Email not displaying correctly? View it in your browser. ([link removed])
[link removed]

-Issue 1,607: December 14, 2021-

-Ask the Experts: IAC Answers Questions about COVID-19 Vaccination-

As an additional service to IAC Express readers, we periodically publish special editions such as this one, providing you with new and updated Ask the Experts questions and answers from IAC experts. This issue includes 10 Q&As about COVID-19 vaccination based on recently updated ACIP recommendations.

To find the full set of IAC’s Ask the Experts COVID-19 vaccination Q&As, visit www.immunize.org/askexperts/experts_cov.asp

You can find all of these questions and answers, plus more than a thousand others about vaccines and vaccine administration, on our "Ask the Experts" gateway page at www.immunize.org/askexperts ([link removed]) .

IAC's team of experts includes Kelly L. Moore, MD, MPH (team lead), Carolyn B. Bridges, MD, FACP, and Lyabode Beysolow, MD, MPH.

COVID-19 Vaccination Questions

* Q: Who is eligible to receive a booster dose of a COVID-19 vaccine?
* Q: What is the difference between an “additional primary dose” of COVID-19 vaccine recommended for an immunocompromised person and a “booster dose”?
* Q: My patient, age 30, has moderate immunocompromise and received an additional primary dose as recommended. Is a booster dose also recommended?
* Q: My patient, age 45, is immunocompromised and is recommended to receive an additional primary dose of mRNA COVID-19 vaccine, but it has already been over 6 months since his second mRNA dose. What do I do now?
* Q: What are the differences in the orange cap and purple cap formulations of Pfizer-BioNTech COVID-19 Vaccine?
* Q: My patient turns 12 years old later this month. Should they get the orange cap Pfizer-BioNTech formulation for children now or wait to get the purple cap Pfizer-BioNTech vaccine formulation for adolescents and adults?
* Q: What do we know about the orange cap Pfizer-BioNTech COVID-19 Vaccine effectiveness and side effects in children ages 5 through 11 years?
* Q: We have a patient who was partially vaccinated with a COVID-19 vaccine not authorized for use in the United States. What should we do?
* Q: We have a patient who was fully vaccinated outside the United States with a vaccine not authorized by FDA and not on the WHO emergency use list (WHO-EUL). What do we do?
* Q: What are CDC’s COVID-19 Vaccine Emergency Use Instructions (EUI) and who do they apply to?
------------------------------------------------------------
COVID-19 Vaccination Questions
------------------------------------------------------------
Q: WHO IS ELIGIBLE TO RECEIVE A BOOSTER DOSE OF A COVID-19 VACCINE?

A: As of December 9, 2021, CDC recommends that all people age 16 or older who have completed primary vaccination against COVID-19 should receive a booster dose at an appropriate interval. Recipients of a Janssen COVID-19 Vaccine (Johnson & Johnson) should be given a booster dose of any COVID-19 vaccine at least 2 months after their primary dose. Recipients of an mRNA COVID-19 vaccine primary series (Moderna or Pfizer-BioNTech) who are age 18 years or older should be given a booster dose of any COVID-19 vaccine at least 6 months after completing the primary series. Only the Pfizer-BioNTech COVID-19 vaccine is authorized and recommended for adolescents age 16 and 17. Booster doses are not recommended for any person younger than age 16 at this time.

------------------------------------------------------------
Q: WHAT IS THE DIFFERENCE BETWEEN AN “ADDITIONAL PRIMARY DOSE” OF COVID-19 VACCINE RECOMMENDED FOR AN IMMUNOCOMPROMISED PERSON AND A “BOOSTER DOSE”?

A: An additional primary dose of mRNA vaccine after the standard 2-dose primary series of mRNA vaccine is recommended by CDC for people age 12 years or older with moderate or severe immunocompromise. In these populations, the immune response following the primary 2-dose series is likely to be insufficient, and the third primary dose increases the likelihood of developing a sufficient immune response. The additional primary dose of mRNA vaccine should not be delayed but is recommended to be the same brand and dose size as the original primary series doses. It may be given 28 days or more after the second dose of the primary series.

The term “booster dose” applies to an additional dose of vaccine administered only after the initial sufficient immune response to the primary series is likely to have waned over time. Booster doses are currently recommended only for individuals age 16 years or older. The interval between a primary series and a booster dose varies by vaccine type and the brand of the booster dose does not need to match the primary series if more than one brand is licensed or authorized for the recipient’s age. The recommended booster dose of Moderna COVID-19 Vaccine is half of a primary series dose (50 mcg instead of 100 mcg). Immunocompromised individuals age 16 years or older who have received an additional primary dose should receive a booster dose at least 6 months after the additional primary dose.

For details about vaccination of immunocompromised people, see the section on special populations or CDC’s interim clinical considerations for the use of COVID-19 vaccines: www.cdc.gov/vaccines/covid-19/clinical-considerations/covid-19-vaccines-us.html#considerations-covid19-vax-immunocopromised.

------------------------------------------------------------
Q: MY PATIENT, AGE 30, HAS MODERATE IMMUNOCOMPROMISE AND RECEIVED AN ADDITIONAL PRIMARY DOSE AS RECOMMENDED. IS A BOOSTER DOSE ALSO RECOMMENDED?

A: Yes. CDC recommends that people age 12 years or older with moderate or severe immunocompromise who receive an mRNA COVID-19 vaccine 2-dose primary series should receive an additional primary dose at least 28 days after their second dose. If using Moderna vaccine, a full 100 mcg (0.5 mL) dose should be given as the additional primary dose.

People who receive an additional primary dose and are age 16 or older also should receive a booster dose at least 6 months after receiving the additional primary (3rd) dose, for a total of four doses.

The booster (4th) dose may be any authorized or licensed COVID-19 vaccine. If using Moderna vaccine, administer a 50 mcg (0.25 mL) booster dose.

------------------------------------------------------------
Q: MY PATIENT, AGE 45, IS IMMUNOCOMPROMISED AND IS RECOMMENDED TO RECEIVE AN ADDITIONAL PRIMARY DOSE OF MRNA COVID-19 VACCINE, BUT IT HAS ALREADY BEEN OVER 6 MONTHS SINCE HIS SECOND MRNA DOSE. WHAT DO I DO NOW?

A: The patient should receive his additional primary dose now, using the same brand as the first two doses. If the primary series is Moderna, a full 100 mcg (0.5 mL) additional primary dose should be used.

The patient should be counseled to return 6 months after the additional primary dose for a booster dose of any authorized or licensed COVID-19 vaccine. If Moderna is used for the booster dose at that time, administer a 50 mcg (0.25 mL) booster dose. Booster doses are currently recommended only for people age 16 years and older.

------------------------------------------------------------
Q: WHAT ARE THE DIFFERENCES IN THE ORANGE CAP AND PURPLE CAP FORMULATIONS OF PFIZER-BIONTECH COVID-19 VACCINE?

A: The purple cap formulation of Pfizer-BioNTech COVID-19 Vaccine for age 12 and older has a purple plastic vial cap over the vial stopper and purple trim on the vial label, and the EUA Fact Sheets for this formulation have a corresponding purple box around the title. The “orange cap” formulation for ages 5 through 11 years has an orange plastic vial cap over the vial stopper and orange trim on the label, and the EUA Fact Sheets for this formulation have a corresponding orange box around the title.

The orange cap formulation of Pfizer-BioNTech COVID-19 Vaccine given to children age 5 through 11 years contains the same mRNA encoding the same antigen as the original (purple cap) formulation, but it comes in a different package, in a different vial, with a different concentration, a different dilution volume, a different dose, and has different storage requirements. Vaccinators should practice extreme care to ensure that they follow the correct storage, preparation, and administration directions for each product to avoid vaccine handling or administration errors.

All EUA Fact Sheets for licensed and authorized Pfizer-BioNTech formulations are posted by the FDA on this website: www.fda.gov/emergency-preparedness-and-response/coronavirus-disease-2019-covid-19/comirnaty-and-pfizer-biontech-covid-19-vaccine.

------------------------------------------------------------
Q: MY PATIENT TURNS 12 YEARS OLD LATER THIS MONTH. SHOULD THEY GET THE ORANGE CAP PFIZER-BIONTECH FORMULATION FOR CHILDREN NOW OR WAIT TO GET THE PURPLE CAP PFIZER-BIONTECH VACCINE FORMULATION FOR ADOLESCENTS AND ADULTS?

A: Do not wait. Ideally, children should receive the vaccine dosage and formulation authorized specifically for their age on the day of vaccination with each dose. If a child turns 12 years old between their first and second dose, they should receive the age-appropriate 30 mcg purple cap Pfizer-BioNTech COVID-19 Vaccine formulation for their second dose to complete their series. However, the FDA authorization provides flexibility in this circumstance. Children who will turn age 12 years between their first and second dose in the primary regimen may receive two orange cap doses, two purple cap doses, or any combination of orange cap and purple cap: in any of these circumstances the child is considered fully vaccinated. This is not considered an error and VAERS reporting is not indicated.

------------------------------------------------------------
Q: WHAT DO WE KNOW ABOUT THE ORANGE CAP PFIZER-BIONTECH COVID-19 VACCINE EFFECTIVENESS AND SIDE EFFECTS IN CHILDREN AGES 5 THROUGH 11 YEARS?

A: Preliminary clinical trial results (initial enrollment of 2,268 children) showed that two 10-microgram (mcg) doses of orange cap Pfizer-BioNTech COVID-19 Vaccine formulation for age 5 through 11 years, administered 21 days apart, reduced the risk of symptomatic COVID-19 illness by 90.9 percent for at least two months. The immune response to this dose in this age group was at least as strong as the immune response to two 30 mcg doses of the purple cap Pfizer-BioNTech COVID-19 Vaccine formulation among recipients age 16 through 25 years.

During the 7 days following vaccination, almost 9 in 10 children reported a local reaction, primarily pain at the injection site, and 2 of 3 reported a systemic reaction (most commonly fatigue or headache). The vast majority of reactions were mild or moderate and resolved within 1–2 days; reactions were milder than those reported by young adult recipients of the purple cap formulation. Systemic reactions were more likely to be reported following dose 2. No serious adverse events related to vaccination were observed in the clinical trial.

------------------------------------------------------------
Q: WE HAVE A PATIENT WHO WAS PARTIALLY VACCINATED WITH A COVID-19 VACCINE NOT AUTHORIZED FOR USE IN THE UNITED STATES. WHAT SHOULD WE DO?

A: People who received only the first dose of a COVID-19 vaccine brand not authorized in the United States should be offered a complete primary series with an FDA-authorized or licensed COVID-19 vaccine. The minimum interval between the last dose of a non-FDA authorized vaccine and an FDA-authorized or licensed COVID-19 vaccine is 28 days.

------------------------------------------------------------
Q: WE HAVE A PATIENT WHO WAS FULLY VACCINATED OUTSIDE THE UNITED STATES WITH A VACCINE NOT AUTHORIZED BY FDA AND NOT ON THE WHO EMERGENCY USE LIST (WHO-EUL). WHAT DO WE DO?

A: People in the United States who received a complete series of a vaccine not listed for emergency use by the WHO should be offered a complete primary series with an FDA-approved or FDA-authorized COVID-19 vaccine, beginning at least 28 days after their last non-FDA-approved or -authorized vaccine. After completion of primary vaccination with an FDA-approved or FDA-authorized vaccine, these individuals are considered fully vaccinated and are not recommended to receive an additional primary or booster dose at this time.

------------------------------------------------------------
Q: WHAT ARE CDC’S COVID-19 VACCINE EMERGENCY USE INSTRUCTIONS (EUI) AND WHO DO THEY APPLY TO?

A: CDC has issued emergency use instructions (EUI) for the use of the FDA-licensed purple cap adolescent/adult Pfizer-BioNTech COVID-19 Vaccine (Comirnaty) that differ from the FDA-approved package insert. These instructions apply to certain people who completed primary series COVID-19 vaccination with vaccines not authorized or approved by the FDA as a part of a clinical trial or as a routine vaccination outside the United States.

The CDC EUI provides guidance that moderately and severely immunocompromised persons age 12 years or older who completed a primary series of WHO-EUL COVID-19 vaccines that are not FDA authorized or approved are eligible to receive a single additional primary series dose of the purple cap adolescent/adult formulation of Pfizer-BioNTech COVID-19 Vaccine at least 28 days after the most recent primary series dose.

The CDC EUI currently provides guidance that adults age 18 years or older who have completed a primary series of WHO-EUL COVID-19 vaccines that are not FDA authorized or approved are eligible to receive a single booster dose of the purple cap adolescent/adult formulation of Pfizer-BioNTech COVID-19 Vaccine at least 6 months after the most recent primary series dose.

People who receive a dose of Pfizer-BioNTech COVID-19 Vaccine in accordance with the CDC EUI should be provided a copy of a specifically-written EUI Fact Sheet for Recipients and Caregivers, available from CDC here: www.cdc.gov/vaccines/covid-19/eui/downloads/EUI-Caregiver.pdf.

CDC EUI resources, including the EUI fact sheet for providers and the EUI fact sheet for recipients and caregivers, are available here: www.cdc.gov/vaccines/covid-19/eui/index.html.

------------------------------------------------------------
SUGGEST A QUESTION FOR "ASK THE EXPERTS"

If you have a question that you think may be of interest to our readers, please send it to us using our online form ([link removed]) . We will consider it for inclusion in a future update of the “Ask the Experts” feature.


[link removed]


IAC Express

IAC Express Home ([link removed])

2021 Issues: July–Dec ([link removed])

2021 Issues: Jan–June ([link removed])

2020 Issues ([link removed])

2019 Issues ([link removed])


2018 ([link removed]) – (#IACX4) 1997 Issues ([link removed])

------------------------------------------------------------

[link removed]

[link removed]

[link removed]

[link removed]

------------------------------------------------------------

[link removed]
[link removed]
------------------------------------------------------------

Follow Us

[link removed]
[link removed]

------------------------------------------------------------

Technically Speaking

[link removed]
Read Dr. Wexler's column for the Vaccine Education Center's monthly newsletter, Vaccine Update

------------------------------------------------------------

Vaccinating Adults:
A Step-by-Step Guide

[link removed]

New! IAC's 142-page book available for free download ([link removed]) .

------------------------------------------------------------

Calendar of Events

[link removed]
Conferences, meetings, and training opportunities

------------------------------------------------------------

Patient Record Cards

[link removed]
Record cards for patients --child & teen ([link removed]) , adult ([link removed]) , and lifetime ([link removed]) -- are printed on durable paper and sized to fit in a wallet when folded

------------------------------------------------------------

DVD: Immunization Techniques

[link removed]
Every practice should have this award winning, "how-to" training video

------------------------------------------------------------

Protect Newborns Guidebook
[link removed]

Comprehensive guide Hepatitis B: What Hospitals Need to Do to Protect Newborns ([link removed])

------------------------------------------------------------

Editorial Information
Editor-in-Chief
Kelly L. Moore, MD, MPH
Managing Editor
John Grabenstein, RPh, PhD
Associate Editor
Sharon 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
Robin VanOss

About IAC Express
We encourage you to reprint any of these Q&As in your own newsletters. When you do so, please add a note that the Immunization Action Coalition is the source of the material and provide a ([link removed]) link to this issue ([link removed]) .

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.

IAC Express Disclaimer ([link removed])
ISSN: 1526-1786
Our mailing address is
2550 University Avenue West, Suite 415 North
Saint Paul, MN 55114

To unsubscribe to this publication, go to: [link removed]
==============================================

Unsubscribe [email protected] from this list:
[link removed]