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Clinical trials of AstraZeneca coronavirus vaccine resume in UK after hiatus over safety concerns



The AstraZeneca building in Luton, Great Britain.

Tim Ireland | Xinhua News Agency | Getty Images

Phase three trials for AstraZeneca’s coronavirus vaccine have resumed in the UK after being halted earlier this week due to safety concerns, the company announced Saturday.

AstraZeneca said it received confirmation from the UK medicines health regulator that it was safe to resume clinical trials. The company declined to disclose medical information about the trial pause, but earlier this week it indicated that a potentially unexplained disease was under investigation.

The company said the “standard review process triggered a voluntary pause”

; for all global trials on September 6 so that independent committees and internal regulators could review the safety data. While trials can now resume in the UK, the status of trials elsewhere remains unclear.

“The Company will continue to work with health authorities around the world and will be guided on when other clinical trials can resume to provide the vaccine broadly, fairly and without profit during this pandemic,” AstraZeneca said in a statement.

The University of Oxford, which developed the vaccine in collaboration with AstraZeneca, said on Saturday that around 18,000 people have received the vaccination in trials so far.

“In large trials like this one, some participants are expected to get sick and each case must be carefully evaluated to ensure a careful safety assessment,” Oxford said in a statement.

STAT News reported earlier this week that AstraZeneca CEO Pascal Soriot said during a private conference call that the “potentially unexplained disease” occurred in a woman in the UK who exhibited neurological symptoms consistent with a spinal inflammatory disorder called transverse myelitis. The call was organized by investment bank J.P. Morgan, STAT reported.

In the same call, Soriot also confirmed that AstraZeneca’s clinical trials had stopped once in July after one participant experienced neurological symptoms, but the disease was not related to the experimental vaccine.

AstraZeneca’s potential coronavirus vaccine, called AZD1222, is among the first in the race towards a safe and effective vaccine that could dent the global pandemic. The company started its late stage trials at the end of August. It is one of at least three candidate vaccines, along with Pfizer and Moderna, in an advanced stage of testing.

The United States has invested more than $ 10 billion in six efforts to bring a coronavirus vaccine to market. On May 21, the United States announced that it would invest $ 1.2 billion in the AstraZeneca effort in exchange for at least 300 million doses if the candidate proved safe and effective enough.


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