Covaxin from Bharat Biotech will be studied as a Covid-19 vaccination candidate in the United States
Bharat Biotech’s Covid-19 vaccine Covaxin clinical trials have been approved in the US. This allows the Made in India vaccine to be licensed for use in the US market.
In the United States, Covaxin will be examined as a Covid-19 vaccination candidate. According to a statement made by Bharat Biotech on Saturday, the US Food and Drug Administration (FDA) has lifted its medical hold on Ocugen’s Investigational New Drug Application (INDA) to research the Covid-19 vaccine candidates, BBV152, known as Covaxin outside the US.
Ocugen, the vaccine maker’s US partner for Covaxin, presented an Investigational New Drug Application (IND) to the FDA in October 2021 to conduct clinical research.
According to a press release from the US company, the Phase 3 trial proposed in the IND is intended to determine whether the immune reaction experienced by people in a finished Phase 3 efficacy trial in India is similar to that observed in a demographically representative, healthy individual population in the United States.
Dr. Shankar Musunuri, co-founder and CEO of Ocugen, stated at the time that they are extremely thrilled to take this to the next stage in the development of Covaxin, which they think will move them closer to providing a different form of Covid-19 vaccination to the American population. They also expressed optimism that if the IND is approved, the study would assist establish that the data from India is applicable to the US population.
Covaxin, along with Covishield and Sputnik V, is one of six vaccines that have acquired emergency use authorization from India’s medicines authority and are being used in the country’s immunization program. It is also the country’s only Covid-19 vaccine licensed for use in children aged 15 to 18.
In November of last year, the World Health Organization authorized Covaxin for emergency use. The WHO approval was a key step toward Covaxin’s acceptance by other governments.