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OPA COVID-19 Vaccines and Therapeutics: August 9, 2022 Update

 

New National Immunization Awareness Month Resources 
Vaccines have played a crucial role in protecting against severe side effects and even death due to COVID-19. National Immunization Awareness Month (NIAM), observed in August, provides an opportunity to discuss the importance of immunizations with patients. The U.S. Food and Drug Administration (FDA) has shared a NIAM resource webpage to assist with communicating about immunizations. This webpage includes information on COVID-19 vaccines and adult vaccine assessment tools. Additional toolkits for targeted populations such as pediatric and geriatric patients are also included.

Reminder: Federal Government Plans to Approve New COVID-19 Booster Formulation in the Fall
Last week, the White House shared plans to promote newer COVID-19 booster vaccine formulations in the Fall. This follows a recommendation from the U.S. Food and Drug Administration (FDA) urging vaccine manufacturers to create updated COVID-19 booster vaccine formulations. Moderna and Pfizer-BioNTech are currently working to test and obtain emergency use authorization for booster formulations that contain new components from the omicron subvariants BA.4/5 along with the original formulation. These bivalent booster formulations aim to alleviate a potential spike in cases as individuals congregate more indoors as the weather cools and protection from previously administered vaccines begins to wane. Vaccinators can use this information to help answer patients' questions about booster doses and their necessity in the coming months.

Reminder: ODH Opens Ordering for Novovax COVID-19 Vaccine, Adjuvanted
Last week, the Ohio Department of Health (ODH) announced that vaccinators could administer the Novovax COVID-19 Vaccine, Adjuvanted, under EUA to prevent COVID-19 in individuals ages 18 and older. This vaccine provides an alternative to the messenger RNA vaccines made by Pfizer-BioNTech and Moderna. Ordering can be done through the ImpactSIIS Vaccine Ordering Management System (VOMS).

Novavax is a two-dose primary series (5 mcg/0.5 mL) given intramuscularly at least 21 days apart (with a flexible interval of 3-8 weeks between doses). Novavax can only be used for the primary vaccine series. This product is not authorized for booster doses and is not interchangeable with other COVID-19 vaccines. If Novavax is given as a first dose in the primary vaccine series, the second dose must also be the Novavax product. The second dose should be given 21 days after the first for immunocompromised individuals.

Novavax is available in multi-dose vials (10 doses per vial/10 vials per carton) with a minimum order of 100 doses and a maximum order of 500 doses per order. Ancillary kits will be included and may be shipped separately. 

Orders should account for both first and second doses. Providers should retain half of the inventory received to facilitate supply for second doses. For example, an order of 100 doses would vaccinate 50 individuals; an order of 500 doses would vaccinate 250 individuals. To maximize doses administered per vial and minimize wastage, providers are encouraged to schedule appointments for Novavax initially if possible.

Storage and Handling
Novavax can be stored in the refrigerator (2 degrees to 8 degrees Celsius or 36 degrees to 46 degrees Fahrenheit). It should not be stored in any type of freezer. The Novavax vial and carton do not have a printed expiration date. To find the expiration date, access www.NovavaxCovidVaccine.com, navigate to the United States Healthcare Professional section of the website, and enter the lot number printed on the carton or vial into the “Expiry Date Checker” tool. The expected expiration date for these initial orders is February 2023.

No diluent is required, and the vaccine is preservative free. After the first puncture, the vaccine can be stored at room temperature for up to 6 hours at 2º C to 25º C (36º F to 77º F). Providers should record the date and time of the first puncture on the vial.

Additional Resources:

Reminder: Ohio Medicaid Pharmacist COVID-19 Reimbursement Incentive New Deadline
The Ohio Department of Medicaid (ODM) and Ohio’s Managed Care plans announced that the enhanced COVID-19 administration reimbursement for pharmacists is ending on September 30, 2022. This is based on recent guidance as ODM switches to Gainwell Technologies as their single pharmacy benefit manager at the beginning of October. OPA encourages pharmacists to continue promoting COVID-19 vaccines for all eligible patients in anticipation of the discontinuation of this incentive before September.

Additional deadlines that have already been posted are as follows:

  • OutcomesMTM and CSS Health tips on COVID-19 counseling and administration ended on June 30, 2022.
  • Patient gift cards for all COVID-19 vaccines also ended on June 30, 2022. If your pharmacy received physical gift cards for patients, please fill out the gift card trackers and send them to [email protected].
  • Physical gift cards must be returned to the following address: Meera Patel-Zook, 4349 Easton Way Suite 201, Columbus, OH 43219.

Reminder: FDA Authorizes Pharmacist Prescribed Paxlovid COVID-19 Treatment with Certain Limitations
The FDA authorized state-licensed pharmacists to prescribe Paxlovid (nirmatrelvir and ritonavir) with certain limitations. The updated Emergency Use Authorization permits pharmacists to prescribe the medication based on the following conditions:

  • The pharmacist can access patient health records to assess renal and hepatic function through:
    • Patient health records that are less than 12 months old;
    • A consultation with a healthcare provider who has an established relationship with the specific patient.
  • The pharmacist can obtain a comprehensive medication list (prescribed and non-prescribed) that the patient is currently taking to check for drug interactions through:
    • Patient health records that are less than 12 months old;
    • Patient reporting of medication history;
    • A consultation with a healthcare provider who has an established relationship with the specific patient.

Pharmacists should refer patients for clinical evaluation with a physician, advanced practice registered nurse, or physician assistant licensed or authorized under state law to prescribe drugs if any of the following apply:

  • Sufficient information is not available to assess renal and hepatic function.
  • Sufficient information is not available to assess (and/or monitor) for potential drug interactions.
  • Modification of other medications is needed due to potential drug interactions.
  • Paxlovid is not an appropriate therapeutic option based on the current Fact Sheet for Healthcare Providers.

Paxlovid is authorized for the treatment of mild-to-moderate COVID-19 in adults and pediatric patients (12 years of age and older, weighing at least 40 kilograms or about 88 pounds) with positive results of direct SARS-CoV-2 viral testing, who are at high risk for progression to severe COVID-19, including hospitalization or death. Patients in the authorized population who report a positive home test result from a rapid antigen diagnostic test or a positive PCR test to their provider are eligible for Paxlovid under the EUA. Confirmation of a positive home rapid antigen diagnostic test with additional direct SARS-CoV-2 viral testing, such as a PCR, is not required. Antibody tests are not considered to be direct SARS-CoV-2 viral tests.

Additional Resources:

  • To order Paxlovid from the Ohio Department of Health:

Reminder: Funding Opportunity for COVID-19 Vaccine Administration to Uninsured Individuals
The Ohio Department of Health (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 [email protected].

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 [email protected].


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 WebpageCOVID-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].

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