The pharmaceutical company Astrazeneca has published a 111-page test plan, after several questions were raised about its Covid-19 vaccine trials as two participants in the UK reported the disease. Reports say that experts are quite concerned about Covishield, developed by the University of Oxford and Astrazeneca, as not much is known about the trials.
What does the plan say?
* Says the goal is to develop a vaccine that is 50 percent effective, as mandated by the Food and Drug Administration.
* There will have to be 150 sick people with confirmed coronavirus among the participants who were vaccinated or received placebo injections.
* A safety board will conduct an early review after there have only been 75 cases.
* When the vaccine is determined to be 50% effective, the government will be requested to release the vaccine early for emergency use.
Read also | AstraZeneca’s test illnesses may not be due to Covid-19 vaccine, says Oxford University
Posting the blueprint for an investigational vaccine is believed to be unusual, as several other rival companies are also competing to develop an effective Covid-19 vaccine. But Moderna, Pfizer, Astrazeneca, the three pharmaceutical companies have published their blueprints detailing how they are proceeding with the tests.
Oxford-Astrazeneca vaccine controversy
On September 8, Astrazeneca confirmed that it had stopped the trials on September 6 after two participants reported they were ill. He declined to release more information about the disease. Trials in other countries were also stopped. After UK authorities announced that the reported illness was not related to the vaccine injection, Astrazeneca resumed its trial. However, the United States has not yet allowed the Oxford vaccine trial to resume.
What do we know so far about the disease that supposedly caused the Astrazeneca vaccine injections?
According to the New York Times, one participant developed inflammation of the spinal cord after receiving an injection of the vaccine. Subsequently, it was found that the volunteer had a “previously undiagnosed case of multiple sclerosis.”
Third phase trial in India likely to start tomorrow
The final phase of Oxford-Astrazeneca’s Covishield human clinical trial will begin at Sassoon General Hospital in Pune next week, after the Indian Controller General of Drugs gave the go-ahead to the Serum Institute of India (SII) to continue your essay. “The phase III trial of the ‘Covishield’ vaccine will begin at Sassoon hospital starting next week. It is likely to start on Monday. Some volunteers have already come forward for the test. The candidate vaccine dose will be administered between 150 and 200 volunteers, ”Dr. Muralidhar Tambe, Dean of Sassoon General Hospital, told PTI.
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