• FDA Expands Authorization of Two Monoclonal Antibodies for Treatment and Post-Exposure Prevention of COVID-19 to Younger Pediatric Patients, Including Newborns - On December 3, 2021, the U.S. Food and Drug Administration (FDA) revised the emergency use authorization (EUA) of bamlanivimab and etesevimab (previously authorized for pediatric patients 12 years of age and older weighing at least 40 kilograms, or about 88 pounds), to additionally authorize bamlanivimab and etesivimab administered together for the treatment of mild to moderate COVID-19 in all younger pediatric patients, including newborns, who have a positive COVID-19 test and are at high risk for progression to severe COVID-19, including hospitalization or death. This revision also authorizes bamlanivimab and etesevimab, to be administered together, for post-exposure prophylaxis for prevention of COVID-19 in all pediatric patients, including newborns, at high risk of progression to severe COVID-19, including hospitalization or death.
• FDA SARS-CoV-2 Viral Mutations: Impact on COVID-19 Tests - On December 7, 2021, the FDA provided general recommendations for clinical lab staff and healthcare providers about COVID-19 tests in the context of SARS-CoV-2 variants. FDA also provided an update on molecular tests that might be impacted specifically by the Omicron variant: 1) The Tide Laboratories DTPM COVID-19 RT-PCR Test, which is conducted at multiple labs across the U.S., but not in Virginia, is expected to not detect the Omicron variant. 2) FDA reports that overall test sensitivity with S-Gene drop out (or S-gene target failure) molecular tests should not be impacted by the Omicron variant. The presence of the S-gene drop out provides a clue that the Omicron variant might be present, but it does not confirm it because other variants can also have similar results. Whole genome sequencing is required to confirm the Omicrant variant.
• President Biden Announces New Actions to Protect Americans Against the Delta and Omicron Variants As We Battle COVID-19 this Winter - On December 2, 2021, the White House has released a statement detailing strategies in a nine-step plan to help protect Americans from COVID-19 this winter. The plan aims to keep the economy running and includes boosters for adults, vaccinations for children to provide protection from COVID-19 and keep schools open, expanding free at-home testing for Americans, stronger public health protocols for safe international travel, protections in workplaces to keep our economy open, rapid response teams to help battle rising cases, supplying treatment pills to help prevent hospitalizations and deaths, continued commitment to global vaccination efforts, and steps to ensure we are prepared for all scenarios
• VDH Clinician Letter: COVID-19 Update for Virginia - The latest clinician letter from December 3, 2021 includes updates on the Omicron variant, information on CDC’s Health Alert Network (HAN) Health Advisory about increasing seasonal Influenza A (H3N2), and upcoming webinars on monoclonal antibodies and COVID-19 vaccines.
• CDC HAN Health Advisory: New SARS-CoV-2 Variant of Concern Identified: Omicron (B.1.1.529) Variant - In this December 1 advisory, CDC provided background information about what is known and not known about Omicron.
  • Recommendations for health departments are provided for case identification, reporting, and contact tracing, including isolation of infected persons, testing of close contacts and quarantine as appropriate; voluntary testing will be offered to international travelers upon arrival at select U.S. airports.
  • Recommendations for laboratories for surveillance are provided. Because Omicron has and Delta does not have S-gene target failure (SGTF) on certain PCR assays, the presence of SGTF can be used as a screen to identify potential Omicron infections.
  • Recommendations for healthcare providers for diagnosis and treatment are provided. Providers are encouraged to collect a detailed travel history for suspected and confirmed cases. Because the Omicron impact on therapeutics is unknown, providers should closely follow the National Institute of Health’s COVID-19 treatment guidelines.
  • Recommendations for the public include using getting vaccinated and boosted and layering other mitigation strategies (e.g., masking, improved ventilation, distancing, handwashing, and testing).

• CDC Science Brief: Omicron (B.1.1.529) Variant - Provides an overview of what is known and not known about the characteristics of Omicron and information about the public health response to Omicron.

• Administration Data Update

• • Beginning on Monday, December 13, the VaxMax system will be updated to refresh vaccine administration data daily at 12:00am. The administration data will represent COVID-19 vaccine administrations processed in VIIS as of 10:30pm the previous day. Please contact the VaxMax Helpdesk (vaxmax_help@vdh.virginia.gov) for questions regarding vaccine administration data in VaxMax.

• Reminder on Pfizer Expiration Extension

• • Please note that the Pfizer expiration extension is still in effect. Cartons and vials of Pfizer-BioNTech COVID-19 Vaccine with an expiry date of August 2021 through February 2022 printed on the label may remain in use for 3 months beyond the printed date as long as approved storage conditions between -90ºC to -60ºC (-130ºF to -76ºF) have been maintained.

Pfizer 1170 Transition Plan & Timeline

• A new formulation of Pfizer vaccine for adults/adolescents will be available this December

• • The U.S. Government (USG) will soon be introducing a smaller dose configuration of Pfizer adult/adolescent vaccine.
  • This formulation (Pfizer Tris Sucrose Adult formulation) does not require diluent for mixing at administration sites, may be stored at 2-8 C (36-46 F) for up to 10-weeks, and can be used on individuals 12 years of age and older. The vials will have a gray cap.
• This formulation will be available for ordering DECEMBER 23
  • The USG will retire the current Pfizer PBS (1170 and 450 packs) ordering and transition to the Pfizer Tris-Adult formulation (300 Minimum Dose Quantity)
  • Ordering of Pfizer Tris-Adult formulation will begin on Dec 23 for jurisdictions and federal entities.
  • Jurisdictions should utilize existing PBS formulations (1170 and 450 dose packs) to the greatest extent possible prior to ordering Pfizer Tris.

• Transition before ordering the new formulation:

• • Before jurisdictions can order Pfizer Tris formulation, in-field inventory for Pfizer PBS vaccine should be below 28-days of supply as reflected in Tiberius.

• • Pfizer Tris-Adult product ordering may begin as early as Dec 23 dependent on CAG (Countermeasures Acceleration Group)/CDC inventory assessment.

• • All order thresholds thereafter will be for Pfizer Tris-Adult product in the smallest unit order of 300 doses (current Pfizer PBS will no longer be available).

• • CAG (Countermeasures Acceleration Group) and CDC will review awardee progress and use of current Pfizer PBS in-field inventory on a weekly basis to assess if each jurisdiction meets the criteria above. Once an awardee meets the criteria, Pfizer Tris-Adult will be added to their ordering threshold.

• Key Considerations:

• • Jurisdictions and sites should maximize use of all remaining Pfizer PBS doses prior to using the Tris-Adult.
  • Jurisdictional regional teams and CAG VTCC can assist with inventory redistribution coordination across jurisdictions as needed
  • Provider sites should ideally carry only one Pfizer adult formulation at a time.
  • Provider sites utilizing the Pfizer thermal shipping containers for temporary storage must prepare for use of an ULT(Ultra-low Temperature)freezer -or- refrigerator moving forward; these shipping containers cannot be utilized to store the Pfizer Tris-Adult formulation.
  • In order to avoid mistakes during this period of transition when both products may be in circulation, these products should not be offered/administered at the same time.
  • As Always: CAG and CDC teams will work closely with each jurisdiction and federal entity to monitor this transition from Pfizer PBS to Pfizer Tris-Adult formulation and address unexpected issues and needs that may arise during this transition

Small Shipment Redistribution Program (SSRP) Reminder: Important Updates

• Providers are now able to request both Pfizer vaccine types (purple cap 12+ years vaccine and orange cap 5-11 years vaccine) through the SSRP. As a result, the provider request window for SSRP has changed. The provider request window for SSRP requests opens on Thursdays at 5 a.m. as it has in the past, but closes at 5 p.m. on Fridays. After 5 p.m. on Fridays, providers will not be able to make SSRP requests until the following Thursday.
• Providers should request enough vaccine doses to cover their expected demand for at least a month. SSRP requests from the same provider in consecutive weeks will not be filled.
• Please note that the shipment of orders may be delayed at the end of December. Please submit your request at the earliest opportunity to reduce the chances of being affected by shipping delays.

Christmas and New Year Holiday Cadence

• NO ORDERS WILL BE DELIVERED THURSDAY, DECEMBER 23 THROUGH MONDAY, DECEMBER 27.
• NO ORDERS WILL BE DELIVERED THURSDAY, DECEMBER 30 THROUGH TUESDAY, JANUARY 4.

• Pfizer
  • No vaccine deliveries will occur Thursday, December 23 through Monday, December 27.
  • If you need vaccine for clinics scheduled on the holiday weekend:
    • Submit your orders early, preferably the week of December 13.
  • Deliveries are available on Thursday, December 23 and can be requested by submitting a holiday order template to Pfizer by 8 p.m. ET Monday, December 20 to cvgovernment@pfizer.com.
  • If an exception for Thursday, December 23 delivery is not submitted, orders placed into VTrckS by 9 a.m. ET Monday, December 20 and 9 a.m. ET, Wednesday, December 22 will deliver on December 28 or December 29. (No deliveries December. 30).
  • Normal deliveries will be carried out on Tuesday December 28 and Wednesday December 29.
  • No vaccine deliveries will occur Thursday, December 30 through Tuesday, January 4.
  • If you need vaccine for clinics scheduled on the holiday weekend:
    • Submit your orders early, preferably the week of Dec. 13 in anticipation of the limited work hours over Christmas week.
  • Deliveries are available on Thursday, December 30 and can be requested by submitting a holiday order template to Pfizer by 8 p.m. Monday, December 27 to cvgovernment@pfizer.com.
  • If an exception for Thursday, December 29 delivery is not submitted, orders placed into VTrckS between 9 a.m. ET on Mon. December 27 and 9 a.m. ET, Thursday, December 30 will deliver Wednesday, January 5.
  •  Christmas
  • New Year Holiday

• Moderna and J&J
  • Christmas
    • No vaccine deliveries will occur Thursday, December 23 through Monday, December 27.
    • If you need vaccine for clinics scheduled on the holiday weekend
    • Submit your orders early, preferably the week of December 13.
    • Deliveries are available on Thursday, December 23 and can be requested by submitting a holiday order template to McKesson by Wednesday, December 22 9:00 a.m. ET to: COVIDVaccineSupport@McKesson.com.
    • If an exception for Thursday, December 23 delivery is not submitted, orders placed into VTrckS between 9 a.m. ET on Wed. December 22 and 9 a.m. ET, Sunday, December 26 are expected to deliver on December 28 or December 29. (No deliveries December 30)
    • Normal deliveries will be carried out on Tuesday December28 and Wednesday December 29.
  • New Year Holiday
    • No vaccine deliveries will occur Thursday, December 30 through Tuesday, January 4.
    • If you need vaccine for clinics scheduled on the holiday weekend:
    • Submit your orders early, preferably the week of December 13 in anticipation of the limited work hours over Christmas week.
    • Deliveries are available on Thursday, December 30 and can be requested by submitting a holiday order template to McKesson by Wednesday, Dec. 29, 9:00 a.m. ET to COVIDVaccineSupport@McKesson.com.
    • If an exception for Thursday, Dec 29 delivery is not submitted, orders placed into VTrckS between 9 a.m. ET on Wed. Dec. 29 and 9 a.m. ET, Thursday, Dec 30 are expected to deliver Wednesday, Jan. 5.

Please note—there are separate templates for Pfizer and McKesson.  If you want to request deliveries of the Pfizer vaccine, you must submit a completed template to Pfizer, and if you want to request deliveries of the Moderna or the J&J vaccine, you must submit a completed template to McKesson.

• Submit requests for special deliveries to:
  • Christmas - by Monday, December 20, 8:00 p.m. ET
  • New Year – by Monday, December 27, 8:00 p.m. ET
  • Christmas - by Wednesday, December 22, 9:00 a.m. ET
  • New Year – by Wednesday, December 29, 9:00 a.m. ET
  • Pfizer- Submit the completed Pfizer template to cvgovernment@pfizer.com
  • Moderna and J&J/Janssen- Submit the completed McKesson template to COVIDVaccineSupport@McKesson.com

• For questions about VaxMaX and its functionality, please visit the VaxMaX Help website, which includes reference guides and tutorial videos.

• Check out our complete list of COVID-19 Vaccination Clinic Best Practices and our Lightning Learnings: Best Practices for Busy Providers!

Upcoming Events

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• VDH: Travelers page - Updates were made to add the new requirement that, as of December 6, all international travelers get tested for COVID-19 within 1 day of boarding a flight to the United States or provide documentation of recent recovery.
• VDH: Prevention Webpage: Updates were made to the booster doses section to reflect CDC's strengthened recommendation on booster doses.
• VDH: Variants of the Virus that Causes COVID-19 - Updated to include Omicron being designated a Variant of Concern (VOC) in the United States and other available information.
• VDH: Vaccination FAQs - Updates were made to the booster section.
• Biden-Harris Administration Makes 100% Federal Medicaid Matching Funds Available for State Expenditures on Certain COVID-19 Vaccine Counseling Visits for Children and Youth. The Centers for Medicare & Medicaid Services (CMS) issued a press release announcing the Biden-Harris Administration is requiring states to cover COVID-19 vaccine counseling visits in which healthcare providers talk to families about the importance of kids’ vaccination. Medicaid provides health insurance coverage to over 40% of all children in the United States and is a significant source of coverage for Black and Brown children.