There is a Coronavirus vaccine with promising clinical trials on its 3rd phase developed by the University of Oxford and biopharmaceutical company AstraZeneca been put on hold as a result of a “suspected serious adverse reaction” in one of the study’s participants according to a report by STAT news.
The vaccine which is known as AZD1222 is said to be one of a handful promising Coronavirus vaccines which had recently begun undergoing clinical testing in the US as well as the UK.
A spokesperson told STAT the hold is “a routine action which has to happen whenever there is a potentially unexplained illness in one of the trials.” A review process triggered the pause, according to the spokesperson.
The scientific approach to clinical trials is to always pause testings in order to investigate the nature of any adverse events which is why scientists usually conduct a much more stringent phase 3 trials which is designed to ensure the highest level of safety before the vaccines an be rolled out tot he general public.
“This, while disappointing, should reassure us that the proper processes and safety precautions are being followed, despite the urgency of this pandemic,” said Hassan Vally, an infectious diseases epidemiologist at La Trobe University. “The reality is that these reactions do occur and they need to be examined closely.”
It’s not yet clear what is the nature of the adverse reaction but its said to being investigated and said to have been in a participant in the UK. However, these participants are expected to recover from it. Also, its unclear whether the adverse reaction can be traced to the vaccination.
“One person in 50,000 having an unexplained illness during a human trial has a significant chance of this being unrelated to the vaccination,” says Madgalena Plebanski, professor of immunology at RMIT University, Melbourne, Australia. “No need to panic yet.”
Vally suggests more information on the event is required. Other researchers suggest it may not be just minor side effects.
“Would be good to know what the problem was,” said Katherine Seley-Radtke, a medicinal chemist studying antivirals at the University of Maryland, “but the fact it has put a hold on things sort of speaks for itself.”
This event is affecting the trials of other vaccines being conducted by the AstraZeneca biopharmacist as other researchers on other trials are reviewing data to look for similar reactions in participants.
AstraZeneca did not immediately respond to a request for comment.
On the 31st of August, the US National Institutes of Health made it known that about 30,000 adult volunteers across the country would be enrolled for the phase 3 trial which is designed to evaluate the vaccine in a diverse population and then monitor for any adverse reactions.
This trial was meant to further accelerate the COVID-19 treatments in the country as well as being part of the Operation Warp Speed.
Last week, the Australian government announced it would be ordering 33.8 million doses of the vaccine and says 3.8 million of those doses would be delivered in January and February 2021 if the vaccine is successful.
Meanwhile the vaccine in itself is a “viral vector” which uses weakened cold virus to present a a small piece of COIV-19 genetic data to human cells. It’ meant to mimic the coronavirus infection and also designed to stimulate an immune response by exposing cells to the coronavirus “spike protein.”
In results from phase 1 and 2 trials, published in medical journal The Lancet in July, the Oxford vaccine was shown to stimulate white blood cells and antibodies — which can attack or neutralize a virus. The researchers note mild and moderate reactions were common, but many were reduced by use of paracetamol and no serious adverse events were reported.
With both first and second phases gone, the phase 3 looked really promising with clinical trial but then the new adverse reactions requires more examinations to be looked into the matter to see how well things can go before furthering the program.
