Oxford Covid-19 vaccine trials may resume in India in 3 days

PUNE: After safety watchdogs in the UK cleared concerns, human trials of the Oxford University Covid-19 vaccine candidate in India are expected to resume in three days, top officials from the Indian Council of Medical Research confirmed on Sunday.
The late-stage trials of the vaccine were temporarily put on hold globally following a reported side-effect in a UK patient.

On Saturday, British drugmaker AstraZeneca said it was restarting the advanced human trials of the vaccine candidate it has developed jointly with the Oxford University.
The UK development has offered relief to Indian investigators involved in conducting the human trials of the Oxford vaccine which will be manufactured by the Pune-headquartered Serum Institute of India (SII) under the name Covishield.
“By Wednesday, all processes in terms of reviewing the UK trials' vaccine safety data will be over. After receiving the green signal from the Drug Controller General of India, the trial will resume across 17 trial sites in India,” a senior ICMR official requesting anonymity said.
The council is supervising the Oxford University vaccine trials in the country.
The review of the safety clearances from Data Safety Board of India in India as well as the UK board is paramount to restart the vaccine trials, the official said.
A total of 17 trial sites across the country are involved in conducting phase 2 and phase 3 human trials of the vaccine among 1,600 healthy adult volunteers.
The trial sites are currently awaiting the go-ahead to move into phase 3 testing of the vaccine.
A total of 100 volunteers have already received the trial dose of the vaccine in the phase 2 trials and none of them have reported any adverse reactions, so far.
“As I’d mentioned earlier, we should not jump to conclusions until the trials are fully concluded. The recent chain of events is a clear example of why we should not (have a) bias (towards) the process and should respect the process till the end,” Serum Institute of India CEO Adar Poonawalla tweeted on Saturday night after the announcement.
The SII said that it would resume trials “once DCGI will give us the permission to restart the trials in India”.