COVID-19 Vaccine Providers Newsletter 10.14.2021

  • On October 4, 2021, the U.S. Food and Drug Administration (FDA) issued an emergency use authorization (EUA) for the ACON Laboratories Flowflex COVID-19 Home Test, an over-the-counter (OTC) COVID-19 antigen test, which adds to the growing list of tests that can be used at home without a prescription.This should significantly increase the availability of rapid, at-home tests and is expected to double rapid at-home testing capacity in the U.S. over the next several weeks. By year’s end, the manufacturer plans to produce more than 100 million tests per month, and this number will rise to 200 million per month by February 2022.  For more information on the ACON Labs Flowflex COVID-19 Home Test, please see the FDA EUA letter and the home instructions.
  • COVID-19 Vaccination Record with a QR Code
    • Individuals may now begin to present the COVID-19 Vaccination Record with QR Code on paper or on their mobile device as proof of vaccination. The COVID-19 Vaccination Record with QR Code may be presented in a variety of ways such as a photo on their mobile device, stored in the Apple Health or Google Pay mobile applications, or printed out in a paper copy.
    • The COVID-19 Vaccination Record with QR Code is an alternative to a paper vaccine card and is an official record of the Virginia Department of Health.
    • The COVID-19 Vaccination Record with QR Code is a valid vaccination record drawn from the data stored in the Virginia Immunization Information System (VIIS) and can be used to provide proof of vaccination. The record displays all information that is on the standard physical copy of the COVID-19 vaccine card: name, date of birth, vaccine date(s), and vaccine manufacturer. The record will also contain a scannable QR Code that will allow for entities to scan the QR Code to validate the information on the record.
    • Individuals who received their vaccine through Department of Defense (DOD), Veterans Administration (VA), and other federal facilities will not have access to a Virginia QR code, as these doses are not reported to VIIS.
    • To receive a COVID-19 Vaccination Record with QR Code through the Vaccination Record Portal, a phone number is required. Individuals  may request that their healthcare provider add a recent phone number to their VIIS record, so they are able to obtain their COVID-19 Vaccination Record with QR Code.
    • While entities are not required to scan the COVID-19 Vaccination Record with QR Code, they can be verified when scanned by a tablet or smartphone with the  SMART Health Verifier App. Once scanned, the scanning device will display to the reader your name, date of birth, vaccine date(s), and vaccine type. Entities can also see all COVID-19 vaccination information directly on the COVID-19 Vaccination Record with QR Code without needing the SMART Health Verifier App.
    • For questions about the COVID-19 Vaccination Record with QR Code, please call the Virginia COVID Information Center 1-877-VAX-IN-VA (1-877-829-4682) Mon-Fri 8am-6pm or look at the “Records” section of the VDH Vaccination Frequently Asked Questions.
  • Updated guidance on the use of bamlanivimab plus etesevimab
    • As of October 8, 2021, based on FDA’s evaluation of the most recently available SARS-CoV-2 variant frequency data, bamlanivimab and etesevimab, administered together, can be used in all U.S. states, territories, and jurisdictions EXCEPT HAWAII under the conditions of authorization for EUA 94. ASPR will resume the distribution of bamlanivimab and etesevimab together and etesevimab alone (to pair with existing supply of bamlanivimab at a facility for use under EUA 094) to all other U.S. states, territories, and jurisdictions.
    • As of September 16, 2021, bamlanivimab and etesevimab, administered together, are recommended for the post-exposure prophylaxis of high-risk individuals 12 years of age and older who have not been fully vaccinated against COVID-19 or are not expected to mount an adequate immune response to complete vaccination, and have been exposed to someone infected with SARS-CoV-2 or who are at high risk of exposure in an institutional setting, including a nursing home or prison.
  • In celebration of American Pharmacists Month, VDH wants to personally thank you and your pharmacy staff for the service you have provided over the course of this pandemic. It has been an extremely difficult time and has pushed us to our limits. However, pharmacists and pharmacy technicians have persevered and proven to be exceptional partners to address the needs of our communities.
  • In honor of American Pharmacist Month, the Commonwealth's state officials also wanted to say thank you. Please share this video with your teams and know that we could not do this without you.
  • Monoclonal Antibody (mAb) Ordering
    • Ordering functionality was deployed in Vaxmax on October 12 at 1pm. It allows all current vaccine providers to place their mAb requests within the same provider portal where they currently request COVID-19 vaccine.
    • Development is underway for non-vaccine providers to place requests in Vaxmax as well, but that functionality has not yet been completed. Because of this, we are asking that non-vaccine providers continue to request their mAbs through the existing REDCap survey.
  • For questions about VaxMaX and its functionality, please visit the VaxMaX Help website, which includes reference guides and tutorial videos.

Best Practice Spotlight

Upcoming Events

  • On Thursday, October 14 and Friday, October 15, 8:30 AM to 5:30 PM EDT, the FDA's Vaccines and Related Biological Products Advisory Committee (VRBPAC) will meet to discuss the use of booster doses of the Moderna COVID-19 Vaccine and the Janssen COVID-19 Vaccine.  Additional meeting information is available here. VDH recommendation and guidelines will be presented by VDH after the ACIP meeting on October 21 and CDC’s recommendations.
  • VRBPAC will also be meeting on Tuesday, October 26  to discuss Pfizer's data on its COVID-19 vaccine for children aged 5-11 years.  The live stream link is here and additional meeting info will be available here. VDH recommendation and guidelines will be presented by VDH after the ACIP meeting that is currently scheduled for Monday, November 1 and Tuesday, November 2 and the release of CDC guidance.

Helpful Resources

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