Jennifer Barrett is the senior editor for Drug Topics® and Total Pharmacy®.
After a temporary pause, investigators have received the green light to resume clinical trials for COVID-19 vaccine candidate AZD1222 following a safety review.
A clinical trial evaluating AstraZeneca’s coronavirus disease 2019 (COVID-19) vaccine candidate AZD1222 in the UK has resumed after the study was put on hold last week.
The vaccine trial, which is currently in phase 3 stages, was paused following reports that a serious adverse event hospitalized a UK participant. Trial investigators have resumed clinical trials following confirmation from independent reviewers that it was safe to do so.
AstraZeneca has not released any specific details about the illness of the patient that led to the pause.
“AstraZeneca and the University of Oxford, as the trial sponsor, cannot disclose further medical information,” AstraZeneca said in a statement. “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.”
AZD1222, which was co-invented by the University of Oxford and Vaccitech, uses a replication-deficient chimpanzee viral vector based on a weakened version of a common cold virus that causes infections in chimpanzees and contains the genetic material of a severe acute respiratory disease coronavirus 2 virus spike protein.
AstraZeneca recently announced the vaccine was moving into phase 3 trials following interim results from its ongoing phase 1/2 trial showing AZD1222 was generally tolerable, and generated robust immune responses against the SARS-CoV-2 virus in all evaluated participants. The US phase 3 trial includes up to 30,000 adult participants.
COVID-19 vaccine AZD1222 clinical trials resumed in UK. Press release. AstraZeneca; September 12, 2020. Accessed September 14, 2020. https://www.astrazeneca.com/content/astraz/media-centre/press-releases/2020/covid-19-vaccine-azd1222-clinical-trials-resumed-in-the-uk.html.