Clinical trials of the Oxford COVID-19 vaccine will resume after they were paused on September 6th due to unexplained neurological symptoms in a participant. At the time, AstraZeneca described it as a “routine” pause in the case of “an unexplained illness”.
In a press release, AstraZeneca announced that “Clinical trials for the AstraZeneca Oxford coronavirus vaccine, AZD1222, have resumed in the UK following confirmation by the Medicines Health Regulatory Authority (MHRA) that it was safe to do so.”
“On 6 September, the standard review process triggered a voluntary pause to vaccination across all global trials to allow review of safety data by independent committees and international regulators. The UK committee has concluded its investigations and recommended to the MHRA that trials in the UK are safe to resume.
AstraZeneca 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.
AstraZeneca is committed to the safety of trial participants and the highest standards of conduct in clinical trials. The Company will continue to work with health authorities across the world and be guided as to when other clinical trials can resume to provide the vaccine broadly, equitably and at no profit during this pandemic.”
Oxford University believed that this process showed that they are committed to the safety of their volunteers and the highest standards of conduct in their studies. A spokesperson for the University said that illnesses in large trials happen by chance, but still need to be checked independently.
The AZD1222, formerly known as ChAdOx1 nCoV-19, is a weakened form of the common cold virus that has been genetically moderated so that it cannot grow in humans. It contains the genetic material of the SARS-CoV-2 virus spike protein, and has been confirmed to trigger an immune response against SARs-CoV-2.
The pause came only days after the announcement from the University of Oxford that trials were being expanded, led by AstraZeneca. On the 2nd September, it was reported that “A new arm of the ongoing global clinical trials of the ChAdOx1 nCoV-19 vaccine led by AstraZeneca has launched in the US to assess safety, efficacy and immunogenicity of the vaccine for the prevention of COVID-19.”
These trials will recruit 30,000 adult volunteers across the US from a diverse range of backgrounds. Volunteers living with underlying medical conditions, such as HIV, will also be tested to ensure the vaccine’s safety. Sites outside the US, including in Chile and Peru, are due to begin recruitment shortly.
According to an article published on the University’s Vaccine Development website, “Participants are being randomised to receive two doses of either ChAdOx1 nCoV-19 or a saline control, four weeks apart, with twice as many participants receiving the potential vaccine than the saline control. The trial is assessing the efficacy and safety of the vaccine in all participants, and local and systemic reactions and immune responses will be assessed in 3,000 participants.
The news that the vaccine trials have restarted will be welcomed across the world since international vaccination sites in Brazil, South Africa and the USA had to be put on hold last week.