A subject expert committee (SEC) of India's drug regulator has allowed Bharat Biotech to conduct a phase 2 trial where participants will get a third shot of Covaxin six months after the second dose, Mint reported.
A phase 2 trial is used to test the immune response provided by the vaccine against a disease in a person. This differs from a phase 3 trial, which tests for efficacy, or what proportion of people are protected by the vaccine, said the paper.
The trial will be used to test the immune response provided by the vaccine against a disease in a person. Bharat Biotech's vaccine had shown 81 per cent efficacy in preventing symptomatic Covid-19 in an interim analysis of a late-stage trial in India.
In its phase 2 trial, which the firm started in August, it divided 380 participants into two groups, where one was given two doses of 3 mcg and another 6 mcg. In both groups, the two doses were given one month apart, Mint reported. Hiwever, it is not clear now why Bharat Biotech has modified the trial to test for a third dose six months after the second dose.
"COVAXIN demonstrates high clinical efficacy trend against COVID-19 but also significant immunogenicity against the rapidly emerging variants," said Bharat Biotech Chairman Krishna Ella in a statement, referring to its vaccine.
Health Minister Harsh Vardhan said on Friday both Covaxin and Covishied are completely safe and immunogenic and as of now, there are no concerns about the safety of these vaccines being used in the country. He said this at the India Economic Conclave while responding to the growing concerns surrounding Covishield after reports emerged of the vaccine causing blood clots.
Such cases are being examined by the respective governments of the countries where those have emerged. In India, all cases of adverse events following immunisation (AEFI) are monitored through a well-structured and robust surveillance system, Vardhan said.