FDA widens probe into AstraZeneca's US coronavirus vaccine trial: report
AstraZeneca, Oxford University's Phase 3 COVID-19 vaccine trial in US has been on hold since early September
The Food and Drug Administration (FDA) is reportedly expanding its investigation of a serious illness a patient suffered while participating in AstraZeneca and Oxford University's COVID-19 vaccine study.
In furthering its probe into the "unexplained illness," the FDA will look into earlier trials of similar vaccines that were developed by the same scientists, sources familiar with the matter told Reuters. The sources said the government agency is looking to see if similar side effects emerged in these trials that were designed by researchers at Oxford University. The pharmaceutical giant is partnering with Oxford on the coronavirus vaccine.
ASTRAZENECA COVID-19 TRIAL ON HOLD IN US AS FDA INVESTIGATES UK PARTICIPANT'S SERIOUS ILLNESS
However, this does not mean the FDA believes there were safety issues associated with those vaccines, rather "it just shows that the FDA is being thorough," one of the sources told Reuters.
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Days after AstraZeneca initiated an internal investigation to see if the illness was a side effect of the shot, Oxford announced it was resuming the trial for a coronavirus vaccine after regulators gave the go-ahead.
However, AstraZeneca and the university's Phase 3 COVID-19 vaccine trial in the United States has been on hold since early September in order for the agency to initiate its own investigation into the matter.
ASTRAZENECA WAITING FOR FDA TO GREENLIGHT RESTART OF US DRUG TRIAL
"We’re here to protect the American public and we’re going to do very significant work with the company to figure out if there’s a significant safety issue or not,” FDA chief Stephen Hahn told South Carolina Republican Sen. Tim Scott during an Instagram Live interview last month.
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| AZN | ASTRAZENECA PLC | 65.45 | +0.16 | +0.25% |
Although Oxford would not disclose information about the patient’s illness due to participant confidentiality, an AstraZeneca spokesman said earlier this week that a woman had developed severe neurological symptoms that prompted the pause. Specifically, the woman is said to have developed symptoms consistent with transverse myelitis, a rare inflammation of the spinal cord.
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“We don’t have all facts, so we don’t know the causation per se of this, but we really need to look into it," Hahn added. "And that's our primary responsibility, the safety of the American people."
Volunteers from some of the worst-affected countries — Britain, Brazil, South Africa and the U.S. — are taking part in the trial.
So far, the U.K., Brazil, India and South Africa have been given clearance by regulators to resume clinical trials there.