• CDC’s- Interim Clinical Considerations for Use of COVID-19 Vaccines Currently Approved or Authorized in the United States - CDC updated guidance for use of Pfizer-BioNTech COVID-19 vaccine as a booster dose in persons aged 16 years and older. Only the Pfizer-BioNTech COVID-19 vaccine is authorized and recommended for adolescents ages 16 and 17, and this population is now recommended to get a booster shot at least six months after completing their primary COVID-19 vaccination series.

• FDA Press Release Coronavirus (COVID-19) Update: FDA Expands Eligibility for Pfizer-BioNTech COVID-19 Booster Dose to 16- and 17-Year-Olds - On December 9, the U.S. Food and Drug Administration amended the emergency use authorization (EUA) for the Pfizer-BioNTech COVID-19 Vaccine, authorizing the use of a single booster dose for administration to individuals 16 and 17 years of age at least six months after completion of primary vaccination with the Pfizer-BioNTech COVID-19 Vaccine. On Nov. 19, the FDA authorized the use of a single booster dose of the Pfizer-BioNTech COVID-19 Vaccine for administration to all individuals 18 years of age and older after completion of primary vaccination with any FDA-authorized or approved COVID-19 vaccine. FDA’s action on December 9 expands the use of a single booster dose of the Pfizer-BioNTech COVID-19 Vaccine for administration to individuals 16 and 17 years of age at least six months after completion of a primary series of the Pfizer-BioNTech COVID-19 Vaccine. The FDA-authorized Pfizer-BioNTech COVID-19 Vaccine and the FDA-approved Comirnaty (COVID-19 Vaccine, mRNA) are the only COVID-19 vaccines currently available for the 16- and 17- year-old age group. Individuals who are 16 and 17 years of age should only receive the Pfizer-BioNTech COVID-19 Vaccine or Comirnaty as their booster dose.
  • FDA fact sheets for healthcare providers and recipients/care givers have been revised.

• On December 14, FDA announced revisions to the Janssen COVID-19 Vaccine Fact Sheet for Heath Care Providers Administering Vaccine (Vaccination Providers) and the Fact Sheet for Recipients and Caregivers. FDA reported the following:
  • The fact sheets will now include a contraindication to the administration of the Janssen COVID-19 Vaccine to individuals with a history of thrombosis with thrombocytopenia following the Janssen COVID-19 Vaccine or any other adenovirus-vectored COVID-19 vaccine, and to update the information about the risk of thrombosis with thrombocytopenia syndrome or TTS following vaccination.
  • Cases of TTS following administration of the Janssen COVID-19 Vaccine have been reported in males and females 18 years of age and older, with the highest reporting rate of approximately 1 (one) case per 100,000 doses administered in females 30-49 years of age; overall, approximately 1 out of 7 cases has been fatal.
  • The FDA and CDC continue to investigate the level of potential excess risk. The FDA continues to find that the known and potential benefits of the Janssen COVID-19 Vaccine outweigh its known and potential risks in individuals 18 years of age and older. Individuals should speak to their provider to determine which COVID-19 vaccine is most appropriate for their own situation.

• FDA updated the SARS-CoV-2 Viral Mutations: Impact on COVID-19 Tests web page to share the latest information.
  • The impact of the SARS-CoV-2 omicron variant on test performance. Since the Revogene SARS-CoV-2 test is a single target test that targets a portion of the N-gene where deletions occur with the omicron variant, the test is expected to fail to detect the SARS-CoV-2 omicron variant.
  • Meridian Biosciences has not yet distributed this test and does not intend to distribute this test, within or outside the United States, until this issue is resolved.
  • Not all patient samples with the omicron variant display the mutation that leads to an S-gene drop out; and
  • The presence of the S-gene drop out detection pattern is not a definitive confirmation of the presence of the omicron variant.
  • FDAadded new information about the Meridian Bioscience, Inc. Revogene SARS-CoV-2 test, including:
  • FDA also added new information about tests with S-gene drop out, specifically:

• COVID-19 Therapeutics Update
  • On December 3, FDA expanded the emergency use authorization (EUA) for bamlanivimab and etesevimab (“Bam/Ete”), two monoclonal antibodies that are administered together. Bam/Ete can now be administered to younger pediatric patients, including newborns, for the treatment of mild to moderate COVID-19 or postexposure prophylaxis (PEP) in those at high risk for severe COVID-19; previously, this combination therapy was authorized for patients 12 years of age and older. FDA issued the revised EUA package insert on December 3.
  • On December 8, FDA granted an EUA to AstraZeneca’s Evusheld (tixagevimab co-packaged with cilgavimab and administered together) for the pre-exposure prophylaxis (prevention) of COVID-19 in certain adults and pediatric individuals. This product is authorized for persons 12 years of age or older (weighing at least 88 pounds) who are not currently infected with COVID-19, who have not been exposed to COVID-19, and who either have moderately to severely compromised immune systems or a history of severe adverse reactions to a COVID-19 vaccine and/or its component(s) such that vaccination is not recommended. FDA issued the EUA package insert on December 8. The U.S. Government has purchased doses of Evusheld. From communications with the U.S. Department of Health and Human Services (HHS), it appears the initial allocation of the drug will be small (1,200 doses) and available in the Commonwealth either this week or next. Available initial doses will likely go to larger medical centers that treat high numbers of immunocompromised patients.

• There will not be a newsletter next week of December 20th - December 24th

• Monoclonal Antibody Ordering / Therapeutics Ordering

• • As more treatments continue to be approved to treat COVID-19 in different capacities, Vaxmax's role is being expanded to order more than just mABs. In the coming week, the mAB ordering feature will be changed to "Therapeutics", and new treatments will be available to order. As different therapies are released, we will provide as much advance notice as possible.
  • Ordering Cadence
    • Providers will maintain their ability to place a request for therapeutics at any time; however, VDH will be placing orders with the CDC on Mondays, Wednesdays and Fridays only. It is not anticipated that this will cause any major operational changes.
  • Evusheld
    • Evusheld, the AstraZeneca treatment formerly known as AZD7442, has been authorized under an Emergency Use Authorization. To prepare for it's expected release in the upcoming weeks, it will be available for pre-order in Vaxmax starting on 12/20.
    • If you submit a pre-order, it will go into a "In Review" status when it is received by VDH, and it will remain that status until the doses are released to the Commonwealth for ordering. At that time, we will fulfill as many requests as possible.

• Administration Data Update

• • Beginning on Monday, December 13, the VaxMax system was 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 (gray cap) 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 2-8ºC (36-46ºF) 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.
  • Please use all purple cap prior to using the gray cap

• 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 Countermeasures Acceleration Group (CAG)/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 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.
  • 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

• Due to the holidays, SRRP will have a limited window to send all deliveries. Because of this, we are asking that providers only place an SSRP request if it is absolutely necessary to meet the demand for your facility over the next few weeks.
  • Orders placed on December 16-17 will only be shipped on December 20-21
  • Orders placed on December 23-24 will only be shipped December 27-29
  • Orders placed December 30-31 will be shipped as normal on January 3

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
  • 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 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.
  • New Years
    • 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 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 Monday, December 27 and 9 a.m. ET, Thursday, December 30 will deliver Wednesday, January 5.

• 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 Wednesday, 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, December 28 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, December 29, 9:00 a.m. ET to COVIDVaccineSupport@McKesson.com.
    • If an exception for Thursday, December 29 delivery is not submitted, orders placed into VTrckS between 9 a.m. ET on Wednesday December 29 and 9 a.m. ET, Thursday, December 30 are expected to deliver Wednesday, January 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:
  • Pfizer- Submit the completed Pfizer template to cvgovernment@pfizer.com 
    • Christmas - by Monday, December 20, 8:00 p.m. ET
    • New Year - by Monday, December 27, 8:00 p.m. ET
  • Moderna and J&J/Janssen- Submit the completed McKesson template to COVIDVaccineSupport@McKesson.com
    • Christmas - by Wednesday, December 22, 9:00 a.m. ET
    • New Year - by Wednesday, December 29, 9:00 a.m. ET

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

• Preventing vaccine administration errors in the pediatric population:
  • Color-coded wristbands or other strategies may be used to match each child to the type of vaccine they are receiving. For younger children, avoid placing a color-coded sticker on their clothing, as children may “swap” and “trade” the stickers while waiting in line. We suggest color coding the wrist bands with the color of the cap of the correct vaccine. Signs in the same color can be posted throughout the clinic area to remind vaccinators to double check the wristband of the vaccinee.
• 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 Clinician Letter - December 14 - provided updates on the Omicron variant that has been detected in Virginia, booster doses that are recommended for everyone aged 16 years and older, COVID-19 therapeutics, and recent widespread flu activity in Virginia
• VDH Vaccination FAQs:
  • Updated the booster section on December 10 to include new recommendation for 16- and 17-year olds.
  • New additions include Omicron specific vaccines or boosters. Updates include Virginia vaccination data; booster guidance; safety and surveillance; COVID-19 vaccines in people with a history of MIS-C or MIS-A; status of COVID-19 vaccines for younger children; cases numbers of TTS, myocarditis or pericarditis, and GBS; international travel testing requirements.
• VDH Health Professionals: updated on December 10 to add new hot topics (Omicron, expansion of booster age eligibility, EUA expansion of bamlanivimab used with etesevimab (Bam/Ete), and CDC's updated science brief on masking)
• VDH Monoclonal Antibodies: updated on December 10to add new mAb hot topics (new EUA for AstraZeneca monoclonal antibody, expanded EUA for Bam/Ete)
• VDH Therapeutics: updated on December 13 to account for the expanded age eligibility for bamlanivimab plus etesevimab (newborn and older); added a new therapeutic (tixagevimab plus cilgavimab) to the table; added a link to the recent MMWR on initial U.S. cases caused by Omicron and that scientists are studying the variant's impact on therapeutics; and added links to AAP's most recent pediatric treatment guidance.
• VDH - Virginia COVID-19 Long-Term Care Task Force: added a new VDH resource called Visiting a Loved One in a Nursing Home? Tips for a Safe Visit