JOIN USExpert panel to review SII, Pfizer, Bharat Biotech's Covid-19 vaccine applications today: Report
As India readies the distribution of the Covid-19 vaccine, an expert panel appointed by the government will review the applications of companies that applied for Emergency Use Authorisation (EUA) for their Covid-19 vaccination.
Over the last four days, the Indian arm of US pharmaceutical giant Pfizer, Pune-based Serum Institute of India (SII) and Hyderabad-based Bharat Biotech International (BBIL) have applied to the Drugs Controller General of India (DCGI) seeking EUA for their Covid-19 vaccines.
The government on Tuesday had assured that early licensure was possible for all or any of the vaccines.
However, the Hyderabad-based Bharat Biotech applied for the EUA during an ongoing efficacy trial, and it also changed the dosage from 3 micrograms of antigen to 6 antigens during its trial, reported Business Standard.
"Several points would be discussed in meeting - for one, BBIL had changed its dosage during the trial. It had come to seek approval for the same. We will be reviewing this bit very carefully," Business Standard quoted a person close to the matter.
The New Drugs and Clinical Trials Rules, 2019, clearly specifies that under specific special situations, relaxation, abbreviation, omission, or deferment of data including local clinical trial data may be considered for approval.
ICMR Director General Balram Bhargava said that while granting EUA, the regulator has to be satisfied with the risk-benefit ratio and in such an emergency if the benefit is more than the risk it may consider.