Covid vaccine may not be sold in open market anytime soon

PUNE: Union health secretary Rajesh Bhushan said on Friday that the two Covid-19 vaccines given approval for restricted use would not be available in the open market till the country’s apex drug regulator, Drug Controller General of India (DCGI), approved the data sought from their manufacturers.

“As of now, no time frame can be set for the rollout of Covid-19 vaccines in the open market. The government’s focus now is only on covering the priority population in the next seven-eight months,” Bhushan told TOI. He added that no market authorisation has been given to any of the emergency-approved vaccines currently in use in India and abroad. “The market authorisation comes after the stipulated follow-up on all the trial phases,” he said. Market authorisation is a pre-requisite to sell vaccines in the open market.

Bhushan said the vaccine manufacturers had committed on some timelines to submit data, which would be assessed and approved by the regulator. Health experts from various apex institutes stated that the final data from the vaccines’ phase-three clinical trials , with a good number of months of followup, should be scrutinised before their full pre-qualification. “The full authorisation will depend on the data of phase-three trials,” WHO chief scientist Dr Soumya Swaminathan told TOI.