COVID-19 and solid organ transplant

update

FDA takes multiple actions to expand use of Pfizer-BioNTech COVID-19 vaccine

The U.S. Food and Drug Administration (FDA) has amended the emergency use authorization (EUA) for the Pfizer-BioNTech COVID-19 Vaccine to:

• Expand the use of a single booster dose to include use in individuals 12 through 15 years of age
• Shorten the time between the completion of primary vaccination of the Pfizer-BioNTech COVID-19 Vaccine and a booster dose to at least five months
• Allow for a third primary series dose for certain immunocompromised children 5 through 11 years of age

For more detail, read the FDA statement.

FDA approves antibody-based COVID-19 prophylaxis for immunocompromised people

The U.S. Food and Drug Administration (FDA) has issued an emergency use authorization for a COVID-19 pre-exposure prophylaxis that combines two different monoclonal antibodies. The therapy is approved only for immunocompromised adults and adolescents who do not currently have COVID-19 and have not been exposed recently to the virus. For more detail, read the FDA statement.

Updated CDC guidance addresses potential COVID-19 vaccine booster for some immunocompromised people

The U.S. Centers for Disease Control and Prevention (CDC) has updated interim guidance regarding COVID-19 vaccination for moderately to severely immunocompromised people. The guidance says, at the discretion of the clinical team, a booster for immunocompromised adults may be provided six months or more after they have received a third dose of an mRNA vaccine, or at least two months after they have received a Johnson & Johnson vaccine. For more detail, read the CDC guidance.

ASTS statement on the role of COVID-19 vaccination for transplant candidates and recipients

The American Society of Transplant Surgeons continues to recommend routine vaccination for all organ recipients (along with timely boosters). It also recommends vaccines for those on the waiting list (if possible within time limitations). These recommendations are consistent with ASTS’ existing “routine standards of care,” which focus on patient safety by reducing known infectious disease prior to organ transplantation. Read more here.

Protocols for vaccination requirements

Transplant hospitals decide which patients to add to the transplant waiting list based on their own specified criteria and medical judgment to create the best chance for a positive transplant outcome, with the understanding that the patients will be active participants in their medical care. UNOS, as the national Organ Procurement and Transplantation Network (OPTN), does not have any authority over or provide guidance regarding these decisions. Our authority begins after a transplant program adds a transplant candidate to the list, where we then primarily address organ matching.

Patients have the right to seek transplant at an alternate hospital. However, the requirements may be the same. UNOS does not track transplant programs based on their requirements to receive the COVID vaccine nor other vaccinations. Patients can contact a specific transplant hospital directly to ask questions about their protocols for vaccination requirements.

Third dose of COVID-19 vaccine approved for immunocompromised people

The U.S. Food and Drug Administration (FDA) has amended emergency usage authorizations to administer an additional dose of either the Pfizer-BioNTech or Moderna COVID-19 vaccine for certain immunosuppressed individuals, such as organ transplant recipients. For more information, refer to the FDA statement.

The Centers for Disease Control and Prevention (CDC) has also endorsed the recommendation for an additional dose of vaccine. For more information, read the CDC statement.

Organ recovery teams should be aware of donor hospital vaccine requirements before traveling. Given the spread of the Delta variant, many hospitals now require evidence of COVID vaccination from their employees and other professionals who enter the facility.

Some hospitals are requiring the local OPO to certify that teams are fully vaccinated, so some OPOs are also now requiring teams to show evidence of COVID vaccination.

Carrying a vaccine card or other evidence of vaccination will help recovery teams meet hospital requirements and avoid disruptions to the organ recovery process.

• Lower respiratory testing of all potential lung donors for SARS-CoV-2 to take effect May 27
• Effective April 1, 20201: COVID-19 data amnesty status for follow-up forms ended; Retrospective forms due July 1
• Emergency actions help members protect patient safety and access to transplant during COVID-19
• COVID-19 offer refusal codes
• Changes to wait time initiation for non-dialysis kidney candidates
• Relaxation of TIEDI data submission requirements
• COVID-19 infectious disease testing in DonorNet
  • Report suspected transplant-related disease transmission

View more on COVID-19 policy actions

The COVID-19 Summary of Evidence report has been updated, with information specific to the Omicron variant as well as results from a longer term of monitoring data regarding required lower respiratory specimen testing for potential lung donors.

Compiled by the OPTN Ad Hoc Disease Transmission Advisory Committee (DTAC), the document includes the latest information known for minimizing the risk of donor-derived COVID-19 transmission while maximizing donor utilization.

The committee developed the summary in collaboration with colleagues representing AST, ASTS, AOPO, HRSA and the CDC. DTAC is reviewing the document on a quarterly basis.

• May 27, 2021: SRTR announces monitoring changes for January 2022 reporting cycle in response to COVID-19
• Mar. 16, 2021: SRTR announces monitoring changes for July 2021 reports in response to COVID-19
• Aug. 7, 2020: SRTR modifying evaluation metrics for transplant programs and OPOs
• April 1, 2020: SRTR extends data review period deadline to May 31

On March 25, 2021, the OPTN Membership and Professional Standards Committee agreed to resume monitoring of transplant program functional activity and patient notification requirements, effective July 1, 2021.

All updates to monitoring changes may be found in a supplement to the OPTN member evaluation plan on the OPTN compliance page.

View the updated list of time-limited monitoring changes

This supplemental document serves as a quick-reference guide to all temporary member monitoring changes implemented as a result of the pandemic. Unless new monitoring changes are implemented or effective dates are delayed, it will be retired on July 1, 2021. Any remaining changes as of that date will be published in the OPTN Member Evaluation Plan.

Site surveys to remain virtual in January 2022 updated

Member Quality site survey teams are monitoring pandemic conditions as they plan the slow reintroduction of onsite interactions. While Member Quality hopes to conduct all routine reviews for all member organizations onsite beginning in 2022, all January 2022 site surveys will be conducted virtually in order to ensure the health and well-being of members and their patients as well as our site survey staff. We will continue to monitor the pandemic conditions and keep you informed of any changes.

UNOS site survey teams received overwhelmingly positive feedback about the virtual site survey experience, while also getting feedback that members miss the relationship-building opportunities offered by in-person visits. While COVID-19 continues to presents us with enormous challenges in terms of connecting with members, it also offers new lessons. Member Quality is working to develop a hybrid model that will let the highest-impact work be conducted at the member facility.

Please email MQfeedback@unos.org with any questions about site surveys.

Performance monitoring

The MPSC and the Scientific Registry of Transplant Recipients have made adjustments to the July 2021 program-specific reports (PSRs) and OPO-specific reports (OSRs). Evaluation cohorts will continue to exclude transplants and follow-up time beyond March 12, 2020. Find details about the SRTR monitoring changes here.

About MPSC and rationale for COVID-19 updates

The MPSC is a body of peers from within the donation and transplant community. It maintains membership criteria and monitors OPTN member compliance with OPTN membership criteria, OPTN bylaws and policies, and the OPTN Final Rule.

OPTN policies and requirements have not been suspended as a result of COVID-19. However, deviations from OPTN requirements will be evaluated in the context of the circumstances that have arisen due to this national crisis. The MPSC will look for a commitment to patient safety, stewardship of donated organs, and the rationale for the decisions that your transplant program or OPO make.

The OPTN is collecting information about challenges and issues created by the outbreak in order to evaluate further improvements or assistance that HHS, the OPTN and UNOS can provide. Please use the survey tool linked below to report interruptions or issues. Please note that the link works in the Google Chrome browser, but it does not work in Internet Explorer.

Report COVID-19 issues

• Report transplant candidate data new
• Status report available: Follow up data submission requirements
• Report cause of death for transplant candidates and recipients

• System modification to Waitlist^SM allows hospitals to reactivate liver candidates without having to update labs
• Reactivation process for multiple kidney transplant candidates now available
• Making candidates temporarily inactive
• Maintain wait time for inactive candidates
• Temporary COVID-19 precaution inactivation for multiple kidney transplant candidates

Questions about program inactivation due to COVID: Please email MembershipRequests@unos.org or call (833) 577-9469

New

Updated CDC guidance addresses potential COVID-19 vaccine booster for some immunocompromised people

The U.S. Centers for Disease Control and Prevention (CDC) has updated interim guidance regarding COVID-19 vaccination for moderately to severely immunocompromised people. The guidance says, at the discretion of the clinical team, a booster for immunocompromised adults may be provided six months or more after they have received a third dose of an mRNA vaccine, or at least two months after they have received a Johnson & Johnson vaccine. For more detail, read the CDC guidance.

Third dose of COVID-19 vaccine approved for immunocompromised people

The U.S. Food and Drug Administration (FDA) has amended emergency usage authorizations to administer an additional dose of either the Pfizer-BioNTech or Moderna COVID-19 vaccine for certain immunosuppressed individuals, such as organ transplant recipients. For more information, refer to the FDA statement.

The Centers for Disease Control and Prevention (CDC) has also endorsed the recommendation for an additional dose of vaccine. For more information, read the CDC statement.

AST COVID-19 guidance documents

• Position statement on the role of COVID-19 vaccination for transplant candidates and recipients
• Joint statement about vaccine efficacy in organ transplant recipients

ISHLT

• COVID-19 vaccination in heart and lung transplantation: Recommendations from the International Society of Heart & Lung Transplantation (ISHLT) COVID-19 Task Force

VCU Health

• COVID-19 vaccines and transplant patients: Is vaccination safe?

Find additional patient-focused vaccination resources on the Transplant Living website.

• AJT: “Coronavirus disease 2019: Implications of emerging infections for transplantation”
• AHA: “Challenges in heart transplantation in the era of COVID-19”

To the extent practical, continue to follow the match run. If transportation systems become disrupted and an organ cannot be transported to a hospital on the match run, use the 861 bypass code and proceed to allocate as high on the match run as logistics allow. These decisions should be based on the availability of transportation options, not on DSA or regional boundaries.

• Lower respiratory testing of all potential lung donors for SARS-CoV-2 to take effect May 27
• Lower respiratory tract testing available, resource PDF
• Record donor COVID-19 testing and results data in DonorNet

• COVID-19 Weekly RUM Report now available in the Data Portal
• Refer to the AOPO informational resource addressing donor evaluation and OPO procedures in light of potential COVID-19 infection