COVID-19 and solid organ transplant
News and resources for organ procurement organizations and transplant hospitals about COVID-19
CDC updates guidance on COVID-19 boosters; NIH updates guidance on influenza season and COVID-19
FDA authorizes booster; Updated guidance from CDC for immunocompromised and NIH on monoclonal antibodies; and COVID-19 Summary of Evidence updated
NIH updates guidance for people who are immunocompromised; FDA advises repeat testing following a negative COVID-19 test
New FDA announcements on Paxlovid and Novavax vaccine, Adjuvanted; Summer 2022 regional meetings to be in-person
Find patient vaccine FAQs on the Transplant Living website.
Vaccination information (updated 10/6/22)
CDC updates guidance on COVID-19 boosters
The Centers for Disease Control and Prevention (CDC) has updated their recommendations for vaccine boosters within each age group. Read the guidance.
NIH updates guidance on influenza season and COVID-19
The National Institute of Health’s (NIH) COVID-19 Treatment Guidelines Panel has updated their recommendations for the upcoming influenza season. Read the latest recommendations from NIH.
FDA authorizes updated COVID-19 booster
The Food and Drug Administration (FDA) has authorized the use of updated Moderna and Pfizer vaccines to protect against the Omicron variant of COVID-19 for use as a single booster dose at least two months following a primary or booster vaccination. Read the release.
CDC updates vaccination guidance for immunocompromised
The Center for Disease Control and Prevention (CDC) has released interim clinical considerations for use of bivalent vaccines. Read the guidance. The CDC has also issued an updated vaccination schedule for people who are moderately or severely immunocompromised.
NIH updates guidance on monoclonal antibodies
NIH updates guidance for the immunocompromised
The National Institute of Health’s (NIH) COVID-19 Treatment Guidelines Panel has updated their recommendations for the immunocompromised. Read the latest recommendations.
FDA advises repeat testing following a negative COVID-19 test
The FDA advises repeat testing following a negative test result, to reduce the risk an infection may be missed (false negative result) and to help prevent people from unknowingly spreading the virus to others. Read the safety communication.
FDA authorizes emergency use of Novavax COVID-19 vaccine, Adjuvanted
FDA authorizes use of Novavax COVID-19 vaccine, Adjuvanted for the prevention of COVID-19 in individuals 18 years of age and older. Read the release.
FDA authorizes pharmacists to prescribe Paxlovid with certain limitations
FDA authorizes state-licensed pharmacists to prescribe Paxlovid to eligible patients, with certain limitations to ensure appropriate patient assessment. Read the release.
CDC releases interim recommendations for use of Moderna and Pfizer-BioNTech vaccines for children from 6 months of age
CDC Advisory Committee on Immunization Practices has issued interim recommendations for the use of COVID-19 vaccines in children from 6 months of age. Read the release.
FDA recommends inclusion of Omicron BA.4/5 component for COVID-19 vaccine boosters
FDA advisory committee voted in favor of including a SARS-CoV-2 omicron component in COVID-19 vaccine boosters in the U.S. beginning in fall 2022. Read the release.
FDA authorizes Moderna and Pfizer-BioNTech vaccines for children from 6 months of age
The FDA has authorized emergency use of the Moderna and Pfizer-BioNTech COVID-19 vaccines for the prevention of COVID-19 to include use in children from 6 months of age. Read the release.
CDC releases infographic showing COVID-19 vaccination schedule recommendations for patients
CDC has released a new infographic showing recommended vaccine doses and schedules, including recommendations for those who are immunocompromised. See the infographic.
NIH updates vaccine guidance for potential organ donors
The National Institute of Health’s (NIH) COVID-19 Treatment Guidelines Panel has added COVID-19 vaccination recommendations for potential organ and stem cell donors and for close contacts of transplant and cellular immunotherapy candidates and recipients. Read the latest recommendations from NIH.
FDA expands Pfizer-BioNTech vaccine booster eligibility to children 5 through 11 years
FDA authorizes first nonprescription COVID-19 test that also detects flu and RSV
The test utilizes at-home sample collection with testing performed in a laboratory. Read the release on the FDA website.
FDA announces tentative committee meeting schedule to discuss COVID-19 vaccines
FDA revises committee meeting schedule to discuss COVID-19 vaccines. Read the tentative list of upcoming meetings.
FDA limits use of Janssen COVID-19 vaccine
The U.S. Food and Drug Administration (FDA) has limited the authorized use of the vaccine to certain individuals 18 years of age or older. Read the key points of this update.
NIH updates guidance for second doses of Evusheld
The National Institute of Health’s (NIH) COVID-19 Treatment Guidelines Panel has modified their recommendations for the second dose of Evusheld. Read the latest recommendations from NIH.
Distribution of sotrovimab paused nationwide
The National Institute of Health’s (NIH) COVID-19 Treatment Guidelines Panel no longer recommends sotrovimab as a treatment option for nonhospitalized patients, citing substantially decreased in vitro activity against the dominant COVID-19 subvariant Omicron BA.2. Read the latest recommendations from NIH here.
FDA gives full approval to the Moderna COVID-19 vaccine
The Moderna COVID-19 vaccine, which had been widely available under an emergency use authorization granted December 2020, has now been given full approval by the FDA. This approval means the vaccine meets the FDA’s standards for safety, effectiveness and manufacturing quality. Read the news release from the FDA here.
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 posted interim guidance regarding COVID-19 vaccination for moderately to severely immunocompromised people. 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.
Reminder for organ recovery teams to carry proof of vaccine
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.
COVID-19 policy and data actions (updated 3/31/22)
- Candidate data reporting due to COVID-19 impact will expire April 11
- 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
COVID-19 Summary of Evidence report updated (updated 8/22/22)
The OPTN Ad Hoc Disease Transmission Advisory Committee has completed its quarterly update of the SARS-CoV-2 Summary of Evidence. The Aug. 22, 2022 updated version includes current information on Omicron sublineages BA.4/BA.5 as well as the most recent literature on SARS-CoV-2 and its effect on transplant.
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.
AST recommendations and guidance for organ donor testing
- 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
MPSC reviews (site survey, updated 11/21/22)
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.
This supplemental document serves as a quick-reference guide to all temporary member monitoring changes implemented as a result of the pandemic.
Now site surveys have transitioned into in-person visits updated
Member Quality is conducting all routine reviews for member organizations onsite. We will continue to monitor the pandemic conditions and will be prepared to pivot back to our virtual survey model if needed.
Please email [email protected] with any questions about site surveys.
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.
Reporting interruptions and issues
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.
Ethical analysis: living donor transplantation during COVID-19
- Immunogenicity of a Single Dose of SARS-CoV-2 Messenger RNA Vaccine in Solid Organ Transplant Recipients
Journal of Nephrology
- COVID-19 and the kidney: what we think we know so far and what we don’t (Published: 20 July 2020)
- FAQ for organ transplantation updated
- Recommendations and guidance for organ donor testing
- Vaccine FAQ updated
CDC COVID-19 website
- SARS-CoV-2 Infections among Recent Organ Recipients, March–May 2020, United States
- CDC list of state health department websites for information about travel restrictions
- Interim infection prevention and control recommendations
- Morbidity and Mortality Weekly Report
NAS Annual Meeting: Experts Discuss COVID-19 Pandemic and Science’s Response
Inactivating and reactivating programs and candidates
- System modification to WaitlistSM 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
Treatment guidelines (updated 5/12/22)
COVID-19 therapeutic locator
The U.S. Department of Health and Human Services maintains a national map displaying public locations that have received shipments of COVID-19 therapeutics granted an Emergency Use Authorization by the U.S. Food and Drug Administration (FDA). These therapies require a prescription, and the locator is intended for provider use. Patients are encouraged to collaborate with their care team in clinical decisions about treatment of COVID or the use of preventative medications and strategies. You can view the locator map here.
NIH releases new COVID-19 treatment guidelines
The National Institute of Health (NIH) has updated their Coronavirus disease (COVID-19) guidelines with the latest developments in COVID-19 treatment for health care providers and patients.
Read all of the NIH COVID-19 treatment guidelines here.
- newNIH updates guidance for second doses of Evusheld (5/12/22)
- NIH no longer recommends sotrovimab as a treatment option for nonhospitalized patients (4/15/22)
- NIH statement: Role of Bebtelovimab for the treatment of high-risk, nonhospitalized patients with mild to moderate COVID-19 (3/2/22)
- NIH statement: therapies for high-risk, nonhospitalized patients with mild to moderate COVID-19 (2/1/22)
- Statement on the prophylaxis Evusheld for COVID-19 prevention
- Guidance on the prioritization of patients for outpatient therapeutic COVID-19 treatments when there are supply constraints
Patient resources and questions
Organ procurement organizations
Organ matching guidance
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.
COVID-19 testing and results
Additional resources for organ procurement
- Refer to the AOPO informational resource addressing donor evaluation and OPO procedures in light of potential COVID-19 infection
COVID Updates and Controversies
The American Society of Transplantation hosted an educational webinar for organ donation and transplant professionals on Oct. 4.
COVID-19: Organ Donation and Transplant Town Hall International Webinar #4
Organ transplant organizations convened for a fourth town-hall style webinar to discuss the impact of COVID-19 on organ donation and transplant.
Recorded webinars: Effective practices and guidance
Members, you can now find COVID-19 webinars on UNOS Connect. Transplant and OPO professionals share effective practices related to organ recovery and transplantation during COVID-19. Available now:
- COVID-19: Past, present and future OPO operations
- Telemedicine, transplant and COVID-19: One transplant center’s experience
- COVID-10: Past, present and future transplant center operations