Source: Ohio Department of Health
For a limited time, vaccine providers who plan to administer COVID-19 vaccines to children younger than age 5 years following federal authorization of Pfizer-BioNTech’s new pediatric formulation (ages 6 months through 4 years) and Moderna’s pediatric formulation (ages 6 months through 5 years) can place advance orders for the vaccine products.
By placing an advance order, physicians and other health care professionals can be among the first recipients of the new vaccine products and have the vaccine available on site in storage and ready to administer promptly following all required federal approvals. The vaccine can be shipped to providers following U.S. Food and Drug Administration (FDA) emergency use authorization (EUA); however, doses cannot be administered until the Centers for Disease Control and Prevention (CDC) issues recommendations for use.
The first ordering winder through the ImpactSIIS Vaccine Ordering Management System (VOMS), closed at noon on June 7. A second ordering window will open at 8 a.m. Wednesday, June 8, and will remain open through noon on Monday, June 13. The delivery window for shipments is to be determined.
The new Pfizer and Moderna vaccines are specially made for young children and are not interchangeable with the current Pfizer or Moderna products for adults, adolescents, and children. The Pfizer-BioNTech (ages 6 months through 4 years) and Moderna (ages 6 months through 5 years) vaccines will have new product configurations with new packaging and a new national drug code.
Physicians and other healthcare professionals are encouraged to order only one of the two vaccine options initially to avoid administration and/or storage errors, as each vaccine has different and unique criteria for storage and handling.
Due to national demand, placing an order through VOMS in this instance does not guarantee delivery of these new vaccine products for young children. Orders will be processed in the order they received. The Ohio Department of Health (ODH) has the discretion to adjust orders to ensure equitable distribution of this supply.
The FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) is scheduled to meet to review the Pfizer and Moderna applications for EUA:
- Tuesday-Wednesday, June 14-15: Moderna’s EUA request for COVID-19 vaccine for people 6 years through 17 years of age; Moderna’s EUA request for COVID-19 vaccine for children 6 months through 5 years of age; and Pfizer’s EUA request for COVID-19 vaccine for children 6 months through 4 years of age.
The full FDA will act after reviewing the panel’s recommendations. Then, the CDC’s Advisory Committee on Immunization Practices (ACIP) will convene to make recommendations for the vaccine products’ uses. Following a review of ACIP’s recommendations, the CDC director will then issue the final recommendation and clinical considerations.
Pending FDA authorization and CDC recommendations, physicians and other healthcare professionals should be ready to vaccinate children in these younger age ranges as soon as practical.
- VOMS is open for providers to place orders 24 hours a day, 7 days a week.
- Orders for the first round of deliveries of vaccine for young children starting on Monday, June 20, must have been submitted in VOMS no later than noon June 7.
- The minimum order quantity will be 100 doses. Physicians and other healthcare professionals may choose either the Pfizer or the Moderna vaccines for young children.
- Orders can be placed using the existing COVID-19 – Pfizer and COVID-19 Moderna order sets. The new formulation of each vaccine will be one of the product options available within the order set. Physicians and other healthcare professionals must enter the total quantity requested in the “Doses Requested” field in multiples of 100.
- The ability to administer all 10 doses within 12 hours once a vial is opened should be a planning consideration for initial orders. Sites should consider currently configured vial size (10-dose vials) when scheduling children for vaccination, especially early in the program, to optimize use of the supply.
- A “soft-cap” maximum of 1,000 doses will be placed on each order at this time to help with the equitable distribution of the vaccine. Please order only what you plan to use in the near future. If you have a special request for a local vaccination effort that would require more than 1,000 doses, please call the ODH Provider Call Center at 1.844.9ODHVAX (1.844.963.4829) and ODH will work with you.
- The new Pfizer or Moderna product for young children should be the only product requested in your pre-order. A separate order will need to be created for doses of other already authorized COVID-19 vaccines.
- While it is highly recommended to plan to order early to ensure you are among the first to vaccinate young children as soon as eligible, there will also be future opportunities to order vaccine.
ODH has prepared Interim Provider Guidance for COVID-19 Vaccines for Children based on preliminary information to help physicians and other healthcare professionals begin learning about the different products, including information about ordering, storage, handling, and administration. This guidance document will be updated following federal regulatory action and clinical considerations that will be published by the CDC.
ODH will continue to share updates and resources as it learns more about these COVID-19 vaccine products for children.
The ODH COVID-19 Provider website is a hub for a variety of resources for vaccine providers. Vaccine providers with questions may call the ODH Provider Call Center at 1.844.9ODHVAX (1.844.963-4829) between 8 a.m. and 5:30 p.m. Mondays through Fridays or email COVIDVACCINE@odh.ohio.gov.