Clinical trials for the AstraZeneca Oxford coronavirus vaccine, AZD1222, have resumed across the world with regulators in the US, UK, Brazil, South Africa and Japan confirming that it was safe to do so.
The coronavirus vaccine is considered one of the top candidates, with the U.S. government investing heavily in its development.
The Food and Drug Administration (FDA) today authorized the restart in the US, following the resumption of trials in other countries in recent weeks. The FDA reviewed all safety data from trials globally and determined it was safe to resume the trial.
As part of the standard review process for trial safety events, a voluntary pause to vaccination across all global trials was triggered on Sept. 6 to allow the examination of safety data by independent monitoring committees. The recommendations from these reviews have been supported by international regulators, who also confirmed that the trials were safe to resume.
Pascal Soriot, Chief Executive Officer, said: “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. 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.”
AZ noted that it is not unusual that in large scale vaccine trials, some participants will become unwell, and every case has to be evaluated to ensure the careful assessment of safety. It was widely reported that one case led to the pause.
Results from the late-stage trials are anticipated later this year, depending on the rate of infection within the communities where the clinical trials are being conducted.
While trials are ongoing, AstraZeneca and Oxford University will continue to provide information to regulators, study investigators and participants according to clinical trial and regulatory standards.
AZD1222 was co-invented by the University of Oxford and its spin-out company, Vaccitech. It uses a replication-deficient chimpanzee viral vector based on a weakened version of a common cold virus (adenovirus) that causes infections in chimpanzees and contains the genetic material of the SARS-CoV-2 virus spike protein. After vaccination, the surface spike protein is produced, priming the immune system to attack the SARS-CoV-2 virus if it later infects the body.
Should the vaccine pass through trials, it would involved the use of two injections, according to published reports.
AstraZeneca employs 1,500 in logistics and headquarters facilities in northern Delaware. The company is based in Cambridge, UK.