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AstraZeneca's COVID-19 Vaccine Trial Delays May Worsen As FDA Widens Investigation

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AstraZeneca's COVID-19 Vaccine Trial Delays May Worsen As FDA Widens Investigation

AstraZeneca Plc’s (NYSE: AZN) coronavirus vaccine development program could hit by further delays, as the Food and Drug Administration has widened the scope of its probe into the halted trial, Reuters reported Wednesday.

What Happened: The federal agency is inquiring whether side effects similar to the one seen in the COVID-19 vaccine trial — transverse myelitis — also emerged in trials of other vaccines designed by Oxford University, AstraZeneca's partner, Reuters said, citing people familiar with the matter. 

The vaccines reportedly under review use a modified adenovirus as a vector and target illnesses such as the Middle East Respiratory Syndrome and the flu.

Oxford’s vaccines use a chimpanzee adenovirus, ChAdOx1, unlike other vaccine developers that use a human variant.  

A review of research papers by Reuters found that in one trial, a serious side effect event cited by researchers was classified as unrelated to the vaccine.

Another complication that may affect the trial: the Reuters report said the FDA is requesting data from the British pharmaceutical firm that is in a different format than the one used by the FDA. 

People familiar with the developments told Reuters the FDA’s actions aren't an indicator there are safety issues related to any of the vaccines under review.

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Why It Matters: Last month, AstraZeneca’s coronavirus vaccine trials were halted after a volunteer developed symptoms of a serious neurological disorder known as transverse myelitis.

The Cambridge, United Kingdom-based company has resumed trials in India, South Africa, Brazil and the U.K.

Some scientists have questioned why the drugmaker’s COVID-19 vaccine trials remain suspended in the U.S.

While AstraZeneca experiences delays, Pfizer Inc (NYSE: PFE) is seeking FDA clearance to expand its late-stage trials by adding more participants.

AZN Price Action: AstraZeneca shares ended Wednesday's session down 0.54% at $54.81 and fell slightly further after-hours. 

 

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