Serum Institute Asked To Amend Oxford COVID-19 Vaccine Trial Protocol
New Delhi: An expert committee at the apex drug regulator, Central Drugs Standards Control Organisation (CDSCO) has deferred its earlier call on Serum Institute of India Pvt Ltd’s vaccine trial. Instead, the panel asked the firm to change its protocol for the phase II and III clinical trials of the vaccine candidate of University of Oxford.
“After detailed deliberation the committee recommended for amendment to the protocol… Accordingly, the firm should submit revised protocol for evaluation of the committee,” the minutes of the subject expert committee (SEC) meeting was quoted by Mint.
The regulatory panel, as part of amendment protocol, has asked the firm to demarcate trials of phase II and III and distribute it across India.
The company has also been asked to specify Indian Council of Medical Research’s (ICMR’s) role in the trial. The Mint report said that an email sent to Serum Institute of India was unanswered.