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www.fdanews.com/articles/199080-nih-troubled-by-safety-issue-in-astrazenecas-phase-3-vaccine-trial

NIH Troubled by Safety Issue in AstraZeneca’s Phase 3 Vaccine Trial

September 16, 2020

The National Institutes of Health (NIH) is deeply concerned that an unexplained patient illness under review in AstraZeneca (AZ)’s phase 3 COVID-19 vaccine trial could throw the promising candidate off course, and the NIH has opened its own investigation into the issue, an NIH clinical director has disclosed.

Although UK and Brazilian health regulators have given AZ the go-ahead to resume trials in their countries after independent safety and monitoring committees reviewed information about the serious adverse event, the FDA and regulators in other countries are still investigating it and the trials remain on hold in those places. The NIH has opened its own investigation, according to Avindra Nath, a senior investigator with the National Institute of Neurological Disorders and Stroke (NINDS).

The NIH is still “in the planning stages” of its investigation and has not yet obtained tissue or blood samples from the UK patient that experienced the adverse event, Nath told California Healthline, a service of the California Health Care Foundation, noting that the NIH is worried the adverse event could lead to further obstacles for the vaccine, which is seen as one of the strongest candidates in the global race to find an effective COVID-19 vaccine.

“The highest levels of NIH are very concerned. Everyone’s hopes are on a vaccine, and if you have a major complication the whole thing could get derailed,” he said.

The NIH wants to lend its support, but it has had difficulty doing so due to AZ’s cautious, tight-lipped release of details related to the adverse event, Nath said, calling on the drugmaker to “be more forthcoming with a potential complication of a vaccine which will eventually be given to millions of people.”

AstraZeneca is not specifically addressing the NIH investigation. "We will continue to work with health authorities across the world, including the FDA in the U.S., and be guided as to when other clinical trials can resume to provide the vaccine broadly, equitably and at no profit during this pandemic," a spokesperson said Tuesday.

Last week, an AZ spokesperson said published reports that the UK participant was confirmed to have transverse myelitis, a rare neurological disorder caused by spinal cord inflammation, were incorrect. He stated that the company’s CEO, Pascal Soriot, clarified that there is currently no final diagnosis and that one will not be made until more tests are conducted (DID, Sept. 10).

The British drugmaker has said that its initial move to pause all phase 3 vaccine trials was made as part of routine safety procedures. It has not been confirmed one way or the other that the serious adverse event of the UK trial participant had any connection with the company’s vaccine candidate. — James Miessler