AstraZeneca resumes clinical trials in UK after green signal

 While AstraZeneca resumes clinical trials in the UK, the Indian regulator has asked Serum Institute of India (SII) to suspend recruitments for phase-2 and 3 clinical trials of the Oxford-AstraZeneca vaccine candidate and has directed the firm to increase the safety monitoring of the subjects already vaccinated as part of the trial.

In a statement, the British drug major said on Saturday that following the confirmation by the Medicines Health Regulatory Authority (MHRA), clinical trials of AZD1222 have resumed in the UK. The MHRA said that it was safe to do so, the company said.

Adar Poonawallah, CEO of SII tweeted, "As I’d mentioned earlier, we should not jump to conclusions until the trials are fully concluded. The recent chain of events are a clear example why we should not bias the process and should respect the process till the end. Good news, @UniofOxford".

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"On September 6, the standard review process triggered a voluntary pause to vaccination across all global trials to allow review of safety data by independent committees, and international regulators. The UK committee has concluded its investigations and recommended to the MHRA that trials in the UK are safe to resume," the statement read.

It added that all trial investigators and participants will be updated with the relevant information and this will be disclosed on global clinical registries, according to the clinical trial and regulatory standards.

Meanwhile, in an order on Friday, the drug controller general of India VG Somani directed the Pune based vaccine maker to suspend recruitments till further orders. SII is conducting trials in India for the Oxford-AstraZeneca vaccine.

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Somani had issued a show cause notice to SII earlier this week asking it to explain why the permission to conduct trials should not be suspended unless patient safety is established. SII responded to the show cause notice saying that Data and Safety Monitoring Board (DSMB) noted no safety concerns from the Indian study with the first dose and seven day post vaccination data.

The DSMB has, however, recommended that the study be paused until the investigations in the serious adverse event.

In its Friday order, Somani has asked SII to increase the safety monitoring of the subjects already vaccinated with the vaccine under trial and submit the plan and report. The DCGI has also asked SII to DSMB UK as well as DSMB India to obtain clearance for resumption of clinical trials.

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

 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”.

A participant in the UK trials —now in phase 3 — fell sick with what may be called a suspected case of serious adverse reaction, and needed hospitalisation. The drug maker voluntarily put trials on hold, saying it was reviewing the event given that such side effects are never ruled out.

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The reason for the event gaining significance is that the sickness was not only serious, but also unexplained. The firm, however, seeks to ensure the event will not result in any delay to the trials.

There will be a meeting of the Data and Safety Monitoring Board (DSMB) for a review of the situation, the person told Business Standard.

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Virologists point out that events of unexplained sickness were not uncommon in trials. It could also be someone who received a placebo shot, which will be unravelled when the DSMB analyses the event, said senior virologist Jacob John, former professor at Christian Medical College (Vellore). He explained that in case it was a placebo shot, trials would be back on track.

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He added that trials in Indian need not be halted because it is an independent arm, and there would be no need to conduct trials here if a decision was taken based on data from the UK trials alone.

This candidate was recently described by the World Health Organization (WHO) as the world’s leading one, which was in advanced stages of investigation or trials.

All eyes were on this vaccine, and shares prices reacted negatively to the news — with the Indian arm of AstraZeneca shedding up to 12 per cent in intra-day trade on Wednesday. It ended the session at Rs 4,070 apiece, down 3.8 per cent. In London, the news triggered a 2 per cent fall in shares.

International agencies said the final decision on resumption in trials will be taken by British medical regulator MHRA.

If trials go off gear, it could have financial implications for SII. It is conducting phase-2 and phase-3 trials in India to have data on Indian demographics. SII CEO Adar Poonawalla had said he would start manufacturing the vaccine at his ‘personal risk’, even before results were out.

AstraZeneca Pharma hits fresh record high of Rs 4,489; stock surges 15%

 Continuing their northward movement, shares of Astrazeneca Pharma India hit a fresh record high of Rs 4,489, up 15 per cent on the BSE on Monday, in an otherwise range-bound market, amid expectation that the company’s candidate, AZD1222, could be viewed as a frontrunner in a global race to deliver an effective vaccine to combat the Covid-19 virus.

At 03:05 pm, the stock was trading 13 per cent higher at Rs 4,411 on the BSE. In comparison, the S&P BSE Sensex was trading 0.36 per cent lower at 38,218 points. The stock of the pharmaceutical company was trading higher for the fifth straight day, surging 26 per cent during the period.

According to a Reuters report, Australia expects to receive its first batches of a potential Covid-19 vaccine in January, Australian Prime Minister Scott Morrison said on Monday, as the number of new daily infections in the country’s virus hotspot fell to a 10-week low. CLICK HERE TO READ FULL REPORT

AstraZeneca Plc, the company's parent firm, is expected to release initial data on whether a vaccine can stop people from getting the virus on September 15. The drugmaker has pledged as many as 30 million doses to the UK by the end of the month.

Meanwhile, since August 18, 2020, the stock of Astrazeneca Pharma has gained 35 per cent, after the company received import and market permission in Form CT-20 (Marketing Authorization) from the Drugs Controller General of India for Olaparib Film-Coated tablets 100 mg and 150 mg - additional indication. CLICK HERE FOR RELEASE