The Drug Controller General of India (DCGI) has given the nod for conducting phase 3 trials to test Biological E’s Covid vaccine Corbevax as booster shots, News18.com has learnt. The Hyderabad-based firm on Tuesday received permission as emergency-use authorisation for manufacturing and marketing the first indigenously developed receptor-binding domain (RBD) protein subunit vaccine against SARS-CoV-2.
RBD protein subunit vaccines are useful for people with compromised immune systems, have no live components because of which there is no risk of the vaccine prompting disease, and are also considered largely stable.
After the approval of the vaccine, Biological E’s previous application on using Corbevax for booster shots was also taken up.
“The company has been given the go-ahead to conduct phase 3 trials using Corbevax as a booster dose. The approvals have been given for conducting trials on those who will receive first and second dose of Corbevax,” a senior official from the ministry of health and family welfare told News18.com. “To date, there is no clarity on mixing of vaccines. Hence, this decision was not taken earlier. Now, the company can start the trial for boosters as it will start jabbing the public with first and second doses of primary vaccination against Covid-19.”
Earlier, the DCGI’s Subject Expert Committee (SEC) had recommended the company to submit a revised clinical trial protocol on conducting the trial for boosters and emphasised on noting that safety and efficacy data from the phase 3 trials were yet to be evaluated.
It had also asked for complete safety and immunogenicity data of the vaccine, justification for the proposed age group, timing of the booster shot and the sample size.
“All parameters were up to the mark. Data that was observed for the clearance of Corbevax for inoculation drive was enough for clearing booster application,” the official said.
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