• On October 21, 2021, CDC Director Rochelle P. Walensky, M.D., M.P.H., endorsed the CDC Advisory Committee on Immunization Practices’ (ACIP) recommendation for a booster shot of COVID-19 vaccines in certain populations.
  • For individuals who received a primary mRNA COVID-19 vaccine series (Pfizer-BioNTech or Moderna), the following groups are eligible for a booster shot at 6 months or more after completion of their initial series:
    • 65 years and older
    • Age 18+ who live in long-term care settings
    • Age 18+ who have underlying medical conditions
    • Age 18+ who work or live in high-risk settings
    • The dose for the Moderna booster is 0.25 mL, or 50 micrograms (mcg), which is half the dose of the primary series vaccine.
      • While the dose of the booster is half that of the primary series, the product used for both purposes is the same.
  • For people who got the Johnson & Johnson (J&J) COVID-19 vaccine, booster shots are also recommended for those who are 18 and older and who were vaccinated 2 or more months ago.
    • The dose and the product for the J&J booster is the same as the initial dose (0.5 mL).
  • CDC’s recommendations now allow for heterologous (or “mix and match”) booster doses. Eligible individuals may choose which vaccine they receive as a booster dose. Some people may have a preference for the vaccine type that they originally received and others may prefer to get a different booster.
  • COVID-19 vaccine providers can begin vaccinating in accordance with the recommendations listed above.
    • When determining eligibility and dosing intervals for booster vaccination, refer to the booster recommendations for the primary vaccination series that the person received.
• CDC is expected to update Clinical Considerations next week to help providers better understand these recommendations as well as more targeted guidance to the public.
• On October 20, 2021, the U.S. Food and Drug Administration (FDA) amended emergency use authorizations (EUAs) for COVID-19 vaccines to allow for single booster doses of Moderna and Johnson & Johnson vaccines and mix and match booster dosing.
  • Updated Fact Sheets:
    • Moderna: Healthcare Providers and Recipients and Caregivers
    • Johnson & Johnson: Healthcare Providers and Recipients and Caregivers
    • Pfizer: Healthcare Providers and Recipients and Caregivers

• The CDC has communicated vaccine allocation procedures for the Pfizer vaccine for children aged 5-11 years with the jurisdictions (Virginia), and the process will initially be different than that of our other COVID-19 vaccines.  To ensure that vaccines can be distributed as quickly as possible and to facilitate providers’ ability to administer doses as soon as the final recommendation is issued, the Federal Government is shipping an initial “bolus” of the Pfizer vaccine for children aged 5-11 years to preposition doses with individual providers. This will ensure that the launch of the distribution of pediatric formulation is equitable, timely, and efficient.
  • There are approximately 28 million children between the ages of 5-11 years in the United States and approximately 748,000 live in Virginia. The U.S. government has procured enough vaccine to support vaccination of this population.
  • Orders for the initial allocation of Pfizer vaccines for children aged 5-11 years will not be processed through VaxMaX, but through your Local Health District from 10/19 through 10/25. If you did not receive or have not already completed the Pfizer vaccine for children aged 5-11 years Provider Readiness Survey, please contact your LHD as soon as possible if you have capacity and willingness to vaccinate children aged 5-11 years. Please note that the minimum site order quantity is 300 doses, and that site supplies will need to accommodate children aged 5-11 years. Additional considerations are listed below:
    • Pediatric doses for children aged 5-11 years are a completely new configuration and are not interchangeable with the formulation for individuals aged 12 years and older. Please note the ten dose vial size and different diluent and vaccine dosing for children compared to adult/adolescents as well.
    • Pfizer pediatric doses for children aged 5-11 years will be shipped at ultra-cold temperatures in a new disposable thermal shipper along with dry ice and Controlant digital data logs (cannot be used as temporary storage). Please note that hub and spoke sites will no longer be able to reuse the thermal shipper but the hope is the smaller shipment sizes and increased storage length at refrigerator temperatures (10 weeks) will allow for more direct from manufacturer shipments.
    • Pfizer adult 1170 orders will be suspended the week of the rollout to allow Pfizer to shift resources to support the initial pediatric orders. Clarity on the exact dates of the suspension will be forthcoming.
    • Pediatric doses can go straight into the fridge upon receipt and Beyond Use Labels will be available for printing by providers. Wastage messaging for Pfizer pediatric doses is forthcoming.
    • At this time, the availability of vaccines after the initial allocation is unknown. As a result, providers should plan to use the vaccines they receive initially for both first and second doses until VDH receives more information. VDH will contact providers with updated guidance as soon as it is available.
    • Vaccine ancillary supply kits will be provided with the vaccine.  CDC has not provided additional details about the contents of these ancillary supply kits.
  • VDH will return to the weekly allocation cycle in VaxMaX once the initial allocation process ends. Weekly allocation after the initial allocation will have a minimum site order quantity of 100 doses. Following the initial launch, a weekly ordering process for Pfizer vaccine for children aged 5-11 years will begin for jurisdictions.
  • FDA’s VRBPAC is scheduled to meet October 26 to discuss Pfizer’s submission for vaccines for 5-11 year old children. If the FDA amends the Pfizer EUA, product will immediately begin to be filled and delivered. Deliveries will arrive in the days immediately following EUA issuance, with some orders arriving as soon as the next day. The CDC’s Advisory Committee on Immunization Practices (ACIP) is scheduled to meet to discuss this issue on November 2-3. Even with vaccines on site, vaccinations for children aged 5-11 years cannot begin until after the CDC makes a recommendation for use, consistent with requirements in the vaccine provider agreement.
  • A comparison sheet of Pfizer’s adult/adolescent vaccine and pediatric vaccine for children aged 5-11 years is available here.
• Summary of Legal Authorities for Pharmacist to Administer COVID-19 Vaccine is posted at  https://www.vdh.virginia.gov/content/uploads/sites/191/2021/04/Summary-of-Legal-Authorities-for-Pharmacists-to-Administer-COVID-19-Vaccine.pdf
• FDA: The FDA announced that it intends to withdraw, effective December 31, 2021, guidance documents originally issued in March 2020 outlining temporary policies for manufacturers that were not drug manufacturers at the time to produce certain alcohol-based hand sanitizer and alcohol for use in hand sanitizers during the public health emergency. Effective December 31, 2021, companies manufacturing alcohol-based hand sanitizers under the temporary policies must cease production of these products. Hand sanitizers manufactured before or on December 31, 2021, and produced under the temporary guidances, must no longer be sold to wholesalers or retailers by March 31, 2022.
• CDC
  • Updated: Interim Public Health Recommendations for Fully Vaccinated People - Based on evolving evidence, CDC recommends fully vaccinated people get tested 5-7 days after close contact with a person with suspected or confirmed COVID-19. Added Annex describing what vaccines qualify people as fully vaccinated and how to interpret vaccine records

• VDH Vaccination FAQs:
  • NEW: suspicious use of COVID-19 vaccines

• How to Edit Phone Numbers in VIIS-  It has come to our attention that some sites would like to update phone numbers for their patients. VDH always encourages a practice/organization to add as much information on a patient as possible to their chart.

• Step 1: Click “EDIT PATIENT” from the immunization history screen OR search for patient by clicking “PATIENT SEARCH” under the Patients Section

• • Step 2: Expand the “ADDRESS INFORMATION” tab and enter the phone number into the “HOME PHONE” section, even if it is a cell number. Click “SAVE” on the top right corner to complete.
  • Or refer them them to the COVID Hotline: Vaccinate Virginia Call 877-VAX-IN-VA

• MODERNA
  • ADULT (Ages 18+)
  • There are currently 25 Million doses of Moderna in the field
  • IF THERE IS ACIP AND CDC Director’s approval of the 50 mcg Booster Recommendation, all Moderna orders will receive double ancillary shipments with each order. You will be able to use all of the vaccine that is in the field to support booster. Updated information for sites will be made available regarding the 50-mcg dose draw.

• 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

• CDC Science Brief: Evidence Used to Update the List of Underlying Medical Conditions Associated with Higher Risk for Severe COVID-19:
  • Updates to the list of underlying medical conditions that put adults of any age at higher risk for severe illness from the virus that causes COVID-19 were based on evidence from published reports, scientific articles in press, unreviewed pre-prints, and internal data. Updates to the following conditions were completed based on evidence from the date range below:
    • Chronic lung disease (including bronchiectasis, bronchopulmonary dysplasia, interstitial lung disease, pulmonary hypertension, pulmonary embolism, tuberculosis) and chronic liver disease (including cirrhosis, non-alcoholic fatty liver disease, alcoholic liver disease, and autoimmune hepatitis) were added September 2021 based on evidence published between December 1, 2019 and August 31, 2021 using the updated review methods outlined below.
    • Mental health disorders (such as mood disorders including depression, and schizophrenia spectrum disorders) were added September 2021 based on evidence published between December 1, 2019 and August 31, 2021.
    • No conditions were removed from the previous underlying medical conditions list.
•  Holiday Celebrations - Includes tips for safer ways to celebrate the holidays