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FDA Authorizes COVID-19 Vaccine for Ages 5-11

FDA Authorizes COVID-19 Vaccine for Ages 5-11

Children 5 to 11 years of age may soon be able to receive the Pfizer-BioTech COVID-19 vaccine. The Food and Drug Administration (FDA) expanded emergency use authorization (EUA) on Oct. 29 to include the new age group. The Centers for Disease Control and Prevention (CDC) is expected to release clinical recommendations this week.

The FDA considered an EUA amendment request on Oct. 26 for use of the Pfizer-BioNTech COVID-19 vaccine in children 5 through 11 years of age. It was clear by the end of the meeting that the majority of healthcare professionals in attendance supported the expansion.

UPDATE 11/4/21: The CDC has recommended the Pfizer-BioNTech COVID-19 vaccine for children ages 5-11 years. The Centers for Medicare & Medicaid Services (CMS) issued a press release on Nov. 3, stating that healthcare providers and other entities administering the vaccine may not deny anyone vaccination based on insurance coverage status and must administer the vaccine at no out-of-pocket cost to recipients.

New CPT® Codes for Pediatric Vaccine

Another clue the amendment was going to happen was the Oct. 6 release of the following new CPT® codes for a pediatric COVID-19 vaccine formulation and corresponding administration codes:

Effective Oct. 29, 2021, product code 91307 Severe acute respiratory syndrome coronavirus 2 (SARS-CoV2) (coronavirus disease [COVID-19]) vaccine, mRNA-LNP, spike protein, preservative free, 10 mcg/0.2 mL dosage, diluent reconstituted, tris-sucrose formulation, for intramuscular use, and administration codes 0071A Immunization administration by intramuscular injection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (coronavirus disease [COVID-19]) vaccine, mRNA-LNP, spike protein, preservative free, 10 mcg/0.2 mL dosage, diluent reconstituted, tris-sucrose formulation; first dose, and 0072A Immunization administration by intramuscular injection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (coronavirus disease [COVID-19]) vaccine, mRNA-LNP, spike protein, preservative free, 10 mcg/0.2 mL dosage, diluent reconstituted, tris-sucrose formulation; second dose are added for reporting the Pfizer COVID-19 vaccine and immunization administration for the tris-sucrose pediatric (i.e., 5 through 11 years of age) dosage formulation.

An October 2021 special edition CPT® Assistant introduces these new codes and provides guidance on their appropriate use.

New CPT® Code for COVID-19 Booster

A new CPT® code for reporting COVID-19 booster vaccines was also added in October. CPT® code 0034A Immunization administration by intramuscular injection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (coronavirus disease [COVID-19]) vaccine, DNA, spike protein, adenovirus type 26 (Ad26) vector, preservative free, 5×1010 viral particles/0.5 mL dosage; booster dose is for reporting the Janssen booster vaccine administration, effective Oct. 20, 2021.

The CDC reports that 192.5 million people in the United States are fully vaccinated and 18.6 million have received a booster dose.

CPT® 2021 Errata Posted

An update to the 2021 CPT® code set was issued Oct. 27, to add newly released codes to applicable parenthetical notes. The pending FDA approval symbol also is removed from COVID-19 vaccine code 91306 and the effective date for this code and admin code 0064A is changed to Oct. 20, 2021.

Can’t keep all the EUAs for COVID-19 vaccines straight? See the table below.

Table 1. Emergency Use Authorizations of COVID-19 Vaccines

SponsorAuthorized Use (Interval)Indicated PopulationDate of EUA or EUA Amendment
Pfizer-BioNTech2-dose primary series (3 weeks apart) Individuals ≥5 years of age **October 29, 2021
Pfizer-BioNTech2-dose primary series (3 weeks apart)Individuals ≥16 years of age

Individuals ≥12 years of age
December 11, 2020  
May 10, 2021
Pfizer-BioNTech3rd primary series dose (at least 1 month after the second dose)Individuals ≥12 years of age with compromised immune systems due to solid organ transplantation or conditions considered to have an equivalent level of immunocompromiseAugust 12, 2021
Pfizer-BioNTechBooster dose (at least 6 months after completing a primary series of COMIRNATY and/or Pfizer-BioNTech COVID-19 Vaccine)• Individuals 65 years of age and older
• Individuals 18 through 64 years of age and at high risk of severe COVID-19
• Individuals 18 through 64 years of age with frequent institutional or occupational exposure to SARS-CoV-2
September 22, 2021
Moderna2-dose series (4 weeks apart)2-dose primary series in adults ≥18 years of ageDecember 18, 2020
Moderna3rd dose (at least 1 month after the second dose)Individuals ≥12 years of age with compromised immune systems due to solid organ transplantation or conditions considered to have an equivalent level of immunocompromiseAugust 12, 2021
ModernaBooster dose (at least 6 months after completing a primary series of Moderna COVID-19 Vaccine• Individuals 65 years of age and older
• Individuals 18 through 64 years of age and at high risk of severe COVID-19
• Individuals 18 through 64 years of age with frequent institutional or occupational exposure to SARS-CoV-2
October 20, 2021
JanssenSingle doseIndividuals ≥18 years of ageFebruary 27, 2021
JanssenBooster doseIndividuals ≥18 years of ageOctober 20, 2021
Pfizer, Moderna and JanssenSingle heterologous booster dose following completion of primary vaccination with another authorized or approved COVID-19 vaccine (same interval as authorized for a booster dose of the vaccine used for primary vaccination)Same population(s) as those eligible to receive a booster dose of the vaccine used for primary vaccinationOctober 20, 2021
** This row is not in the Oct. 26, 2021, document. www.fda.gov/media/153447/download

The new codes reported here are in addition to the plethora of other CPT® COVID-19-related codes the CPT® Editorial Panel has created in the past two years.


Source: FDA Authorizes Pfizer-BioNTech COVID-19 Vaccine for Emergency Use in Children 5 through 11 Years of Age, Oct. 29, 2021

Certified Pediatrics Coder CPEDC

Renee Dustman
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Renee Dustman, BS, AAPC MACRA Proficient, is managing editor - content & editorial at AAPC. She holds a Bachelor of Science degree in Media Communications - Journalism. Renee has more than 30 years' experience in journalistic reporting, print production, graphic design, and content management. Follow her on Twitter @dustman_aapc.

4 Responses to “FDA Authorizes COVID-19 Vaccine for Ages 5-11”

  1. BRYANT says:

    So NONE of the vaccines that are being injected into people right now are FDA approved.

  2. BRYANT says:

    That’s very misleading – “FDA Approves COVID-19 Vaccine for Ages 5-11”
    FDA only authorized it with EUA.

  3. Renee Dustman says:

    The article clearly states that the FDA approved the vaccine for emergency use.

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