Clinical trials are usually kept secret. During a crisis as unprecedented as the coronavirus pandemic, a growing chorus of researchers and scientists insist that details of the vaccine trials be made available to the public.
"One of the reasons transparency is so important is when people can't look behind the curtain and make a judgment about whether the FDA is doing its job properly, then this is the kind of condition that can inspire suspicion or doubt vaccine safety, "said Jonathan Kimmelman, PhD, who studies clinical drug studies at KNX Radio. Dr. Kimmelman is a bioethicist and director of ethics and policy at McGill University.
A week after all AZD1222 COVID-19 vaccination sites were told to shut down after a study participant became ill with possible side effects, some study sites were cleared for resumption. The quick pause and restart has raised questions about transparency regarding the vaccine study. The vaccine is being jointly developed by Oxford University and AstraZeneca.
The patient's condition was not disclosed publicly. Pascal Soriot, Managing Director of AstraZeneca, only shared this information during one of J.P. Morgan arranged private meetings with investors, the New York Times reported. Dr. Kimmelman said it was shoe leather journalism that uncovered information about the sick patient. It was first reported by STAT.
"I can imagine that most citizens would like to believe that all scientists share their data, that this process can be examined by the scientific community," said Dr. Peter Doshi, editor of the BMJ Medical Journal, told the New York Times. "Just not true."
AstraZeneca isn't the only pharmaceutical company under fire for withholding important details about the coronavirus vaccine. Pfizer recently proposed expanding its clinical trial to include thousands more participants. However, the announcement was vague and did not include a description of how the company would determine the vaccine's effectiveness in a larger study.
Last week, nine well-known pharmaceutical companies pledged to “stand with science” and not release a COVID-19 vaccine until it has been properly tested for safety and effectiveness. The nine promised that any potential vaccine would be developed on the basis of "large, high-quality clinical trials" and follow the guidelines of the Food and Drug Administration.
AstraZeneca and Pfizer are among the nine companies that signed the pledge, as is Moderna. These three companies are testing their vaccines in late-stage studies in the United States.
Some researchers welcomed the promise that the statement could increase public confidence in a coronavirus vaccine at a time when skepticism is high, according to the New York Times. However, other researchers said the statement should contain a promise to share more details with the public and scientists about their clinical trials.
The fact that governments are co-funding these clinical trials is all the more reason to demand transparency, said Dr. Kimmelman. Fierce Pharma reported that AstraZeneca has received federal funding of $ 1.2 billion for its vaccine development efforts.
A recent survey by the Kaiser Family Foundation found that two-thirds of Americans are concerned that, under political pressure from President Trump, the FDA will quickly approve a COVID-19 vaccine before ensuring that it is safe and effective. Dr. Kimmelman believes transparency is the best antidote to distrust.
"The only thing you really want to try and encourage is trust in the supervisory systems," he told KNX Radio. "They want people to trust companies like the FDA," that approve therapies.