‘A vaccine with 50 per cent effectiveness’: Astrazeneca releases 111-page Covid-19 vaccine trial blueprint | All you need to know
When the vaccine will be found 50 per cent effective, Astrazeneca will apply to the government for early release of the vaccine for emergency use.Updated: Sep 20, 2020, 18:52 IST
Pharma company Astrazeneca has released a 111-page trial blueprint, after several questions were raised about its Covid-19 vaccine trials since two participants in the UK reported illness. Reports said experts are quite concerned about Covishield, developed by Oxford University and Astrazeneca as not much is known about the trials.
What does the blueprint say?
* It says that the goal is to develop a vaccine with 50 per cent effectiveness, as mandated by the Food and Drug Administration.
* There will have to be 150 people ill with confirmed coronavirus among participants who were vaccinated or received placebo shots.
* A safety board will perform an early analysis after there have been just 75 cases.
* When the vaccine will be found 50 per cent effective, it will apply to the government for early release of the vaccine for emergency use.
Releasing the blueprint of a vaccine under research is believed to be unusual as several other rival companies are also racing to develop an effective Covid-19 vaccine. But Moderna, Pfizer, Astrazeneca, all three pharma companies have released their blueprints detailing how they are proceeding with the trials.
Controversy over Oxford-Astrazeneca vaccine
On September 8, Astrazeneca confirmed that it has stopped trials on September 6 after two participants reported illness. It refused to divulge any further information regarding the illness. The trials running in other countries were also stopped. After the UK authorities announced that the illness reported was not related to the vaccine shot, Astrazeneca resumed its trial. However, the United States has not yet permitted the resumption of Oxford vaccine trial.
What we know so far about illness reportedly prompted by Astrazeneca vaccine shots?
According to New York Times, one participant developed spinal cord inflammation after receiving one shot of the vaccine. Later, it was found that the volunteer had a “previously undiagnosed case of multiple sclerosis”.
Third-phase trial in India likely to begin tomorrow
The final phase of human clinical trial of Oxford-Astrazeneca’s Covishield will begin at the Sassoon General Hospital in Pune next week, after Drugs Controller General of India gave Serum Institute of India (SII) a go-ahead to continue its trial. “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,” Dr Muralidhar Tambe, dean of Sassoon General Hospital, told PTI.