ABSTRACT
Purpose: The safety of SARS-CoV-2 mRNA vaccines in solid organ transplant recipients (SOTRs) remains unknown. We investigated adverse events in SOTRs who received these mRNA vaccines. Methods: We studied SOTRs between 12/16/2020 - 2/10/2021 who received at least one dose of a vaccine. Vaccine reactogenicity within one week following the first or second dose was self-reported via an interactive, online platform. Results: A total of 790 SOTRs received either the Pfizer/BioNTech (49%) or Moderna (51%) vaccine. Most participants have, thus far, received only one dose, but 211 (27%) received both doses. The median (IQR) age was 58 (43-68), with 57% female, 90% White, and 81% college educated. Organs transplanted include kidney (56%), liver (20%), and heart (16%), with a median (IQR) of 6 (3-13) years since transplantation. There were no reports of new COVID-19 infection, acute rejection, anaphylaxis requiring epinephrine, or new neurological conditions such as Guillain- Barré or Bell's palsy. Overall, moderate to severe local and systemic adverse reactions remained low (Figure 1). Comparison between the first and second dose showed that moderate to severe systemic adverse reactions, while uncommon, were higher after the second dose, including fatigue (22% vs 12%, p<0.001), headache (14% vs. 8%, p<0.01), chills (6% vs. 2%, p<0.01), and fever (3% vs. 1%, p<0.001)(Table 1). Conclusions: In our observational cohort, there were no reports of new COVID-19 infection, acute rejection, anaphylaxis requiring epinephrine, or new neurological conditions following SARS-CoV-2 mRNA vaccination. While uncommon, moderate to severe systemic adverse reactions were higher after the second dose. Thus far, there are no large safety concerns for SARS-CoV-2 mRNA vaccines in SOTRs.
ABSTRACT
Purpose: The response to SARS-CoV-2 may be blunted in transplant recipients, impacting reinfection risk, treatment selection, and vaccine protocols. We quantified antibody response and durability after COVID-19 in solid organ transplant recipients (SOTRs). Methods: SOTRs with PCR-confirmed COVID-19 were recruited through the EMR August 21-October 15, 2020. Participants underwent at-home blood sampling with the TAPTM Blood Collection Device, Second Edition (7SBio, Medford, MA). Serum samples were screened using Elecsys® anti-SARS-CoV-2 immunoassay (Roche), which uses a recombinant protein representing the nucleocapsid antigen. Confirmatory testing was performed using EUROIMMUN anti-SARS-CoV-2 enzyme-linked immuosorbent assay (ELISA) for semi-quantitative detection of IgG antibodies to spike protein (anti-S1-IgG), a likely correlate of neutralizing immunity. Results: Eighteen SOTRs were studied, for whom COVID-19 occurred at a median of 6 years (IQR 2-9) post-transplant. Median age was 56 years (IQR 42-63);56% were female;33% were Black and 11% were Hispanic. Most participants (89%) had experienced COVID-19 symptoms;72% were hospitalized. Among those hospitalized, 15% were admitted to the ICU and 8% were mechanically ventilated. COVID-19 convalescent plasma (CCP) was administered to 3 kidney and 2 lung recipients. At median 98 days (IQR 55-147) after COVID-19 diagnosis, 78% had reactive screening immunoassays (Table 1). Of the four patients with non-reactive immunoassays, 2 were the lung recipients treated with CCP and 1 was the kidney recipient receiving IVIg. Of those who screened positive, anti-S1-IgG was detectable in 83%. SOTRs who received CCP and/or IVIg were less likely to develop anti-S1- IgG and had lower antibody levels. Conclusions: We found antibody levels suggestive of neutralizing immunity in the majority of participants. However, those who were administered CCP and/or IVIg were less likely to mount a durable immune response. This raises the possibility that exogenous antibody preparations may blunt durable antibody formation. We observed a significant association between more severe disease and higher antibody levels. Seropositivity might decline over time;however, we were unable to distinguish between impaired production or rapid decrement. Our findings are important for individuals with compromised immune systems, whether deliberately for conditions like organ transplantation and cancer, or naturally in the elderly, frail, and autoimmune populations.