Illness In Paused AstraZeneca Trial Likely Wasn’t Caused By Vaccine, Oxford University Says

Topline

 Oxford University said Wednesday its coronavirus vaccine with British drugmaker AstraZeneca may not have caused an illness that led to the halt to trials earlier this month.

Key Facts

In an information sheet for prospective participants, Oxford University said, “After an independent review, these illnesses were either considered unlikely to be associated with the vaccine or there was insufficient evidence to say for certain that the illnesses were or were not related to the vaccine,” Reuters first reported.

AstraZeneca paused trials on September 6 after a U.K. participant developed an “unexplained illness.” 

Trials have resumed in the U.K., Brazil and South Africa but it’s unclear if the U.S. Food and Drug Administration will follow, as NIH officials have said they are “very concerned” about the adverse illness.

AstraZeneca has not released any details about the situation, but the New York Times reported, citing an anonymous source, that the participant developed symptoms consistent with transverse myelitis, or an inflammation of the spinal cord.

Neither AstraZeneca nor Oxford immediately responded to a request for comment from Forbes.

Chief Critic

 Dr. Ashish Jha, dean of the Brown University’s School of Public Health, told CNN he’s concerned AstraZeneca hasn’t been transparent enough. 

“The bigger issue here is the lack of transparency. The company discloses at an investor conference. We haven’t been given the details of exactly what happened. You can protect patient confidentiality and still share information,” he said. 

Key Background

Oxford and AstraZeneca’s vaccine is one of several candidates involved with Operation Warp Speed, a public-private partnership launched by the federal government to develop and deliver vaccines as fast as possible. The Trump administration has invested $1.2 billion in the vaccine’s development so far as it undergoes Phase 3 efficacy trials. Eight other vaccines, including those developed by Moderna and Pfizer, are also in Phase 3, according to the New York Times vaccine tracker.

Tangent

CDC Director Robert Redfield said Wednesday a vaccine will likely only be widely available in the U.S. by mid-2021, despite Trump’s public touting of a more optimistic timeline. Meanwhile, Democratic presidential nominee Joe Biden said he would be skeptical of one coming from the Trump administration without “total transparency.”

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