The SEC was called soon after the UK regulator authorised Oxford University/AstraZeneca’s Covid-19 vaccine for use. The approval by UK regulator to Oxford/AZ vaccine has brightened chances of approval to Serum’s vaccine in India.
The SEC in its earlier meeting on December 9 had not cleared the Covid 19 vaccine market approval applications of SII and had sought updated data from the companies.
The ten member panel said Serum Institute should submit the outcome of the assessment of the AstraZenca Oxford University trials done by the UK drug regulator.
“Since the approval by MHRA is for two doses, and the trial in India is also on two doses, the chances to get approval in India are bright,” the official further said.
In its earlier meeting, the SEC had noted that Serum Institute had been granted approval to conduct phase 2 and 3 trials in the country on the condition that the data generated from these trials shall be considered along with the data generated from the Oxford trials. AstraZeneca-Oxford University proposal for emergency use authorisation is currently under evaluation with the UK regulator.
The committee further said Serum Institute has submitted safety data till November 14 and asked for updated safety data as well as immunogenicity data from clinical trials in India and UK.
People in the know told ET that Serum had submitted fresh data.
Niti Aayog member, Vinod Paul had earlier said that the Indian drug regulators were in touch with the MHRA on the approval process.
Along with SII, Pfizer and Bharat Biotech has also approached the drug regulator. “Their applications will also be examined by the SEC,” the official added.
In the earlier Subject Expert Committee (SEC) meeting on December 9 Pfizer did not make a presentation to the panel and sought more time to do so.
The committee needs to be fully satisfied about the safety and efficacy of the jabs before it approves them.
As reported by ET earlier, Covishield, the potential vaccine against Covid-19 by SII has already passed the quality test at government’s Central Drug Laboratory (CDL) Kasauli, which means that these batches can be rolled out immediately once it gets the approval from India’s drug regulator.
Around 2.5 crore doses have been tested for quality at CDL Kasauli.
In an earlier interview with ET, its CEO Adar Poonawalla said that it is hopeful of receiving marketing authorization from India’s drug controller by January 2021