COVID-19 Vaccine FAQs

COVID-19 Vaccination Information

UPDATED INFO: 12-20-2022

Comprehensive Interim Clinical Considerations for COVID-19 Vaccines in the United States are available here https://www.cdc.gov/vaccines/covid-19/clinical-considerations/covid-19-vaccines-us.html

On December 8, 2022, the Food and Drug Administration (FDA) granted Emergency Use Authorization (EUA) for COVID-19 Omicron updated bivalent vaccines from Moderna for people ages 6 months through 5 years and from Pfizer-BioNTech for ages 6 months through 4 years.

December 9, 2022 the Centers for Disease Control and Prevention (CDC) followed with recommendations. This HAN offers a summary of those changes, expanding specifically on: (A) recommended use of an Omicron (bivalent) Moderna booster shot in people ages 6 months through 5 years; (B) Recommended use of an Omicron (bivalent) Pfizer-BioNTech primary series shot in people ages 6 months through 4 years; and (C) Additional considerations.

Highlights:

  • Moderna Omicron (bivalent) vaccines are authorized as a booster for those ages 6 months through 5 years who completed the Moderna 2-dose primary series at least 2 months prior.
  • Pfizer Omicron (bivalent) vaccines are authorized only as the third dose in the 3-dose primary series, with NO BOOSTER for ages 6 months through 4 years.
    • An original (monovalent) Pfizer vaccine is administered as the first and second dose, followed by one Omicron (bivalent) Pfizer vaccine as the third dose in the 3-dose primary series – administered at least 2 months after the second (original/monovalent) dose.
  • The Pfizer updated Omicron (bivalent) vaccine is not authorized as a booster for children ages 6 months through 4 years, including those who completed a Pfizer 3-dose primary series. That is, there is no Pfizer booster (monovalent or bivalent) for anyone ages 6 months through 4 years at this time.
  • There is no mix-and-match for Moderna and Pfizer for any dose of any type in infants and children ages 6 months through 4 years.

Moderna COVID-19 Omicron (Bivalent) Vaccine:

The Moderna COVID-19 Omicron (bivalent) booster is authorized as a single booster dose administered at least 2 months after completion of the 2-dose primary series vaccination with the Moderna original (monovalent) COVID-19 vaccine.

  • The Moderna Omicron (bivalent) vaccine for individuals ages 6 months through 5 years is supplied in a multiple-dose vial with a dark pink cap and a label with a yellow box.
  • Carefully read the labels to differentiate among the Moderna COVID-19 vaccines.
  • Note that each vial contains 2 doses.
  • The volume of a single booster dose for ages 6 months through 5 years is 0.2 mL.

This Moderna product is not diluted prior to use (same as other Moderna COVID-19 vaccines). 

Pfizer-BioNTech COVID-19 Omicron (Bivalent) Vaccine:

The Pfizer COVID-19 Omicron (bivalent) vaccine is authorized as the third dose of the 3-dose primary series, following two doses of the monovalent Pfizer COVID-19 vaccine in children 6 months through 4 years of age.

  • Dose 3 of the Pfizer COVID-19 Omicron (bivalent) vaccine is administered at least 8 weeks after Dose 2 (doses 1 and 2 are the monovalent vaccine) to complete the 3-dose primary series for ages 6 months through 4 years.
  • The Pfizer Omicron (bivalent) vaccine for individuals 6 months through 4 years of age is supplied in multiple dose vials with maroon caps and labels with maroon borders.
  • The volume after dilution of a single dose for ages 6 months through 4 years is 0.2 mL.

 

This Pfizer product MUST BE DILUTED before use (as with the monovalent product for this age group, dilute with 2.2 mL sterile 0.9% Sodium Chloride Injection, USP prior to use).

Other Considerations:

Special Situations: Age Transitions & Interchangeability –  There are important considerations for children who will transition between ages 4 and 5 years during their Pfizer primary series, and between ages 5 and 6 years during their Moderna primary series. There is also expanded information on interchangeability (i.e., no mix-and-match for ages 6 months through 4 years).

Storage/Handling –  Information on storage/handling and more is in the EUA Fact Sheets.

Naming NoteThere are several terms being used across the country to refer to the updated vaccines. “Bivalent” is a term not easily understood or recognized by the general public. Instead, “Omicron Booster” and “Updated Booster” are commonly used and better understood by the public. Providers should note that “bivalent,” “Omicron,” and “updated” boosters are referring to the same products. Consider using more common language (i.e., Omicron, updated) when discussing options with patients.   

UpdatesThe CDC’s Interim Clinical Considerations for the Use of COVID-19 Vaccines and related resources are partially updated. As more official clinical guidance resources become available, state resources such as the WV COVID-19 Vaccination Due Date Calculator, FAQs on vaccinate.wv.gov

PREP ACT Declaration 

The US Department of Health and Human Services has EXTENDED the authority for authorized persons (including pharmacists, pharmacy interns, qualified pharmacy technicians as explained below) to give vaccinations to those ages three and up per ACIP and FDA guidance. This is found here https://www.phe.gov/Preparedness/legal/prepact/Pages/COVID-Amendment-6.aspx It has been EXTENDED until October 1, 2024 or until withdrawn by US. DHHR.  This is distinct and separate from the WV Declaration of a State of Emergency. 

The FDA authorized and the CDC/ACIP recommended the Pfizer COVID-19 vaccine for adolescents age 12-15 years old.  Pharmacists may order AND administer while interns or pharmacy technicians may administer under the supervision of a registered immunizing pharmacist the Pfizer COVID-19 vaccine to ages 12-15 years per the PREP Act Amendment.

You can view the requirement indicating both FDA authorization AND being ordered according to ACIP’s COVID-19 vaccine recommendation at https://www.phe.gov/Preparedness/legal/prepact/Pages/4-PREP-Act.aspx

The CDC authorization can be found at https://www.cdc.gov/media/releases/2021/s0512-advisory-committee-signing.ht

1. To enroll your pharmacy as a COVID-19 WV Vaccine provider please email WV DHHR Chris Young at christopher.d.young@wv.gov and ask to have your pharmacy enrolled.

2.  Can my WV licensed pharmacy technician give COVID-19 vaccinations?

Yes.  The WV BOP voted to recognize the PREP Act Amendment linked here.

  1. The pharmacy technician must be CPhT.  He/she must complete one of the training programs listed here under the “PTCB-recognized Immunization Administration Education/Training Program”. The pharmacy technician does not have to have completed the PTCB Immunization Administration Assessment -Based Certificate Program, as this is not a requirement to meet the standard of the PREP Act. 
  2. The pharmacy technician must also complete an approved CPR program listed on the WV BOP website.
  3. These documents must be kept on file at the pharmacy where the technician is vaccinating.
  4. PLEASE REMEMBER:
  • This is ONLY during the COVID-19 State of Emergency.
  • The vaccination must be ordered by the supervising qualified pharmacist who is a registered immunizer
  • The supervising registered immunizing pharmacist must be readily and immediately available to the immunizing qualified pharmacy technicians.
  • The vaccine must be FDA-authorized or FDA-licensed.
  • In the case of a COVID-19 vaccine, the vaccination must be ordered and administered according to ACIP’s COVID-19 vaccine recommendation(s).
  • In the case of a childhood vaccine, the vaccination must be ordered and administered according to ACIP’s standard immunization schedule.
  • The qualified pharmacy technician must complete a minimum of two hours of ACPE- approved, immunization-related continuing pharmacy education during the relevant State licensing period(s).
  • The supervising registered immunizing pharmacist must comply with recordkeeping and reporting requirements of the jurisdiction in which he or she administers vaccines, including informing the patient’s primary care provider when available and submitting the required immunization information to the state or local immunization information system (vaccine registry).
  • The supervising registered immunizing pharmacist is responsible for complying with requirements related to reporting adverse events.
  • The supervising registered immunizing pharmacist must review the vaccine registry or other vaccination records prior to ordering the vaccination to be administered by the qualified pharmacy technician or State-authorized pharmacy intern.
  • The qualified pharmacy technician and State-authorized pharmacy intern must, if the patient is 18 years of age or younger, inform the patient and the adult caregiver accompanying the patient of the importance of a well-child visit with a pediatrician or other licensed primary-care provider and refer patients as appropriate.
  • The supervising registered immunizing pharmacist must comply with any applicable requirements (or conditions of use) as set forth in the CDC’s COVID-19 vaccination provider agreement and any other federal requirements that apply to the administration of COVID-19 vaccine(s).

3. .  Are there additional vaccinations that pharmacy technicians can administer?

According to the PREP Act, pharmacy technicians can administer

(1) vaccines that the Advisory Committee on Immunization Practices (ACIP) recommends to persons ages three through 18 according to ACIP's standard immunization schedule or

(2) seasonal influenza vaccine administered by qualified pharmacy technicians and interns that the ACIP recommends to persons aged 19 and older according to ACIP's standard immunization schedule; or

(3) FDA authorized or FDA licensed COVID -19 vaccines to persons ages three or older.

This PREP Act Amendment can be viewed here.

4.  Additional information regarding the CDC recommendations for Pfizer COVID-19 vaccination in 12-15 year olds:

Page Updated: 12/20/2022 1:03:11 PM