Complete Story
 

OPA COVID-19 Vaccines and Therapeutics: September 6, 2022 Update

 

New FDA Approves Two COVID-19 Bivalent Booster Formulations 
Last week, the U.S. Food and Drug Administration (FDA) amended the Emergency Use Authorizations of Moderna and Pfizer-BioNTech’s COVID-19 vaccines to allow their bivalent booster formulations for use as a single booster dose. This booster includes the original formulation plus a formulation targeting Omicron subvariants BA.4 and BA.5. The Moderna bivalent booster is a single dose approved for individuals ages 18 years and above, at least two months after completion of a primary COVID-19 vaccine series or the most recent COVID-19 booster dose. The Pfizer-BioNTech bivalent booster is authorized as a single dose for individuals 12 years and older, at least two months after a completed primary COVID-19 vaccination series or the most recent COVID-19 booster dose.

The original (monovalent) mRNA COVID-19 vaccines are no longer authorized as booster doses for individuals ages 12 years and older. Patients in this age group who are already scheduled for a booster dose using the original monovalent formulations should be directed to reschedule their appointment to receive the bivalent formulation once it is available at the vaccination location. Note: Children ages 5 through 11 years are allowed to receive the originally approved Pfizer-BioNTech COVID-19 monovalent vaccine. At this time, there are no changes to the recommended COVID-19 vaccine schedules for children ages 6 months through 11 years.

Related Information

New ODH Ordering Guidance for COVID-19 Bivalent Booster Formulations 
The Ohio Department of Health (ODH) shared that Ohio vaccine providers who preordered the bivalent vaccines can begin administering vaccinations as soon as shipments arrive and providers have had a chance to review storage, handling, and administration details found on the EUA fact sheets. Providers who placed preorders are urged to check their email messages for delivery updates from vaccine distributors. Shipment information also is available through the Vaccine Ordering Management System (VOMS). 

How to order bivalent COVID-19 vaccine boosters:
ODH is accepting orders for the bivalent boosters through VOMS. 

  • VOMS is open for providers to place orders 24 hours a day, 7 days a week.
  • Orders can be placed using the COVID-19 – Pfizer and COVID-19 – Moderna order sets. The minimum order quantity is 300 doses for Pfizer (30 mcg/0.3 mL) and 100 doses for Moderna (50 mcg/0.5 mL). A “soft-cap” maximum of 600 doses for Pfizer and 200 doses for Moderna doses will be placed on each order at this time to help with equitable distribution of the vaccine.
    • Please order only what you plan to use in the near future.
    • Order quantities may be adjusted to ensure fair and equitable distribution across the state.
    • If you are part of a large healthcare system or have a special request for a local vaccination effort that would require more doses, please call the ODH Provider Call Center at 1-844-9ODHVAX (1-844-963-4829) and they will work with you.
  • Smaller quantities of the Pfizer-BioNTech COVID-19 bivalent booster vaccine can also be requested.
    • The Ohio Department of Health (ODH) Receipt, Store, and Stage (RSS) warehouse facility will offer 60-dose quantities of the Pfizer bivalent booster once initial shipments have arrived.
    • Please use the COVID-19 ODH RSS order set to request these smaller quantities beginning this afternoon.

New FDA Provides Additional Guidance for Paxlovid Therapy Evaluation 
The FDA provided an updated  Prescriber Patient Eligibility Screening Checklist to help prescribers evaluate potential drug interactions for Paxlovid therapy for COVID-19. Dispensing and prescribing providers should review each patient’s full list of medications and use other resources to evaluate for potential drug interactions in patients who take medications that are not included on the Fact Sheet or checklist at this time. A listing of additional resources is provided at the end of the checklist.

Reminder: Funding Opportunity for COVID-19 Vaccine Administration to Uninsured Individuals 
ODH announced a new funding opportunity for COVID-19 vaccine providers in Ohio. This is intended to reimburse the costs of administering COVID-19 vaccines to uninsured individuals.

Before April 5, 2022, the Health Resources & Services Administration (HRSA) accepted claims for COVID-19 vaccine administration reimbursement to providers who vaccinated uninsured individuals. The HRSA program stopped accepting claims on April 5 due to insufficient funds. The Centers for Disease Control and Prevention’s COVID-19 Vaccination Program requires providers to continue administering COVID-19 vaccines at no out-of-pocket cost to recipients. As a result, some providers may be negatively impacted without reimbursement for these costs.

ODH is responding to this important need for providers to receive reimbursement to continue providing COVID-19 vaccines. Ohio COVID-19 vaccine providers who previously received reimbursement for vaccine administration through the HRSA COVID-19 Uninsured Program may apply for funding. Applicants shall not seek reimbursement through any other source for vaccines administered with this funding. Click here to download the Application for Uninsured Vaccine Administration Reimbursement. Downloaded applications will need to be signed, then emailed to Procurement@odh.ohio.gov.

The total funding available through ODH will be $1.7 million, which will be available through June 30, 2023, or until the available funds are exhausted. Funding will be awarded on a first-come, first-served basis. Vaccine providers will receive the money upfront based on the provider’s estimated number of vaccinations of uninsured individuals from the date of award through June 30, 2023. Providers will have the option of payment by electronic fund transfer or by check. Providers will be required as part of the agreement to submit quarterly reports with a total number of vaccinations of uninsured individuals to be reviewed and validated by ODH. Providers will be required to return any funding received in excess of the actual vaccines administered. Please submit any questions regarding this funding opportunity to ODH by email at Procurement@odh.ohio.gov.


OPA is working diligently to facilitate communication between state decision-makers and member pharmacists. OPA has created multiple COVID-19 resources, including a COVID-19 Vaccine Information Webpage, COVID-19 Testing Hub, and COVID-19 Resources Webpage, on the OPA website www.ohiopharmacists.org under the Resources drop-down box. Please contact Myriam Shaw Ojeda, Director of Pharmacy Extension and Public Health Initiatives, for further questions at mshawojeda@ohiopharmacists.org.

Printer-Friendly Version