COVID-19 Vaccine Providers Newsletter 02.16.2022


  • FDA Authorizes New Monoclonal Antibody Bebtelovimab
    • On February 11, 2022, the U.S. Food and Drug Administration (FDA) granted Emergency Use Authorization (EUA) to Bebtelovimab (Eli Lilly)
    • Bebtelovimab is a single monoclonal antibody (mAb) that has shown in lab testing that it has activity against the Omicron variant and subvariants (BA.1, BA.2 and BA.1.1)
    • Bebtelovimab is indicated for the treatment of mild to moderate COVID-19 in adults and pediatric patients (12 years of age and older who weigh at least 40 kg) who:
      • Have a positive SARS-CoV-2 viral test, and
      • Are at high-risk for progression to severe COVID-19, and
      • Who are not hospitalized due to COVID-19, and
      • For whom alternative COVID-19 treatment options approved or authorized by FDA are not accessible or clinically appropriate
    • Bebtelovimab is administered as a single intravenous injection and should be given as soon as possible after the diagnosis of COVID-19 has been made and within 7 days of symptom onset.
    • The U.S. Department of Health and Human Services (HHS) purchased 600,000 doses of Bebtelovimab; distribution to states began on February 14, 2022.  Virginia received 1,085 doses which will be allocated to monoclonal antibody administration sites in the state.



  • Updated: Interim Clinical Considerations for the Use of COVID-19 Vaccines
    • On February 11, 2022, the Centers for Disease Control and Prevention (CDC) updated their Interim Clinical Considerations for the Use of COVID-19 Vaccines.
    • for people who are moderately or severely immunocompromised:
      • An update that people who have completed a primary series of an mRNA vaccine (Pfizer-BioNTech or Moderna) are recommended to receive an mRNA booster dose 3 months (instead of 5 months) after the last primary dose.
      • An update that people who have received a single Johnson & Johnson COVID-19 vaccine should receive one additional dose of an mRNA COVID-19 vaccine and one booster dose (preferably mRNA) for a total of 3 vaccine doses.
      • A clarification of a current recommendation to confirm that those who have completed their primary series of 3 mRNA doses should receive an mRNA vaccine booster dose—to make a total of 4 doses.
    • For those who previously received passive COVID-19 antibody products:
      • A simplification of existing guidance in that they do not need to wait for any period prior to COVID-19 vaccination.
    • Updated guidance on receiving a booster dose if vaccinated outside the United States.
    • Updated contraindication and precaution section to include history of myocarditis or pericarditis after an mRNA COVID-19 vaccine as a precaution.
  • Vaccine providers are responsible for adhering to all requirements outlined in the CDC COVID-19 Vaccination Program Provider Agreement. Specifically, providers must administer COVID-19 vaccines in accordance with all program requirements and recommendations of CDC, the Advisory Committee on Immunization Practices, and the FDA. This applies to COVID-19 vaccines either authorized or approved by FDA. Accordingly, use of these products outside of those that have been approved and authorized by FDA (often referred to as “off-label use”) is not recommended. It would violate the provider agreement and could expose providers to the following risks:
    • Administration of the product off-label may not be covered under the PREP Act or the PREP Act declaration; therefore, providers may not have immunity from claims.
    • Individuals who receive an off-label dose may not be eligible for compensation under the Countermeasures Injury Compensation Program after a possible adverse event.
    • CDC has defined the scope of the CDC COVID-19 Vaccination Program in terms of how the U.S. government-provided vaccines may be used in the program. Providers giving off-label doses would be in violation of the CDC Program provider agreement, potentially impacting their ability to remain a provider in the CDC program.
    • Administration fees may not be reimbursable by payers.
    • On a case-by-case basis, providers caring for patients who are moderately to severely immunocompromised may administer mRNA COVID-19 vaccines outside of the FDA and CDC dosing schedules based on their clinical judgment.
    • Providers should not routinely administer additional doses outside of what is recommended in CDC guidance.



  • Updated: Interim Guidance for COVID-19 Prevention in Virginia PreK-12 Schools (pgs. 6-8)
    • Changed header title to 4. Notifications of disease to school community, outbreak reporting, and focused contract tracing
    • Added clarifying language, which is consistent with K-12 FAQ language shared with school superintendents and LHDs: “Schools should notify parents and families of a case of COVID-19 in a member of the school community. Schools are no longer expected to conduct contact tracing on every individual case of COVID-19. However, contact tracing remains one component of the layered prevention strategies approach and should be continued in partnership with local health departments when there are outbreaks or when sustained transmission is thought to be occurring within the school.”
    • Added sub-bullet “Continue to communicate isolation and quarantine recommendations to the school community so that students, teachers, and staff are aware of recommended practices.”
    • Added to the reference list:  Andrejko KL, Pry JM, Myers JF, et al. Effectiveness of Face Mask or Respirator Use in Indoor Public Settings for Prevention of SARS-CoV-2 Infection — California, February–December 2021. MMWR Morb Mortal Wkly Rep. ePub: 4 February 2022.
  • Updated: General FAQs 
    • New questions were added to address COVID-19 treatment locator; protection, duration and limitations of natural immunity; free N95 masks; and protection from previous COVID-19 infections.
    • Revisions involved updating FAQs about VDH contact tracing; testing scams and fraud; ongoing or household exposures; COVID-19 Isolation & Quarantine calculator; convalescent plasma donation; transmission of Omicron; test to stay program; HRSA COVID-19 Coverage Assistance Fund; VDH Algorithm for Evaluating a Child with COVID-19 Symptoms or Exposure; risk assessment tool to evaluate healthcare personnel exposure to SARS-CoV; NIH treatment guidelines; HHS monoclonal antibody distribution and LTCF guidance.
  • Pfizer Vaccine Updates for Children Aged 6 Months to 4 Years
    • VDH has been informed by the U.S. Department of Health & Human Services (HHS) that the initially scheduled roll-out for this new vaccine has been placed on a complete freeze. At this time, no additional orders for pre-positioning will take place until further notice.
    • Many providers across the state, specifically pediatric providers, have been in communications with their Local Health Departments on receiving part of the initial allotment of vaccine that was expected to ship next week; however, all of these orders have been canceled, and no doses will arrive in the field until further notice due to the delay in FDA's review.
  • New: Pfizer Controlant Data “SAGA Logger” Coming This Week 
    • Starting this week, Pfizer vaccine shippers will begin transitioning to an updated data logger from Controlant.  This new device, SAGA Logger, will provide improved performance for monitoring and reporting during shipment.  The key improvements to this device include:
      •  Enhanced location accuracy with WiFi
      •  Utilization of the 4G cellular network
      •  Interactive LCD display with an improved user interface
      • 150 days of backup storage when no cloud is available
      • Longer battery life
      •  Improved data transmission capability

The new interactive LCD tracker display shows current temperatures and the minimum and maximum temperatures of the shipper contents during transit.  The screen also includes an easy-to-read status indicator for the safer NiMH extended-life battery.

The new SAGA Logger is slightly larger in size and, as with the previous logger, requires return shipping in the packaging materials provided with your order.

For additional information or questions, visit the Pfizer Webinar Series for Healthcare Providers for a complete schedule of trainings for February and March and to access links and passwords for each course.

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

Best Practice Spotlight

Upcoming Events

  • Postponed: Vaccines and Related Biological Products Advisory Committee Meeting originally scheduled for February 15, 2022

Helpful Resources



  • Updated: Quarantine and Isolation Guidance for Homeless Clients
      • Interim Guidance for Homeless Service Providers to Plan and Respond to Coronavirus Disease 2019 (COVID-19)
        • Staff and people experiencing sheltered homelessness should quarantine for 10 days after close contact with someone who had COVID-19 and get tested at least 5 days after close contact.
        • Staff can follow the guidance for quarantine and isolation for the general public for activities other than returning to work.
        • Staff and people experiencing sheltered homelessness with COVID-19 or who have symptoms of COVID-19 should isolate for 10 days.
        • In critical staffing space shortages, quarantine or isolation duration may be shortened in consultation with state, local, or tribal health authorities.
      • Consolidated the following three guidance documents that were previously posted on the CDC COVID-19 Corrections webpage: Interim Guidance on Management of Coronavirus Disease 2019 (COVID-19) in Correctional and Detention Facilities; Interim Guidance for SARS-CoV-2 Testing in Correctional and Detention Facilities; and Recommendations for Quarantine Duration in Correctional and Detention Facilities.
      • Reduced quarantine duration during routine operations from 14 days to 10 days.
      • Added recommendations on isolation and quarantine duration for staff and residents in correctional and detention facilities during crisis-level operations.
      • Added description of the use of medication for prevention of severe COVID-19 disease.
      • Updated language on vaccination status to include booster doses and additional doses for people who are eligible for them. (Removed references to “fully vaccinated” to refer instead to being “up to date on COVID-19 vaccines.”)
  • Updated recommendations on use of personal protective equipment (PPE), masks, and respirators for correctional residents and staff (Table 1).

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