COVID-19 update: Feb. 3, 2022

NEW
Resources for members to share with patients

To help you share updates and resources about COVID-19 prevention with your patients, please see the new “patient-friendly information” section below. We encourage you to copy and use this resource in your communications about COVID-19 prevention.

Even in a time of evolving clinical understanding of COVID-19 precautions, it is important for transplant programs to communicate proactively and systematically with transplant candidates and recipients on ways to prevent COVID-19 transmission and to monitor themselves for potential exposure. Many patients are particularly seeking guidance on vaccination, in light of new recommendations for COVID-19 vaccination for immunocompromised individuals.

UNOS is working with medical and scientific organizations and public health agencies to provide transplant hospitals with updated information to guide patient care. We will continue to update the COVID-19 resource pages on the OPTN and UNOS websites, so please check back frequently for news and updates you can use to help keep your patients informed.

As always, individual transplant programs are in the best position to advise patients in their care regarding vaccination, masking and social distancing.

FDA advisory committee meeting to discuss authorizing the Pfizer COVID-19 vaccine for young children

The FDA committee plans to hold a virtual meeting on Feb. 15 to discuss issuing an emergency use authorization of the Pfizer-BioNTech COVID-19 vaccine for children between 6 months and 4 years of age. The FDA will stream the meeting on their website.

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.

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.

Some recent additions:

• Guidance on the prioritization of patients for outpatient therapeutic COVID-19 treatments when there are supply constraints
• Updates to the statement on therapies for high-risk, nonhospitalized patients with mild to moderate COVID-19
• Statement on the prophylaxis Evusheld for COVID-19 prevention

Read all of the NIH COVID-19 treatment guidelines here.

Winter 2022 public comment is now open

Reinstatement of updates to candidate data during the COVID-19 emergency is up for public comment. You can read all the public comment proposals and provide feedback on the OPTN website.

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Reminders

COVID-19 Summary of Evidence report updated

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.

Transplant candidate waiting list data reporting policy reinstated due to COVID-19 impact

The OPTN Executive Committee has reinstated OPTN Policy 1.4.F, which authorizes transplant programs, as needed, to “carry forward” the most recent clinical data available when obtaining updated data is not feasible due to effects of the COVID-19 pandemic. Details of the policy are available in the policy notice on the OPTN website.

This is the same policy earlier in effect from March 17, 2020, to July 27, 2021.

Several transplant hospitals requested reinstatement of the policy due to resource challenges posed by the current surge in COVID-19 cases. The OPTN Executive Committee approved this action Jan. 11, 2022, as an emergency policy per the OPTN bylaws. The policy will expire in 90 days unless the Executive Committee deems it necessary to continue in light of the current COVID-19 situation.

This policy does not reinstate all previous emergency policies that address broader data collection requirements.

Additional information, including an illustrated example, is available here on the UNOS website.

Winter 2022 regional meetings to be virtual

In order to protect the safety of our community and their patients during the wave of Omicron infections occurring right now, the OPTN has changed all regional meetings to virtual meetings. Please visit your region’s page for more information about your specific meeting.

Registration and additional meeting details are also available on your region’s webpage. Learn more about regional meetings.

Site surveys to remain virtual in February 2022

While Member Quality hopes to conduct all routine reviews for all member organizations onsite beginning in 2022, all February 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 pandemic conditions and keep members informed of any changes.

Please email [email protected] with any questions about site surveys.

The latest data on organ donation and transplant in the U.S.

Find high-level data on transplants, deceased donors recovered, patients added to the waitlist and patients temporarily moved to inactive waitlist status.

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Questions

For COVID-19 related policy and operational questions, email [email protected]