• New 11/2 Press Release: CDC Recommends Pediatric COVID-19 Vaccine for Children 5 to 11 Years - CDC Director Rochelle P. Walensky, M.D., M.P.H., endorsed the CDC Advisory Committee on Immunization Practices’ (ACIP) recommendation that children 5–11 years old be vaccinated against COVID-19 with the Pfizer-BioNTech pediatric vaccine. CDC now expands vaccine recommendations to about 28 million children in the United States in this age group and allows providers to begin vaccinating them as soon as possible.
  • Effectiveness: In the clinical trial, immune responses of children 5–11 years of age were comparable to those of individuals 16–25 years of age. In addition, the vaccine was found to be over 90% effective in preventing COVID-19 in children 5–11years.
  • Safety: The vaccine’s safety was studied in approximately 3,100 children ages 5–11 years who received the vaccine and no serious side effects have been detected in the ongoing study.
  • The Pfizer vaccine for children aged 5–11 years will be administered as a two-dose series 21 days apart. Each shot will include 10 micrograms of active ingredient, compared with 30 micrograms in older children and adults.
  • While the active ingredients in the Pfizer COVID-19 vaccine for 5–11 year olds are the same as the Pfizer vaccine available to those 12 and up, the product formulations and vials are different. Vaccine providers must use the Pfizer product for 5–11 year olds when vaccinating children in this age group.
  • Pfizer Inc. has updated its safety monitoring plan to include evaluation of myocarditis, pericarditis and other events of interest in children 5–11 years of age. In addition, the FDA and the CDC have several systems in place to continually monitor COVID-19 vaccine safety and allow for the rapid detection and investigation of potential safety problems.
• 10/29/21 Press Release: FDA Authorizes Pfizer-BioNTech COVID-19 Vaccine for Emergency Use in Children 5 through 11 Years of Age.
  • The FDA also authorized a manufacturing change for the Pfizer COVID-19 vaccine to include a formulation that uses a different buffer. The new formulation is more stable for longer during refrigeration, providing greater flexibility for vaccinators. The new formulation contains Tris buffer, which is commonly used in other FDA-approved vaccines and other biologics, including products for children. The FDA said Tris buffer doesn't present safety or effectiveness concerns.
  • FDA Vaccine EUA Fact Sheets for Recipients and Caregivers
    • Pfizer BioNTech COVID-19 Vaccine EUA Fact Sheet for Recipients and Caregivers, 12 Years of Age and Older (updated)
    • Pfizer BioNTech COVID-19 Vaccine EUA Fact Sheet for Recipients and Caregivers, 5–-11 Years of Age (new)
•  FDA Vaccine Fact Sheets for Healthcare Providers Administering Vaccine
  • Pfizer-BioNTech COVID-19 Fact Sheet for Healthcare Providers, 12 Years of Age and Older, Purple Cap (must dilute) (update)
  • Pfizer-BioNTech COVID-19 Fact Sheet for Healthcare Providers, 12 Years of Age and Older, Gray Cap, (no dilution) **This formulation is not yet available in the United States** (update)
  • Pfizer-BioNTech COVID-19 Fact Sheet for Healthcare Providers, 5–-11 Years of Age, Orange Cap (must dilute) (new)
• New: Long-Term Care Facilities
  •     Guidance
    • VDH COVID-19 Outbreak Response Method in LTCFs (updated)
    • VDH Quarantine Recommendations for Asymptomatic, Exposed      Individuals Living or Working in Healthcare Settings (removed/archived)
    •  Management of Hemodialysis Patients Residing in Long Term Care Facilities (removed/archived)
• Updated: COVID-19 Vaccination FAQs -  Updates: Booster dose recommendations; "mix and match" booster dose guidance; links to Who is Eligible for a COVID-19 Booster Shot?; updated Pfizer, Moderna, and J&J fact sheets; status of vaccines for younger children; studies on vaccine safety in pregnancy; testing after exposure for fully vaccinated; protection after being fully vaccinated; guidance on boosters for HCPs; interchangeability of vaccine brands; additional doses from multidose vials; guidance for moderately to severely immunocompromised individuals who received J&J; booster guidance for individuals vaccination abroad; booster guidance for immunocompromised individuals who received an additional (third) primary series dose.
• Updated: On the COVID-19 Outpatient Monoclonal Antibody Therapy Resource Center website, updated the table of Monoclonal Antibody Infusion Sites in Virginia
• COVID-19 Vaccine Resources
• • Adult and adolescent COVID-19 Vaccine Dosing and Scheduling Table
• New: The most recent updates of boosters doses of COVID-19 vaccines and information on Pfizer-BioNTech COVID-19 Vaccines for 5–11 year olds as of October 28 are provided in VDH’s Clinician Letter.
• New: The Advisory Committee on Immunization Practices’ Interim Recommendations for Additional Primary and Booster Doses of COVID-19 Vaccines — United States, 2021 - ACIP issued recommendations for an additional primary mRNA COVID-19 vaccine dose for immunocompromised persons and a COVID-19 vaccine booster dose in eligible groups; this was published in the MMWR as an Early Release.
• Updated: CDC COVID-19 Vaccine Booster Shots - Added information on choosing a COVID-19 booster shot.
• The standing order for COVID-19 vaccines has been updated to include the new 5–11 year old Pfizer recommendations. The standing order can be found on the VDH Healthcare Professionals Website and clicking on "Summary of Legal Authorities". A direct link to the standing order can be found here.

• New: FDA authorized the Pfizer-BioNTech COVID-19 vaccine for emergency use in children 5–11 years old. Wave 1 vaccine orders will begin to ship with expected delivery Nov 1-2. Please coordinate coverage to receive vaccine Nov. 2 if you are expecting Wave 1 vaccine. As of November 2, FDA has authorized and CDC has recommended these vaccines, and administration can begin immediately in the 5–11 year old age group.
• Allocation
  • Starting for the request period on 11/4, the Pfizer pediatric vaccine for 5 - 11 year olds will be available to request in Vaxmax. The minimum shipment quantity is 100 doses. We are working to implement these doses into the SSRP program, but that won't be available for the first few weeks.
  • Important Note on Requesting Pfizer 5 - 11: Requesting doses does not guarantee that you will have your request fulfilled. However, doses are continuing to be allocated each week, and we are confident there will be enough doses for everyone.
• Expiration Dates
  • It's come to our attention that the doses do not have the expiration date listed on the vial. However, it does have the Manufactured date, which shouldn't be confused with the expiration date.
  • When you receive the vaccine, the doses should come with a packing label that has the expiration date listed in the bottom right corner. If you have already discarded the packing label, please refer to the Fact Sheet to determine the dose's expiration date based on the manufactured date.

For any questions about VaxMaX and its functionality, please visit the VaxMaX help website as a resource for reference guides and tutorial videos.

• VDH has published the "Vaccination of the School-Age Population in a School Setting and in the Community: Playbook to Support Vaccination Events," which can be accessed here. The playbook covers pre-planning steps, necessary communications, mapped out day-of operations, and important legal considerations. Templates for consent forms and communications, in addition to additional tools and helpful links, can also be found in the playbook. Please note that this playbook is a work in progress and will be updated in accordance with guidance from the CDC and feedback from clinic planners.

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

Upcoming Events

• New: The VDH Adult and Adolescent COVID-19 Vaccine Dosage and Scheduling Table has been added to the VDH vaccine healthcare professionals page.
• Do I need a COVID-19 additional primary dose or booster vaccine flow chart
• We have been alerted to a problem regarding imported medical gloves. Visit FDA’s website for more information and to learn how to report problems with medical gloves.
• Updated: VDH’s Current COVID-19 Topics website is updated with information for the general public about vaccines for 5–11 year olds and booster doses for certain populations.
• Updated: VDH:  When to End Isolation or Quarantine Infographic:Page 3: In the "Who is Not Required to Quarantine After Exposure" section, changed the recommended time frame for testing after exposure for fully vaccinated people from 3–5 days to 5–7 days in line with updated CDC guidance. Removed the "Critical Infrastructure Workers" section and removed reference to CDC's Critical Workers Exposed to COVID-19 at the bottom of the page.Added a summary of changes on page 4.
• Updated: CDC COVID-19 Communication Tools
  • CDC Talking Points
  • CDC Key Messages (updated)
  • CDC Vaccine Pediatric Information for Information for Jurisdictions, Healthcare Providers, Pharmacists and Community Partners
  • Guide to On-Site Vaccination Clinics for School | WECANDOTHIS.HHS.GOV
  • Videos and infographics here: Vaccine Administration Resource Library | CDC
    • Includes information about vaccine administration e-learn with continuing education  for pharmacists, infographics for identifying injection sites , short video demonstration injection and holding children.
  • The Vaccine Administration chapter of Epidemiology and Prevention of Vaccine-Preventable Diseases at Pinkbook: Vaccine Administration | CDC includes strategies to decrease anxiety and procedural pain.
  • All COVID-19 clinical materials, including product-specific trainings, guidance and infographics, are here: COVID-19 Vaccination Clinical and Professional Resources | CDC