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

The Serum Institute of India (SII) received a go ahead from the Drugs Controller General of India (DCGI) on September 15, 2020 to resume clinical trial of the Oxford COVID-19 vaccine candidate in the country.

Sep 16, 2020 16:00 IST
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The Serum Institute of India (SII) received a go-ahead from the Drugs Controller General of India (DCGI) on September 15, 2020 to resume clinical trial of the Oxford COVID-19 vaccine candidate in the country. The drug controller had earlier put its trials on hold after a DCGI order.

The DCGI revoked the earlier order suspending any new recruitment for phase two and three trial. However, the approval comes with certain conditions. The DCGI has asked the Serum Institute to restart trials based on certain conditions like taking extra care during screening, providing additional information in informed consent and close monitoring for adverse events during study follow-ups.

The conditions have to be "scrupulously" followed by Serum Institute of India. The 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.

AstraZeneca partly resumes Covid-19 vaccine trials after temporary halt

AstraZeneca announced partial resumption of its COVID-19 vaccine trials in the United Kingdom on September 12 after a temporary pause. The last-stage clinical trials of its coronavirus vaccine resumed in the UK after British regulator gave its go ahead after deeming it safe.

However, the AstraZeneca COVID vaccine trials in other countries including the United States continue to remain paused while AstraZeneca works with national health authorities to conclude its safety. 

DCGI's Previous Trial Suspension Order

The Drugs Controller General of India (DCGI) Dr. VG Somani had ordered the SII earlier on September 11, 2020 to suspend any new recruitment in phase 2 and 3 clinical trials for the COVID-19 vaccine till further orders. The DCGI order came soon after Serum Institute submitted its reply to DCGI giving explanation on the show cause notice issued to the drugmaker as to why it did not halt the ongoing clinical trial of AstraZeneca Oxford COVID-19 vaccine candidate till doubts regarding the patient.

Key Details

The DCGI's order directed SII to increase the safety monitoring of the subjects already vaccinated with the vaccine under trial and submit the plan and report.

The order also directed the Serum institute to submit clearance from DSMB UK and DSMB India to obtain clearance from this office prior to the resumption of future recruitment in the trial.

The order then quoted SII's reply to DCGI's show-cause notice, in which the institute had stated that DSMB noted no safety concerns from the phase 1 and phase 2 of the Indian study with the first dose and seven days post-vaccination safety data.

Further, the order stated that DSMB has recommended pausing further recruitment into the study until ongoing investigations reported in the UK study is completed and the UK DSMB is satisfied that it doesn't pose any safety concern.

Background

The DCGI had issued a show-cause notice to Serum Institute for not pausing the ongoing clinical trial of the COVID-19 vaccine, developed by AstraZeneca along with the researchers of Oxford University.

The show-cause notice was issued after AstraZeneca paused its ongoing last-stage trial of the vaccine candidate after a volunteer fell ill in the United Kingdom due to an unexplained illness. AstraZeneca has halted its clinical trial being conducted across four countries - US, UK, South Africa and Brazil till it investigates the recipient's "potentially unexplained" illness and find out whether it is a side effect of the vaccine shot. 

Though the Serum Institute had initially said that it will continue its trials in India, on September 10, the institute issued a statement saying that they are reviewing the situation and pausing India trials till AstraZeneca restarts its trials. The statement read that they are following DCGI's instructions.

The Drugs Controller General of India had on August 2, 2020 granted permission to SII to conduct a phase II/III clinical trial of the Oxford COVID-19 vaccine at various sites across India to determine its safety and immunogenicity. The Serum Institute in India has partnered with AstraZeneca and the Oxford University to manufacture their vaccine in large volumes once it passes all the trials and gets the required approval. 

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