OPA COVID-19 Vaccines: December 27, 2021 Update
NewFDA Approves Two Oral COVID-19 Oral Antivirals
Last week, the U.S. Food and Drug Administration (FDA) approved two oral antivirals, Paxlovid and Molnupiravir, to treat COVID-19 in certain adults and pediatric patients.
Pfizer’s Paxlovid (nirmatrelvir and ritonavir tablets, co-packaged for oral use)
Paxlovid has been issued an emergency use authorization (EUA) to treat mild to moderate COVID-19 in adult and pediatric patients ages 12 and older and weighing at least 40 kilograms (about 88 pounds) who have tested positive for COVID-19. This group also includes individuals at high risk for progression to severe COVID-19, including hospitalization or death. This prescription-only medication must be taken after a diagnosis of COVID-19 within five days of symptom onset. See more information in this press release from the FDA.
Other useful resources:
- Paxlovid EUA Letter of Authorization
- Frequently Asked Questions on the Emergency Use Authorization for Paxlovid
- Emergency Use Authorization: Drugs and Non-Vaccine Biological Products
- Coronavirus Disease (COVID-19)
- Coronavirus Treatment Acceleration Program (CTAP)
Molnupiravir has been issued an emergency use authorization (EUA) to treat mild to moderate COVID-19 in adults who have tested positive for COVID-19. This group also includes individuals at high risk for progression to severe COVID-19, including hospitalization or death, or for whom alternative treatment options authorized by the FDA are not accessible or clinically appropriate. This medication is available by prescription only and should be initiated after a diagnosis of COVID-19 within five days of symptom onset. See more information in this press release by the FDA.
Other useful resources:
- Molnupiravir EUA Letter of Authorization
- Frequently Asked Questions on the Emergency Use Authorization for Molnupiravir
Ohio Supply of Oral COVID-19 Antivirals
The Ohio Department of Health (ODH) is set to receive a limited amount of these oral COVID-19 antivirals in the initial phase of distribution. ODH will distribute them to a limited number of healthcare providers. As the allocated supply increases, the distribution model will incorporate additional providers, including pharmacies already providing COVID-19 vaccines. More information about allocation and future distribution plans will be released soon.
New $100 COVID-19 Medicaid Administration Fee Deadline Extended
The Ohio Department of Medicaid (ODM) and Ohio’s Medicaid Managed Care Plan (MCP) leaders announced that the administration fee for COVID-19 vaccines is $100 for all COVID-19 shots, including first, second, and booster doses for Medicaid members has been extended to June 30, 2022. The MCP leadership encourages pharmacies to assist Medicaid patients with accessing first, second, and booster shots through phone calls, walk-in appointments, and other personalized outreach.
NewMedicaid COVID-19 Patient Vaccine $100 Gift Card Incentive Deadline Extended
Ohio’s managed care plans announced that the $100 gift card incentive for Medicaid patients receiving their first dose of the COVID-19 vaccine has been extended to June 30, 2022.
- Pharmacies can receive Visa gift cards directly to give to patients. If you are an independent pharmacy vaccinator, please email [email protected] for your gift card needs. Thank you to those who have already responded with the projected gift cards needed.
- Once you get to 75% of your gift card allocation, please reach out to Attn: Meera Patel-Zook – Gift Card Request at [email protected] so that they can ship out an additional allotment to your store.
Note: If you have received gift cards, please ensure that you track their use through the COVID-19 Vaccine Gift Card Tracker Example. Vaccinators can now add all the information for all MCOs in ONE tracker and send that tracker to [email protected].
Reminder: ODH COVID-19 Vaccine Reporting Requirements
ODH reminds vaccinators to report vaccine administration within 24 hours of providing the vaccine to patients through the Ohio Impact Statewide Immunization Information System (ImpactSIIS). This will help provide an accurate picture of vaccine administration in the state. This will also help providers determine a patient’s eligibility for second and booster doses. ODH offers job aids and videos that will take you step-by-step through processes that are crucial for administering the COVID-19 vaccine to patients and sharing critical data. Visit the ODH Provider Training webpage for additional training resources.
Reminder: Pfizer-BioNTech COVID-19 Formulation Change
Starting Thursday, December 23, 2021, the Pfizer-BioNTech COVID-19 vaccine for individuals ages 12 and above will be available in smaller quantities and stored at standard refrigerator temperatures for a longer time without the requirement for dilution. Here is additional information about the new formulation:
Storage and Handling
- The new formulation will be called the Pfizer Tris Sucrose (gray cap)
- The formulation will not require a diluent
- A new update to storing guidelines is that the vials can be stored for up to 10 weeks at standard refrigerator temperature (35°F to 46°F).
- Vials can ONLY be stored in an ultracold freezer (-130°F to -76°F) or a standard refrigerator (35°F to 46°F), NOT a standard freezer (-13°F to 5°F) attached to a standard refrigerator.
- The vials cannot be stored in their original thermal shipping container long-term. Upon delivery, the vials must be moved either to an ultracold freezer or standard refrigerator
- Vials stored in standard refrigerators must be stored towards the bottom of the refrigeration unit. Additionally, the vials should not be placed next to the temperature monitoring device or next to other refrigerated vaccines.
- The new thermal shippers are disposable but come with temperature data loggers that must be returned. Instructions to return the loggers will be provided in the shipper.
- See more details about storage and handling here: Pfizer-BioNTech COVID-19 Vaccine for Ages 12 and Older (Gray Cap) - Fact Sheet for Healthcare Providers
- ODH urges vaccinators to use existing supplies of the original purple capped formulation before ordering the newer formulation.
ODH will be conducting training sessions on ordering, storing, and handling this new formulation. Please save the following dates. Additional links to the online webinar and recordings of the sessions will be provided soon. Pfizer will also be conducting future training sessions. Please visit https://www.pfizermedicalinformation.com/en-us/medical-updates for updated training sessions.
Providers can request the new gray cap through Vaccine Ordering Management System (VOMS). Orders will be reviewed by ODH and be approved based on existing inventory. Delivery of the new product will begin January 4. Further details are as follows:
- The minimum ordering quantity is 300 doses
- Ordering is available through the “COVID-19 – Pfizer” order set in VOMS
- Vaccinators requiring smaller quantities can order from the ODH Receipt, Stage and Store (RSS) Warehouse through VOMS
- The minimum order is 60 doses (with 60 dose increments)
- Ordering is available through the “COVID-19 – Pfizer RSS” order set in VOMS
- Ordering will follow the standard Tuesday/Thursday/Friday delivery cadence
Note: The Pfizer pediatric formulation will only be available for direct shipment in 100 dose increments through the “COVID-19-Pfizer” order set. The RSS warehouse will focus on repackaging and distributing the new Pfizer Adult/Adolescent formulation into smaller quantities.
Helpful State Vaccine Resources and Information
The following resources are helpful for vaccinators to contact ODH regarding vaccine shipments:
- COVID Vaccine Provider Call Center: 1-844-963-4829 (The ODH Provider Call Center is open daily from 8:00 am – 7:00 pm Monday through Friday and is no longer open on weekends)
- COVID-19 Vaccine Provider Resources website
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 [email protected].