Issue 1,644: July 27, 2022
 
Top Stories
 
Immunize.org Pages and Handouts
 
Vaccine Information Statements
 
Featured Resources
 
Notable Publications
 
Upcoming Events
 
Top Stories

Immunize.org summarizes ACIP’s July 19 meeting recommending use of Novavax COVID-19 Vaccine for adults age 18 years and older

The Advisory Committee on Immunization Practices (ACIP) met on July 19, 2022 and recommended use of Novavax COVID-19 Vaccine as a two-dose primary series in adults age 18 years and older. The ACIP recommendation followed the FDA’s July 13 Emergency Use Authorization (EUA) for the vaccine. The Novavax vaccine joins others from Pfizer-BioNTech, Moderna, and Janssen as the fourth COVID-19 vaccine to receive EUA status and a CDC recommendation. Presentation slides from the meeting are available online. Basic information on this vaccine follows.
 
Vaccine platform: The Novavax vaccine is an adjuvanted protein subunit vaccine. It contains a small quantity (5 mcg) of manufactured spike protein that imitates the natural spike protein on the SARS-CoV-2 virus, combined with a saponin-derived adjuvant (Matrix-M). The adjuvant enhances the immune response to the vaccine. Protein subunit vaccines are common and have been used in the United States for decades.
 
Indications for use: The Novavax vaccine is administered intramuscularly (IM) in the deltoid muscle as a primary series of two 0.5 mL doses given 3 to 8 weeks apart.* At this time, it is not authorized for use as a booster dose.  
*An interval of up to 8 weeks may enhance the immune response and may reduce the risk of myocarditis after dose 2, compared to a 3-week interval. A 3-week interval remains preferred for people age 65 years or older, immunocompromised people, and others in circumstances where rapid protection is needed.

Clinical considerations: CDC’s Interim Clinical Considerations for Use of COVID-19 Vaccines in the United States should be carefully reviewed by all vaccinators for details on vaccine use. Highlights related to the Novavax vaccine include:
  • Reactogenicity: During clinical trials, pain or tenderness at the injection site was the most frequently reported local reaction, with redness and swelling reported less frequently. Fatigue, headache, and muscle pain were the most commonly reported systemic reactions. Most symptoms were mild to moderate in severity and resolved within 1–3 days. Overall, symptoms were more frequent in adults younger than age 65 compared to those 65 years and older and were more likely to occur after the second dose.
  • Immunocompromising conditions: Currently, people who are moderately or severely immunocompromised are recommended to receive the same 2-dose schedule of Novavax vaccine as the general population. No additional dose is recommended.
  • Coadministration with other vaccines: In general, COVID-19 vaccines (including the Novavax vaccine) may be administered without regard to timing of other vaccines. However, CDC now advises vaccinators to consider deferring COVID-19 vaccination up to 4 weeks after orthopoxvirus vaccination of individuals affected by the ongoing monkeypox outbreak. When urgent protection from monkeypox is indicated for a recent COVID-19 vaccine recipient, orthopoxvirus vaccination should not be delayed.
  • Contraindications and precautions: The Novavax vaccine is contraindicated in people with a history of a severe allergic reaction after a previous dose or a diagnosed allergy to any vaccine component, such as polysorbate.
Vaccine safety: A small number of cases of myocarditis were identified during the clinical trials and additional cases have been identified in post-marketing safety data from countries where the Novavax vaccine is already in widespread use. After reviewing the available data, ACIP determined that the risk of this rare occurrence was outweighed by the benefits provided by vaccination, especially in light of evidence that the risk of myocarditis and other heart problems is much higher following COVID-19 infection than after COVID-19 vaccination. No anaphylactic reactions or thrombosis with thrombocytopenia (TTS) were reported during the trials.
 
Although pregnant individuals were excluded from participation in the Novavax vaccine clinical trials, some participants became pregnant or their pregnancy was detected after vaccination. The limited data available from these participants did not indicate adverse effects on mother or fetus. Novavax established a pregnancy exposure registry to continue to study the effects of vaccination during pregnancy.
 
Storage and handling: The vaccine is supplied in 10-dose vials in cartons of 10 vials each. It is maintained at standard refrigeration temperatures of 2° to 8° C (36° to 46° F) and must not be frozen.
 
Once punctured, the preservative-free multidose vial may be refrigerated or kept at room temperature (2° to 25°C [36° to 77° F] for up to 6 hours. Any vaccine remaining after 6 hours must be discarded. The expiration date is not printed on the vial or carton: users must check the “Expiry Date Checker Tool” at the Novavax website to determine the expiration date of an unopened vial.
 
Anticipated demand: Adding this adjuvanted protein subunit vaccine as a choice for primary vaccination against COVID-19 to the previously authorized vaccines offers a valuable new option for previously unvaccinated people. Approximately 26–37 million US adults remain unvaccinated against COVID-19. Some have not been vaccinated because of hesitancy about currently available products developed using newer technology. In an unpublished survey (CDC and University of Iowa/RAND), 16% of unvaccinated respondents indicated they “probably” or “definitely” would accept an available adjuvanted protein-based COVID-19 vaccine that was manufactured using traditional technology common to other routine vaccines. Because the Novavax vaccine is not authorized as a booster dose at this time, initial uptake is expected to be limited.
 
Vaccine effectiveness: Clinical trials demonstrated that the Novavax vaccine was highly effective at preventing moderate or severe COVID-19 illness caused by the variants circulating at the time. Because the clinical trials took place well before the emergence of Omicron variants, the effectiveness of the vaccine against the SARS-CoV-2 variants circulating today is not known. Limited studies of antibodies from the serum of Novavax vaccine recipients suggest that vaccination is likely to show good effectiveness against severe disease caused by current variants, as the other authorized vaccines do.
 
In addition to the Novavax vaccine discussion, ACIP members received an update on current COVID-19 epidemiology and vaccine coverage in the United States, as well as a review of vaccine-associated myocarditis. There were no significant new findings since the update in June 2022.

The next scheduled ACIP meeting will be held on October 19–20, 2022, although additional emergency meetings may be announced prior to that time. Information about past and future ACIP meetings may be found on the ACIP website. 

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HHS and CDC offer July 29 webinar for parents, caregivers, and community partners on COVID-19 vaccination for children age 6 months and over

The U.S. Department of Health and Human Services (HHS), Office of Minority Health (OMH), and CDC Office of Minority Health and Health Equity (OMHHE) will host a webinar titled  Protecting Our Children and Youth from COVID-19: Information for Parents, Caregivers, and Community Partners from 1:30–3:00 p.m. (ET) on July 29. Speakers include pediatric vaccine experts from HHS, CDC, and community partners leading vaccine efforts for children and youth. Webinar attendees will learn the latest information on: 

  • CDC’s COVID-19 vaccination recommendations for everyone age 6 months and older
  • Where to find resources and credible information on vaccine safety
  • The risks, benefits, and myths associated with COVID-19 vaccinations for children and youth
  • What to ask a health provider about COVID-19 vaccination if your child has a disability
  • How community partners are working to protect Black/African American, Hispanic/Latino, American Indian/Alaska Native, Asian American, and Native Hawaiian/Pacific Islander children and youth with disabilities who live in communities disproportionately impacted by COVID-19

Register for the webinar

For questions about the webinar, please contact CDC’s Office of Minority Health and Health Equity at omhhe@cdc.gov

CDC also offers communication resources and printable fact sheets in six languages for the webinar that can be distributed widely. Please use #ProtectChildren along with CDC's social media messages and images to share information across your social media channels. 

For more information on COVID-19 vaccination for children and youth, please visit the Protecting Our Children and Youth from COVID-19: Information for Parents, Caregivers, and Community Partners web page.


National Immunization Awareness Month starts August 1; promote vaccination with CDC resources

August is National Immunization Awareness Month (NIAM). This annual observance highlights the efforts to protect people of all ages against vaccine-preventable diseases through on-time vaccination. This year, NIAM serves as an important reminder to catch up on routine visits and vaccinations that may have been disrupted by the COVID-19 pandemic.

During NIAM, encourage your patients to schedule appointments to ensure they are up to date on annual exams and recommended vaccines. Research shows that healthcare providers are the most trusted source of vaccine information for parents and patients.



CDC’s NIAM web page includes two toolkits, one for reaching healthcare professionals and the other for reaching parents and patients. Each includes key messages, sample social media content, and educational resources. CDC encourages its partners to share these messages and resources throughout August using the hashtag #ivax2protect. Stay tuned for more resources to be released throughout the coming weeks.

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Immunize.org updates its two guides to contraindications and precautions for commonly used vaccines

Immunize.org recently updated Guide to Contraindications and Precautions to Commonly Used Vaccines in Adults, which is based on the version found in the 2022 "Recommended Immunization Schedule for Adults." The Immunize.org guide adds more detail for the category of "Not Recommended" to address the ACIP guidance for two HepB vaccine products and HPV vaccination during pregnancy.  

Immunize.org also updated Guide to Contraindications and Precautions to Commonly Used Vaccines for All Ages, which is based on the versions found in both the 2022 "Recommended Immunization Schedule for Children and Adolescents" and "Recommended Immunization Schedule for Adults." The Immunize.org guide adds more detail for the category of "Not Recommended" to address the ACIP guidance for two HepB vaccine products and HPV vaccination during pregnancy.

     

Related Links


Immunize.org updates “Healthcare Personnel Vaccination Recommendations” resource for staff

Immunize.org updated its 1-page guide Healthcare Personnel Vaccination Recommendations to include both Twinrix and PreHevbrio as HepB vaccine options, and to include a recommendation for a third dose of MMR for healthcare personnel who are identified by public health authorities to be at increased risk for mumps during an outbreak.

 

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Spotlight: Immunize.org’s “Clinic Tools” main page is a one-stop source of practical information for vaccines

Immunize.org's Clinic Tools main page compiles resources from Immunize.org, CDC, and other organizations containing practical, “how-to” information about providing vaccinations in a medical office or non-traditional setting. This page can be found by selecting the “Clinic Tools” tab in the middle of the blue banner atop every Immunizeorg web page

In the left-hand column, you will find links to Immunize.org’s web pages:



The right-hand column features resources from partners, including CDC’s vaccine recommendations, “General Best Practice Guidelines for Immunization,” and The Epidemiology and Prevention of Vaccine-Preventable Diseases (“The Pink Book”).

Visit the Clinic Tools main page on Immunize.org.

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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.


Vaccines in the news

These recent articles convey the potential risks of vaccine-preventable diseases and the importance of vaccination.

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Immunize.org Pages and Handouts

Recap: These updated Immunize.org educational materials and web pages for clinicians were released during June and July

IZ Express regularly provides readers with information about Immunize.org’s new and updated educational materials and web pages. All Immunize.org materials are free to distribute.
 
In case you missed them during recent weeks, updates were made to these helpful materials:

Immunize.org Updated Printable Materials for Clinicians

Immunize.org Updated Web Pages Immunize.org Updated Printable Materials for Patients Related Links
  • Immunize.org: Handouts main page to see educational materials sorted by category
  • Immunize.org: Ask the Experts main page to access more than 1,400 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 VISs and VIS translations were released during June and July

IZ Express regularly provides readers with information about new and updated Vaccine Information Statements (VISs) and their translations. 

In June, CDC released three VISs:

Here are recent VIS translations posted during June and July: Additionally, two handouts related to VISs were updated: Related Links

Featured Resources

Novavax COVID-19 Vaccine EUA factsheets for recipients and caregivers are now available in 12 languages

The Novavax COVID-19 Vaccine received Emergency Use Authorization (EUA) from the FDA to provide a two-dose primary series to individuals age 18 and older. The Novavax COVID-19 Vaccine, Adjuvanted Fact Sheet for Recipients and Caregivers is now available in 12 languages, courtesy of Oregon Immunization Program. The languages include: 

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Recognize colleagues and students with Immunize.org's elegantly designed "Vaccines Save Lives" black enamel pins

Immunize.org’s elegantly designed “Vaccines Save Lives” pins are meaningful gifts for people who care about vaccination. The pin makes a refined statement in hard black enamel with gold lettering and edges, measuring 1.125" x 0.75".


The pin is a stick-through-post variety with the back end covered by a round rubber cap that holds the pin securely. A gold metal spring-lock clasp is also provided.

Wear these pins on clothing, uniforms, and white coats to show that you value vaccines.

  

Click here for "Vaccines Save Lives" pin pricing and ordering information.


Notable Publications

“Workplace Perceptions and Experiences Related to COVID-19 Response Efforts among Public Health Workers—Public Health Workforce Interests and Needs Survey, United States, September 2021–January 2022” published in MMWR

CDC published Workplace Perceptions and Experiences Related to COVID-19 Response Efforts among Public Health Workers—Public Health Workforce Interests and Needs Survey, United States, September 2021–January 2022 on July 22 in MMWR. A portion of the summary appears below. 

The COVID-19 pandemic has strained many essential frontline professionals, including public health workers....

The 2021 Public Health Workforce Interests and Needs Survey recorded the perspectives of the governmental public health workforce. During March 2020–January 2022, 72% of the workforce fully or partially served in a COVID-19 response role. Apart from funding, 51% of respondents cited a need for additional staff capacity to respond to COVID-19. Approximately 40% of the workforce intends to leave their jobs within the next 5 years....

Purposeful succession planning and focused attention on recruitment and retention that promotes diversity will be critical as the workforce rebuilds while the COVID-19 pandemic evolves.

Access the MMWR article in HTML or PDF.

Related Link

  • MMWR's main page provides access to MMWR Weekly and its companion publications
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“Symptoms of Mental Health Conditions and Suicidal Ideation among State, Tribal, Local, and Territorial Public Health Workers—United States, March 14–25, 2022” published in MMWR

CDC published Symptoms of Mental Health Conditions and Suicidal Ideation among State, Tribal, Local, and Territorial Public Health Workers—United States, March 14–25, 2022 on July 22 in MMWR. A portion of the summary appears below. 

In 2021, state, tribal, local, and territorial (STLT) public health workers reported high levels of symptoms of at least one mental health condition (depression, anxiety, or posttraumatic stress disorder [PTSD])....

In a 2022 survey of 26,069 STLT public health workers, higher PTSD prevalence was associated with more weekly work hours and more time spent on COVID-19 response activities. Most (75.5%) respondents did not think their employer increased mental health support....

To support the mental health of public health workers, public health agencies can modify work-related factors, including making organizational changes for emergency responses and facilitating access to mental health resources and services.

Access the MMWR article in HTML or PDF.

Related Link


“Influenza Activity and Composition of the 2022–23 Influenza Vaccine—United States, 2021–22 Season” published in MMWR

CDC published Influenza Activity and Composition of the 2022–23 Influenza Vaccine—United States, 2021–22 Season on July 22 in MMWR. A portion of the summary appears below. 

CDC collects, compiles, and analyzes data on U.S. influenza activity and viruses....

The severity of the 2021–22 influenza season was low, with two waves of influenza A activity. Influenza activity continued from October 2021 through mid-June 2022, with A(H3N2) viruses predominating throughout the season. This report also describes the composition of the Northern Hemisphere 2022–23 influenza vaccine....

Because of the atypical timing and duration of influenza activity, providers and patients should consider influenza infection as a cause of respiratory illness. Testing for seasonal influenza and monitoring for novel viruses, especially avian A(H5N1) and swine viruses, should continue year-round. Receiving a seasonal influenza vaccine each year remains the best way to protect against seasonal influenza and its potentially severe consequences.

Access the MMWR article in HTML or PDF.

Related Link

  • MMWR's main page provides access to MMWR Weekly and its companion publications
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“Effectiveness of 2, 3, and 4 COVID-19 mRNA Vaccine Doses among Immunocompetent Adults during Periods When SARS-CoV-2 Omicron BA.1 and BA.2/BA.2.12.1 Sublineages Predominated—VISION Network, 10 States, December 2021–June 2022” published in MMWR

CDC published Effectiveness of 2, 3, and 4 COVID-19 mRNA Vaccine Doses among Immunocompetent Adults during Periods When SARS-CoV-2 Omicron BA.1 and BA.2/BA.2.12.1 Sublineages Predominated—VISION Network, 10 States, December 2021–June 2022 on July 22 in MMWR. A portion of the summary appears below. 

Little is known about COVID-19 vaccine effectiveness (VE) during the Omicron variant BA.2/BA.2.12.2–predominant period or VE of a fourth COVID-19 vaccine dose in persons aged ≥50 years....

VE during the BA.2/BA.2.12.2 period was lower than that during the BA.1 period. A third vaccine dose provided additional protection against moderate and severe COVID-19–associated illness in all age groups, and a fourth dose provided additional protection in eligible adults aged ≥50 years....

Immunocompetent persons should receive recommended COVID-19 booster doses to prevent moderate to severe COVID-19, including a first booster dose for all eligible persons and second dose for adults aged ≥50 years at least 4 months after an initial booster dose. Booster doses should be obtained immediately when persons become eligible.

Access the MMWR article in HTML or PDF.       

Related Link

  • MMWR's main page provides access to MMWR Weekly and its companion publications

Upcoming Events

Virtual: HHS, OMH, and CDC offer webinar "Protecting Our Children and Youth from COVID-19: Information for Parents, Caregivers, and Community Partners" on July 29

As described in detail in today’s Top Stories above, the U.S. Department of Health and Human Services (HHS), Office of Minority Health (OMH), and CDC Office of Minority Health and Health Equity (OMHHE) will host a webinar titled Protecting Our Children and Youth from COVID-19: Information for Parents, Caregivers, and Community Partners from 1:30–3:00 p.m. (ET) on July 29.

Register for the webinar. Share this opportunity with interested parents and community members.

For questions about the webinar, please contact CDC’s Office of Minority Health and Health Equity at omhhe@cdc.gov

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On-demand: CDC’s recorded webinars on principles of vaccination and general best practice guidelines, as well as other segments in “The Pink Book,” now rolling out weekly; CE available 

CDC continues its 19-part pre-recorded webinar series to provide a chapter-by-chapter overview of the 14th edition of Epidemiology and Prevention of Vaccine-Preventable Diseases (also known as "The Pink Book"). 

The fourth webinar, on immunization strategies, was released on July 26; no registration is required. Additional webinars will be released weekly, concluding on November 1, 2022.
 
Information and program details are available on CDC's Pink Book Webinars series web page.

CME, CNE, CPE, and CEU credits are available for each event. Questions about the material can be submitted to nipinfo@cdc.gov.

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For more upcoming events, visit our Calendar of Events.

About IZ Express

IZ Express is supported in part by Grant No. NH23IP922654 from CDC’s National Center for Immunization and Respiratory Diseases. Its contents are solely the responsibility of Immunize.org and do not necessarily represent the official views of CDC.

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Editorial Information

  • Editor-in-Chief
    Kelly L. Moore, MD, MPH
  • Managing Editor
    John D. Grabenstein, RPh, PhD
  • Associate Editor
    Sharon G. Humiston, MD, MPH
  • Writer/Publication Coordinator
    Taryn Chapman, MS
    Courtnay Londo, MA
  • Style and Copy Editor
    Marian Deegan, JD
  • Web Edition Managers
    Arkady Shakhnovich
    Jermaine Royes
  • Contributing Writer
    Laurel H. Wood, MPA
  • Technical Reviewer
    Kayla Ohlde

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