Oxford Covid-19 Vaccine Trial Suspended While Participant's Illness Is Investigated

AstraZeneca, co-developer of one of the most prominent Covid-19 trial vaccines has suspended their study for an independent investigation of a single trial participant's illness. PhotobyTawat/Shutterstock.com

Updatethe trials are to restart Oxford University announced on Satudarday September 12. The sickness was the rare spinal condition transverse myelitis, but with only one case reported out of tens of thousands of trial participants there is no confirmation the inflammation was related to the vaccine. 

Pharmaceutical Company AstraZeneca has placed its phase III trial of a Covid-19 vaccine on hold while an independent committee examines the illness of one participant. The announcement closely follows the commitment by nine vaccine developers to resist pressure to release vaccines before they have proven safe.

The vaccine AstraZeneca is developing with the UK's University of Oxford (widely known as the Oxford vaccine) carries the hopes of much of the world. Where other vaccines that have reached stage III are likely to be very expensive, or subject to “vaccine nationalism,” the Oxford vaccine is expected to be more widely and affordably available if it proves to be safe and effective.

Consequently, AstraZeneca's announcement could delay the quest to return the world to normal. However, it is currently unconfirmed if the vaccine was responsible for what the company is calling a “single event” to a trial participant in the UK. Even if so, it seems unlikely such effects are common.

"This is 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," the statement reads. "In large trials, illnesses will happen by chance but must be independently reviewed to check this carefully." As yet the details of the illness are unknown.

Some 50,000 people have been recruited to participate in the Oxford vaccine trials. Not all have received their injections yet, and some will have received the meningacoccol vaccine, which is being used as a control instead of a placebo. Nevertheless, if major negative reactions occurred at a rate even approaching 1 percent, they would have been picked up well before now.

The anti-vaccination movement falsely claims harm from vaccines is widespread but regularly swept under the rug by the manufacturers. The tendency of profit-driven companies to hide news that will be bad for their bottom line does exist across industries. However, AstraZeneca's actions indicate just how seriously the possibility of even rare reactions is taken during the clinical trial phase.

Further evidence pharmaceutical companies are prioritizing safety over speed comes from a statement issued by pharmaceutical chief executives pledging not to seek FDA approval to distribute Covid-19 vaccines until stage III trials have confirmed their safety and effectiveness. The CEOs wrote: “We believe this pledge will help ensure public confidence in the rigorous scientific and regulatory process by which Covid-19 vaccines are evaluated and may ultimately be approved.” AstraZeneca CEO Pascal Soriot is one of the signatories.

The statement has been interpreted as a response to fears the Trump administration will pressure the FDA to grant early approval to vaccines that have not been proven safe in time to affect the presidential election result in November.

Scientists fear that if one unsuitable vaccine gets approval it will not only harm those who get it, but embolden the anti-vaccine movement and reduce the prospects for better vaccines being widely accepted.

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