• FDA authorizes and CDC expands eligibility of booster doses for all adults.  Press Release: CDC Expands Eligibility for COVID-19 Booster Shots to All Adults

• Updated Pfizer-BioNTech fact sheets:
  • • Pfizer-BioNTech COVID-19 Fact Sheet for Healthcare Providers, 12 Years of Age and Older, Purple Cap (must dilute)
    • Pfizer-BioNTech COVID-19 Fact Sheet for Healthcare Providers, 12 Years of Age and Older, Gray Cap, (no dilution) Coming Soon...(this is the fully licensed formulation and we will be transitioning to this formulation soon)
    • Pfizer BioNTech COVID-19 Vaccine EUA Fact Sheet for Recipients and Caregivers, 12 Years of Age and Older
  • Updated Moderna fact sheets:
    • Moderna COVID-19 Fact Sheet for Healthcare Providers
    • Moderna COVID-19 Vaccine EUA Fact Sheet for Recipients and Caregivers
  • Updated J&J fact sheets:
    • Janssen(J&J) COVID-19 Vaccine EUA Fact Sheet for Healthcare Providers
    • Janssen(J&J) COVID-19 Vaccine EUA Fact Sheet for Recipients and Caregivers

• CDC updates- Booster doses:
  • COVID-19 Vaccine Booster Shots - Added new information - "People aged 18 years and older who received Pfizer-BioNTech or Moderna COVID-19 vaccines should get a booster."
  • Pfizer-BioNTech COVID-19 Vaccine Overview and Safety
  • Moderna COVID-19 Vaccine Overview and Safety
  • Interim Public Health Recommendations for Fully Vaccinated People
  • The following were updated to include increased risk for stillbirth among pregnant people with COVID-19.
    • Considerations for Inpatient Obstetric Healthcare Settings
    • Investigating the Impact of COVID-19 during Pregnancy
    • COVID-19 Vaccines While Pregnant or Breastfeeding
    • Pregnant and Recently Pregnant People

•  A Proclamation on Suspension of Entry as Immigrants and Nonimmigrants of Certain Additional Persons Who Pose a Risk of Transmitting Coronavirus Disease 2019.
  • The White House has implemented new travel restrictions for travelers entering the United States from Botswana, Eswatini, Lesotho, Malawi, Mozambique, Namibia, South Africa, and Zimbabwe due to the detection of the Omicron (B.1.1.529) Variant of Concern. CDC will also implement other mitigation measures for travelers departing from the countries listed and destined to the United States, as needed. Noncitizen travelers who were physically present in the countries listed above will be restricted from entering the U.S. "during the 14-day period preceding their entry or attempted entry to the United States." This proclamation went into effect on November 29, 2021. For additional details, please refer to the proclamation hyperlinked above or CDC’s website: Travelers Prohibited from Entry to the United States. CDC has also developed a new Travel Assessment to learn what’s required to travel by air to the United States.
• CDC Statement on B.1.1.529 Variant (Omicron Variant). On November 26, 2021 WHO classified a new variant (B.1.1.529) and named it Omicron. No cases of the variant have been identified in the U.S. to date. CDC is working with U.S. partners and global public health and industry partners to learn more about this variant and will continue to monitor its path. CDC recommends that everyone five years or older get vaccinated and everyone 18 years or older who is fully vaccinated get a booster dose when they are eligible. Layering other measures, like wearing a mask in indoor public settings, avoiding crowds and poorly ventilated spaces, physically distancing from others, frequent handwashing, getting tested and isolating when appropriate are also recommended.

• Ancillary Kit Deficiency Reporting
  • Vaccine providers are encouraged to report any issues with equipment in the ancillary kits that are shipped with their federal vaccine orders.  There are four steps to reporting to ensure enough information is gathered so problem trends in packaging and shipping can be identified.
    • Report deficiencies to McKesson directly, the customer service desk is charged with responding to problems and identifying trends.
    • Report deficiencies to the State Department of Health or clinic/hospital leadership who may then contact the Operation Regional LNO. This helps identify trends in problem equipment.
    • If an error or injury occurs during vaccine administration, enter the information into Vaccine Adverse Event Reporting System (VAERS) at https://vaers.hhs.gov/reportevent.html.
    • Because syringes are a medical device, complete FDA form 3500  https://www.accessdata.fda.gov/scripts/medwatch/
  • Be prepared to provide photos, lot number, order number, date ordered and dates received when filing a report for a deficient ancillary kit.

• Syringe/Extraction Guidance
  • CDC has received a number of questions regarding use of syringes with 0.2 mL tick marks to draw up doses of the Moderna booster vaccine (0.25mL) and Pfizer pediatric diluent (1.3mL).
  • ACIP and CDC do not yet have any official guidance on this issue. Providers are advised that when using syringes that have tick marks at 0.2 mL intervals, they should use their best judgment to draw up half-way between the tick marks to extract the proper volume.  For example, Moderna booster vaccine should be drawn to between 0.24mL and 0.26mL.  Pfizer diluent should be drawn between 1.2mL and 1.4mL.  Alternatively, if a provider has a syringe in their inventory they are more comfortable using, they may use this syringe to administer the vaccine and replace syringes from their private supply with those from the ancillary supplies kit.
  • Pfizer recommends the use of a syringe with appropriate graduations to dilute with the directed 1.3 mL of saline. The impact to the final dose with a 1.2 or 1.4 mL dilution volume would be within 4% of the target dose. This suggests that using a syringe with 0.2 mL graduations and estimating the 1.3 mL volume will not significantly impact the intended dose.

• Transition to Pfizer Tris-sucrose Vaccine Formulation (Comirnaty)
  • Beginning in mid-December, the USG is planning to begin the transition to the Pfizer fully licensed vaccine formulation (Comirnaty) for ages 12+.  This formulation will have a gray vial cap and allow for smaller pack ordering and easier use. The minimum order size is expected to be 300 doses and the product does not require diluent.  The 6-dose vial will have the same dose volume as the current purple cap (0.3mL) and be stable at 2o-8oC for up to 10 weeks. The product can also be stored at -90o – 60oC for up to 6 months.
  • Jurisdictions should use up the Pfizer purple cap product in the field prior to transitioning to the new gray cap product to help ensure vaccine is not wasted.  Criteria for the transition is being developed by the CAG and will be provided as soon as it is available

• Small Shipment Redistribution Program (SSRP) Important Updates
  • Starting next week (December 9), the SSRP will allow providers the ability to request both Pfizer vaccine types (purple cap 12+ years vaccine and orange cap 5-11 years vaccine). As a result, the provider request window for SSRP will become shorter. It will open on Thursdays at 5 a.m. as it has in the past, but will close on Fridays at 5 p.m.
  • For example: Next week, the provider request window will open on Thursday morning, Dec. 9. SSRP requests will be accepted until Friday, Dec. 10 at 5 p.m. Regular VaxMaX requests will continue to be accepted until Monday, Dec. 13 at 7 p.m. After that, providers will be unable to request vaccine until the next provider request window opens on Thursday, Dec. 16.
  • Providers should request enough vaccine to cover their expected demand for at least a month. SSRP requests from the same provider in consecutive weeks will not be filled.

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

• The HOPE Animal Assisted Crisis Response Group is an asset that has been used around the Far Southwest region to provide trained therapy dogs to communities who have experienced significant crisis or loss.
  • Given the current operational tempo around COVID-19 vaccination efforts and understanding the amount of stress that can place on children, The Region worked with nursing staff and the Hope Animal group to have a trained therapy dog at 5 year old-11 year old COVID PODs in Carroll County.  This was an excellent use of this resource and has been well received by staff and children at the event.
  • The Vaccine training team wanted to highlight this initiative as a way to make vaccination less frightening to children.

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 Updated: Health Professionals webpage - Added new hot topics on expanded booster eligibility for everyone aged 18 years and older and CDC's emergency use instructions for COVID-19 vaccines.
• VDH’s Vaccination of the School-Age Population in a School Setting and in the Community Playbook to Support Vaccination Events
• CDC’s Myths and Facts about COVID-19 Vaccines for Children - This is a new website for child-specific myths and facts about COVID-19 vaccine.
• CDC’s COVID-19 Vaccines for Moderately to Severely Immunocompromised People - Updated section on who needs a booster shot.
• VDH’s Vaccination FAQs -
  • New FAQs address  revaccination for HCT and CAR-T-cell recipients.
  • Updated FAQs address: new booster dose guidance; VDH Health Equity Dashboard; Long COVID; public health goals for COVID-19 vaccinations; protecting family and friends; population immunity- benefits in smaller groups; CDC discussion of SARS-CoV-2 infection-induced and vaccine-induced immunity; booster doses for pregnant individuals; breakthrough cases; myocarditis risk after booster doses; Emergency Use Instructions: fact sheet for healthcare providers; Moderna prescriber information: additional doses from multidose vials; guidance for individuals vaccinated through clinical trials; healthcare provider booster guidance; long-term care facility booster guidance; Virginia data on vaccines for 5-11 year olds; instructions for v-safe for dependents; booster doses for recipients of WHO Emergency Use Listing  COVID-19 vaccines; booster side effects.
• Storing Vaccine Micro-learning