BRIEF—AstraZeneca's COVID-19 vaccine trials cleared to resume

Clinical trials for the AstraZeneca and Oxford University COVID-19 vaccine, AZD1222, have resumed in the UK, following confirmation by the Medicines Health Regulatory Authority (MHRA) that it was safe to do so, the UK drug major announced today.

On September 6, 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. This was as a result of a serious adverse reaction in a single UK volunteer. The UK committee has concluded its investigations and recommended to the MHRA that trials in the UK are safe to resume.

Although AstraZeneca had not confirmed the nature of the adverse reaction, it was reportedly a case of transverse myelitis – an inflammation of both sides of one section of the spinal cord.

AstraZeneca and the University of Oxford, as the trial sponsor, cannot disclose further medical information, the company said. 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.

Reaction from Russia, which has approved Sputnik V

Within hours of the AstraZeneca announcement, Kirill Dmitriev, chief executive of the Russian Direct Investment Fund (RDIF), whose COVID-19 vaccine Sputnik V was controversially approved by the domestic regulatory on the basis of only early stage trials, commented: “We are delighted that AstraZeneca has resumed its trials and continues to move forward. At the same time, the suspension of trials clearly showed the fallacy of the approach, when entire countries exclusively rely on novel and untested platforms when choosing a vaccine for widespread use, including the use of a monkey adenovirus vector or mRNA technology. We have frequently discussed the potential risks that new technologies may pose, as well as comparing these risks with the Sputnik V vaccine, which is based on a well-studied platform using human adenoviral vectors, that has been proven to be safe and effective. At the same time in the US and Western Europe, proven and safe platform of human adenoviral vectors account for only 15% of the volume of total vaccine procurement.

“The postponement of clinical trial also puts into question the request of some of the pharma companies for full indemnification from any risks from their vaccines by purchasing countries. Russia will not follow such an approach as it has demonstrated the safety and efficiency of its human adenoviral vector platform, including its Sputnik V vaccine.”