After Being Pulled Up Serum Institute Of India Halts Trial Of Oxford COVID Vaccine In India

Pune-based Institute of India (SII) has reportedly halted the testing of the COVID-19 vaccine being developed by AstraZeneca and the University of Oxford in India, after it was halted in the UK due to a serious adverse reaction in a participant. The move was in response to a notice issued by the drugs regulator following the developments in the UK.

Earlier, on Wednesday SII had said that "We (Serum Institute of India) can't comment on reports of AstraZeneca pausing the trials in the UK, other than that they have been paused for review and shall restart soon. The Indian trials are continuing and we have faced no issues at all," SII tweeted.

We (Serum Institute of India) can't comment on reports of AstraZeneca pausing the trials in the UK, other than that they have been paused for review and shall restart soon. The Indian trials are continuing and we have faced no issues at all.#SII #COVID19 #Latestnews pic.twitter.com/HWPUrQydWc

¡ª SerumInstituteIndia (@SerumInstIndia) September 9, 2020

On Wednesday, the Drugs Regulator General of India (DCGI) had issued a show-cause notice to SII seeking an explanation as to why the ongoing clinical trial of the Covishield vaccine has not been stopped.

Reuters

The Times of India reported that Drugs Controller General of India V G Somani has sought to know why permission granted for Phase 2 and 3 trials shouldn¡¯t be suspended till patient safety is established.

The DCGI letter also stated that SII has not submitted causality analysis of the reported serious adverse event with the investigational vaccine for the continuation of Phase 2 and 3 clinical trials of the subject vaccine in the country in (the) light of safety concerns.

SII has reportedly said that said there was no explicit directive yet to pause the trials and that the vaccine is completely safe.

Reuters

¡°As far as Indian trials are concerned, we have faced no issues at all.¡± ¡°We are going by the DCGI¡¯s direction, and so far haven¡¯t been told to pause the trials. If the DCGI has any safety concerns, we will follow the instructions and abide by the standard protocols,¡± the Serum Institute statement said.

We (Serum Institute of India), were going by DCGI's direction and were not instructed to pause the trials. If DCGI has any safety concerns, we will adhere to their instructions and abide by the standard protocols. pic.twitter.com/u0yaGAU0Eo

¡ª SerumInstituteIndia (@SerumInstIndia) September 9, 2020

The phase-3 human trials of the Oxford-AstraZeneca vaccine which will be called Covishield in India was also underway in India since last month.

The trials of Covishield vaccine will involve 1,600 people above the age of 18 years across 17 locations in Pune, Mumbai and Ahmedabad.

A total of 100 volunteers in India have already received the trial dose of the Covishield vaccine.

The Oxford-AstraZeneca vaccine which was the lead candidate to become the COVID-19 vaccine landed in trouble after one of the participants in the UK developed an unexplained illness.

AFP/ REPRESENTATIONAL IMAGE

A spokesperson for AstraZeneca said that the company's "standard review process triggered a pause to vaccination to allow review of safety data".

In a follow up statement, AstraZeneca said it initiated the study hold. The nature of the adverse reaction and when it happened were not immediately known, though the participant is expected to recover, Stat News reported.

The spokesperson described the pause as "a routine action which has to happen whenever there is a potentially unexplained illness in one of the trials, while it is investigated, ensuring we maintain the integrity of the trials". The spokesperson also said that the company is "working to expedite the review of the single event to minimize any potential impact on the trial timeline".