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.
Reminders
Updated CDC guidance addresses potential COVID-19 vaccine booster for some immunocompromised people
The U.S. Centers for Disease Control and Prevention (CDC) has updated interim guidance regarding COVID-19 vaccination for moderately to severely immunocompromised people. The guidance says that at the discretion of the clinical team, a booster for immunocompromised adults may be provided six months or more after they have received a third dose of an mRNA vaccine, or at least two months after they have received a Johnson & Johnson vaccine. For more detail, read the CDC guidance.
Site surveys to gradually transition to in-person visits starting in December
After more than a year and a half of successful virtual site surveys since the start of the pandemic, UNOS Member Quality is preparing for the community’s phased return to onsite review visits.
The site survey teams are planning a slow reintroduction of onsite interactions, with transplant hospitals beginning this month. Member Quality hopes to conduct all routine reviews for all member organizations onsite by early 2022. However, during this time we will continue to monitor the pandemic conditions and will be prepared to pivot back to our virtual survey model if needed.
UNOS site survey teams received overwhelmingly positive feedback about the virtual site survey experience, while also getting feedback that members miss the relationship-building opportunities offered by in-person visits. While COVID-19 continues to presents us with enormous challenges in terms of connecting with members, it also offers new lessons. Member Quality is working to develop a hybrid model that will let the highest-impact work be conducted at the member facility.
Site surveyors will contact your organization’s staff directly to learn more about your facility’s COVID protocols in order to make the safest arrangements possible for an in-person visit. Please email [email protected] with any questions about site surveys.
Webinar on the COVID-19 vaccine and transplant recipient children
Transplant Families and the American Society of Transplantation (AST) recently held a webinar for parents of pediatric organ recipients to share information related to the COVID-19 vaccination and children. Topics included:
- Vaccination of pediatric transplant recipients (ages 5-11) and the importance of encouraging vaccination for those around them
- Information on what the transplant infectious diseases community has learned, and specific medical effects COVID-19 may have on pediatric patients
- Vaccine-induced myocarditis
View the webinar here.
ASTS position 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.
Committee meetings
The health and safety of OPTN members is a priority for UNOS. The list of all scheduled meetings will be updated on the calendar of events to reflect updates related to in-person vs. virtual meetings.
Resources
The latest data on organ donation and transplant in the U.S.
High-level data on transplants, deceased donors recovered, patients added to the waitlist and patients temporarily moved to inactive waitlist status.
Updated COVID-19 FAQs for patients
As the pandemic continues to impact our lifesaving mission, find our newly updated list of frequently asked questions and answers on Transplant Living.
Questions
For COVID-19 related policy and operational questions, email [email protected]
