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COVID-19 Vaccine Trial Put On Hold Because of Possible Adverse Reaction
The New York Times is reporting that a study volunteer in the U.K. developed transverse myelitis.
One of the leaders in the race to develop a COVID-19 vaccine has suffered a setback because a participant in the vaccine’s phase 3 trial developed a serious condition that might be related to vaccine.
The New York Times is reporting that a study volunteer in the U.K. developed transverse myelitis, a condition characterized by inflammation of the spinal cord. According to an National Institute of Neurological Disorders and Stroke fact sheet about transverse myelitis, the causes can include a number of different autoimmune disorders, an abnormal immune response to cancer, and viral, bacterial, and fungal infections.
Stat broke the news about the possible adverse reaction and the pause in the enrollment in the AstraZeneca's phases 3 study yesterday.
In response to Stat's story, AstraZeneca put out a statement that said it had voluntarily paused vaccination. The statement described the stoppage as a “routine action, which has to happen whenever there is a potentially unexplained illness," and cautioned that in "large trials illnesses will happen by chance."
AstraZeneca announced on Aug. 31 that it was starting to enroll study volunteers in the United States with a goal of recruiting up to 30,000 participants. The trial is designed so some people are randomized to get two doses of the vaccine — known temporarily as AZD1222 — four weeks apart and others, a saline solution.
The Times reported that the vaccine, which was developed by University of Oxford researchers, is in phase 2/3 trials in England and phase 3 trials in Brazil, South African and the United States.
Bridging the Diversity Gap in Rare Disease Clinical Trials with Harsha Rajasimha of IndoUSrare
November 8th 2023Briana Contreras, an editor with Managed Healthcare Executive, spoke with Harsha Rajasimha, MD, founder and executive chairman of IndoUSrare, in this month's episode of Tuning in to the C-Suite podcast. The conversation was about how the disparity in diversity and ethnicity in rare disease clinical trials in the U.S. has led to gaps in understanding diseases and conditions, jeopardizing universal health, and increasing the economic burden of healthcare.
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Managing Editor of Managed Healthcare Executive, Peter Wehrwein, had a discussion with William Shrank, M.D., a venture partner with Andreessen Horowitz, a venture capital firm in Menlo Park, California, about how artificial intelligence's role is improving healthcare, where we are today with value-based care and the ongoing efforts of reducing waste in the healthcare space for this episode of the "What's on Your Mind" podcast series.
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Air Pollution May Negatively Affect Male Reproductive Health
November 30th 2023A potential mechanism by which air pollutants may affect reproductive health is by endocrine disruption. Air pollutants are made up of mixtures of particulate matter that may include endocrine disruptors, such as polycyclic aromatic hydrocarbons (PAHs) and heavy metals.
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35th World AIDS Day Marks 20 Years of PEPFAR: Challenges and Strategies to Combat HIV/AIDS
November 29th 2023PEPFAR, having invested $100 billion and saved 25 million lives in the global fight against HIV/AIDS, faces Congressional hurdles in its reauthorization due to abortion debates. Despite widespread support and no evidence of abortion-related activities, the legislative process is at a standstill. Members of PEPFAR and authors of a recent editorial stress the significance of PEPFAR and advocate for integrating behavioral and social science into healthcare programs to achieve UNAIDS targets and address barriers in HIV/AIDS testing and treatment.
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