AstraZeneca Oxford vaccine trial, Climate change 'unabated' by coronavirus lockdowns

 AstraZeneca Oxford vaccine trial, Climate change 'unabated' by coronavirus lockdowns.

The British-Swedish pharma company AstraZeneca has temporarily halted phase 3 clinical trials of the AZD1222 COVID-19 vaccine after a trial participant reportedly developed severe adverse reactions, STAT News has reported. Rebecca Robbins, a reporter with the news outlet, tweeted the statement the company had issued early on September 9; in full:

As part of the ongoing randomised, controlled global trials of the Oxford coronavirus vaccine, our standard review process triggered a pause to vaccination to allow review of safety data. 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. In large trials illnesses will happen by chance but must be independently reviewed to check the carefully. We are working to expedite the review of the single event to minimise any potential impact on the trial timeline. We are committed to the safety of our participants and the highest standards of conduct in our trials.

In a follow-up, the company specified that it had “voluntarily” paused the trial – as if to indicate the pause hadn’t been called for by any external regulators.

Reuters also reported a similar statement by a company spokeswoman named Michele Meizell: “Our standard review process was triggered and we voluntarily paused vaccination to allow review of safety data by an independent committee.”

AZD1222, also known as the Oxford vaccine because its developers are affiliated to the University of Oxford, is one of nine potential COVID-19 vaccines currently undergoing phase 3 clinical trials around the world. According to STAT News, clinicaltrials.gov – the American clinical trials registry – indicates its phase 3 trials are underway in 62 sites in the US, although not all have kicked off, and that phase 2/3 trials are on in Brazil, South Africa and the UK.

It remains unclear which site the patient who suffered the severe adverse reaction is enrolled at as a participant or what the reaction was. However, the patient is reportedly expected to recover.

The results of a phase 1/2 clinical trials of the same vaccine conducted in the UK were published in The Lancet on July 20. In that paper, the researchers conducting the trial wrote, “Local and systemic reactions were more common in the [group that received the vaccine] and many were reduced by use of prophylactic paracetamol, including pain, feeling feverish, chills, muscle ache, headache, and malaise. There were no serious adverse events related to” the vaccine. This suggests a severe adverse reaction is likely to be a clinically worse condition.