Bharat Biotech got an approval for its COVID-19 vaccine and along with it came a lot of flak from critics who believe that the process was rushed for no valid reason. Dr Krishna Ella, the founder and chairman of Bharat Biotech, retaliated blaming everyone from the media to rival vaccine makers, except that his arguments hold no water.
The drug regulator’s approval for any new drug or vaccine is based on the understanding that the drug or vaccine’s benefits outweigh its risks. However, considering that he admitted that Phase-III trials are still underway, there is no final estimate of Covaxin’s efficacy, and without that number, the approval should not have been granted.
Benefits like how effective the vaccine is in preventing disease, and risks such as high mortality rate if the vaccine is not given or vaccine side-effects, are critical data that inform the approval. (Read more)