Serum Institute of India stops clinical trials of Oxford-AstraZeneca COVID-19 vaccine

Serum Institute of India has put trials of AstraZeneca's COVID-19 vaccine candidate on hold until the British drugmaker restarts the trials, Serum said on Thursday."We are reviewing the situation and pausing India trials," Serum said in a brief statement.AstraZeneca said on Tuesday it had paused trials of its experimental coronavirus vaccine because of an unexplained illness in a study participant, but its partner Serum had at the time said its trials in India were still ongoing.The SII decision came a day after the DCGI issued a show-cause notice to the vaccine maker for not informing it about AstraZeneca suspending the clinical trials of the Oxford vaccine candidate in other countries, and also for not submitting casualty analysis of the "reported serious adverse events". 

The British-Swedish biopharmaceutical major AstraZeneca put a pause on the COVID-19 trials after a UK patient reported illness. Notably, the Oxford vaccine was described by the World Health Organisation (WHO) as the world's leading candidate and the most advanced in terms of development. Pausing of trials could delay the vaccine development process as Serum Institute is the frontrunner when it comes to companies producing COVID-19 vaccines in India. The country's apex drugs regulator had on August 2 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.The vaccine will be manufactured by Serum Institute in India under technical collaboration with Oxford University/AstraZeneca and is called as Covishield (SII-ChAdOx1 nCoV-19).Covishield vaccine contains replication-deficient simian adenovirus vector ChAdOx1 containing structural surface glycoprotein (spike protein) antigens of SARS-CoV-2. India, which is now the second most affected country after the US in terms of COVID-19, registered a record single-day spike of 95,735 COVID-19 cases and 1,172 fatalities in one day, taking the country's caseload past 44 lakh, and death toll to 75,062, the latest government data suggests.