AstraZeneca vaccine trials resume

Coronavirus: Drug controller tells Serum Institute to stop recruiting for further vaccine trials

Promising Coronavirus Vaccine Resumes Trials After Brief Pause

Trials for this vaccine candidate had been paused recently, after one of the participants developed a serious ailment, that news reports described as a neurological disorderaffecting the spinal cord. "On 6 September, the standard review process triggered a voluntary pause to vaccination across all global trials to allow the review of safety data by independent committees and worldwide regulators", AstraZeneca stated.

The joint statement noted that scientific evidence for regulatory approval must come from "large, high quality clinical trials that are randomized and observer-blinded, with an expectation of appropriately designed studies with significant numbers of participants across diverse populations".

Chinese state-owned bio-pharm company Sinopharm, through its China National Biotec Group (CNBG) unit, has two inactivated vaccines. Bourla claims that Pfizer has already invested US$1.5 billion on the development of its vaccine.

Coronavirus: Drug controller tells Serum Institute to stop recruiting for further vaccine trials

In July, the pharmaceutical company reported interim results from their ongoing phase 1/2 trial showing AZD1222 was generally tolerable, and generated robust immune responses against the SARS-CoV-2 virus in all evaluated participants.

Pointing out that Pfizer turned down inclusion in the U.S. government's $10 billion Operation Warp Speed initiative for accelerated COVID-19 vaccine development, Bourla said this was done in an effort to "liberate our scientists from any bureaucracy" as "money from someone always comes with strings" and would entail providing detailed and continuous progress reports.

Health Secretary Matt Hancock told LBC last week that AstraZeneca had already started to produce doses of the vaccine.

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Pfizer Inc. Chief Executive Officer Albert Bourla said it's "likely" the USA will deploy a Covid-19 vaccine to the public before year-end and that the company is prepared for that scenario, pushing back against more tepid expectations shared by health authorities.

An AstraZeneca spokesperson previously described the decision as a "routine action which has to happen whenever there is a potentially unexplained illness" in a trial.

He also added that people who were sent to high-risk places in the country and those who came from overseas including health workers, diplomats and other employees were given the vaccine doses.

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By last week, around 30,000 people in the United Kingdom, the US, Brazil and South Africa had taken part, in a tie-up with pharma giant AstraZeneca.

The scenario as of now is - 180 vaccine candidates in pre-clinical or clinical trials, 35 of them in clinical trials, 8 in final stages, phase-3 of human trials.

The pharma giant also stated that it had "voluntarily paused" the trial.

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