US Health Regulator Lifts Hold On Covaxin's Clinical Trials
NDTV
The FDA's earlier decision, in April, to put on hold the trials was based on the US firm's decision to voluntarily implement a temporary pause in dosing participants of the jab, following the World Health Organisation's observations on Covaxin manufacturing plants in India.
The US Food and Drug Administration which has put on hold the phase 2/ 3 clinical trials of Bharat Biotech's COVID-19 vaccine Covaxin, in USA, has lifted the pause, according to a statement issued by Ocugen Inc, Bharat Biotech's partner for the jab in USA and Canada.
"We're extremely pleased that we can proceed with our clinical trials for Covaxin our whole virus inactivated COVID-19 vaccine candidate. The need for delivering an additional, differentiated vaccine option, we believe, remains a priority," Dr Shankar Musunuri, Chairman, CEO and Co-Founder, Ocugen Inc said.
The FDA's earlier decision, in April, to put on hold the trials was based on the US firm's decision to voluntarily implement a temporary pause in dosing participants of the jab, following the World Health Organisation's observations on Covaxin manufacturing plants in India.
"Thank you to our clinical trial partners and site collaborators for their ongoing support. Ocugen will now work with study sites to fully resume this clinical development program immediately," he further said.
