Two Major Coronavirus Vaccine Trials Have Restarted After Being Paused For Safety Investigations
Pharmaceutical companies running clinical trials for two high profile coronavirus vaccine candidates announced on Friday that the trials would resume, after safety investigations found that serious illnesses in volunteers did not appear to be related to the vaccines.
The FDA authorized AstraZeneca to resume its trial after a six-week pause spurred by a neurological illness in a trial participant. Johnson & Johnson’s trial was paused earlier this month.
Study pauses are not unusual in clinical trials. Unexpected illnesses are expected in trials that involve large numbers of patients, and safety investigations are necessary to determine whether the illnesses are linked to the vaccine.
“The restart of clinical trials across the world is great news as it allows us to continue our efforts to develop this vaccine to help defeat this terrible pandemic,” AstraZeneca CEO Pascal Soriot said in a statement. “We should be reassured by the care taken by independent regulators to protect the public and ensure the vaccine is safe before it is approved for use.”
AstraZeneca’s trial, which is being conducted in a partnership with the University of Oxford in the UK, has been halted twice. The first pause occurred after a patient in July developed …continued .