AstraZeneca plc (NYSE: AZN) can heave a sigh of relief following resumption of its coronavirus vaccine study that was voluntarily paused by the company.
What Happened: The U.K. pharma giant said U.K. regulatory agency, the Medicines Health Regulatory Authority (MHRA) has given its concurrence to resume the late-stage study of AZD1222 — the vaccine candidate it is jointly developing with the Oxford University against SARS-CoV-2.
Following a standard review process, AstraZeneca paused all global trials on Sept. 6 after an unidentified illness was reported in one of the trial participants. The company later clarified that the person was a woman in the U.K., who experienced symptoms associated with transverse myelitis, a spinal inflammatory disorder.
The pause was to allow review of safety data by independent committees, and international regulators.
The U.K. independent committee has concluded its investigations and recommended to MHRA that the trials in the U.K. are safe to resume.
The company, however, said further medical information cannot be disclosed.
“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 said.
Why It’s Important: AstraZeneca was hustling to develop a vaccine for the novel coronavirus, and was considered to be among the frontrunners in the race.
The pause prompted analysts and researchers to suggest the company might be ceding the first-to-market advantage in a highly competitive arena.
Apart from AstraZeneca, there are a host of others which have their respective vaccine candidates either in early- or mid-stage trials. The Pfizer Inc. (NYSE: PFE)/BioNTech SE – ADR (NASDAQ: BNTX) team and Moderna Inc. (NASDAQ: MRNA) are currently conducting late-stage studies.
The late-Tuesday disclosure of the pause led to a 2% decline in AstraZeneca shares on Wednesday. At the same time, stocks of other coronavirus vaccine makers moved higher in the session.
The trial resumption should help AstraZeneca proceed with the studies, without impacting the timelines.
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