OPA COVID-19 Vaccines and Therapeutics: October 4, 2022 Update

^New Pfizer-BioNTech COVID-19 Bivalent Booster for Children Preorders Open 
The Ohio Department of Health (ODH) announced that vaccinators can now preorder the Pfizer-BioNTech COVID-19 bivalent booster for children ages 5 to 11. Preorders can be made through the ImpactSIIS Vaccine Ordering Management System (VOMS). With limited quantities available, providers should plan to first offer boosters to children at high risk for severe illness from COVID-19 based on their age or medical conditions.

The vaccine can be shipped shortly after the U.S. Food and Drug Administration (FDA) approves the emergency use authorization (EUA). The Centers for Disease Control and Prevention (CDC) Advisory Committee on Immunization Practices (ACIP) issues recommendations for the use of the new booster doses, and the CDC director issues final recommendations and clinical guidance. Immediately afterward, providers will be authorized to administer the vaccine. The Ohio Department of Health will continue to share updates as more information becomes available.

^New Pfizer Training on COVID-19 Vaccine Bivalent Boosters 
Pfizer Medical has begun virtual training for all providers on the potential authorization of the Pfizer-BioNTech COVID-19 Vaccine, Bivalent, as a single booster dose in individuals 5 through 11 years of age at the request of the U.S. Government.  These sessions are for training purposes only. To access dates and links for upcoming training sessions, please visit https://www.pfizermedicalinformation.com/en-us/medical-updates.

^New FDA Reissues EUA for Novavax COVID-19 Vaccine

The U.S. Food and Drug Administration (FDA) reissued its emergency use authorization (EUA) for the Novavax COVID-19 Vaccine. Changes were made to revise the conditions of authorization related to reporting requirements to the Vaccine Adverse Event Reporting System (VAERS). The EUAs and Fact sheets now have broader definitions of serious adverse events, including pericarditis and myocarditis. Both symptoms have been seen in some cases following vaccine administration and can now be better reported using VAERS.

Updated Information:

Fact Sheet for Healthcare Providers Administering Vaccine

Fact Sheet for Recipients and Caregivers

Letter of Authorization (reissued 9/12/22)

Reminder: Funds Available from ODH Uninsured COVID-19 Vaccine Grant

The Ohio Department of Health (ODH) still has a small amount of funds available to reimburse pharmacies for vaccinating patients who are uninsured with the COVID-19 vaccine. Vaccinators are encouraged to apply as soon as possible. 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.

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.

Reminder: 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.

Reminder: FDA Provides Additional Guidance for Paxlovid Therapy Evaluation 
The FDA provided an updated 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.

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.