• The Advisory Committee on Immunization Practices’ Interim Recommendation for Use of Pfizer-BioNTech COVID-19 Vaccine in Children Aged 5–11 Years — United States, November 2021 - On October 29, 2021, the U.S. Food and Drug Administration (FDA) granted Emergency Use Authorization for the Pfizer-BioNTech COVID-19 vaccine for children aged 5–11 years. On November 2, 2021, after a systematic review of available data, the Advisory Committee on Immunization Practices (ACIP) made an interim recommendation for use of the Pfizer-BioNTech COVID-19 vaccine in children aged 5–11 years in the United States for prevention of COVID-19. The Pfizer-BioNTech COVID-19 vaccine has high efficacy (>90%) against COVID-19 in children aged 5–11 years, and benefits outweigh risks for vaccination. Vaccination is important to protect children against COVID-19 and its complications, reduce community transmission of SARS-CoV-2, and allow for safer return to school and social interactions.
• The FDA has authorized a COVID-19 vaccine for children 5–11 years of age, and the Centers for Disease Control and Prevention’s (CDC) ACIP has new recommendations on vaccinating this population. Below is a list of new clinical materials related to these recommendations:
  • The Pfizer-BioNTech COVID-19 Vaccine Standing Orders for Administering Vaccine to Persons 5 through 11 Years of Age 
  • The Pfizer-BioNTech COVID-19 Vaccine Preparation and Administration Summary form (Persons 5 through 11 Years of Age) 
  • The Pfizer-BioNTech COVID-19 Vaccine Storage and Handling Summary (5 through 11 years of age) 
  • The Pfizer-BioNTech COVID-19 Vaccine Storage and Handling labels (5 through 11 years of age) 
  • The Pfizer-BioNTech COVID-19 Vaccine Beyond Use Date guidance and labels (5 through 11 years of age) 
  • The Pfizer-BioNTech COVID-19 Vaccine Transporting Vaccine for Vaccination Clinics Held at Satellite, Temporary or Off-Site Locations (5 through 11 years of age) 
  • The materials listed above and additional clinical information are available at CDC’s Pfizer-BioNTech COVID-19 Vaccine website.
  • Fact Sheet: Biden Administration Announces Details of Two Major Vaccination Policies
    • New Vaccination Requirements for Healthcare Workers
      • Centers for Medicare and Medicaid Services (CMS) is requiring workers at healthcare facilities participating in Medicare or Medicaid to have received the necessary shots to be fully vaccinated – either two doses of Pfizer or Moderna, or one dose of Johnson & Johnson – by January 4, 2022.
      • The rule applies to employees regardless of whether their positions are clinical or non-clinical and includes employees, students, trainees, and volunteers who work at a covered facility that receives federal funding from Medicare or Medicaid. It also includes individuals who provide treatment or other services for the facility under contract or other arrangements.
    • The Department of Labor’s Occupational Safety and Health Administration (OSHA) issued a COVID-19 Vaccination and Testing Emergency Temporary Standard (ETS) to require employers with 100 or more employees (i.e., “covered employers”) to:
      • Ensure their employees are vaccinated by January 4, 2022 and require unvaccinated employees to produce a negative test on at least a weekly basis.
      • Pay employees for the time it takes to get vaccinated.
      • Ensure all unvaccinated employees are masked.
      • In Virginia, the OSHA standard is not effective until it is adopted by the Virginia Safety and Health Codes Board. The Board will meet in December to consider adoption of the ETS.
      • Additional information is available below in OSHA’s press release and the COVID-19 Vaccination and Testing ETS webpage.
    • Streamlining Implementation and Setting One Deadline Across Different Vaccination Requirements
      • To make it easy for all employers to comply with the requirements, the deadline for the federal contractor vaccination requirement will be aligned with those for the CMS rule and the ETS. Employees falling under the ETS, CMS, or federal contractor rules will need to have their final vaccination dose – either their second dose of Pfizer or Moderna, or single dose of Johnson & Johnson – by January 4, 2022.

• CDC’s COVID-19 Vaccine Product Guide - An  updated version of the Product Guide, which includes information on both the Pfizer pediatric 100 and 300 and Moderna booster ancillary supplies can be found via the link below.. This guide provides specifications for COVID-19 vaccine and associated products. This is not  a catalog from which you can order products. It provides key product information including product package dimensions and weight, minimum order quantities, product presentation, distribution method, storage information, and additional information. This guide is updated as more products become available.

• • Also linked below is the updated Ancillary Redistribution Gadget for Healthcare (ARGH) to assist with redistribution efforts. The ARGH tool consists of several tables that calculate the quantity of each kit item that must be repackaged to support administration of the number of doses requested.
  • Links to both of these documents are available on the VDH Healthcare professionals webpage
    • Product Information Guide
    • Ancillary Redistribution Gadget
• Pfizer Pediatric Ancillary Kits 
  • The Advisory Committee on Immunization Practices recommends a 22–25 gauge 1-inch needle when administering a vaccine by intramuscular injection to children 1 year of age and older. Vaccine administration guidelines are outlined here: ACIP Vaccine Administration Guidelines for Immunization | CDC and a chart summarizing needle length recommendations can be found here Vaccine Administration: Needle Gauge and Length (cdc.gov). Of note: A copy of this chart is included in each ancillary supply kit.
  • It is critical for all intramuscular injections that the needle should be long enough to reach the muscle mass and prevent vaccine from seeping into subcutaneous tissue. Some experts allow intramuscular injection with a ⅝-inch needle but ONLY if the skin is stretched flat. However, the most common technique when administering an IM injection is grabbing the muscle and bunching subcutaneous and muscle tissue to minimize the chance of striking bone, thus requiring a 1-inch needle or larger to ensure intramuscular administration. Studies have shown that use of longer needles is associated with less redness or swelling than occurs with shorter needles because of injection into deeper muscle mass, preventing irritation of the subcutaneous tissue.
• Pfizer Diluent Extraction for Pediatric Vaccines – Mixing Syringes
  • CDC has received a number of questions regarding use of syringes with 0.2mL intervals to draw up doses of Pfizer diluent that is provided with the pediatric vaccine formulation. The FDA Emergency Use Authorization requires addition of 1.3mL diluent to every Pfizer pediatric vaccine vial.
  • 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.
  • If a provider has a syringe in their inventory that they are more comfortable using, they may use this syringe to dilute the vaccine and replace syringes from their private supply with those from the ancillary supplies kit.
• Pfizer Doses- We have heard from the CDC that any additional doses beyond 10 should not be administered. This may be subject to change but this is the existing guidance. The CDC has also been hearing that providers have been getting less than 10 doses (9) including reporting from Virginia

• Moderna Configuration Change

• • Starting on 11/11, Moderna has halted all ordering for the 14-dose vial configuration and has transitioned all ordering to the 10-dose/10-vial configuration. This means all orders will now take place in intervals of 100 doses. The smaller vial size should help reduce waste and will allow providers to order a smaller number of doses for a given shipment.
  • Vaxmax will reflect the change on 11/11, so there is nothing additional that any providers need to do to prepare for the transition. All current inventory and waste guidance for Boosters will remain the same.

• Thanksgiving Holiday Cadence: NO ORDERS WILL BE DELIVERED NOVEMBER 24–28.  (Deliveries resume Monday, November 29). All channels should plan to order early prior to the holiday week.

• Pfizer
  • No vaccine deliveries will occur on Wednesday November 24 through Sunday November 28.
  • If you need vaccine for clinics scheduled on the holiday weekend:
    • Submit your orders early, preferably the week of November 18.
    • Limited deliveries are available on Wednesday, November 24 and can be requested by submitting a holiday order template to Pfizer by Friday, November 19, 9:00am ET to cvgovernment@pfizer.com.
    • If an exception for Wednesday, November 24 delivery is not submitted, orders placed into VTrckS between 9:00am ET Friday, November 19 and 9:00am ET Wednesday, November 24 will deliver the week of November 29.

• Moderna Centrally Distributed Vaccines
  • No vaccine deliveries will occur on Wednesday Nov. 24 through Sunday Nov. 28.
  • If you need vaccine for clinics scheduled on the holiday weekend
    • Submit your orders early, preferably the week of Nov. 18
    • Limited deliveries are available on Wednesday, Nov. 24 and can be requested by submitting a holiday order template to McKesson by Friday, Nov. 19, 9:00am ET to COVIDVaccineSupport@McKesson.com.
    • If an exception for Wednesday Nov. 24 delivery is not submitted, orders placed into VTrckS between 9:00am ET Friday, Nov. 19 and 9:00am ET Wednesday, Nov. 24 will deliver the week of Nov. 29.

• EXCEPTIONS:
  • Jurisdictions may request special deliveries on Wednesday, Nov. 24 by submitting the order templates to Pfizer and McKesson.
  • 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 vaccine, you must submit a completed template to McKesson.

• The Deadline to request Wednesday, Nov. 24 deliveries:
  • Pfizer
    • Submit the completed Pfizer template by Friday, Nov. 19, 9:00am ET to cvgovernment@pfizer.com      
  • Moderna and J&J/Janssen
    • Submit the completed McKesson template by Friday, Nov. 19, 9:00am ET to COVIDVaccineSupport@McKesson.com

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

• Needle Stick Just in Time Training (JITT)

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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• New: The VDH Child, Adolescent, and Adult COVID-19 Vaccine Dosage and Scheduling Table has been added to the VDH Vaccine Healthcare Professionals website.
• There are now materials on the VDH COVID Comms Hub to support vaccination events for children, including:
  • Activity sheets for children
  • Customizable social media shareables to announce vaccination events
  • An FAQ sheet to hand out to parents about the Pfizer-BioNTech vaccine for 5–11 year olds.
  • The handout and activity sheets can also be found on the K-12 webpage as part of the Resources for School-Age Vaccination Clinics toolkit.

• School Vaccine Clinic Resources-The Department of Education and the Department of Health and Human Services sent a joint letter to school officials today. The Departments urged school officials to (1) host a COVID-19 vaccination clinic at their school(s), (2) distribute information about the COVID-19 vaccine to all families with children ages 5–11 years, and (3) hold conversations with their school communities on the COVID-19 vaccine. Other valuable federal resources for school-related vaccine clinics include:

• COVID-19 Vaccination for Children 5-11 Years Old | CDC
• COVID-19 Vaccines for Children and Teens | CDC
• Considerations for Planning School-Located Vaccination Clinics | CDC
• Guidance for COVID-19 Prevention in K-12 Schools | CDC
• Guide to On-Site Vaccination Clinics for School | WECANDOTHIS.HHS.GOV
• Frequently Asked Questions about COVID-19 Vaccination | CDC
• VDH Flow Chart: Do I need a COVID-19 additional primary dose or booster vaccine?