Pharmaceutical company Astrazeneca released a 111-page trial plan after several questions were raised about its Covid-19 vaccine trials as two participants in the UK reported illness. According to reports, experts are very concerned about Covishield, which was developed by Oxford University and Astrazeneca, as not much is known about the studies.
What does the blueprint say?
* The goal is to develop a vaccine with a 50 percent effectiveness as mandated by the Food and Drug Administration.
* Among the participants who were vaccinated or received placebo admissions, 150 people must have a confirmed coronavirus.
* A security agency carries out an early analysis after only 75 cases.
* If the vaccine is found to be 50 percent effective, he will request the government to release the vaccine early in case of emergency.
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The release of the blueprint of a research vaccine is believed to be unusual as several other competing companies are also battling to develop an effective Covid-19 vaccine. But Moderna, Pfizer, Astrazeneca, all three drug companies have published their plans detailing how to proceed with the trials.
Oxford Astrazeneca Vaccine Controversy
On September 8, Astrazeneca confirmed that the studies were halted on September 6 after two participants reported an illness. It refused to reveal any further information about the disease. The trials in other countries were also discontinued. After the UK authorities announced that the reported disease was unrelated to the vaccine, Astrazeneca resumed the process. However, the United States has not yet allowed the vaccine trial to resume at Oxford.
What do we know so far about diseases that are reported to have been caused by vaccinations with Astrazeneca?
According to the New York Times, one participant developed spinal cord inflammation after receiving a shot of the vaccine. It was later discovered that the volunteer had a “previously undiagnosed case of multiple sclerosis”.
The third phase process in India is expected to begin tomorrow
The final phase of the human clinical trial with Covishield from Oxford-Astrazeneca will begin next week at the Sassoon General Hospital in Pune after the Indian drug control officer approves the Serum Institute of India (SII) to continue the study. “The Phase III study of the Covishield vaccine will begin next week at Sassoon Hospital. It is expected to start on Monday. Some volunteers have already signed up for the process. Around 150 to 200 volunteers will be given the vaccine candidate dose, ”said Dr. Muralidhar Tambe, Dean of Sassoon General Hospital, told PTI.