Pharmaceutical group AstraZeneca on Tuesday announced a pause in clinical trials of its experimental vaccine against COVID-19 after the appearance of a “potentially unexplained disease”, arguably a serious side effect, in a participant.
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AstraZeneca is the industrial partner of the UK University of Oxford, and their vaccine is one of the most advanced Western projects, tested on tens of thousands of volunteers in the UK, Brazil, South Africa and since 31 August, the United States, in what is called phase 3 of the trials, the last, to verify safety and effectiveness.
“As part of the University of Oxford’s global randomized clinical trials of the coronavirus vaccine, our normal assessment process was triggered and we voluntarily paused vaccinations to allow for an assessment of the safety data by an independent committee, ”a company spokesperson said in a statement.
“This is a routine action that is required as soon as a potentially unexplained disease appears in one of the trials, during the investigation, in order to maintain the integrity of the trials,” the spokesperson continued.
The nature and severity of the event is unknown, but according to the Statnews site, the affected person should recover.
This is the first known suspension from a clinical trial involving an investigational vaccine against COVID-19.
Depending on the length of the investigations, this could have an impact on the tight development schedule. The British Minister of Health had said on Monday that he hoped for the results of AstraZeneca’s trials by the end of the year or the beginning of 2021.
The company has already pre-sold hundreds of millions of doses to multiple countries, in case its vaccine proves effective.