CHHS Public Health Provider COVID-19 Update: 3rd dose mRNA vaccines for moderate/severely immunocompromised; K-12

August 16, 2021

Local and state COVID-19 update

  • As of 8/13­­/2021, there have been 19,878 confirmed cases of COVID-19 and 332 COVID-19 related deaths in Buncombe County residents since the start of the pandemic.
  • Thanks to the delta variant, NC continues to see large and rapid increases in 4 key metrics – the number of new cases, hospitalizations, percent positivity and the percent of emergency department visits that are for COVID-like illness.
  •    Case rates are increasing across all age groups, although most rapidly in 18-49 year olds.
  •    The vast majority of those getting infected, hospitalized and dying from COVID continue to be the unvaccinated.
  •    The delta variant makes up the vast majority of sequenced variants in NC.
  •          Buncombe County trends mimic those of the state. We are now at 258 cases per 100,000 population in the last 7 days in Buncombe County (almost 10x the number we had a month ago) and a percent positivity of 8.2%.
  •          All 3 COVID-19 vaccines available in the US have been shown to be effective against this highly contagious variant. Please continue to encourage your patients, colleagues, friends and family members to get vaccinated if they haven’t yet done so.
  • Per the NCDHHS dashboard, 62% of the total Buncombe County population has been vaccinated with at least 1 dose of COVID-19 vaccine and 58% are fully vaccinated. More details on the demographics of those vaccinated can be found on the dashboard.

 

Additional dose of mRNA vaccines approved for those with moderately to severely compromised immune systems

  •          On Friday, following FDA updates to the EUAs for the Pfizer-BioNTech and Moderna vaccines and an ACIP recommendation, the CDC endorsed the administration of an additional dose of the mRNA COVID-19 vaccines to people with moderately to severely compromised immune systems after an initial two-dose mRNA vaccine series.
    •    Vaccine providers now are able to administer these additional doses.
  •          CDC will hold a clinician call on Tuesday, 8/17, from 2-3pm on this topic.
  •          The age groups authorized to receive the additional dose are unchanged from those authorized to receive the primary vaccination series:
    •    Pfizer-BioNTech vaccine: aged ≥12 years
    •    Moderna: aged ≥18 years
  •          The additional dose should be administered at least 28 days after the completion of the initial mRNA COVID-19 vaccine series.
  •          The additional mRNA COVID-19 vaccine dose should be the same vaccine product as the initial 2-dose mRNA COVID-19 primary vaccine series.
    •    If the mRNA COVID-19 vaccine product given for the first two doses is not available, the other mRNA COVID-19 vaccine product may be administered.
  •          Currently there are insufficient data to support the use of an additional mRNA COVID-19 vaccine dose after a single-dose Janssen (J&J) COVID-19 vaccination series in immunocompromised people. FDA and CDC are actively working to provide guidance on this issue.
  •          The clinical considerations for use of an additional dose of an mRNA COVID-19 vaccine apply only to people who are moderately or severely immunocompromised.
  •          Conditions and treatments associated with moderate and severe immune compromise include, but are not limited to:
    •    Active treatment for solid tumor and hematologic malignancies
    •    Receipt of solid-organ transplant and taking immunosuppressive therapy
    •    Receipt of CAR-T-cell or hematopoietic stem cell transplant (within 2 years of transplantation or taking immunosuppression therapy)
    •    Moderate or severe primary immunodeficiency (e.g., DiGeorge syndrome, Wiskott-Aldrich syndrome)
    •    Advanced or untreated HIV infection
    •    Active treatment with high-dose corticosteroids (i.e., ≥20mg prednisone or equivalent per day), alkylating agents, antimetabolites, transplant-related immunosuppressive drugs, cancer chemotherapeutic agents classified as severely immunosuppressive, tumor-necrosis (TNF) blockers, and other biologic agents that are immunosuppressive or immunomodulatory.
  •          Patients may self-attest to having a medical condition that causes moderate to severe immune compromise.
    •    At this time, BCHHS will not require documentation from a healthcare provider in order for individuals presenting at our vaccine clinic to receive an additional dose.
  •          Rationale for the recommendation:
    •    The currently FDA-authorized COVID-19 vaccines are not live vaccines and therefore can be safely administered to immunocompromised people.
    •    Studies indicate some immunocompromised people have a reduced immune response following a primary COVID-19 vaccine series compared to vaccine recipients who are not immunocompromised.
    •    Studies have further demonstrated that including an additional mRNA COVID-19 vaccine dose after an initial 2-dose primary mRNA COVID-19 vaccine series in some immunocompromised populations may enhance immune response.
    •    The clinical benefit of an additional mRNA vaccine dose after an initial 2-dose primary mRNA COVID-19 vaccine series for immunocompromised people is not precisely known. However, for people with moderate to severe immune compromise due to a medical condition or receipt of immunosuppressive medications or treatments, the potential to increase immune response coupled with an acceptable safety profile, support the recommendation for an additional mRNA vaccine dose after an initial 2-dose primary mRNA COVID-19 vaccine series.

 

No current recommendation for COVID-19 vaccine booster dose

  • Unlike the above recommendation for an additional dose of vaccine due to the likelihood of insufficient immune response in those who are immunocompromised, a booster dose would be an additional dose of vaccine administered when the initial sufficient immune response to a primary vaccine series is likely to have waned over time.
  • The need for and timing of a COVID-19 booster dose have not been established yet.
  • No booster doses are recommended at this time.

 

Updated CDC guidance for healthcare providers

  •          Since my last email, the CDC’s Interim Clinical Considerations for Use of COVID-19 Vaccines Currently Authorized in the US have been updated to include:
    •    a new section on considerations for use of an additional mRNA COVID-19 vaccine dose after an initial 2-dose primary mRNA COVID-19 vaccine series for immunocompromised people
    •    considerations for COVID-19 vaccination in people with a history of Guillain-Barré syndrome (GBS), as follows:
      •   People with a history of GBS can receive any FDA-authorized COVID-19 vaccine. However, given the possible association between the Janssen COVID-19 vaccine and an increased risk of GBS, a patient with a history of GBS and their clinical team should discuss the availability of mRNA COVID-19 vaccines to offer protection against COVID-19.
    •    considerations for people who are pregnant, lactating, trying to get pregnant now, or might become pregnant in the future
      •   A growing body of evidence on the safety and effectiveness of COVID-19 vaccination – in both animal and human studies – indicates that the benefits of vaccination outweigh any known or potential risks of COVID-19 vaccination during pregnancy.
    •    additional information in Appendix A on vaccine administration errors and deviations, including inadvertent mixed doses and incorrect time intervals
    •    clarification of mRNA vaccine dosing intervals in the Vaccine Administration section, such that it now states “individuals who receive the second dose up to 4 days before or at any time after the recommended date can be considered fully vaccinated.”
  •          CDC’s Prevaccination Checklist for COVID-19 Vaccines was updated on 8/9/2021 to include a question about history of Guillain-Barré syndrome.
  •          CDC held a clinician call last week on “Therapeutic Options to Prevent Severe COVID-19 in Immunocompromised People”
    •    The webinar was recorded and CME is available.

 

K-12 school guidance

  •          Please review the requirements for return to school for students and school staff on pages 16-18 of the StrongSchoolsNC Toolkit so that you correctly counsel families on when they can return to school.
  •          Changes for this school year regarding quarantine:
    •    Students who are not fully vaccinated and are identified as a close contact to a student with COVID-19 will not have to quarantine if masks were being worn appropriately and consistently by both them and the student with COVID-19. This applies to exposures in classrooms, other in-school settings, and school transportation.
      •   This exception to quarantine does not apply to exposures during extracurricular or athletic activities, to exposures at schools that do not have other COVID prevention strategies in place (like universal masking, physical distancing, increased ventilation), and to teachers, staff, or other adults in the indoor classroom setting.
    •    Individuals who are fully vaccinated and do not have symptoms will not need to quarantine after a close contact.
      •   They should get tested 3-5 days after exposure and wear a mask around others until receiving a negative test result.
    •    Individuals who have tested positive for COVID-19 within the past 3 months and recovered and do not have symptoms will not have to quarantine.
    •    In those situations where quarantine is necessary, at this time, BCHHS Public Health will allow shortened quarantine options for students and staff at K-12 schools.
      •   An exception to this would be those in congregate living at boarding schools, where a 14 day quarantine remains in place.

 

BCHHS COVID-19 Vaccine Clinics

  • Our COVID-19 vaccine clinic continues at the BCHHS building at 40 Coxe Ave. in downtown Asheville. The clinic is open Mon-Fri from 9a-4p to walk-ins. We continue to vaccinate those 12 years of age and older, and have all 3 authorized vaccines available onsite.
  •          While supplies last, until the end of August, $100 incentive cards are available to those 18 years of age and older who are getting their 1st dose of COVID vaccine through the BCHHS COVID-19 Vaccine Clinic. ­­­­­­­­­­­­A limited number of $25 incentive cards also are available to those providing a ride to individuals getting a first dose of vaccine. Due to limited physical supply, we may run out of incentive cards, however, we are able to offer individuals the option to sign up for an electronic version or have an incentive card mailed to them.

 

Potential timeframes for additional vaccine updates

  •          Moderna authorization for 12 years of age and older – possibly later this month
  •          Full authorization of Pfizer-BioNTech vaccine – possibly in September
  •          Authorization for vaccine administration to those <12 years of age – potentially late Fall/early Winter

 

Want to start providing COVID-19 vaccine to your patients? Need more vaccine?