COVID-19 Vaccine FAQs
COVID-19 Vaccination Information
UPDATED INFO: 5/15/23
On May 11, 2023, the federal COVID-19 state of emergency ended. Secretary Becerra of the Department of Health and Human Services did extend PARTS of the PREP Act for pharmacists, pharmacy technicians, and pharmacy interns. The HHS extension can be read here.
Under the PREP Act, for ages 3 years and up, pharmacists, pharmacy interns, and pharmacy technicians may provide:
- COVID-19 vaccinations for ages 3 years and up without a prescription, pharmacist may order
- Influenza vaccinations for ages 3 years and up without a prescription, pharmacists may order
Under WV law currently, pharmacists and pharmacy interns may provide:
- All ACIP/CDC recommended vaccinations ages 18 years and up without a prescription, pharmacist may order
- All ACIP/CDC recommended vaccinations ages 11 years and up WITH a prescription
Additional parts of the PREP Act that will continue:
- Authority for pharmacists to order and administer COVID-19 tests and treatments. This includes prescribing Paxlovid® as is indicated in the EUA of the product.
Pharmacy technicians: Need to have completed the training requirements of the PREP Act in order to provide vaccinations as above.
After the FDA updated the Emergency Use Authorization for the mRNA COVID-19 bivalent vaccines, yesterday (4-19-23) the CDC issued new, simplified recommendations effective now. Their complete guidance can be found here. The CDC is working to update the Interim COVID-19 Vaccine Clinical Considerations and this will be updated as soon as possible. We will add them and a link to the WV BOP FAQ section as soon as they are available. See below for a summary of the new guidelines. WHAT THIS MEANS: Monovalent mRNA vaccines are no longer authorized for use.
- CDC’s new recommendations allow an additional updated (bivalent) vaccine dose for adults ages 65 years and older and additional doses for people who are immunocompromised. This allows more flexibility for healthcare providers to administer additional doses to immunocompromised patients as needed.
WHAT THIS MEANS:
- Individuals ages 65 years and older who have NOT received a bivalent mRNA dose, are eligible for one bivalent mRNA dose and then at least 4 months later may receive an OPTIONAL additional bivalent mRNA dose
- Individuals ages 65 years and older who have received a bivalent mRNA dose, may receive an OPTIONAL additional bivalent mRNA dose at least 4 months after their first bivalent mRNA dose
- Immunocompromised individuals ages 6 years and older who already received a bivalent mRNA dose, may receive an optional additional bivalent mRNA dose at least 2 months after the last bivalent dose and then health care providers can determine the need for additional bivalent mRNA doses as needed at least 2 months apart based on the level of immunocompromise for conditions such as stem cell transplant, CAR-T therapy, B-cell depletion, and others. The immunocompromised patient determination remains a self-attestation and does not require additional documentation.
- Monovalent (original) COVID-19 mRNA COVID-19 vaccines will no longer be recommended for use in the United States.
- CDC recommends that everyone ages 6 years and older receive an updated (bivalent) mRNA COVID-19 vaccine, regardless of whether they previously completed their (monovalent) primary series.
WHAT THIS MEANS: Completion of a primary monovalent series is no longer necessary to be eligible for the bivalent mRNA dose. Because data shows that enough people either were vaccinated or have had the virus and the bivalent mRNA vaccine are able to induce and immune response when given as either a primary or booster dose, the FDA removed the authorizations for the monovalent mRNA vaccines. There are no changes to the Novavax or Janssen COVID-19 vaccines. Thus, regardless of whether an individual completed a monovalent mRNA primary series, the individuals ages 6 years and older are recommended to receive and updated (bivalent) mRNA COVID-19 vaccine.
- Individuals ages 6 years and older who have already received an updated mRNA bivalent vaccine do not need to take any action unless they are 65 years or older or immunocompromised.
- For young children, multiple doses continue to be recommended and will vary by age, vaccine, and which vaccines were previously received. Details for these recommendations will be available ASAP. Below is the link for the EUA for both the Moderna and Pfizer Bivalent mRNA products.
- Moderna Bivalent mRNA vaccine Healthcare Provider EUA Fact Sheet
- Moderna Bivalent mRNA vaccine Recipients and Caregiver EUA Fact Sheet
- Pfizer Bivalent mRNA vaccine Healthcare Provider EUA Fact Sheet
- Pfizer Bivalent mRNA vaccine Recipient and Caregiver EUA Fact Sheet
Alternatives to mRNA COVID-19 vaccines remain available for people who cannot or will not receive an mRNA vaccine. CDC’s recommendations for use of (monovalent) Novavax or Johnson & Johnson’s Janssen COVID-19 vaccines were not affected by the changes made today.
By eliminating the use of the monovalent mRNA vaccines, we go from 11 mRNA vaccine products on the market to six mRNA products and eliminate products with the same cap and label color. However, in the youngest population (6 months-5 years), the dosing from the vials will necessitate paying close attention as it is different with the Moderna products.
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.
- 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.
- The pharmacy technician must also complete an approved CPR program listed on the WV BOP website.
- These documents must be kept on file at the pharmacy where the technician is vaccinating.
- 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 an influenza 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) 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
(2) FDA authorized or FDA licensed COVID -19 vaccines to persons ages three or older.
The HHS extension can be read here.
4. Additional information regarding the CDC recommendations for Pfizer COVID-19 vaccination in 12-15 year olds:
- The pediatric toolkit will be here: https://www.cdc.gov/coronavirus/2019-ncov/vaccines/toolkits.html
- The web page for parents/guardians and adolescents is live now: https://www.cdc.gov/coronavirus/2019-ncov/vaccines/recommendations/adolescents.html
- FAQs on consent for minors: https://www.cdc.gov/vaccines/covid-19/info-by-product/pfizer/pfizer-bioNTech-faqs.html#vaccination-minors