Washington, September 20: Pharmaceutical giant AstraZeneca PLC, which is developing a vaccine against COVID-19 in coordination with the Oxford University, released a 111-page trial blueprint. Also referred to as the "protocol", the document shares the strategy which would be enacted by the company for final phase of vaccine development. Oxford-AstraZeneca COVID-19 Vaccine: NIH 'Very Concerned' About Side-Effect on UK Trial Participant, Suspects Case of 'Transverse Myelitis'.
The blueprint, in which AstraZeneca claimed that its goal is to develop a vaccine with "50 percent effectiveness", was primarily aimed at allaying the apprehensions raised by the United States' National Institute of Health (NIH) - which had flagged the adverse reactions faced by two vaccine trial participants in the UK as "very serious".
The top American health body had claimed that the prima facie data shared by AstraZeneca, on the health issue faced by the two volunteers, point towards a possible case of 'Transverse Myelitis'. A person suffering from this disease faces severe inflammation along the spinal cord.
"(AstraZeneca) needs to be more forthcoming with a potential complication of a vaccine which will eventually be given to millions of people," the NIH had said, earlier this week.
'Goal is Develop a Vaccine With 50% Effectiveness'
In the blueprint of AstraZeneca, as accessed by the New York Times, the drugmaker claimed that its "goal is to develop a vaccine with 50 percent effectiveness".
The developers will await at least 150 confirmed coronavirus cases among those who received received placebo shots. When the number reaches 75, an early analysis would be undertaken.
If the vaccine is found to be 50 percent effective, then the company would apply for authorisation of emergency use. The blueprint also mentions that the 50 percent target is in accordance to the guidelines issued by the Food and Drug Administration (FDA) to the vaccine developers.