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The trial had been halted due to a side-effect in an English patient.
Trials have resumed for a COVID-19 coronavirus vaccine candidate being developed by AstraZeneca and Oxford University in the U.K. after the Medicines Health Regulatory Authority (MHRA) confirmed that it was safe to do so.
According to a news release, the standard review process triggered a voluntary pause to vaccination across the global trials on Sept. 6 to allow a safety review by independent committees and international regulators. The U.K. committee has concluded that trials in that country can resume.
The Associated Press reported that an AstraZeneca spokesman said the trial was paused due to a woman developing symptoms consistent with transverse myelitis, a rare inflammation of the spinal cord.
In May, AstraZeneca inked a $1 billion deal with the U.S. Health Department’s Biomedical Advanced Research and Development Authority to supply at least 400 million doses of the vaccine candidate AZD1222. The company has secured capacity for one billion doses.
In July, the candidate produced a strong immune response with predominantly mild and moderate unsolicited adverse events in the 28 days after the injection. The immune spike peaked 28 days after injection among the about 1,000 test subjects. The subjects median age was 35 years old, there was a nearly equal split between men and women, and the vast majority, 90.9 percent, were white.
The Trump administration is gearing up for the release of a vaccine, with the Centers for Disease Control and Prevention sent letters Aug. 27 to governors across the country directing them to ease the permitting and licensing requirements for new distribution sites by fast-tracking applications or otherwise waiving the requirements which could hinder their opening by Nov. 1 while assuring that any requirements that are waived will not compromise the vaccines distributed from the sites.
The push for a vaccine before the November election has caused consternation among observers who are concerned that President Donald J. Trump, who has seen a large drop in favorability over his administration’s response to the COVID-19 coronavirus pandemic, may urge agencies to ignore or downplay possible quality concerns in the interest of his political future.
This led the CEOs of nine drug manufacturers to take the unprecedented move of writing an open letter pledging that any coronavirus vaccine will be safe before it is distributed to the public.