- AstraZeneca CEO Pascal Soriot during a private call with investors on Wednesday provided additional details on a participant in one of the drugmaker's Phase 3 coronavirus vaccine trials who became sick, which caused the company to pause all of its Phase 3 trials on the vaccine candidate while AstraZeneca investigates the incident, STAT News reports. The participant developed neurological symptoms consistent with transverse myelitis, a rare inflammatory syndrome that affects the spinal cord and often is triggered by viral infections. Soriot said the participant's diagnosis hadn't been confirmed as of Wednesday. However, he said the participant's condition was improving, and the participant likely would be discharged from the hospital soon. AstraZeneca's board charged with overseeing data and safety in the drugmaker's clinical trials confirmed that the participant had been given the company's coronavirus vaccine candidate, Soriot said. He added that the company also had paused the clinical trial in July, when a participant had developed neurological symptoms that were later determined to be unrelated to the experimental vaccine, STAT News reports (Feuerstein, STAT News, 9/9).
- Roche last week announced that FDA has issued an emergency use authorization for its test that can detect whether a patient is infected with the novel coronavirus or one of two types of influenza. Thomas Schinecker, Roche's head of diagnostics, in a statement said coronavirus infections and influenza infections "can hardly be differentiated by symptoms alone," but with Roche's new test, providers "can confidently provide the right diagnosis and most effective treatment plan for their patients" (Neghaiwi, Reuters, 9/4).
- A team of Russian scientists last week in the The Lancet published their first report of clinical data on the country's coronavirus vaccine. According to the report, the vaccine was safe and generated an immune response to the novel coronavirus in all 76 trial participants who received the vaccine. Russian officials said they expect the country to begin conducting mass vaccinations by the end of this year (Zimmer, New York Times, 9/4; Kantchev, Wall Street Journal, 9/4).
- Ugur Sahin, CEO and co-founder of BioNTech, on Tuesday said the coronavirus vaccine candidate his company is developing with Pfizer likely will be ready for FDA approval by mid-October or early November of this year. Sahin said the company is highly confident in their vaccine candidate based on clinical trial results so far, which he said have shown the experimental vaccine produces favorable antibody results in a variety of patients. Sahin added that he believes FDA will issue an emergency use authorization for the vaccine candidate (Kelley, "Changing America," The Hill, 9/8).
- Researchers at Weill Cornell Medicine have developed a machine learning algorithm that has the ability to identify patients infected with the coronavirus using routine lab blood tests, research shows. In a study published in Clinical Chemistry, researchers tested the algorithm on 27 routine lab tests and found that the model identified coronavirus infections with 76% sensitivity and 81% specificity. Sarina Yang, the first author on the study and an assistant professor of pathology and laboratory medicine at Weill Cornell, said the algorithm could be useful in situations where coronavirus testing results are delayed or where testing resources are limited (Bonislawski, Modern Healthcare, 9/3).
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