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

In a major reprieve, Oxford University on Saturday anunced that it will resume its Coronavirus (COVID-19) trials in partnership with pharmaceutical company AstraZeneca in 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 ding 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 tice, issues statement

Oxford resumes COVID vaccine trials in UK

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

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

SII: 'Must t jump to conclusions'

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

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

SII pauses trials after DCGI show-cause tice

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

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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 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.