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Issue 1599
Issue 1,599: November 10, 2021
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IAC summarizes November 2 ACIP meeting recommending Pfizer-BioNTech COVID-19 Vaccine for children age 5 through 11 years

The Advisory Committee on Immunization Practices (ACIP) met on November 2–3, 2021. The November 2 session was devoted to use of Pfizer-BioNTech COVID-19 Vaccine in children age 5 through 11 years. Presentation slides are available online, and highlights of the meeting are provided below. 
 
On October 29, FDA authorized emergency use of the Pfizer-BioNTech COVID-19 Vaccine for children age 5 through 11 years. During the November meeting, ACIP reviewed additional information and unanimously voted to recommend use of the Pfizer-BioNTech vaccine in this age group. Moderna and Janssen (Johnson & Johnson) COVID-19 Vaccines remain authorized only for adults age 18 years and older.
 
COVID-19 disease burden in age 5 through 11 years – Children are at least as likely to be infected with SARS-CoV-2 as adults, though childhood infections are less likely to be reported because children develop serious illness less frequently. Among U.S. children age 5 through 11 years, more than 1.9 million cases of COVID-19 infection were reported through September 2021, including 8,300 hospitalizations, 2,316 cases of Multisystem Inflammatory Syndrome in Children (MIS-C), and 94 deaths.
 
Although hospitalizations due to COVID-19 in children age 5 through 11 years have been consistently lower than in other age groups, they peaked in September 2021. One-third of children hospitalized from March 2020–August 2021 had no underlying medical conditions. Of those with a reported underlying condition, chronic lung disease (primarily asthma) and obesity were most common. Approximately one-third of hospitalized children were admitted to an ICU.
 
Vaccine efficacy and safety – During the clinical trials of 5 through 11-year-olds, which included approximately 4,600 participants, vaccine efficacy (VE) against symptomatic infection was 90.7%. Most reported adverse events were mild to moderate in intensity and self-limited. The most common reactions were injection site pain, fatigue, and headache. Systemic reactions (including fever) were less common than those seen in recipients age 16 through 25 years. No serious adverse events related to the vaccine, including myocarditis, were reported in these trials. Multiple complementary surveillance systems are being used to monitor for vaccine safety signals among COVID-19 vaccine recipients of all ages and will be used to monitor vaccine recipients age 5 through 11 years.
 
Vaccine administration – Each dose of the pediatric formulation of the vaccine (orange cap) contains 10 mcg of antigen, one-third the amount contained in each dose of the formulation for age 12 and older (purple cap). A primary series of the pediatric formulation consists of two 0.2-mL (10 mcg) doses given at least 3 weeks apart. At this time, the FDA has not authorized a third primary series dose in children age 5 through 11 years with moderate or severe immunocompromise. Standing orders for vaccine administration are available on the CDC web page.
 
Interim clinical considerations for vaccination of children have been posted and should be consulted for complete vaccine administration guidance. Selected information from these clinical considerations is highlighted below:
  • Vaccine co-administration – Like all COVID-19 vaccines, the pediatric formulation of the vaccine may be administered with other vaccines without regard to timing.
  • Age-appropriate vaccine formulations – Children should receive the vaccine dosage and formulation based on their age on the day of vaccination with each dose. However, the FDA Emergency Use Authorization (EUA) for Healthcare Providers allows for children who will turn from age 11 to 12 years between their first and second doses to receive either the pediatric (orange cap) or adult (purple cap) formulation for either dose.
  • Pre-vaccination medication – Routine use of medications such as acetaminophen or non-steroidal anti-inflammatory drugs before vaccination to prevent post-vaccination symptoms is not recommended. These medications may be used to treat discomfort if it develops.
Vaccine storage and handling – Unopened vials of the 10-dose pediatric (orange cap) vaccine formulation may be stored at ultracold conditions (-90 deg. C to -60 deg. C, -130 deg. F to -76 deg. F) for 6 months or in the refrigerator (2 deg. C to 8 deg. C, 35 deg. F to 46 deg. F) for up to 10 weeks. Vaccine should not be stored in a standard freezer (-25 deg. C to -15 deg. C, -13 deg. F to 5 deg. F). Thawed vaccine should not be refrozen.
 
After dilution with 1.3 mL of preservative-free sodium chloride 0.9% (normal saline), the orange cap vaccine vial contains 10 doses. Once the vaccine is mixed with diluent, it must be used within 12 hours or be discarded. Additional storage and handling information are available on the CDC web page.
 
Vaccine intent – Among parents surveyed, about half plan to get their children vaccinated. Parents report preferring to vaccinate their children in their doctor’s office or clinic or in a pharmacy. A strong provider recommendation has a significant influence on a parent’s decision to vaccinate.
 
Future ACIP Meetings
The next ACIP meeting is scheduled for February 23–24, 2022. Information about past and future ACIP meetings may be found on the ACIP website.
 
Related Links CDC publishes ACIP recommendations for use of COVID-19 Vaccine in children age 5–11 years and updates its interim clinical considerations for use of COVID-19 vaccines website

CDC published The Advisory Committee on Immunization Practices’ Interim Recommendation for Use of Pfizer-BioNTech COVID-19 Vaccine in Children Aged 5–11 Years—United States, November 2021 in the November 5 issue of MMWR Early Release

On November 3, CDC updated their Interim Clinical Considerations for Use of COVID-19 Vaccines Currently Approved or Authorized in the United States. This guidance provides additional information for healthcare providers and public health officials on use of COVID-19 vaccines. All healthcare professionals administering or counseling patients on COVID-19 vaccination should review all changes on the web page.

CDC summarized recent changes to its interim clinical considerations as follows:

View the CDC’s Interim Clinical Considerations for Use of COVID-19 Vaccines Currently Approved or Authorized in the United States web page.

Related Links


IAC summarizes November 3 ACIP meeting on hepatitis B, orthopoxvirus, and Ebola vaccines, and 2022 schedules

The Advisory Committee on Immunization Practices (ACIP) met on November 2–3, 2021. The November 3 session focus on hepatitis B, orthopoxvirus, and Ebola vaccines and the recommended child/adolescent and adult immunization schedules for 2022. Presentation slides are available online, and highlights of the meeting are provided below. 
 
Hepatitis B vaccine – Hepatitis B vaccination rates among high-risk adults plateaued below 25 percent over the past decade, whereas incidence rates of acute hepatitis B infection have gradually increased among adults age 30 years and older. Only one-third of reported cases document a risk factor for contracting the infection. The current strategy of vaccinating adults according to a complex list of medical and behavioral risk factors is widely acknowledged as inadequate to meet national hepatitis B disease elimination goals, in contrast to the success of universal childhood hepatitis B vaccination.  
 
To protect more adults against the potentially devastating consequences of hepatitis B infection, ACIP members agreed to broaden and simplify vaccination recommendations for most adults. Following a robust discussion, ACIP unanimously voted to recommend that hepatitis B vaccine should be given to all people through age 59 years and to all people age 60 or older with any risk factor for hepatitis B infection. ACIP also voted that any person age 60 and older with no known risk factor may be vaccinated, acknowledging the low rates of hepatitis B infection among people age 60 and older and the uneven benefits of vaccination among adults of advanced age.
 
Orthopoxvirus vaccines – In June 2021, the FDA licensed Jynneos (Bavarian Nordic), a replication-deficient orthopoxvirus vaccine administered intramuscularly to protect against orthopoxviruses, including smallpox and monkeypox, in adults age 18 years and older who are at high risk of infection due to potential occupational exposures (e.g., research laboratory personnel). This vaccine has important advantages when compared to the currently recommended ACAM 2000 (Sanofi Pasteur), a live vaccinia virus vaccine administered through percutaneous puncture of the skin with a bifurcated needle. ACAM 2000 leads to a superficial infection of the skin at the inoculation site. Lesions at these sites permit vaccinia virus to be transmitted by touch to another part of the recipient’s body (such as the eye) or to close contacts. ACAM 2000 also is contraindicated for people with immunocompromising conditions.
 
In a series of five votes, ACIP unanimously recommended Jynneos vaccine as an alternative to ACAM 2000 and provided guidance on the frequency of booster doses. In summary, these recommendations address primary vaccination with Jynneos in people at highest risk, booster doses for people who remain at increased risk, and an option to use Jynneos as a booster for people who previously received ACAM 2000. Detailed guidance on the recommendations will be published in the MMWR.
 
Ebola vaccine – In February 2020, ACIP recommended pre-exposure vaccination with Ervebo (Merck) vaccine for certain adults at increased risk of potential occupational exposure to Ebola virus. This group includes people responding to an Ebola outbreak, healthcare personnel at federally designated Ebola Treatment Centers, and laboratory workers at certain Biosafety Level 4 facilities. On November 3, ACIP voted to extend this recommendation to two additional populations – healthcare personnel involved in the care and transport of suspect or confirmed Ebola virus patients at state-designated Special Pathogens Treatment Centers and certain personnel at Laboratory Research Network facilities who may handle Ebola virus.
 
Recommended immunization schedules for 2022 – Each year, CDC publishes updated child/adolescent and adult immunization schedules to reflect contemporary vaccine recommendations. ACIP reviewed and approved the proposed 2022 schedules. Links to COVID-19 vaccination pages have been added to guide users to the current information on COVID-19 vaccines. A new appendix has been added to reflect contraindications and precautions for commonly used vaccines. The revised schedules will be announced in the MMWR and posted at www.cdc.gov/vaccines/schedules/ in February 2022.

Future ACIP meetings – The next ACIP meeting is scheduled for February 23–24, 2022. Information about past and future ACIP meetings may be found on the ACIP website.
 
Related Links 
“Effectiveness of 2-Dose Vaccination with mRNA COVID-19 Vaccines against COVID-19–Associated Hospitalizations among Immunocompromised Adults—Nine States, January–September 2021” published in MMWR

CDC published Effectiveness of 2-Dose Vaccination with mRNA COVID-19 Vaccines against COVID-19–Associated Hospitalizations among Immunocompromised Adults—Nine States, January–September 2021 in the November 5 issue of MMWR. A portion of the summary appears below.

Immunocompromised persons benefit from COVID-19 mRNA vaccination but are less protected from severe COVID-19 outcomes than are immunocompetent persons. Immunocompromised persons receiving mRNA COVID-19 vaccines should receive 3 doses and a booster, consistent with CDC recommendations, practice nonpharmaceutical interventions, and, if infected, be monitored closely and considered early for proven therapies that can prevent severe outcomes.

Access the MMWR article in HTML or PDF.

Related Link


CMS issues emergency regulation requiring COVID-19 vaccination for healthcare personnel

On November 5, the Centers for Medicare & Medicaid Services (CMS) issued an emergency regulation requiring COVID-19 vaccination of eligible staff at healthcare facilities that participate in the Medicare or Medicaid programs. This new, national requirement covers more than 17 million healthcare personnel and will protect patients seeking care from nearly 76,000 providers. A portion of the CMS MLN Connects newsletter appears below.

Facilities covered by this regulation must establish a policy ensuring all eligible staff have received the first dose of a two-dose COVID-19 vaccine or a one-dose COVID-19 vaccine prior to providing any care, treatment, or other services by December 5, 2021. All eligible staff must have received the necessary shots to be fully vaccinated – either two doses of Pfizer or Moderna or one dose of Johnson & Johnson – by January 4, 2022. The regulation also provides for exemptions based on recognized medical conditions or religious beliefs, observances, or practices. Facilities must develop a similar process or plan for permitting exemptions in alignment with federal law.

Related Links
AIM and Duke-Margolis Center offer school-located vaccination resources to increase child and adolescent vaccination rates during the COVID-19 pandemic

The Duke-Margolis Center for Health Policy (Duke-Margolis) and the Association of Immunization Managers (AIM), with support from the Rockefeller Foundation, released a series of resources for school leaders on how schools can serve as critical access points for students and families to receive COVID-19 vaccines.
 
New resources include:

These resources were developed based on input from school leaders, state and local public health officials, pediatricians, and other stakeholders in the vaccinating community. In September 2021, Duke-Margolis and AIM hosted a virtual symposium on School-Located Vaccination Strategies to Increase Child and Adolescent Immunization Rates During the COVID-19 Pandemic, which highlighted promising practices and strategies for addressing challenges related to building vaccine confidence and hosting vaccination clinics in school settings.

AMGA launches a national campaign, "Rise to Immunize," to increase routine adult vaccination rates

The American Medical Group Association (AMGA) launched a national campaign, Rise to Immunize, aimed at increasing routine adult vaccinations across the country. This 4-year initiative challenges leading healthcare organizations to work together to administer 25 million vaccinations—influenza, pneumococcal, tetanus-diphtheria (Td), tetanus-diphtheria-pertussis (Tdap), and zoster vaccines—by 2025.



Learn more in the Rise to Immunize campaign brochure or complete the campaign interest form.

Related Link
IAC's Influenza Vaccination Honor Roll for mandatory healthcare worker vaccination now features 1,158 organizations, including two new facilities

There are now 1,158 organizations enrolled in IAC's Influenza Vaccination Honor Roll. The honor roll recognizes hospitals, long-term care facilities, medical practices, pharmacies, professional organizations, health departments, and other government entities that take a stand for patient safety by implementing mandatory influenza vaccination policies for healthcare personnel.

Since our last progress report on September 29, two additional healthcare organizations have been enrolled.

  • All American at Wrentham, Wrentham, MA
  • Peach Tree Healthcare, Marysville, CA

To be included in the Influenza Vaccination Honor Roll, the institutional mandate you report must require influenza vaccination for all staff. Additionally, the application must describe measures to prevent transmission of influenza from unvaccinated personnel to patients (e.g., masking for the entire work shift, reassignment to non-patient-care duties, dismissal).

IAC urges qualifying healthcare organizations to complete the Application page.

Related Links IAC Spotlight! Review of resources at Immunize.org focused on adolescent vaccination

In this week's IAC Spotlight, we summarize resources at Immunize.org that focus on adolescent vaccination. 

Our Resources for Adolescent Vaccination main page offers all the adolescent educational materials from IAC and partner organizations.

Our Adolescent Vaccination main page contains the handouts that pertain to adolescent vaccinations.

Our CDC Schedules main page provides print-ready PDFs of the recommended immunization schedules for adolescents, as well as for children and adults. 

Our Screening Checklists about Vaccine Contraindications and Precautions main page links you to forms that patients can fill out to expedite assessment of vaccination needs and contraindications.

Our Give2MenACWY website offers resources to help providers increase teen vaccination and MenACWY booster dose rates. 

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Journalists interview IAC experts
 
Journalists seek out IAC 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 recent citation. Related Link

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Vaccines in the news

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


Immunize.org Pages and Handouts   
IAC updates its 2021–2022 season standing orders for administering influenza vaccine to children age 6 months through 18 years with Flucelvax age indication change

IAC updated its 2021–2022 Standing Orders for Administering Influenza Vaccine to Children and Teens to include the new expanded age indication for Flucelvax to age 6 months and older. 

Related Links

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IAC updates its print-ready fact sheet "Influenza Vaccine Products for the 2021–2022 Influenza Season" with Flucelvax age indication change

IAC updated its resource Influenza Vaccine Products for the 2021–2022 Influenza Season to include the new expanded age indication for Flucelvax to age 6 months and older. 

Related Links

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Featured Resources

Give thanks for COVID-19 vaccines this season! IAC offers FREE "I Got My COVID-19 Vaccine" buttons and stickers. Available in English and Spanish.

Anyone promoting COVID-19 vaccination can order IAC’s FREE “I Got My COVID-19 Vaccine” buttons and stickers, provided with support from CDC. Available in English and Spanish, the buttons and stickers look great on lab coats, uniforms, jackets, lanyards, ID badges, or backpacks to show confidence in COVID-19 vaccination. 

Click the picture below to go directly to the order form.

Related Links

Keep up with influenza this season: CDC’s FluView surveillance reports posted weekly
 
Influenza season has begun. CDC expects influenza activity, which is currently low, to increase in the coming weeks or months. CDC’s Weekly U.S. Influenza Surveillance Report, FluView, provides a valuable snapshot of influenza activity state-by-state. Visit it regularly to stay informed about influenza in your community this season.



If you don’t provide influenza vaccine at your site, please strongly recommend vaccination and refer people to sites that do vaccinate. Boston Children’s Hospital, in partnership with CDC, has developed VaccineFinder, a user-friendly website to help people of all ages find influenza, COVID-19, and other vaccines. Participating providers can now update their vaccine inventory estimates on VaccineFinder for a more accurate reporting. For questions or more information, contact vaccine@healthmap.org.

Related Links Order IAC’s child, adult, and lifetime immunization record cards—wallet-sized, designed to last!

IAC'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.

Order Immunization Record Cards

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 admininfo@immunize.org.

Visit Shop IAC for additional items, including "Vaccines Save Lives" enamel pins, flu vaccine buttons, and a vaccine administration training video.


IAC's website "Mass-Vaccination-Resources.org" can help you excel; use resources for vaccinating children age 5 through 11 years against COVID-19

The Immunization Action Coalition’s website www.Mass-Vaccination-Resources.org assists you in finding ideas for developing your own high-volume clinics. Mass vaccination efforts are useful for influenza and COVID-19 vaccination.

Many of the documents were written in the pre-pandemic era and need modification to ensure that additional protections (e.g., social distancing, personal protective equipment) help safeguard against COVID-19 transmission.

More resources have been added, including:



In addition, IAC's on-demand full-length webinar (1 h. 46 min.) highlighting best practices and offering practical information, Mass Vaccination Clinics: Challenges and Best Practices, can be viewed on www.Mass-Vaccination-Resources.org.

The www.Mass-Vaccination-Resources.org website includes a Related Resources web page linking to three articles by IAC authors that appeared in Becker’s Hospital Review.

If you have a resource to suggest for the website, please send a message to info@mass-vaccination-resources.org.

The webinar and the new website are supported by a medical education grant from Seqirus.

Related Links


Notable Publications
"Hepatitis B Vaccination among Adults with Diabetes Mellitus, U.S., 2018" published in American Journal of Preventive Medicine

In the November 1 issue, American Journal of Preventive Medicine published Hepatitis B Vaccination among Adults with Diabetes Mellitus, U.S., 2018. The conclusions section appears below. 

Self-reported hepatitis B vaccination coverage among adults with diabetes mellitus remains suboptimal. Healthcare providers should assess patients’ diabetes status, recommend and offer needed vaccinations to patients, or refer them to alternate sites for vaccination.
MMWR Recap: Lab-confirmed COVID-19 among adults with infection or mRNA vaccine-induced immunity and ACIP recommendations for primary and booster doses of COVID-19 vaccines

CDC recently published several articles first distributed as MMWR Early Releases:
  • Laboratory-Confirmed COVID-19 among Adults Hospitalized with COVID-19-Like Illness with Infection-Induced or mRNA Vaccine-Induced SARS-CoV-2 Immunity—Nine States, January–September 2021 (MMWR, November 5, HTML or PDF)
  • The Advisory Committee on Immunization Practices’ Interim Recommendations for Additional Primary and Booster Doses of COVID-19 Vaccines—United States, 2021 (MMWR, November 5, HTML or PDF)
Related Link
  • MMWR main page provides access to MMWR Weekly and its companion publications

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Global News
November 12 is World Pneumonia Day

November 12 is World Pneumonia Day, established by the Stop Pneumonia Initiative in 2009 to raise awareness and advocate for global action.

This year, World Pneumonia Day will be held during COP 26 – the UN Climate Change Conference. This is a critical moment to bring together the health, air quality, and climate community to tackle the biggest infectious killer on the planet.



Access the World Pneumonia Day website for more information.

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"The Effects of the National HPV Vaccination Programme in England, UK, on Cervical Cancer and Grade 3 Cervical Intraepithelial Neoplasia Incidence: A Register-Based Observational Study" published in Lancet
 
In the November 3 issue, Lancet published The Effects of the National HPV Vaccination Programme in England, UK, on Cervical Cancer and Grade 3 Cervical Intraepithelial Neoplasia Incidence: A Register-Based Observational Study. The interpretation section appears below. 

We observed a substantial reduction in cervical cancer and incidence of CIN3 in young women after the introduction of the HPV immunisation programme in England, especially in individuals who were offered the vaccine at age 12–13 years. The HPV immunisation programme has successfully almost eliminated cervical cancer in women born since Sept 1, 1995.

Upcoming Events
COVID-19 vaccination provider webinars to explain new recommendations and products

Moderna and Pfizer-BioNTech are offering educational webinars open to all COVID-19 vaccination providers regarding new recommendations and products. 

Moderna is offering a webinar titled Important Updates on the mRNA-1273 50 mcg Booster Dose at 12:00 p.m. (ET) tomorrow, November 11, for vaccination providers to learn more about the Moderna COVID-19 Vaccine booster dose.

Pfizer-BioNTech is hosting a webinar titled "Immunization Site Training Sessions for All Providers on the Storage, Handling, & Administration for Current & Potential New Formulations." Webinar dates and times are as follows:


Virtual: NAM hosts "Report Release Webinar: Advancing Pandemic and Seasonal Influenza Vaccine Preparedness and Response" on November 18
 
The National Academy of Medicine (NAM) will host a Report Release Webinar: Advancing Pandemic and Seasonal Influenza Vaccine Preparedness and Response on November 18 in two sessions: from 8:00–10:00 a.m. (ET) and from 1:00–3:00 p.m. (ET).

This webinar will discuss findings and recommendations from four reports on Advancing Pandemic and Seasonal Vaccine Preparedness and Response: Harnessing Lessons from the Efforts to Mitigate the COVID-19 Pandemic.

For more upcoming events, visit our Calendar of Events.

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About IAC Express
The Immunization Action Coalition welcomes redistribution of this issue of IAC Express or selected articles. When you do so, please add a note that the Immunization Action Coalition is the source of the material and provide a link to this issue.

IAC Express is supported in part by Grant No. 1NH23IP922654 from the National Center for Immunization and Respiratory Diseases, CDC. Its contents are solely the responsibility of IAC and do not necessarily represent the official views of CDC.

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