Covid-19: Kerala to take part in vaccine trials

THIRUVANANTHAPURAM: Kerala has expressed its willingness to take part in the clinical trials for a vaccine for Covid-19 being conducted across the country.
The state government cleared the proposal by the health department after Hyderabadbased Bharat Biotech’s trials for its Covaxin were approved by the Indian Council of Medical Research (IMCR). "Bharat Biotech approached us seeking our permission to initiate the vaccine trial in the state.We have given our consent," said Rajan N Khobragade, principal secretary (health).
The government is of the view that it should be part of the scientific interventions. The companies, which are developing the vaccines, are approaching us for carrying out the trials. It is up to the companies to choose the states where they want to conduct the trials and hence, they have asked us, he added. "They want subjects, those who haven’t been infected and those who have been. As per their methodology they will suggest the requirements, which we will follow. They are following international standards for the trials and there is nothing to worry. That was the reason why we immediately responded to their request. They are yet to inform us when they are going to begin the trials here," said Khobragade. Serum Institute of India has also started vaccine trials. Khobragade said the government is willing to participate in the clinical trials conducted by the Pune-based drugmaker as well. Bharat Biotech is developing the vaccine in collaboration with the National Virology Institute and ICMR. It received the regulatory approval to advance phase-II trials of its vaccine Covaxin in September first week.
The company had secured the approval from the Drug Controller General of India (DCGI) to conduct the clinical trials in June this year. The phase-I trial had showed that the vaccine is safe.
The phase-I study covered 375 volunteers in the age group of 18-55 from 12 cities across the country. Now, in the second phase, the company is planning to cover 380 volunteers between the age group 12-65 from different parts of the country.