AIDS Healthcare Foundation (AHF), the largest global AIDS organization, today sharply criticized drug companies working on COVID-19 vaccines over a near total lack of transparency on the companies’ respective trials, including setbacks with AstraZeneca’s vaccine trial that briefly forced its suspension last week as well as Pfizer’s claims Saturday that it could have an answer about whether its vaccine works before the end of October—six weeks from now and mere days before the U.S. presidential election—despite also announcing that it was expanding its vaccine trial to 44,000 people, up from its previous goal of 30,000.
On Saturday, AstraZeneca, a perceived frontrunner in the vaccine race, also announced it was resuming its COVID-19 vaccine trial in the U.K. after abruptly halting it earlier last week after ‘a serious adverse reaction’ occurred in one patient in its Phase 3 study in the U.K. which had only begun in late August.
According to the New York Times, “AstraZeneca did not initially report that a participant’s illness had halted its clinical trials around the world. The studies were paused last Sunday, but not reported until the news was broken by STAT on Tuesday. The company still has not disclosed the patient’s illness that led to the pause, even though it has discussed the medical condition of another participant who developed multiple sclerosis in July, which led to another brief halt of the trial. That illness was determined to be unrelated to the vaccine.”
An unnamed individual familiar with AstraZeneca’s trial told the New York Times that the patient whose serious adverse reaction briefly halted the trial had symptoms “…consistent with inflammation of the spinal cord, known as transverse myelitis. The condition can be treated and is typically resolved in a few months, but severe attacks can cause major disabilities.”
“100% transparency on COVID-19 vaccine trials is essential to public trust,” said AHF President Michael Weinstein. “Despite corporate culture and potential market and/or political pressures falling on their heads, the leaders of these drug companies must be transparent about their vaccine trials. The damage done to the public trust from lack of transparency could be so great and so long-lasting that it could severely affect uptake of an eventual successful COVID vaccine as well as any other vaccines that follow.”