COVID-19 and solid organ transplant

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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.

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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.

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.