The morning after the world learned that a closely watched clinical trial of a coronavirus vaccine had been halted last week over safety concerns, the company’s chief executive disclosed that a person given the vaccine had experienced serious neurological symptoms.
It is standard for drug companies to withhold details of clinical trials until after they are completed, tenaciously guarding their intellectual property and competitive edge. But these are extraordinary times, and now there is a growing outcry among independent scientists and public health experts who are pushing the companies to be far more open with the public in the midst of a pandemic that has killed more than 193,000 people in the United States.
None of the three companies with coronavirus vaccines in advanced clinical trials in the United States have made public the protocols and statistical analysis plans for those trials — the detailed road maps that could help the independent scientists better understand how the trials were designed and hold the companies accountable if they were to deviate from their plans.
In an effort to restore public trust, senior regulators at the FDA took the highly unusual step of promising in a USA Today op-ed piece Thursday to uphold the scientific integrity of the process of evaluating treatments and vaccines and to maintain the agency’s independence. AstraZeneca did not initially report that a participant’s illness had halted its clinical trials around the world. The studies were paused Sept. 6 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.
While the broad outlines of the vaccine trial designs have been made available — including on a federal clinical trial registry — crucial details remain a mystery. Company executives have provided some trial details when they have spoken on discussion panels, at investor conferences or in news releases. But researchers looking for clues have had to comb through transcripts, videos and articles posted online rather than examine documents that the companies provided.
More than likely the 'vaccine' has a higher death rate than the actual coronavirus itself thats why.
Not sharing these anymore. It'll scare recruits. The illness was probably not related to the vaccine. I'm glad you're being careful , but let's go already!
My kids and I are fully vaccinated w recommend vax, and annual flu shots. I am not anti vaccine. BUT... I suffer from serious neurological symptoms from a vaccine trial in 2016. We need to make sure a potential coronavirus vaccine is safe! covid19 vaccinetrial
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