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

After Drugs Controller General of India (DCGI) issued a show-cause tice to vaccine manufacturer - Serum Institute of India (SII) on Thursday, confirmed that India trials of 'Covishield' have been paused till ir 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 y were continuing trials inspite of ir UK trials paused as a volunteer developed an ‘unexplained illness’. SII's 'Covishield' is one of three leing COVID-19 vaccine candidates currently under trial in India.     

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

SII pauses trials after DCGI show-cause tice

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DCGI pulls up SII

On Wednesday, DCGI sought an explanation as to why ongoing clinical trial of Covishield vaccine candidate has t been suspended till patients' complete safety is ensured. DCGI Dr. VG Somani h issued tice to SII instructing it to suspend 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 USA, UK, Brazil and South Africa.

In response, SII said, "We (Serum Institute of India), were going by DCGI's direction and were t instructed to pause trials. If DCGI has any safety concerns, we will here to ir instructions and abide by standard protocols". On August 2, DCGI h granted permission to SII to conduct a phase II/III clinical trial of ChOx1 nCoV-19 coronavirus vaccine (recombinant) at various clinical trial sites in country to determine its safety and immugenicity.

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SII's clinical trials

 SII's clinical trials consist of 1,600 participants, all eir being more than 18 years of 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 Gruate 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 world's third-largest vaccine manufacturer is in talks with Centre for mass production, vowing to cap its vaccine price at  Rs 225/dose. 'Covishield' contains replication-deficient simian evirus vector ChOx1 containing structural surface glycoprotein (spike protein) antigens of SARS-CoV-2.

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