AstraZeneca COVID-19 vaccine study paused after ‘potentially unexplained’ illness

After announcing partnership with Michigan Medicine, AstraZeneca places COVID-19 vaccine trial on hold

AstraZeneca COVID-19 vaccine trial paused due to suspected adverse reaction

AstraZeneca's CEO said the company's experimental coronavirus vaccine could still be ready by the end of this year, despite a pause in trials following a suspected adverse reaction in a volunteer.

The issue, Glyn Hughes, the industry's head of cargo, told the BBC, will be transporting the vaccine to developing countries, such as in South Asia and across Africa, where the manufacturing capacity is limited. Money to fund the USA trial came from Operation Warp Speed, a United States federal initiative to quickly disperse funds to the most promising vaccine candidates.

Why was the trial suspended?

Turkey is considering a request from Russian Federation to conduct Phase III trials of Russia's COVID-19 vaccine, Health Minister Fahrettin Koca said on Thursday, adding a decision would be made in the next week.

After announcing partnership with Michigan Medicine, AstraZeneca places COVID-19 vaccine trial on hold

Of the more than 179 vaccine candidates against COVID-19, the ChAdOx1 nCoV-19 is one of the 34 vaccines that are undergoing human trials.

Some medical experts and members of the general public have expressed concern that political pressure may prompt pharmaceutical companies to rush out a COVID-19 vaccine before it has been proven safe and effective. We will continue to closely monitor our study participants.

RBC Capital Markets analyst Bryan Abrahams cautioned the trial participant's condition must be thoroughly investigated.

What are the next steps?

NIH director addresses clinical hold on AstraZeneca vaccine
It said that we may see no widely available vaccine for COVID-19 until "at least" the beginning of 2021. The posting said the cause was being investigated.

The US National Institutes of Health, which is providing funding for AstraZeneca's trial, declined to comment.

The committee would also consider the severity of the episode. If AstraZenecas review finds the adverse event is related to the vaccine, all the doses already manufactured will be thrown away, Collins said. It is a controlled study in which participants are randomized in such a way that for every 2 random participants that receive the vaccine, one receives the placebo.

Walters heard about the pause the day he came to receive his second dose. On Tuesday, AstraZeneca said its "standard review process triggered a pause to vaccination to allow review of safety data". But this interruption is unlikely to affect the integrity of the findings of the study.

A Beijing-based immunologist told the daily that compared with injections, a nasal spray vaccination is easier to administer and would also be easy to mass-produce and distribute as it adopts the mature influenza vaccine production technology. If the data and safety monitoring board decides it's the latter, the trial will resume. The committee has the prerogative to pronounce on this and, to a large extent, the investigators need to adhere to the committee's recommendation. "Other trials will also investigate their data, too".

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Some 9,000 Brazilian volunteers are participating in the Sinovac vaccine trials, which are being conducted by the Butantan Institute in Sao Paulo city and 11 other locations, including the capital, Brasilia. Vaccines aim to train the body to recognize the coronavirus by exposing cells to the distinctive spiky protein on its surface, but they use different technologies to deliver that protein to the body.

"This should be seen as the proper functioning of a vaccine evaluation system".

It is understood preliminary discussions are underway but there remains numerous unknowns including when and where Australia's vaccine will be developed and how road and airfreight will work together to ensure they are distributed quickly.

But current government policies would limit the distribution effort if still in place when the time comes, particularly when it comes to border checks and quarantine measures for key workers like ground crew, truck drivers and sailors.

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BioNTech BNTX.O , among the frontrunners in the vaccine race with partner Pfizer PFE.N , echoed remarks by Soriot that clinical halts are a common feature of immunisation trials.

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