COVID-19 Vaccine FAQs

COVID-19 Vaccination Information

UPDATED INFO: 11/19/2021

Per the CDC

Everyone ages 18+ is eligible for a #COVID19 booster.

If you got an mRNA vaccine, you may get a booster dose 6 months after being fully vaccinated.

If you got a one-dose vaccine, you may get a booster dose 2 months after being fully vaccinated. bit.ly/3qR93av

 

UPDATED INFO 11/2/2021: Pfizer BioNTech Pediatric COVID-19 Vaccine (Orange Cap)

The Pfizer BioNTech Pediatric COVID-19 vaccine has been authroized for ages 5-11 years.  This is a NEW DRUG and the adult (purple cap) cannot be used in this age group.  The vaccine is arriving in WV and is being distributed to providers accross the state.  Additionally, the Federal Pharmacy Program is also receiving the Pediatric Pfizer product.  Please be VERY cautious and pay attention to detail as this product is different from the Adult drug.

WVBOP is following the PREP Act which allows registered immunizing pharmacists, plus appropriately trained pharmacy interns and certified pharmacy technicians to administer vaccines to ages 3 years and up.  The pharmacist can order (prescribe) the vaccine and at this time due to the Prep Act a prescription is not necessary.  Please make certain you have updated your Policy and Procedure manuals as required and have appropriate dosages of Epinephrine, diphenhydramine on hand for this age group in case an emergency arises.

WV has produced a short educational video (15 minutes) for the pediatric Pfizer BioNTech vaccine that will be available later today that any organization obtaining vaccine from the WV State supply is REQUIRED to view prior to administering any pediatric COVID-19 vaccine.  Others may view the video.  The link will be placed in the FAQ COVID-19 Vaccine section on the BOP website.

COVID-19 Vaccine Dosage and Administration

  • Children should receive the age-appropriate vaccine formulation regardless of their size or weight.
  • The Pfizer-BioNTech COVID-19 vaccine is supplied in a multiple dose (10 dose) vial with an orange cap and labeled with an orange border, is administered, after dilution with 1.3mL, as a primary series of 2 doses (0.2 mL each)
  • The formulation for children 5 to 11 years is a 2-dose vaccination series, given intramuscularly, recommended at least 3 weeks (21 days) apart

 

The emergency use authorization fact sheet for providers should be reviewed thoroughly before initiating the start of vaccinations for children 5 to 11 years old.   The emergency use authorization fact sheet for recipients and caregivers must be provided to parents. The updated EUAs are available below.

Interim Clinical Considerations are out. These will answer all of you questions about what to do in a given situation.  They can be found at https://www.cdc.gov/vaccines/covid-19/clinical-considerations/covid-19-vaccines-us.html

Pfizer Pediatrics Training Video Information :

 See below for link and instructions:

 

Instructions:

-Click the below link or copy and paste into your browser:

https://wvpca.webex.com/wvpca/k2/e.php?RCID=b02ba402006c4e1859699e2c2fcb53c6

 

-Click the “View” button

-Enter the following password:  COVID5-11Vaccine

-Click the “OK” button

-Enter your registration information and click “Register”

-You will be automatically directed to the training video, click the arrow in the center of the screen to play

CDC Recommends Booster doses for Additional Populations

Booster doses for all three COVID-19 vaccines have now been authorized for certain populations in the United States. 

UPDATED INFO: 11/19/2021

Per the CDC

Everyone ages 18+ is eligible for a #COVID19 booster.

If you got an mRNA vaccine, you may get a booster dose 6 months after being fully vaccinated.

If you got a one-dose vaccine, you may get a booster dose 2 months after being fully vaccinated. bit.ly/3qR93av

Recommendations when doing Heterologous (Mix and Match) Booster Dose (from ACIP)

  • Heterologous dosing may be considered for the BOOSTER dose only. (Not primary series or additional dose in immunocompromised).
  • Individual benefit-risk assessment may inform which booster product to use      
    • Availability of product
    • Risk profile of vaccine booster, including rare events
  • The interval for the booster should follow the interval recommended by the primary series
    • People who receive a single dose Janssen primary dose can receive a COVID-19 booster dose (any type) at least 2 months after completing the primary series
    • People who receive a primary series of Moderna or Pfizer and qualify for a booster my receive a COVID-19 booster dose (any type) at least 6 month after completing the primary series.
  • If Moderna vaccine booster is used, the booster dose and volume should be used 50µg (0.25mL)
    • Pfizer and Janssen booster doses are the same dose as the primary series.
    • If an individual who is moderately to severely immunocompromised received a primary dose of Janssen vaccine and receives a booster dose of Moderna, the 0.25mL (50µg) dose should be used.
  • No more than 3 doses total if started with mRNA COVID-19 Vaccine Series.
  • All EUAs (Healthcare provider and Patient/Caregiver) have been updated on the wvbop.com website. Please begin using these immediately.

The Moderna vial MAY NOT be punctured more than 20 (TWENTY) times.  If you are just drawing the booster doses of 0.25mL from the vial, there will be liquid remaining.  Per labeling and FDA direction, any drug remaining after 20 punctures MAY NOT be used because of increased contamination and coring risk.

__________________________________________________________________________________________________________

COMIRNATY (Pfizer) received full FDA approval 8/23/2021for ages 16+ years for the 2 dose series.  All other remains under EUA.  Per the CDC, this should NOT be used "off-label" (even with a prescription).

Off label use of the COMIRNATY/Pfizer-BioNTech COVID-19 Vaccine is not authorized at this time. The Administration is preparing systems and logistics to be able to offer COVID-19 booster shots to fully vaccinated adults this fall. The regulatory and clinical details of this booster plan are contingent on FDA conducting an independent evaluation and determination of the safety and effectiveness of a third dose of the mRNA vaccines (Pfizer and Moderna) and CDC’s Advisory Committee on Immunization Practices (ACIP) issuing recommendations based on a thorough review of the evidence when those recommendations are adopted by the CDC Director.

An additional dose for individuals beyond those with certain conditions associated with immunocompromise would be an off-label use at this time. Administration of the product off label may not be covered under the PREP Act or the PREP Act declaration; therefore, providers may not have immunity from claims. Individuals who receive a third dose may not be eligible for compensation after a possible adverse event. Such use also would be in violation of the CDC COVID-19 Vaccination Program provider agreement and therefore may not be reimbursable, and may impact the ability of a provider to remain in the CDC Program, in addition to other potential sanctions. Administration fees for off-label doses may not be reimbursed by payers. https://www.cdc.gov/vaccines/covid-19/info-by-product/pfizer/pfizer-bioNTech-faqs.html?fbclid=IwAR3BEkMPRL8HMLsJfikCUoZBxT98W_6mCrn8vaiQq1P1SC8wXG9AHIkgCy8#off-label-use

August 13, 2021, the Centers for Disease Control recommended an additional dose of the COVID-19 mRNA vaccine for certain immunocompromised individuals after a similar authorization by the Food and Drug Administration yesterday following the Advisory Committee on Immunization Practices (ACIP) meeting today.  Information on this new update can be found at “COVID-19 Vaccines for Moderately to Severely Immunocompromised People.”

Currently, CDC is recommending that moderately to severely immunocompromised people receive an additional dose. These conditions and treatments include but are not limited to:

  • Active treatment for solid tumor and hematologic malignancies
  • Receipt of solid-organ transplant and taking immunosuppressive therapy
  • Receipt of CAR-T-cell or hematopoietic stem cell transplant (within 2 years of transplantation or taking immunosuppression therapy)
  • Moderate or severe primary immunodeficiency (e.g., DiGeorge syndrome, Wiskott-Aldrich syndrome)
  • Advanced or untreated HIV infection
  • Active treatment with high-dose corticosteroids (i.e., ≥20mg prednisone or equivalent per day), alkylating agents, antimetabolites, transplant-related immunosuppressive drugs, cancer chemotherapeutic agents classified as severely immunosuppressive, tumor-necrosis (TNF) blockers, and other biologic agents that are immunosuppressive or immunomodulatory.

Patient attestation (no prescription or additional documentation from health care provider of immunocompromising condition) is necessary to determine the eligibility for the above criteria.

Information regarding level of immunosuppression can be found here.

This recommendation only applies to individuals who received a mRNA COVID-19 series and DOES NOT permit an additional dose for individuals received Johnson and Johnson/Jannsen. 

It is recommended that individuals should receive the same mRNA COVID-19 vaccine (Pfizer or Moderna) received initially.  A person should not receive more than three mRNA vaccine doses. If the mRNA vaccine product given for the first two doses is not available or is unknown, either mRNA COVID-19 vaccine product may be administered.

CDC recommends the additional dose of an mRNA COVID-19 vaccine be administered at least four weeks (28 days) after a second dose of Pfizer-BioNTech COVID-19 vaccine or Moderna COVID-19 vaccine.

Additional information regarding clinical considerations of the additional dose of mRNA COVID-19 vaccine for can be found here.

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. 

The Center for Rural Health Development COVID-19 Vaccine Campaign Press Kit is available at this link and contains many resources for best practices, social media posts, stickers/buttons, printables, and newsletter graphics!

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.html

  1. The Current Approval for Pfizer age 16+ (2 dose) and  Emergency Use Authorizations for Pfizer (age 12-15), Moderna, and Janssen for both healthcare providers and patients/caregivers are available below.  Even though Pfizer is approved for ages 16+ and has EUA for 12-15 year olds, there is only one set of documents below.

Pfizer/BioNTech:                                             

             Healthcare Provider 12 years of age and older purple cap (Must dilute) 11/19/2021

             Patient/Caregiver 12 years of age and older purple cap (Must dilute) 11/19/2021

 

             Healthcare Provider 5 - 11 years of age, orange cap (must dilute) (10/29/2021)

             Patient/Caregiver 5 - 11 years of age (10/29/2021)

       Moderna:                

            Healthcare Provider 11/19/2021

            Patient/Caregiver 11/19/2021

       Johnson and Johnson (Janssen): 

           Healthcare Provider 11/19/2021

           Patient/Caregiver 11/19/2021

 

  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.

 

  1. 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).

4.  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.

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

Page Updated: 11/19/2021 6:17:39 PM