Scientists are asking for answers as to why the US branch of Oxford’s Covid-19 vaccine trial is on hold, two weeks after its first suspension.
AstraZeneca, the drug giant with the rights to experimental jab, stopped global trials on 8 September because a British volunteer was hospitalized and has now been released.
Uncertainty remains about what happened to the anonymous user of 37-year-old medical confidentiality, but leaked documents state that she had developed “transverse myelitis,” a neurological disease that left her helpless.
Doctors restarted trials in the UK on 12 September after an independent protection review committee and UK regulator, the Medicines and Healthcare Regulatory Agency, investigated and said it was prudent to do so.
But U. S. regulators have yet to give it the green light to restart, even though main vaccine trials are also taking place in Brazil, India, and South Africa.
Experts have criticized Cambridge-based pharmaceutical giant AstraZeneca for not being transparent about the side effect, and the company insists that there is no evidence that the adverse reaction was caused by the vaccine itself.
Pascal Soriot, CEO of AstraZeneca, said today: “We are waiting for the FDA’s resolution to seize the United States. “He also said that other people “trust that the experts, whose task is to monitor those tests, are doing an intelligent task” through reviewing the protection data.
That comes after President Donald Trump accused the FDA of seeking to withhold a coronavirus vaccine until the end of the election for political purposes.
Trump to circumvent U. S. general regulatory criteria. To speed up the use of the Oxford vaccine in the United States through October, before the November presidential election.
The US branch of Oxford’s Covid-19 vaccine trial is still on hold while the rest of the global trials run to verify its efficacy.
AstraZeneca CEO Pascal Soriot said we are waiting for the FDA’s resolution to take control of the United States, suggesting that the resolution is in the hands of regulators.
Mr. Soriot at a virtual briefing at the World Economic Forum: “We are waiting for news from the FDA that is reviewing the data.
“Basically, knowledge is reviewed through an independent protection committee that is then presented to the regulator.
“And since the exam is done through Oxford University, we are not the sponsor, they are. And, of course, they are offering all this data to regulators in all other countries where they are sponsors.
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