NEW DELHI: The Central Drugs Standard Control Organisation (CDSCO) has approved human trials of a Covid-19 vaccine candidate by Hyderabad-based Biological E which has entered into an agreement with the USA’s drug maker Johnson & Johnson.
This is the fifth potential Covid-19 vaccine permitted for clinical trial in India. Earlier, Dr Reddy's Laboratories, Indian partner for the Russian Covid-19 vaccine Sputnik V, received a go-ahead to carry out phase 2 and 3 trials in the country.
The subject expert committee under the CDSCO on Covid-19 gave its approval on Monday after analysing the data from the pre-clinical trials or animal studies.
“After detailed deliberation, the committee recommended for grant of permission to conduct the Phase I/ II trial,” said the SEC.
The vaccine maker will now soon start the phase 1 and 2 trial of the vaccine, developed with the SARS CoV 2 particles using adenovirus platform, in the country.
Biological E has got the technology transferred from J & J which has also given the company manufacturing rights of its SARS-Cov2 vaccine.
The development comes as the US drugmaker announced at the World Health Summit that the initial batches of its Covid-19 vaccine could be available for emergency use as early as January.
The company is looking to restart a large late-stage trial of the vaccine that had been halted due to safety concerns. The study involving 60,000 individuals is expected to have initial results by the end of the year.