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VDH COVID-19 Providers,
The CDC has communicated the vaccine allocation procedures for the Pfizer 5-11 vaccine with the jurisdictions (Virginia), and the process will initially be different than that of our other COVID-19 vaccines. To ensure that vaccines can be distributed as quickly as possible and to facilitate providers’ ability to administer doses as soon as the final recommendation is issued, the Federal Government is shipping an initial “bolus” of the Pfizer 5-11 vaccine to preposition doses with individual providers. This will ensure that the launch of the distribution of pediatric formulation is equitable, timely, and efficient.
There are approximately 28 million children between the ages of 5-11 years old in the United States and approximately 748,000 live in Virginia. The U.S. government has procured enough vaccine supply to support vaccination of this population.
Orders for the initial allocation of Pfizer 5-11 vaccines will not be processed through VaxMaX, but through your Local Health District from 10/19 through 10/25. If you did not receive or have not already completed the 5-11 Provider Readiness Survey, please contact your LHD as soon as possible if you have capacity and willingness to vaccinate the 5-11 population. Please note that the minimum site order quantity is 300 doses, and that site supplies will need to accommodate the 5 - 11 population. A few other considerations are listed below:
- Pediatric doses are a completely new configuration and are not interchangeable with the adult formulation. Please note the ten dose vial size and different diluent and vaccine dosing for pediatrics compared to adult/adolescents as well.
- Pfizer pediatric doses will be shipped at ultra-cold temperatures in a new disposable thermal shipper along with dry ice and Controlant digital data logs (cannot be used as temporary storage). Please note that hub and spoke sites will no longer be able to reuse the thermal shipper but the hope is the smaller shipment sizes and increased storage length at refrigerator temperatures (10 weeks) will allow for more direct from manufacturer shipments.
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Pfizer adult 1170 orders will be suspended the week of the rollout to allow Pfizer to shift resources to support the initial pediatric orders. Clarity on the exact dates of the suspension will be forthcoming.
- Pediatric doses can go straight into the fridge upon receipt and Beyond Use Labels will be available for printing by providers. Wastage messaging for Pfizer Pediatric doses is forthcoming.
- At this time the availability of vaccines after the initial allocation is unknown. As a result, providers should plan to use the vaccines they receive initially for first and second doses until VDH receives more information. Upon receiving more information, VDH will contact providers with updated guidance in this regard.
- Vaccine ancillary supply kits will be provided with vaccine. CDC has not provided additional details about the contents of these ancillary supply kits.
VDH will return to the weekly allocation cycle in VaxMaX once the initial allocation process ends. Weekly allocation after the initial allocation will have a minimum site order quantity of 100 doses. Following the initial launch, a weekly ordering process for Pfizer pediatric vaccine will begin for jurisdictions.
FDA’s Vaccines and Related Biological Products Advisory Committee is scheduled to meet October 26th to discuss Pfizer’s submission for vaccines for 5-11 year old children. If the FDA amends the Pfizer EUA, product will immediately begin to be filled and delivered nationwide to sites, and deliveries will arrive in the days immediately following EUA issuance. Some orders will be delivered as soon as the next day following EUA issuance. The CDC’s Advisory Committee on Immunization Practices (ACIP) is scheduled to meet to discuss this issue on November 2-3. Even with vaccines on site, vaccinations for 5- to 11-year olds cannot begin until after the CDC makes a recommendation for use, consistent with requirements in the provider agreement.
We thank you for your patience and understanding as we update you with new information and guidance as it becomes available. For any questions, please contact your LHD. If unsure who to contact, please email vaxmax_help@vdh.virginia.gov.
Thanks,
Virginia Department of Health
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