COVID-19 Vaccination of Individuals With Down Syndrome – Data From the Trisomy 21 Research Society Survey on Safety, Efficacy, and Factors Associated With the Decision to Get Vaccinated

Abstract

Background: Individuals with Down syndrome (DS) are among the highest risk groups for severe COVID-19. Better understanding of the efficacy and risks of COVID-19 vaccines for individuals with DS may help improve uptake of vaccination.

Methods: The T21RS COVID-19 Initiative launched an international survey to obtain information on the safety and efficacy of COVID-19 vaccines for individuals with DS. De-identified survey data collected between March and December 2021 were analyzed.

Findings: Of 2172 individuals with DS, 1973 (91%) had received at least one vaccine dose, 107 (5%) were unvaccinated by choice and 92 (4%) unvaccinated for other reasons. The majority received BNT162b2 (first dose: 1111 (56%), second: 1023 (59%)). Most participants had either no side effects (first dose: 1054 (53%), second dose: 967 (56%)) or mild ones like pain at injection site (first dose: 578 (29%), second dose: 493 (29%)), fatigue (first dose: 217 (11%), second dose: 236 (14%)) and fever (first dose: 183 (9%), second dose: 90 (5%)). Severe side effects occurred in <0.5% of participants. About 1% of the vaccinated individuals with DS contracted COVID-19 after vaccination, and all recovered. Individuals with DS who were unvaccinated by choice were more likely to be younger, previously recovered from COVID-19, or were unvaccinated against other recommended vaccines, but had similar concurrent health conditions.

Interpretation: COVID-19 vaccines have been shown to be safe for individuals with DS and effective in terms of resulting in minimal breakthrough infections and milder disease outcomes among fully vaccinated individuals with DS.

Funding Information: This work is supported by grants from: Down Syndrome Affiliates in Action, Down Syndrome Medical Interest Group-USA, GiGi’s Playhouse, Jerome Lejeune Foundation, LuMind IDSC Foundation, The Matthew Foundation, National Down Syndrome Society, National Task Group on Intellectual Disabilities and Dementia Practices.

Declaration of Interests: Johannes Levin reports speaker fees from Bayer Vital, Biogen and Roche, consulting fees from Axon Neuroscience and Biogen, author fees from Thieme medical publishers and W. Kohlhammer GmbH medical publishers, non-financial support from Abbvie and compensation for duty as part-time CMO from MODAG, outside the submitted work. Andre Strydom is the president of the T21RS and reports consultancies and participation on advisory boards for AC Immune, Aelis Farma, and ProMIS neuroscience; investigator on industry sponsored trials (Roche, GW phamaceuticals) The other authors have nothing to declare.

Ethics Approval Statement: Each institution that planned to disseminate the survey within health services obtained IRB/ethics approval (Table S1). The study was performed according to the Declaration of Helsinki and national guidelines and regulations for data privacy and all participants provided informed consent. All data were anonymized according to good clinical practice guidelines and data protection regulations.

Keywords: Severe acute respiratory syndrome coronavirus (SARS-COV-2), intellectual disabilities, vaccine hesitancy, chromosomal disorder