Clinical trials for the AstraZeneca Oxford coronavirus vaccine, AZD1222, have resumed in the United Kingdom (UK) following confirmation by the Medicines Health Regulatory Authority (MHRA) that it was safe to do so, AstraZeneca said in a press release.
On September 6, AstraZeneca paused the clinical trials across the globe to allow a standard review process to occur in which independent committees and international regulators assess the safety of the trials. Since then, the UK committee has concluded its investigations and recommended to the MHRA that trials in the UK are safe to resume, AstraZeneca said, adding that it is working with health authorities in other parts of the world to determine when those clinical trials may resume.
In an official statement issued last week, AstraZeneca described the pause as a “routine action” that occurs “whenever there is a potentially unexplained illness in one of the trials, while it is investigated, ensuring we maintain the integrity of the trials.”
In announcing the decision to restart the UK trials, AstraZeneca said that it “and the University of Oxford, as the trial sponsor, cannot disclose further medical information. All trial investigators and participants will be updated with the relevant information and this will be disclosed on global clinical registries, according to the clinical trial and regulatory standards.”
According to AstraZeneca, 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.
