Oxford Vaccine Trial Participant Developed 'Neurological Symptoms'

In India, DCGI issues a notice to Serum Institute for not pausing the trials here.

Updated
A large-scale Phase 3 trial of the COVID-19 vaccine candidate being developed jointly by AstraZeneca and the University of Oxford has been halted at dozens of sites across the US.
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A participant in the Oxford-AstraZeneca COVID-19 vaccine trials developed neurological symptoms, prompting the global shutdown of the vaccine trials, reports STAT in an exclusive story.

The report says the participant was a woman and she did receive the vaccine as opposed to a placebo. Her symptoms were similar to a rare but serious spinal inflammatory disorder called transverse myelitis. These details were shared by AZ's chief executive, Pascal Soriot during a private conference call, says the STAT report.

Earlier, a spokesperson for AstraZeneca said that the company’s “standard review process triggered a pause to vaccination to allow review of safety data.” In a follow-up statement, AstraZeneca has said that it had initiated the interruption of the study.

There are currently nine vaccine candidates in Phase 3 trials. AstraZeneca’s is the first Phase 3 COVID-19 vaccine trial known to have been put on hold.

How Does it Impact India?

A global pause should have automatically triggered a pause in trials in India as well. But there were confusing signals all day. Serum Institute of India, the Indian vaccine manufacturer of the Oxford vaccine put out a statement saying they were not pausing the trials in India.

The statement read, "We can't comment much on the UK trials, but they have been paused for further review and they hope to restart soon. As far as Indian trials are concerned, it is continuing and we have faced no issues at all."

However by evening, the Drugs Regulator General of India (DCGI), the apex body responsible for overseeing clinical trials, had issued a show cause notice to Serum for failing to inform them about the pausing of the trial in UK and US.

The notice read, "In view of the above, Drugs Controller General of India and Central Licensing Authority hereby give you an opportunity to show cause... why the permission granted to you on August 2 shall not be suspended till patient safety is established."

Serum reacted by saying they were simply following DCGI's directives.

"We are going by DCGI's direction and so far were not told to pause the trials. If DCGI has any safety concerns, we will follow their instructions and abide by the standard protocols."

AstraZeneca Calls the Pause "An Abundance of Caution"

The study hold has been explained as “a routine action which has to happen whenever there is a potentially unexplained illness in one of the trials, while it is investigated, ensuring we maintain the integrity of the trials.”

Stat News quotes another anonymous source, saying the finding has also affected other AstraZeneca vaccine trials underway, as well as the clinical trials being conducted by other vaccine manufacturers.

The vaccine candidate, known as AZD1222, employs an adenovirus that carries a gene for one of the proteins in SARS-CoV-2, the pathogen responsible for COVID-19. The adenovirus is designed to induce a protective immune system response against the coronavirus.

Such a method has not been used in any approved vaccine, but has been tested in experimental vaccines against other viruses, including the Ebola virus.

To know more about how this vaccine works, click here.

(With inputs from STAT News)

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