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AstraZeneca Covid-19 vaccine study put on hold due to suspected adverse reaction in participant in the U.K.

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signal

signal

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Oct 28, 2017
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www.statnews.com

AstraZeneca Covid-19 vaccine study put on hold due to suspected adverse reaction in participant in the U.K.

AstraZeneca's Covid-19 vaccine study has been put on hold due to a suspected adverse reaction in participant in the U.K.
www.statnews.com www.statnews.com

www.nytimes.com

Drugmaker Pauses Covid-19 Vaccine Trial for Safety Review (Published 2020)

Britain is expected to limit most social gatherings to six people after a spike in cases. A political uproar quashed plans for targeted lockdowns in Israel. People caught maskless in Indonesia were told to lie in a coffin as punishment.
www.nytimes.com www.nytimes.com

The pharmaceutical company AstraZeneca halted global trials of its coronavirus vaccine on Tuesday because of a serious and unexpected adverse reaction in a participant, the company said. The trial's halt, which was first reported by Stat News, will allow the British-Swedish company to conduct a safety review. How long the hold will last is unclear.

In a statement, the company described the halt 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." In large trials like the ones AstraZeneca is overseeing, the company said, participants do sometimes become sick by chance, but such illnesses "must be independently reviewed to check this carefully."
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A person familiar with the situation, and who spoke on the condition of anonymity, said that the participant had been enrolled in a Phase 2/3 trial based in the United Kingdom. The individual also said that a volunteer in the U.K. trial had been found to have transverse myelitis, an inflammatory syndrome that affects the spinal cord and is often sparked by viral infections. However, the timing of this diagnosis, and whether it was directly linked to AstraZeneca's vaccine, is unclear.
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AstraZeneca's vaccine, known as AZD1222, relies on a chimpanzee adenovirus that has been modified to carry coronavirus genes and deliver them into human cells. Although the adenovirus is generally thought to be harmless, the coronavirus components of the vaccine are intended to incite a protective immune response that would be roused again should the actual coronavirus try to infect a vaccinated individual.

Adenoviruses, however, can sometimes trigger their own immune responses, which could harm the patient without generating the intended form of protection.
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AstraZeneca's vaccine is currently in Phase 2/3 trials in England and India, and in Phase 3 trials in Brazil, South Africa and more than 60 sites in the United States. The company intended for its U.S. enrollment to reach 30,000.
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console_logger

console_logger

Banned
Oct 28, 2018
573
Really hoping this isn't related to the vaccine itself, but this is why these clinical trials are so damn important.
 

SasaBassa

Member
Oct 25, 2017
7,049
Glad they caught it now -- the whole point of the phased trial process -- as opposed to once it's out in the wild. Hopefully the individual is okay, too.

One of many candidates and I hope they're all thorough to catch potential issues like this.
 
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