The novel corona virus vaccine developed by Bharat Biotech has now been up for the evaluation in the United States and this has been paving the way for the corona virus vaccine developed in India for the purpose of getting the approval for use in the United States.
Bharat Biotech said, the Covaxin covid-19 vaccine is going to be evaluated as corona virus vaccine candidate in the United States, and the company ‘Ocugen’ is also announced that, the US FDA has also lifted the clinical hold on the Investigational New Drug Application of the company for the purpose of evaluating the corona virus vaccine candidate known as Covaxin outside of the United States.
The company ‘Ocugen’, US partner of Bharat Biotech has now submitted the Investigational New drug Application (IND) to the US FDA for the purpose of conducting the clinical trials. The Ocugen of the United States said that, the Phase 3 trial has now proposed the IND, which has been designed for establishing whether the immune response that have been experienced by the participants in a completed efficacy of the Phase 3 trial in India has been similar to that, which have been observed in the adult population in the United States.
Shankar Musunuri, co-founder of Ocugen said, they are now very excited for taking this next step in the development of the Covaxin covid-19 vaccine that they are hoping will be bringing them closer for introducing a different type of the corona virus vaccine to the people of the United States.
