Amid concerns over safety of its COVID-19 vaccine, AstraZeneca has released a 111-page trial blueprint in a bid to increase transparency about its testing of products. The blueprint is expected to address the concerns about safety around Covishield being developed by Oxford University and Astrazeneca.
AstraZeneca's trial blueprint says that its goal is to develop a vaccine with 50 per cent effectiveness. It is the same threshold that the Food and Drug Administration (FDA) has fixed in its guidance for COVID-19 vaccines.
In total, it requires at least 150 patients suffering from coronavirus among all participants who have received vaccination or placebo shots. Thereafter, a safety board will perform an early analysis after there have been just 75 cases. If the vaccine is 50 per cent effective at that point of time, the company may stop the trial early and apply for authorisation from the government to release the vaccine for emergency use.
AstraZeneca and the University of Oxford on Saturday had recently said that clinical trials for their coronavirus vaccine have resumed in the UK after the Medicines Health Regulatory Authority's (MHRA) confirmed that the trials were safe. The human trials resumed days after a pause had been announced in the trials after an adverse reaction in a couple of the participants.
Meanwhile, The final clinical trial of coronavirus vaccine by Oxford University and being manufactured by the Serum Institute of India (SII) will begin at the Sassoon General Hospital in Pune from Monday.
"The phase-III trial of ''Covishield'' vaccine will begin at Sassoon hospital from next week. It is likely to start on Monday. Some volunteers have already come forward for the trial. Around 150 to 200 volunteers will be administered the vaccine candidate dose," Dean of the state-run Sassoon General Hospital Dr Muralidhar Tambe told PTI.
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