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

• ACIP main page for content from previous meetings, as well as information about future meetings
• CDC: ACIP Presentation Slides: November 2–3, 2021 Meeting web page
• CDC: Interim Clinical Considerations for Use of COVID-19 Vaccines Currently Approved or Authorized in the United States
• CDC: COVID-19 Vaccination for Children 5 through 11 Years Old – Information for Jurisdictions, Healthcare Providers, Pharmacists, Schools, and Community Partners
• CDC: How to Talk with Parents about COVID-19 Vaccination
• CDC Media Statement: CDC Recommends Pediatric COVID-19 Vaccine for Children 5 to 11 Years

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:

• Recommendations and clinical guidance for use of Pfizer-BioNTech COVID-19 Vaccine in children aged 5–11 years including updated section on Vaccination of children and adolescents
• Updated guidance on COVID-19 vaccine dosing and schedule
• Updated guidance for myocarditis and pericarditis after mRNA COVID-19 vaccination in section on Considerations for mRNA COVID-19 vaccines: Pfizer-BioNTech and Moderna
• New guidance for people who received passive immunization via antibody products in section on COVID-19 vaccination and SARS-CoV-2 infection
• Updated guidance in section on People who received COVID-19 vaccine outside the United States
• Updated guidance in section on People who received COVID-19 as part of a clinical trial in the United States
• Updated guidance on Considerations for COVID-19 vaccination in moderately and severely immunocompromised people
• Updated guidance in section on Contraindications and precautions
• Updated Table in Appendix A: Vaccine administration errors and deviations
• Updated Appendix B: Triage of people with a history of allergies or allergic reactions
• Updated Appendix C: Ingredients included in COVID-19 vaccines
• Updated Appendix D: Potential characteristics of allergic reactions, vasovagal reactions, and vaccine side effects following COVID-19 vaccination

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

• “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,” (MMWR Early Release, November 5, HTML or PDF)
• CDC: Summary Document for Interim Clinical Considerations (PDF)
• CDC: Summary Document for Interim Clinical Considerations poster (PDF)
• CDC: COVID-19 Vaccine Administration Errors and Deviations (PDF)
• CDC: COVID-19 Vaccine Administration Errors and Deviations poster (PDF)
• IAC: Vaccines: COVID-19 main page
• IAC: Ask the Experts: COVID-19 web page

---

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 

• ACIP main page for content from previous meetings, as well as information about future meetings
• CDC: ACIP Presentation Slides: November 2–3, 2021 Meeting web page

---

Back to top
 

---

Vaccines in the news