Serum pauses COVISHIELD trials in India after DCGI's notice, issues statement

After Drugs Controller General of India (DCGI) issued a show-cause notice to vaccine manufacturer - Serum Institute of India (SII) on Thursday, confirmed that the India trials of 'Covishield' have been paused till their UK partner AstraZeneca resumes trials. SII - which is conducting Phase-2 & 3 trials of 'Covishield' in 19 locations across India, was questioned by DCGI as to why they were continuing trials inspite of their UK trials paused as a volunteer developed an ‘unexplained illness’. SII's 'Covishield' is one of the three leading COVID-19 vaccine candidates currently under trial in India.     

Serum Institute to follow DCGI's direction, says 'not instructed to pause trials'

SII pauses trials after DCGI show-cause notice

COVID-19 vaccine: 'Oxford trials not paused in India', clarifies Serum Institute

DCGI pulls up SII

On Wednesday, the DCGI sought an explanation as to why the ongoing clinical trial of Covishield vaccine candidate has not been suspended till patients' complete safety is ensured. DCGI Dr. VG Somani had issued the notice to SII instructing it to suspend the clinical trials after AstraZeneca, which is developing COVID-19 vaccine candidate of Oxford University, paused its trial as a volunteer developed an ‘unexplained illness’. Covishield's clinical trials have been suspended across the USA, UK, Brazil and South Africa.

In response, SII said, "We (Serum Institute of India), were going by DCGI's direction and were not instructed to pause the trials. If DCGI has any safety concerns, we will adhere to their instructions and abide by the standard protocols". On August 2, the DCGI had granted permission to SII to conduct a phase II/III clinical trial of ChAdOx1 nCoV-19 coronavirus vaccine (recombinant) at various clinical trial sites in the country to determine its safety and immunogenicity.

Serum Institute's 'COVISHIELD' vaccine trials begin in Pune; 2 administered with dose

SII's clinical trials

 SII's clinical trials consist of 1,600 participants, all either being more than 18 years of age or equal to it. Apart from Pune's  Bharti Vidyapeeth, B J Medical College Hospital in Pune, AIIMS Delhi, Rajendra Memorial Research Institute of Medical Sciences in Patna, Post Graduate Institute of Medical Education and Research in Chandigarh, Nehru Hospital in Gorakhpur and Andhra Medical College in Visakhapatnam have been shortlisted to hold trials. SII - which is the world's third-largest vaccine manufacturer is in talks with the Centre for mass production, vowing to cap its vaccine price at  Rs 225/dose. 'Covishield' contains replication-deficient simian adenovirus vector ChAdOx1 containing structural surface glycoprotein (spike protein) antigens of SARS-CoV-2.

Loan moratorium case: SC says 'no bank account to be declared as NPA' till plea disposed