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June 12, 2021
PHOTO CREDITS: USA TODAY
AstraZeneca, a pharmaceutical and biopharmaceutical company, revealed details of its coronavirus vaccine trials on Saturday, the third in a wave of rare disclosures by drug companies under pressure to be more transparent.
Many experts have criticized pharmaceutical companies’ lack of transparency and communication, especially regarding the newest developments in the fight against the COVID-19 pandemic. For example, the public was not immediately informed about two cases of neurological symptoms of COVID-19 discovered in one of AstraZeneca’s Coronavirus vaccine trials, nor was the FDA. Any further evidence of neurological symptoms and a connection to the vaccine could halt the company’s vaccine development, as well as the development from competing companies using similar technology (NYT). Dr. Peter Jay Hotez, a virologist with Baylor College of Medicine, said that “The communication around it has been horrible and unacceptable.”
The first participant in an AstraZeneca vaccine trial received one dose of the vaccine before developing inflammation of the spinal cord, known as transverse myelitis, according to a participant information sheet. A company spokesman told The New York Times that the volunteer was later determined to have a previously undiagnosed case of multiple sclerosis, unrelated to the vaccine, and that the trial resumed shortly thereafter. The condition is rare but serious, and experts said that finding even one case among thousands of trial participants could be a red flag. The studies have resumed in Britain, Brazil, India and South Africa, but are still on pause in the U.S. About 18,000 people worldwide have received AstraZeneca’s vaccine so far.
The F.D.A has still not allowed the company to resume trials in the United States, as some experts have been critical of the company’s decision to restart trials abroad. Dr Paul Offit, a professor at the University of Pennsylvania and a member of the FDA’s advisory committee on vaccines, said that it is unclear how the company – or the United Kingdom government – determined that the second case was not related to the vaccine. He and other experts noted that transverse myelitis is rare, diagnosed in only about one in 236,000 Americans a year.
EDITOR: CARSON CHOATE, DOMESTIC AFFAIRS