COVID-vaccine results are on the way — and scientists’ concerns are growing
... The drug companies behind the three leading coronavirus vaccines in phase III trials — AstraZeneca, Pfizer and Moderna... released documents describing how their tests are being conducted. These trial protocols include benchmarks for safety and success, and details... [about] how soon the vaccines’ preliminary results could be reported.
... Initially, researchers weren’t too concerned when... enrolment in the UK trial of the Oxford vaccine had been paused on 6 September because of an adverse reaction in a participant... Some scientists have criticized the lack of information being released, especially when it emerged that this was the second pause in enrolment because of an adverse reaction.
... AstraZeneca and Oxford did not respond to questions about calls for greater transparency. But AstraZeneca chief executive Pascal Soriot said... that clinical-trial guidelines recommend against disclosing information about individual participants to avoid compromising their privacy and the integrity of the study. Soriot said that given the public interest in these vaccines, companies were discussing what kind of transparency they could offer without compromising trials.
... Public trust in coronavirus vaccines is already wavering, particularly in the United States, where Trump frequently touts his ‘Operation Warp Speed’ programme to accelerate COVID-19 vaccine development... The AstraZeneca, Pfizer and Moderna protocols revealed that the trials are designed to test whether the vaccines reduce cases of symptomatic COVID-19, not cases of severe disease, such as those that require hospitalization and can end in death. MacIntyre and other researchers say it would have been better to test whether the vaccines reduced severe disease and death... The companies are aiming for the vaccines to stop at least 50% of vaccinated people getting symptomatic COVID-19, the definition of success in the FDA guideline, but they are hoping for an efficacy of 60% or greater...