maurice Hilleman was a determined scientist. Describe what this means and provide an example of determination in science."
This year VEC partnered with Immunize Canada, Kids Boost Immunity, and Students for Herd 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 six winners—three from each country. The winners will each receive $1,000, a certificate, a VEC prize bag, 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.
Influenza activity continues to increase in parts of the country. CDC provides Spanish translation of resources for the public about avian influenza; risk to public remains low.
For week 17, ending on April 30, CDC's Weekly U.S. Influenza Surveillance Report, FluView summary reports that seasonal influenza activity continues to increase in some parts of the country. The levels of outpatient visits due to acute respiratory illness remained stable compared to last week and are below baseline.
In other influenza news, CDC continues to monitor the expanding avian influenza outbreak now present in most U.S. states among poultry and wild birds. CDC’s assessment is that the risk to human health remains low. CDC's What to Know About Bird Flu poster is now available in Spanish, as are CDC's digital avian influenza communication resources (view in Spanish).
Influenza Vaccination Dashboard
CDC's new Weekly Flu Vaccination Dashboard shares preliminary vaccination data. This week’s key fact: based on a CDC-sponsored survey, flu vaccination coverage estimates among adults in all states and DC as of mid-March are 34.7% for age 18–49, 50.6% for age 50–64, and 67.7% for age 65 and older. National coverage for all adults age 18 and older, including DC and Puerto Rico, is 45.4%.
CDC recommends everyone age 6 months and older get an annual influenza vaccine. Influenza and COVID-19 vaccines may be given at the same visit, if needed. COVID-19 vaccination alone provides no protection from influenza or any other respiratory virus.
If you don’t provide influenza vaccine at your site, please strongly recommend vaccination and refer people to sites that do vaccinate. Use VaccineFinder, a user-friendly website to help people of all ages find influenza, COVID-19, and other vaccines. Participating providers can update their vaccine inventory estimates on VaccineFinder. For questions or more information, contact email@example.com.
Spotlight: Review of Immunize.org resources focused on adult vaccination
In this week's Spotlight, we summarize resources at Immunize.org that focus on adult vaccination.
Resources for Adult Vaccination main page offers all the adult educational materials from Immunize.org and partner organizations.
Our free downloadable book, Vaccinating Adults: A Step-by-Step Guide, is a "how to" guide that provides easy-to-use, practical information covering essential adult vaccination activities. This guide was produced in 2017, before the COVID-19 era, and reflects the recommendations of that time.
Adult Vaccination main page contains all of the Immunize.org handouts that pertain to adult vaccinations.
CDC Schedules main page provides print PDFs of the recommended immunization schedules for adults, as well as for children and adolescents.
Screening Checklists about Vaccine Contraindications and Precautions main page links you to forms that patients fill out to expedite assessment of vaccination needs and contraindications.
These recent articles convey the potential risks of vaccine-preventable diseases and the importance of vaccination.
Immunize.org Pages and Handouts
Recap: These updated Immunize.org educational materials and web pages for clinicians were released during March and April
IZ Express regularly provides readers with information about Immunize.org new and updated educational materials and web pages for healthcare professionals. All Immunize.org materials are free to distribute.
Immunize.org Updated Web Pages
Immunize.org Updated PDF Materials for Patients
In case you missed them during recent weeks, updates were made to these helpful materials:
Immunize.org Updated PDF Materials for Clinicians
- Immunize.org: Handouts main page to see educational materials sorted by category
- Immunize.org: Ask the Experts main page to access more than 1,100 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 VIS translations were released during March and April
In March, nine updated translations for pneumococcal conjugate (PCV) vaccine VIS
and recombinant zoster (shingles) VIS
were posted in: Arabic
, Chinese (Simplified and Traditional), French
, and Vietnamese
Also in March, 18 VIS translations were posted in Haitian Creole
In April, six Turkish
VIS translations were updated.
CDC updates its webinar titled “You Are the Key to HPV Cancer Prevention”; CE available
CDC updated its web-on-demand video You Are the Key to HPV Cancer Prevention. While most U.S. adolescents are starting the HPV vaccine series, less than half have finished the series. A clinician's recommendation plays a critical role in getting parents to accept HPV vaccination for their child. This webinar is intended to support clinicians in making effective recommendations. It offers up-to-date information on HPV infection, disease, and vaccine, as well as ways to communicate with parents about HPV vaccination.
Continuing education is valid through April 12, 2024.
Watch the webinar.
Order Immunize.org’s child, adult, and lifetime immunization record cards—wallet-sized, designed to last!
Immunize.org's personal immunization record cards, printed on rip-proof, smudge-proof, water-proof paper, are designed to last a lifetime. They’re sized to fit in a wallet when folded. The record cards are for you to give to your patients as a permanent and 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 firstname.lastname@example.org.
“Effectiveness of a COVID-19 Additional Primary or Booster Vaccine Dose in Preventing SARS-CoV-2 Infection among Nursing Home Residents during Widespread Circulation of the Omicron Variant—United States, February 14–March 27, 2022” published in MMWR
CDC published Effectiveness of a COVID-19 Additional Primary or Booster Vaccine Dose in Preventing SARS-CoV-2 Infection among Nursing Home Residents during Widespread Circulation of the Omicron Variant—United States, February 14–March 27, 2022 on May 6 in MMWR. A portion of the summary appears below.
Nursing home residents are at high risk for COVID-19–associated morbidity and mortality. Little is known about the vaccine effectiveness (VE) of additional or booster COVID-19 vaccine doses against SARS-CoV-2 infection in this population, particularly against the Omicron variant....
Analysis of COVID-19 surveillance and vaccination data from approximately 15,000 skilled nursing facilities found that, compared with primary series vaccination only, an additional or booster dose provided greater protection (relative VE = 46.9%) against SARS-CoV-2 infection during Omicron variant predominance....
All immunocompromised nursing home residents should receive an additional primary dose, and all nursing home residents should receive a booster dose, when eligible, to protect against COVID-19.
Access the MMWR article in HTML or PDF.
Today! Virtual: Vaccinate Your Family hosts webinar “Addressing the Decline in Routine Immunizations” on May 11.
Vaccinate Your Family (VYF) will host a webinar titled Addressing the Decline in Routine Immunizations at 10:30 a.m. (ET) today, May 11. Routine vaccination rates across the lifespan fell during the COVID-19 pandemic. This virtual summit will feature the latest data from CDC, Avalere, and IQVIA, followed by two panels discussing the need of community-based organizations and medical professional societies to help raise the rates.
Register for the webinar.
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Virtual: May 19 ACIP meeting announced
CDC announced that it will convene its Advisory Committee on Immunization Practices (ACIP) on May 19, from 11:00 a.m.–4:00 p.m. (ET). The meeting agenda is not yet available, but will be posted on the website.
No registration is required to watch webcasts of live ACIP meetings or listen via telephone. Opportunities for public comment are described at the website.
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Virtual: HHS hosts webinar “Federal Implementation of Updated Hepatitis B Vaccination Recommendations” on May 23
The U.S. Department of Health and Human Services' (HHS) Office of Infectious Disease and HIV/AIDS Policy (OIDP) will host a webinar titled Federal Implementation of Updated Hepatitis B Vaccination Recommendations from 2:00–3:30 p.m. (ET) on May 23. As part of the Viral Hepatitis National Strategic Plan, federal partners are working together to increase U.S. hepatitis B vaccination uptake. A panel of federal leaders will discuss how HHS agencies plan to encourage vaccination uptake.
Register for the webinar.