By Raju Vernekar
Pune, Jan 2:
“Covishield”, the vaccine candidate from Pune-based Serum Institute of India (SII) was approved by a Subject Expert Committee (SEC) of the Drug Controller General of India (DGCI), while Hyderabad-based Bharat Biotech was asked to furnish more data demonstrating the efficacy of its candidate “Covaxin” on Friday.
The nod for “Covishield” came at the end of a marathon meeting of the SEC which went on till late in the evening. The SEC gives its recommendation to the DGCI, which is the approving authority for drugs and vaccines.
This is the second time in three days that the SEC met to review applications for emergency use approval by SII, BB and Pfizer India. The Pfizer India has sought more time, but the company’s m-RNA vaccine has already been approved, under emergency use conditions, in the United States, United Kingdom and pre-qualified by the World Health Organisation.
“Covishield” is likely to be available for use within the next week. The vaccine has to be given in two doses 4-12 weeks apart. “Covishield”, is similar to the “Oxford vaccine developed by the Oxford University group and marketed by AstraZeneca which was approved by the health regulator in the UK under emergency use conditions on Thursday. The UK regulator approved emergency use conditions, after a spike in cases in recent weeks and decided to ensure that maximum people get at least one dose of a vaccine.
For “Covishield”s appraisal, SEC relied upon the nod by the UK regulator and data from a phase II trial on 100 volunteers in India by SII. Besides, antibody levels generated in the volunteers in response to the vaccine, and safety data from phase-1 studies were also looked into to accord emergency use approval.
SII officials have said India will have a stockpile of 100 million doses as of the first week of January. A longer dosage interval means that potentially more Indians could get at least a single jab of the vaccine. “Covishield” is currently being tested in 1,600 volunteers as part of SII’s phase II/III trial.
Adverse event from the vaccine reported from Chennai is not directly linked to the vaccine. The preliminary efficacy data from India seemed to suggest that it was “similar to” what was seen in the UK and Brazil which formed the bulk of the data set that the UK relied onto accord approval.
