India's 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 US drugmaker Johnson & Johnson.
This is the fifth potential vaccine permitted for 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 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 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.
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.