New ODH Announces COVID-19 Bivalent Booster Vaccine Preordering, Wave 1 Deadline Today
The Ohio Department of Health (ODH) announced that vaccine providers who plan to administer the new bivalent COVID-19 vaccine boosters may preorder vaccine to prepare to administer doses shortly after anticipated federal approval. The bivalent booster shot will include the original formulation and a formulation targeting Omicron subvariants BA.4 and BA.5. Two ordering waves will be available for providers to place preorders for the new Pfizer-BioNTech or Moderna bivalent booster products through the ImpactSIIS Vaccine Ordering Management System (VOMS).
The vaccine can be shipped shortly after the U.S. Food and Drug Administration (FDA) approves the emergency use authorization, the Centers for Disease Control and Prevention (CDC) Advisory Committee on Immunization Practices (ACIP) issues recommendations for use of the new booster doses, and the CDC issues final recommendations and clinical guidance. Immediately afterward, providers will be authorized to administer the vaccine.
New FDA Authorizes Novavax COVID-19 Vaccine for Adolescents
Last week, the FDA announced an emergency use authorization of the Novavax COVID-19 vaccine for individuals ages 12 to 17 years. This vaccine formulation differs from other available formulations as it contains the SARS-CoV-2 spike protein and the Matrix-M adjuvant. The vaccine is already authorized under EUA for adults 18 years and above. This two-dose primary series was shown to have clinical efficacy of around 80% against COVID-19, including Omicron subvariants BA.4 and BA.5.
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Reminder: Federal Government Plans to Approve New COVID-19 Booster Formulation in the Fall
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: 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:
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:
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:
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.
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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.