By Health In Five Writer
Covaxin, the country’s first indigenous Covid-19 vaccine , developed by Bharat Biotech in association with Indian Council of Medical research, was found to be “well tolerated in all dose groups with no vaccine-related serious adverse events,” said the interim findings of phase 1 trial of Covaxin.
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 Astra Zeneca and Oxford University for Covid vaccine, has also sought an 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, Bharat Biotech said in the paper. The data also states that first vaccination, “local and systemic adverse events were predominantly mild/moderate in severity & resolved rapidly, without prescribed medication.”
The trials were conducted on 375 volunteers, the research paper stated.
“All three vaccine formulations resulted in robust immune responses comparable to a panel of convalescent serum,” it said. It also said that most common adverse event was pain at the injection site which resolved spontaneously.
Currently, the Hyderabad-based Bharat Biotech is in phase three of clinical trial with over 22,000 volunteers at 18 sites across the country. It has also applied for emergency use authorisation.