COVID-19 Vaccine Providers Newsletter 05.04.2022


  • New (4/21/22): Clinical Considerations for a Second COVID-19 Vaccine Booster DoseThe document linked above provides factors to consider when determining if eligible people should get a second booster dose of an mRNA vaccine (Pfizer or Moderna) now or wait:
    • Who might consider getting a 2nd booster dose now (among those who are currently eligible):
      • People with underlying medical conditions that increase the risk of severe COVID-19 disease such as those who are moderately or severely immunocompromised
      • People who live with someone who is immunocompromised, at increased risk for severe disease, or who cannot be vaccinated due to age or contraindication
      • People at increased risk of exposure to SARS-CoV-2, such as through occupational, institutional, or other activities (e.g., travel or large gatherings)
      • People who live or work in or near an area where the COVID-19 community level is medium or high or are traveling to such an area
    • Who might consider waiting to receive a 2nd booster dose (among those who are currently eligible):
      • People who have had SARS-CoV-2 infection within the last 3 months
      • People who may be hesitant about getting another recommended booster dose in the future, as a booster dose may be more important in the fall and/or if a variant-specific vaccine is needed
  • Updated: SARS-CoV-2 Variant Classifications and Definitions
    • On April 14, 2022 the U.S Government SARS-CoV-2 Interagency Group (SIG) downgraded Delta from a Variant of Concern to a Variant Being Monitored.
    • This new classification was based on the following:
      • Significant and sustained reduction in its national and regional proportions over time.
      • Evidence suggesting that Delta does not currently pose a significant risk to public health in the U.S.


  • FDA Approves First COVID-19 Treatment for Young Children (Remdesivir)
    • On April 25, 2022 the FDA expanded the approval of the COVID-19 treatment Veklury (Remdesivir) to include pediatric patients 28 days of age and older weighing at least 3 kilograms (about 7 pounds) with positive results of direct SARS-CoV-2 viral testing, who are:
      • Hospitalized, or
      • Not hospitalized and have mild-to-moderate COVID-19 and are at high- risk for progression to severe COVID-19, including hospitalization or death.
    • This action makes Veklury the first approved COVID-19 treatment for children less than 12 years of age.
    • As a result of this approval action, the agency also revoked the emergency use authorization for Veklury that previously covered this pediatric population.
    • Before now, Veklury was only approved to treat certain adults and pediatric patients (12 years of age and older who weigh at least 40 kilograms, and are at high-risk for progression to severe COVID-19) with COVID-19.
  • FDA Announces Tentative Advisory Committee Meeting Schedule Regarding COVID- 19 Vaccines
    • The FDA announced plans to hold virtual meetings of its Vaccines and Related Biological Products Advisory Committee (VRBPAC) in anticipation of complete submissions of emergency use authorization (EUA) requests in the coming months that have been publicly announced by COVID-19 vaccine manufacturers.
    • It is important to note that the dates below are tentative as none of the submissions are complete. Should any of the submissions be completed in a timely manner and the data support a clear path forward following our evaluation, the FDA will act quickly and anticipates convening the following VRBPAC meetings:
      • On June 7, 2022, FDA intends to convene VRBPAC to discuss an EUA request for a COVID-19 vaccine manufactured by Novavax to prevent COVID-19 in individuals 18 years of age and older.
      • On June 8, 21 and 22, 2022, the FDA has held dates for the VRBPAC to meet to discuss updates to the Moderna and Pfizer-BioNTech EUAs for their COVID-19 vaccines to include younger populations. As the sponsors complete their submissions and FDA reviews that data and information, it will provide additional details on scheduling of VRBPAC meetings to discuss each EUA request.
      • On June 28, 2022, FDA plans to convene VRBPAC to discuss whether the SARS-CoV-2 strain composition of COVID-19 vaccines should be modified, and if so, which strain(s) should be selected for a Fall 2022 vaccine. This meeting is a follow-up to the April 6, 2022 VRBPAC meeting that discussed general considerations for future COVID-19 vaccine booster doses and the strain composition of COVID-19 vaccines to meet public health needs.
  • Celltrion USA Recalls Certain Point of Care DiaTrust COVID-19 Ag Rapid Test Kits On April 28, 2022, FDA reported that Celltrion USA issued a recall of some of its point of care (POC) antigen test kits because they had been distributed to unauthorized, non-CLIA-certified users.The product at issue is the Celltrion DiaTrust COVID-19 Ag Rapid Test. This is a POC lateral flow antigen test that has an Emergency Use Authorization for use in a high-complexity lab, medium-complexity lab, or CLIA-waived lab. This test uses a nasopharyngeal swab as the sample.The reason for the recall by Celltrion is that the test kits have gone to labs that don't have the expertise to perform the test (or perform it properly).
  • Counterfeit At-Home OTC COVID-19 Diagnostic Tests - On April 29, 2022, FDA issued a notice stating it was aware of counterfeit at-home over-the-counter (OTC) COVID-19 diagnostic tests being distributed or used in the United States. These counterfeit tests should not be used or distributed. The OTC COVID-19 diagnostic tests that have been counterfeited are the Flowflex COVID-19 Antigen Home Test and the iHealth COVID-19 Antigen Home Test.  The FDA notice goes into detail about how to distinguish valid Flowflex and iHealth COVID-19 Antigen Tests that have an EUA vs. counterfeit items.
  • Weekly Reporting beginning May 1 UPDATE: As of May 1, 2022, providers must report COVID-19 vaccine supply levels at least weekly by close of business on Fridays. All other provisions regarding data remain unchanged.
    • We appreciate your efforts to update data in VaccineFinder. If you have completed the process, thank you for your efforts. For those who have not yet updated VaccineFinder information, please see the details below. It is very important that you zero out providers who are no longer participating in COVID-19 vaccination efforts. Old inventory numbers will impact your own and aggregate performance metrics.
    • How to Add Inventory
      • To report inventory for COVID-19 vaccines that are not already listed in your COVID-19 Locating Health Portal account, please follow the Add Vaccine link to add COVID-19 vaccine NDCs(National Drug Codes) to your location.
      • You can follow this process for all new COVID-19 vaccines that are authorized and recommended in the U.S. Once added, you can begin reporting the number of doses on hand for that vaccine.
    • Quick tips
      • Make sure depots/hubs are updating inventory in VaccineFinder regularly; these facilities represent the largest inventory numbers and greatly impact supply chain estimates
      • Providers no longer participating in COVID-19 vaccination must be zeroed out; old inventory numbers can impact performance metrics
      • Regular reporting of inventory is part of the COVID-19 Vaccination Program Provider Enrollment Agreement
    • Guides for reporting inventory and public display information can be found on the Provider Resources page. If you need support, please contact or 1-833-748-1979.
  • Opt-out Option for All Adult Ancillary Kits: You may now opt out of all COVID-19 adult vaccine ancillary supply kits, including the Pfizer adult ancillary kits.
    • Providers may opt out of ancillaries for any adult vaccine order including:
      • J&J (100 dose MOQ)
      • Moderna 10 (100 dose MOQ)
      • Pfizer Gray (300 dose MOQ)
    • Please note: The opt-out option is not currently available for pediatric COVID-19 vaccine as Pfizer pediatric ancillary kits contain the diluent necessary to administer the vaccine.
    • For Awardees- Opt-out instructions can be found in the VTrckS library at:
    • For Federal Agencies/Commercial Partner
      • Opt-out functionality is available in VPoP
  • For questions about VaxMaX and its functionality, please visit the VaxMaX Help websitewhich includes reference guides and tutorial videos.

Best Practice Spotlight

Best Practices for Inventory Management: What to Do as LOTS of Lots Begin to Expire


Upcoming Events


  • Public Health Ground Rounds: Featuring Preventive Medicine Grand Rounds - Dual Lectures: Strengthening CDC’s One Health & Local Schools’ COVID-19 Response
    • In the first presentation, Dr. Kate Varela will describe how the COVID-19 pandemic was a catalyst for strengthening One Health in the United States through the implementation of an effective One Health Federal Interagency COVID-19 Coordination group.
    • In the second presentation, Dr. Vahey will describe from a local perspective how COVID-19 contact tracing support was provided within three school districts, including challenges and lessons learned.
    • Date and Time: Wednesday May 4, 2022, 1:30 – 3:00 p.m. ET
    • Remote participation only: Passcode (if prompted): PMGR_0504

Helpful Resources


  • Updated: COVID-19 Vaccine Booster Shots - Added a section on some factors that people who are eligible for a second COVID-19 vaccine booster dose should consider when determining if they should get the booster now or wait


VDH External Web Updates:

Updated: COVID-19 Vaccination FAQ - Revisions involved:

  • Updating FAQs about the status of vaccines for younger children
    • Discussion of COVID-19 vaccines and fertility
    • Discussion of breakthrough cases
    • Timing of booster doses after recent infection
    • Guidance for healthcare providers on second boosters
    • Reasons for children to become vaccinated against COVID-19.
  • Updated: Parent Algorithm - On Resources and Support page, under VDH resources and K-12 Education page, under resources for parents -  changed files for new 508 compliant translated documents.
  • Updated: Feeling Sick Comparison Chart - On Resources and Support page, under VDH resources and on Exposure page.Updated COVID-19 symptoms to be more in line with Omicron variant, redesigned overall sheet (non-content updates)

Information about the COVID-19 vaccination program is changing frequently. This newsletter will offer regular updates to providers who have submitted an intent to vaccinate or signed the CDC provider agreement within Virginia.

VDH COVID-19 Vaccination Response: Healthcare Professionals Website