Udayavni Special

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


PTI, Sep 12, 2020, 8:36 AM IST

Image for Representation

Drugs Controller General of India (DCGI) has directed Serum Institute of India to suspend till further orders new recruitment in phase 2 and 3 clinical trials of the Oxford COVID-19 vaccine candidate in the backdrop of pharma giant AstraZeneca pausing the trials in other countries.

In an order, a copy of which has been accessed by PTI,DCGI Dr V G Somani onFriday also directed Serum Institute of India (SII) to increase the safety monitoring of the subjects already vaccinated as part of the trial, and submit the plan and report.

Somani also asked the firm to submit clearance from Data and Safety Monitoring Board (DSMB) in the UK as well as in India to obtain clearance from his office (DCGI) prior to resumption of future recruitment in the trial.

The central drug regulator DCGI had issued a show-cause notice to SII on September 9 for not informing it about AstraZeneca pausing clinical trials of the vaccine candidate in other countries and also for not submitting casualty analysis of the “reported serious adverse events”.

Following which the Pune-based firm,which has partnered withthe British-Swedish biopharmaceutical giant AstraZeneca for manufacturing the Oxford vaccine candidate,on Thursday said it is pausing the clinical trials in India. Earlier this week, AstraZeneca said it had paused the trials because of ‘an unexplained illness’ in a participant in the study.

“We are reviewing the situation and pausing India trials till AstraZeneca restarts the trials,” SII said in a statement on Thursday. According to the DCGI’s order issued on Friday, the SII in its reply stated that DSMB has noted no safety concerns from the Indian study (part 1-phase-2 study) with the first dose and seven days post vaccination safety data.

In its reply, SII also stated that DSMB further recommended “to pause further enrolment into the study until ongoing investigations of SAE reported in the UK study is completed and the sponsor and the UK DSMB are satisfied that it doesn’t pose any safety concerns”.

“In the view of the above, I Dr V G Somani, Drugs Controller General of India, Central Licensing Authority, after careful examination of your reply and the recommendations of the DSMB in India, in exercise of the powers vested under Rule 30 of the New Drugs and Clinical Trials Rules, 2019, direct to you suspend any new recruitment in the phase 2 and 3 clinical trial till further orders,” the order read.

“Increase the safety monitoring of the subjects already vaccinated with the vaccine under trial and submit the plan and report,” the order further stated. On August 2, the DCGI had granted permission to the Pune-based SII to conduct Phase 2 and 3 human clinical trials of the coronavirus vaccine candidate.

AstraZeneca, the biopharmaceutical giant in a tie-up with the Oxford University to produce the vaccine, described the pause of trials as a “routine” one following what was “an unexplained illness”.

Udayavani is now on Telegram. Click here to join our channel and stay updated with the latest news.

Top News

Honnalli MLA MP Renukacharya tests positive for COVID-19

K’taka COVID-19 update: 10453 new cases, 6628 discharges, 136 deaths on Sep 28

Bengaluru: NCB busts drug syndicate, arrests mastermind

India has never accepted so-called unilaterally defined 1959 Line of Actual Control: MEA

We don’t agree with what Kangana said, but is this way to react: HC to Raut

Netherlands shows interest in indigenously developed Feluda test

Mukesh Ambani’s wealth shoots up 73% to Rs 6.58 lakh crore; Adani moves up in net worth rankings




Related Articles More

Delhi Deputy CM Sisodia tests negative for COVID-19, discharged

Earthquake of magnitude 4.1 strikes Gujarat’s Rajkot

India provides Dornier aircraft to Maldives in sync with growing strategic ties

India has never accepted so-called unilaterally defined 1959 Line of Actual Control: MEA

We don’t agree with what Kangana said, but is this way to react: HC to Raut

MUST WATCH

Mangalore: Street Art that speaks on a social issue

Huge Python rescued in byndoor

Want to help farmers, Remove Middlemen | APMC Act Amendment ಆಗ್ಲೇ ಬೇಕು – Shiv Murthy Kota

How to Start Dairy Farm | Cow Farming Explained | Udayavani

Karnataka bandh evokes lukewarm response in Bajpe, Ujire and Belthangady

Latest Additions

Honnalli MLA MP Renukacharya tests positive for COVID-19

K’taka COVID-19 update: 10453 new cases, 6628 discharges, 136 deaths on Sep 28

Udupi: Water monitor appears in Kaup beach parking lot

Delhi Deputy CM Sisodia tests negative for COVID-19, discharged

New Japanese PM Suga urges Putin to resolve island dispute

Thanks for visiting Udayavani

You seem to have an Ad Blocker on.
To continue reading, please turn it off or whitelist Udayavani.