Clinical trials for Oxford vaccine have been put on hold in India
Q. Why is this in news ?
SERUM INSTITUTE of India (SII) on Thursday said that it would pause the ongoing clinical trials in India of the Covid-19 vaccine candidate developed by the University of Oxford.
The move follows a show-cause notice issued by the country’s drug regulator (ICMR) to the Pune-based company over a single adverse reaction that was detected at one of the global trial sites.
Q. What is this vaccine?
One of the most closely watched candidates globally,AZD1222 vaccine works on a mechanism that uses a weakened common cold chimpanzee virus to carry instructions to make part of theSARSCoV-2 virus like a Trojan horse.
Once injected, the virus will infect a cell and tell it to make the spiky outer layer Of the virus, known as the ‘spike protein’—the part of the virus that allows it to infect humans in the first place. The body’s immune system is expected to recognise this spike protein as a threat and develop antibodies to fight it so that it will be ready to defend against the real virus.
Q. What progress had been made in Testing in India Before the halt was announced?
While global trials started in the UK at the end of May and have since been underway in countries like Brazil and South Africa as well, the India trials started on August 26.
The vaccine here is in phase2 human trials, where it is to be tested on 1,600 volunteers to check how effectively it helps the body develop an immune response.
Q. Why has SII paused the trials?
The development stems from a decision by AstraZeneca to temporarily halt the global trials of this vaccine candidate after a volunteer developed a “potentially unexplained illness”.
The volunteer reportedly was enrolled in the UK arm of the trials and had reportedly developed a serious spinal inflammatory syndrome called transverse myelitis.
The pause, which means that the trial sites would not vaccinate any more participants for the time being, was to allow an independent committee to review the safety data from the trials and to ensure that this “single” incident was not caused by the vaccine.
