In the middle of the pandemic turmoil and a lot of pressure from the government and financial lobbies, AstraZeneca followed the clinical trial guidelines and paused their COVID vaccine AZD1222 trial. This phase III trial aimed to enroll up to 50,000 participants globally.
They had reported numerous low to mild adverse events during the first phases of the study, such as headaches and fever, however in this case a severe adverse event was a red flag that put the enterprise on hold. The latest information indicates that one female UK volunteer in the phase III trial suffered from transverse myelitis. Transverse myelitis is an inflammation of the spinal cord that damages the insulating material covering nerves (called myelin), interrupting the communication within the body. Some symptoms include pain, muscle weakness, paralysis, sensory problems, bladder and bowel dysfunction. Infections and immune system disorders that attack the body's tissues can cause myelitis. The woman who suffered transverse myelitis seems to be recovering and was reported that will be leaving the hospital.
However, this unexplained illness triggered a standard review process, leading to the voluntary pause of vaccination across all trials to allow an independent committee to review the safety data of this event in the UK Phase III trial.
The important thing to remember is that clinical trials take years to complete as they need to be done int the right way in order to produce safe and effective treatments, and that is not the end of it, because the treatment/therapy also has to be approved by each regional regulatory entity and this process is long and exhaustive.
In fact, there is at least a 50% failure rate for every phase of a trial, and only 13.8% of phase I clinical trials get approved.
Constant monitoring of clinical trials is a routine activity and it is a good signal that only one adverse event was picked up fast and the reaction was proper.
One of the reasons is that pharma companies know that vaccines that people can't trust are not worthy as you need people to actually get the vaccine, so having the public trust is essential.
Even if this vaccine doesn't prove to be safe and/or effective, almost 200 other candidates, with diverse modes of action are eager to jump to the leading candidate role that AZD1222 was holding so far.
Multiple pharma companies signed an agreement to honor the clinical trial process and don't "rush the science" to ensure the development of safe and effective vaccines.
To learn more about the AZD1222 vaccines click here
References
https://www.statnews.com/2020/09/09/astrazeneca-covid19-vaccine-trial-hold-patient-report/
https://www.fiercebiotech.com/biotech/astrazeneca-s-covid-19-vaccine-hold-sparks-reassessment-race?mkt_tok=eyJpIjoiTkdGbU9EVTRNbUptWVROaiIsInQiOiIrVkc4QlNEdFwvNFl4VFlvamtaXC9WT1JBTzU1ZkU4Y2ZwbWszUEtoZm9SSUh1bnVPQ1wvRWRFZE5mbm5hcVppY21uZ1c0RkpcLzRBenRCNkhzek5taHQ4UktybEdvNkozbkxTUHVxWDFuaUkrU2JZSFk2NjBubXNpTGRLWGlKUUZSMU4ifQ%3D%3D&mrkid=644691
