Covid-19: Serum Institute to halt trial of Oxford vaccine after DCGI notice

On Tuesday, AstraZeneca had decided to stop trials after a participant fell sick with an unexplained illness.

In a major turn of events, the Indian drug regulator on Wednesday issued a show cause notice to Serum Institute of India (SII), which had earlier said it would proceed with clinical trials of AZD1222, the vaccine candidate developed by the University of Oxford, despite a halt on the same by AstraZeneca in the UK. On Tuesday, the British-Swedish drug major had decided to stop trials after a participant fell sick with an unexplained illness. Reacting to the show cause notice, a Serum spokesperson said:

“We were going by the DCGI’s direction, and so far had not been told to pause trials. If the DCGI has any safety concerns, we will follow their instructions and abide by the standard protocols.” Earlier during the day, the company had said that as far as Indian trials were concerned, they would continue as SII had faced “no issues at all”.

Investigators here, however, had expressed concerns during the day. The lead investigator of one of the clinical trial sites in western India had said trials here should have, ideally, been paused as it was the same vaccine being administered to volunteers. The person added that investigators were waiting to hear from the Indian Council of Medical Research (ICMR) and SII on this. In a strongly worded show cause notice to SII, V G Somani, the DCGI, asked the Pune-based firm why the permission granted to it on August 2 should not be suspended till “patient safety is established”…Read More

Covid-19 vaccine: Oxford University to start human trials from today

The vaccine will be tested on around 500 volunteers and will focus on safety and tolerability, as well as providing an initial assessment of how effective the shot is

Oxford University will start human testing with a Covid-19 vaccine they developed from Thursday, the UK government said in a coronavirus press conference. The Oxford team – led by Professor Sarah Gilbert, is testing ChAdOx1 nCoV-19, a candidate based on a chimpanzee adenovirus modified to include the spike or ‘S’ protein on the surface of SARS-CoV-2, the virus that causes Covid-19.

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The government funded the vaccine project with 20 million pounds to Oxford University and another 22 million pounds to a second vaccine project at Imperial College, London, Health Secretary Matt Hancock said on Wednesday, adding the project will help support phase 2 trials and help prepare for a larger phase 3 study. Hancock said a vaccine is the “best way” to defeat the virus and the bring the number of cases down in the country. He said the UK government is committed to provide financial support to build manufacturing capacity for vaccines if they prove effective in clinical testing.

The testing came as the death toll from coronavirus in the UK crossed the 18,000 mark. The global toll has already crossed 184,000v The vaccine will be tested on around 500 volunteers and will focus on safety and tolerability, as well as providing an initial assessment of how effective the shot is. The Imperial candidate has been developed by a team led by Professor Robin Shattock and is an mRNA vaccine against the S protein on SARS-CoV-2 – using a similar approach to a vaccine developed by US biotech Moderna which is already in clinical trials.