COVID-19 and solid organ transplant

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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.

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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.

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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.

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.