COVID-19 update: May 12, 2022

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.

FDA announces tentative committee meeting schedule to discuss COVID-19 vaccines

The FDA has announced their plans to hold virtual meetings to discuss multiple COVID-19 vaccines and emergency use authorization requests. Read the tentative list of upcoming meetings.

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.

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Reminders

FDA approves first COVID-19 treatment for young children

• The FDA has expanded the approval of Veklury (remdesivir) to include pediatric patients 28 days of age or older who weigh at least 3 kilograms and who are hospitalized or at high risk for progression to severe COVID-19. Read the full release.

FDA authorizes COVID-19 diagnostic test using breath samples

• The new test detects chemicals compounds in breath samples associated with a SARS-CoV-2 infection. Read the full release from the FDA.

COVID-19 Summary of Evidence report updated

• The COVID-19 Summary of Evidence report has been updated with information to reflect that the Omicron subvariant BA.2 is prevalent and that long-term outcomes for recipients includes the possibility of thrombotic events.
• 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.

Help your patients locate Evusheld therapy

• The U.S. Department of Health and Human Services maintains a national map displaying public locations that have received shipments of COVID-19 therapeutics such as Evusheld, Molnupiravir and Bebtelovimab. These therapies require a prescription, and the locator is intended for provider use.

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]
• For information and updates about the status of in-person vs. virtual OPTN committee meetings, check the OPTN calendar of events.