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COVID-19: AstraZeneca slams brakes on COVID-19 vaccine trial over unexplained participant illness

2020/09/10  Pharmafile

Global trials for AstraZeneca’s much-hyped COVID-19 vaccine, currently in development in partnership with the University of Oxford, have been halted after an unexplained illness was identified in one of the participants.

Once the illness was discovered, the company launched a standard safety review of the trials, leading to the decision to put the brakes on the studies. While such a move is standard procedure in clinical testing, it will no doubt cause anxiety for those desperately waiting for a treatment, and for national governments that have placed orders for huge reserves of the vaccine for their citizens. AstraZeneca’s shares fell on the news, while rivals Moderna and BioNTech, which are developing their own COVID-19 vaccines, saw gains in their own shares.

The vaccine is being tested at clinical sites in the UK, US, Europe, Latin America, Asia and Africa, with the aim of enrolling up to 50,000 participants.

AstraZeneca was quick to stress that such a move was not out of the ordinary. “This is 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,” a company spokesperson commented. “In large trials illnesses will happen by chance but must be independently reviewed to check this carefully. We are working to expedite the review of the single event to minimise any potential impact on the trial timeline. We are committed to the safety of our participants and the highest standards of conduct in our trials.”

UK Health Secretary Matt Hancock also seemed unperturbed by the news, telling Sky News: “It is obviously a challenge to this particular vaccine trial. It’s not actually the first time this has happened to the Oxford vaccine.”

He added that he did not necessarily agree that the finding would set back development of the vaccine: “it depends on what they find when they do the investigation.”

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