Vaccination and randomisation
Participants received COVID-19 vaccinations through the Brazilian healthcare system and as per guidelines from the Brazilian Ministry of Health, no treatment was provided for symptoms resulting from COVID-19 vaccination.Prior to consent to this sub-study and COVID-19 vaccination, participants had been randomised at a 1:1 ratio to receive a 0.1 ml intradermal injection with BCG-Denmark (AJ Vaccines – Batch: 1198019D/119053A) or placebo (0.9% saline solution) as part of the BRACE trial. Eighteen participants consented to this sub-study received BNT162b2, and due to this low number were excluded from statistical analyses.