Covaxin is an inactivated virus-based COVID-19 vaccine developed by Bharat Biotech. Recently, the Brazilian health regulator Anvisa raised few concerns regarding Covaxin, one of which was- use of a novel imidazoquinoline adjuvant that may increase the chance of developing an autoimmune disease.
Use of an innovative substance in the vaccine formula, imidazoquinoline or IMDG, not yet used commercially in any approved vaccine in the world. According to GGMED, this additional drug may be related to the development of autoimmune disease;
How risky is the use of IMDG in a vaccine like Covaxin?
Edit 1: On GGMED website, I found links to following papers that have findings that connect TLR 7/8 agonists with induction and acceleration of lupus-like autoimmune disease.
Edit 2: Since many people, including me, cannot read Brazilian (Portuguese), I am putting the translation done by google here. The translation is not very good, but perhaps the general idea can be grasped. The actual source of these comments is a pdf in Portuguese that can be found on their official website at this link.
Of particular concern is the superficiality in which the assessment and the vaccine safety results from the phase 3 study, considering that the vaccine has a new adjuvant, imidazoquinoline, or IMDG, not yet used commercially in any approved vaccine in the world. This adjuvant is a 7/8 Toll-like receptor (TLR) agonist and has a potential relationship with development of autoimmune disease. (...) There is no description of adverse events deaths and deaths or analysis and conclusion of causality of adverse events deaths and deaths from the vaccine. It is still quite worrying that the definition is evaluation of adverse events of special interest, as described in the study phase 3, does not include the assessment of neurological, hematological and immunological events, and induction of autoimmune diseases that are especially important due to the presence of the IMDG adjuvant. The definition and assessment of adverse events of interest are at odds with expectations, with the assessment carried out by others. Covid vaccine developers already approved, and at odds with the consensus scientific research to define the safety profile of Covid vaccines.