Panel recommends SII’s Covishield vaccine
“The Subject Expert Committee has recommended in favour of marketing authoritsation to SII’s vaccine but with certain conditions, a person aware of the matter told ET.
“Decision is yet to be taken on Bharat Biotech’s Covaxin and Pfizer‘s vaccine,” the person further said.
Serum’s vaccine is one of India’s best hopes for an early vaccine. Unlike Pfizer and Modern’s jab that have shown encouraging results, the AstraZeneca shot can be stored in a fridge at 3-8 degree temperature and won’t require a super cold storage chain In addition, phase 3 trials of the vaccine have been conducted by Serum Institute in the country.
The Indian government has set an aspirational target to vaccinate 30 crore Indian by July. However, there is no clarity on how the government will buy from Pune based Serum Institute of India (SII).
The SEC in its earlier meeting on December 9 and December 30 had not cleared the Covid 19 vaccine market approval applications of SII and had sought updated data from the companies.
The ten member panel had said Serum Institute should submit the outcome of the assessment of the AstraZenca Oxford University trials done by the UK drug regulator.
In its earlier meeting, the SEC had also 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.
The committee further has also asked Serum to update 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.
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.