• India
More

    Serum Institute gets DCGI nod to resume trials of Oxford COVID-19 vaccine

    Must Read

    ‘Saina’ to release on Amazon Prime Video on April 23

    A month after its theatrical release, actor Parineeti Chopra-starrer Saina, a biopic on ace badminton player Saina...

    Polling progressing smoothly for 5th phase of assembly elections in West Bengal

    Barring a few stray incidents polling for the fifth phase of assembly elections in West Bengal is...

    Actor Vivekh passes away: At the age of 59

    Actor Vivekh who suffered a massive heart attack on Friday, died early Saturday morning (4:35 a.m.), according...

    Drugs Controller General of India (DCGI) Dr V.G. Somani on Tuesday gave permission to Serum Institute of India to resume clinical trial of the Oxford COVID-19 vaccine candidate in the country while revoking its earlier order of suspending any new recruitment for phase two and three trials.

    The DCGI, however, put certain conditions like taking extra care during screening, providing additional information in informed consent and close monitoring for adverse events during follow-up of the study, which have to be scrupulously followed by Serum Institute of India (SII).

    Serum Institute has also been asked to submit to the DCGI’s office details of medication used in accordance with the protocol for management of adverse events.

    The DCGI had on September 11 directed Serum Institute of India to suspend any new recruitment in the phase two and three clinical trial of the Oxford COVID-19 vaccine candidate till further orders in the backdrop of pharma giant AstraZeneca pausing the clinical trials in other countries because of ”an unexplained illness” in a participant in the study.

    On Saturday, British-Swedish biopharmaceutical giant AstraZeneca and the University of Oxford said clinical trials for their coronavirus vaccine have resumed in the UK after the Medicines Health Regulatory Authority’s (MHRA) confirmed that the trials were safe.

    Serum Institute, which has partnered with AstraZeneca for manufacturing the vaccine candidate for COVID-19, on Tuesday submitted the recommendations of the Data and Safety Monitoring Board (DSMB), UK and DSMB, India, and requested for permission to restart enrolment in the clinical trial.

    According to Tuesday’s order issued by DCGI, the DSMB, UK, recommended that the investigators recommence all immunisation in their clinical trials subject to certain conditions.

    DSMB, India, also has recommended to continue the study and enrol the remaining participants in the clinical trial as per protocol subject to certain conditions.

    According to the order, Serum Institute has submitted revised participant information sheet, revised informed consent form and additional safety monitoring plan for the evolved participants.

    The Pune-based firm has also submitted a summary of safety follow-up of seven days post first vaccination, stating that no serious adverse events were experienced by any of the subjects till the date of the reporting, and the reported adverse events were stated to be mild, resolved on their own and did not have any sequela.

    LEAVE A REPLY

    Please enter your comment!
    Please enter your name here

    This site uses Akismet to reduce spam. Learn how your comment data is processed.

    Latest News

    ‘Saina’ to release on Amazon Prime Video on April 23

    A month after its theatrical release, actor Parineeti Chopra-starrer Saina, a biopic on ace badminton player Saina...

    Polling progressing smoothly for 5th phase of assembly elections in West Bengal

    Barring a few stray incidents polling for the fifth phase of assembly elections in West Bengal is going on peacefully. 36.02% polling...

    Actor Vivekh passes away: At the age of 59

    Actor Vivekh who suffered a massive heart attack on Friday, died early Saturday morning (4:35 a.m.), according to hospital sources. He was...

    CISCE defers class10th and 12 board examination

    In light of the nationwide surge in COVID19 cases, Council for the Indian School Certificate Examinations (CISCE) has deferred the Board Examinations...

    Coronavirus: India sees yet another record spike with 2,34,692 new covid cases, 1,341 deaths

    India on Saturday saw yet another record high of Covid-19 cases in 24 hours with 2,34,692 fresh Covid cases and 1,341 deaths....

    More Articles Like This

    - Advertisement -