Covaxin, a covid-19 vaccine of Bharat Biotech has now get the approval by the Food and Drug Administration (FDA) of the United States for the clinical trials in the adult people of the United States, and Bharat Biotech said that, the company and the partner ‘Ocugen’ of the US has expressed their commitment towards bringing the vaccine to the countries including the United States and Canada for all the age groups.
The company has also further informed that, the novel corona virus vaccine has been cleared for the conducting the clinical trials in the adult people of the United States, and the statement of the company also reads that, recently, the phase 2 and phase 3 investigational drugs application of Ocugen for the Covaxin corona virus vaccine had been cleared by the US FDA for conducting clinical trials in the adult people.
The company said that, Ocugen has been intending to continue working with US FDA for the purpose of evaluating the regulating pathway for the pediatric use of the Covaxin covid-19 vaccine. Ocugen has also announced that, the US FDA has also removed the company‘s clinical hold on the IND (Investigational New Drug) application for evaluating the corona virus vaccine candidate known as Covaxin outside of the United States.
