Oxford resumes COVID vaccine trials in UK after safety review; Serum awaits DCGI nod

In a major reprieve, Oxford University on Saturday announced that it will resume its Coronavirus (COVID-19) trials in partnership with pharmaceutical company AstraZeneca in the UK. Days after halting trials after one volunteer developed an illness, Oxford University released a statement that it will resume trials in all sites across UK adding that with 18,000 test cases, some participants are bound to get unwell. India's Drug Controller General of India (DCGI) order AstraZeneca's Indian manufacturer - Serum Institute of India to halt trials and stall recruitment of participants for Phase-2 & 3 trials.

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

Oxford resumes COVID vaccine trials in UK

Oxford also stated that its global trials had been paused as per their standard review process to allow the review of safety data by an independent safety review committee and the national regulators. It added that the independent review process has concluded and following the recommendations of both the independent safety review committee and the UK regulator, the MHRA, the trials will recommence in the UK. However, it declined to disclose medical information about the illness for reasons of participant confidentiality and assured to monitor the situation closely.

DCGI orders Serum Institute of India to suspend recruitment for Oxford COVID-19 vaccine trials

SII: 'Must not jump to conclusions'

Serum Institute of India (SII) owner Adar Poonawalla expressed satisfaction at the update stating that one must not 'jump to conclusions until the trials are fully concluded'. His company stated that once DCGI gives the green light, they will resume trials. Russia, on the other hand, took a snide jab at other countries when Russian Direct Investment Fund (RDIF) CEO Kirill Dmitriev maintained that countries exclusively relying on 'untested platforms' have a fallacy in their approach. Extolling the benefits of the highly contested 'Sputnik-V' vaccine, he said that as the vaccine was based on ' human adenoviral vectors', it was proven to be 'safe and effective'.

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

SII pauses trials after DCGI show-cause notice

On Thursday, SII - the world's third largest vaccine manufacturer, 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.     

Coronavirus LIVE Updates: India's tally at 46,59,985; Union AYUSH Minister discharged

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 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.