Bharat biotech’s indigenous coronavirus vaccine candidate Covaxinis currently in late-stage clinical trials. It has been found to be well-tolerated and has no vaccine-related severe adverse events. It also triggered a robust immune response in early Phase 1 clinical trials, as per a research paper that was published by the Hyderabad-based firm and is to be peer-reviewed.

The subject expert panelis examining Bharat Biotech’s application for emergency use authorisation (EUA) of its vaccine candidate. They have asked to present the safety and efficacy evidence from the ongoing Phase 3 clinical trial for added consideration. The firm has submitted interim safety and immunogenicity data of Phase 1 and 2 trials and is seeking EUA of its vaccine.

Phase 1 human clinical trials of the vaccine candidate is tested on a small group of healthy adults, reveals interim data on two important aspects. First aspect was reactogenicity, the ability to produce anticipated adverse reactions like muscle pain, fever as well serious or rare adverse reactions. Second aspect was immunogenicity or the ability to trigger an immune response.

Phase 1 studyis being jointly conducted by the ICMR and the researchers said that the reactogenicity was absent in the majority of the participants with mild events. Regarding the immune response, the researchers mentioned that both robust humoral and cell-mediated responses were detected.

The researchers further concluded that to confirm generalizability, the study was conducted with participants from varied geographic locations and socioeconomic conditions. They enrolled 375 participants in 11 hospitals. Theenrolment was done during a national lockdown leading to many operational challenges and the total participant retention rate was 97%. The sample size was calculatedly large to allow the implication of meaningful conclusions on immunogenicity and safety.

The researchers said that the overall occurrence rate of local and systemic adverse events was 10%-20% in all vaccine treated arms. The majority of adverse events were mild and got resolved. One serious adverse event that was reported was unrelated to vaccination.

The researchers concluded about safety, that after the 1st vaccination, local as well as systemic adverse events were mostly mild or moderate in severity and got resolved quickly, without any medication. A similar inclination was seen after the 2nd vaccination.

The study also stated that the most common local adverse event was pain at the injection site. Hematological, biochemical and urine parameters that were not in normal ranges had no supporting clinical manifestations.

Source: The Indian Express