Homegrown company Bharat Biotech that is currently in the process of testing its coronavirus vaccine candidate Covaxin has sought approval from drug regulator to proceed to Phase 3 of clinical trials. The Hyderabad-based company has also written to states seeking permission for initiation of the third phase of clinical trials.
The subject expert committee that discussed the matter in a meeting on October 5 has asked the company to resubmit the protocol. It said that after detailed deliberation, the committee opined that the design of Phase 3 clinical trials is satisfactory but the definition of asymptomatic needs to be clarified, as mentioned in a report in The Economic Times.
"However, the study should be initiated with appropriate dose identified from the phase II safety and immunogenicity data. Accordingly, the firm should submit safety and immunogenicity data from phase II trial for consideration," stated the committee as mentioned in the daily.
Bharat Biotech has already approached the drug controller's office and submitted the interim data for Phase I and II clinical trials.
The company has written to multiple states including Maharashtra, Uttar Pradesh, Punjab, Bihar, Assam and Delhi for permission to initiate Phase 3 trials.
Last month the company said that the animal trials of the vaccine showed "protective efficacy". "The results showed protective efficacy, increasing SARS-CoV-2 specific IgG and neutralising antibodies, reducing replication of the virus in the nasal cavity, throat, and lung tissues of monkey," it said, adding that no evidence of pneumonia was observed during histopathological (microscopic) examination in vaccinated groups, unlike the placebo group. "Adverse events were not seen in animals immunised with a two-dose vaccination regimen," said Bharat Biotech in a statement.