Human trials of the Oxford vaccine are still pending in the United States for protective reasons, 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.
Leaked documents claimed that the patient, a 37-year-old woman, had developed transverse myelitis, inflammation around the spinal cord, triggered by viruses, but a prospective-looking effect of other vaccines.
Doctors restarted trials in the UK five days later, on 12 September, after an independent review committee and THE UK regulator, the Medicines and Healthcare Regulatory Agency, considered this, also continued in Brazil, India and South Africa.
But U. S. regulators have not yet resumed experiments on the incident and are “very concerned” that the blow could cause adverse reactions.
The FDA and the National Institutes of Health (NIH) are investigating the reaction, such as the vaccine, an underlying medical condition, or some other unknown factor.
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.
Dr. Anthony Fauci, director of the NIH, said last week that it was only a matter of time before the trial resumed in the United States, and hoped that the vaccine would be one of the first approved again.
Uncertainty remains about what happened to the unnamed woman, who won the first dose of the experimental vaccine in June and the one in August.
AstraZeneca has continually refused to verify the diagnosis of transverse myelitis and insists that there is no evidence that the vaccine is to blame for the woman’s symptoms, which have now disappeared.
Doctors resumed testing the vaccine at Oxford in the UK on Saturday 12 September. They also continued in Brazil, India and South Africa. But U. S. regulators have not yet realized the incident amid reports that they are “very concerned” that blowing can cause adverse effects Photo: AstraZeneca plant in Waltham, Massachusetts
AstraZeneca, the drug giant with the rights to experimental jab, stopped global trials on 8 September because a British volunteer was hospitalized. Pictured: a volunteer is beaten in South Africa
NIH Director Dr. Anthony Fauci told CNN Tuesday that ”it’s only a matter of time ” before the trial resumes in the United States.
This is the time when the trial has been suspended, the first time, in July, just publicly revealed.
The trial was revived after we decided the volunteer had an “undiagnosed case of multiple sclerosis,” a condition that can cause the same neurological reaction as transverse myelitis, which was found to be unrelated to the vaccine.
AstraZeneca has not explained how it reached that conclusion, or why it waited more than a month to mention it publicly, and the main points of the MHRA resolution to resume testing were not revealed.
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Edited through Associated Newspapers Ltd
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