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AstraZeneca suspends vaccine trial for safety review

 


A Food and Drug Administration spokesman declined to comment.

Those familiar with the situation talking about anonymity conditions said participants who experienced suspicious side effects were enrolled in a Phase 2/3 trial based in the UK. Individuals also said volunteers in a British trial were diagnosed with transverse myelitis, an inflammatory syndrome that affects the spinal cord and is often caused by viral infections. However, the timing of this diagnosis, and whether it was directly related to the AstraZeneca vaccine, remains unclear.

Dr. Gabriela Garcia, a neurologist at Yale New Haven Hospital, is believed to be responsible for several causes of the body’s inflammatory response, including viral infections. But she added that the condition is often treatable with steroids.

AstraZeneca refused to comment on the location of the participants and did not confirm the diagnosis of transverse osteomyelitis. “The event is being investigated by an independent committee and it’s too early to conclude a specific diagnosis,” the company said.

Some said the company’s outage was proof that the process was working as expected.

“At this stage, I don’t know if the event that triggered Hold was related to vaccination,” he oversaw the National Security Council’s public health preparations and served as chief scientist under Mr. Trump. Dr. Luciana Borio said. FDA under President Barack Obama. “But it’s important that they be thoroughly investigated.”

The AstraZeneca vaccine uses a viral vector that carries the coronavirus gene into human cells. The viral vector in this case is a modified chimpanzee adenovirus, modified to render it harmless to people. The coronavirus component of the vaccine is intended to elicit a protective immune response that will be re-evoked if the actual coronavirus attempts to infect the vaccinated individual.

In a paper published in The Lancet in July, researchers behind the formulation of AstraZeneca found that the majority of participants in Phase 1/2 studies of vaccines designed to assess product safety , Mild or moderate side effects, Including muscle aches and chills. However, none of the reactions were considered serious or life-threatening and resolved quickly. The vaccine was considered safe enough to proceed to further trials.

The AstraZeneca vaccine is in Phase 2/3 trials in the United Kingdom and India, and in Phase 3 trials in over 60 centers in Brazil, South Africa, and the United States. The company aims to join the US Reaches 30,000, And started the American trial on August 31st.

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