Thursday, December 17, 2020
Covaxin, developed by Hyderabad-based Bharat Biotech International (BBIL), appeared to inch closer to approval as its phase 1 clinical trial results showed a ‘’robust’’ immune response without any serious adverse events, the firm said in a research paper.
Bharat Biotech had recently sought an accelerated approval from the regulator based on phase 1 and phase 2 studies. The company is in the middle of conducting a phase 3 trial with 22,000 subjects. Serum Institute of India, which is partnering with Astra Zeneca and Oxford University for the Covid vaccine, has also sought emergency approval. Pfizer-BioNTech too has applied for the same.
Only one serious adverse event was reported around August which was not found to be causally linked to the investigational product, according the research paper.
