covid vaccine

 


Serum institute of india on wednesday said that ongoing clinical trials in india for covid-19 vaccine, developed by university of oxford & astra zeneca, will countinue not be affected by astrazeneca announcement of putting trails on hold due to adverse recation seen in vaccinet trail participant in UK.

None of the participant in the indian leg of the vaccine trails being carried out by serum have faced any problems, the company said. serum is partnering with astra zeneca to carry out trails and manufacture the covid-19 does in india at its pune facility.



But ICMR scientist tarun bhatnagar said as this was multisite trail, whoever decision was taken by the company at one site should be applicable to all, and this would have an impact on the trail in india.

However, there are no details available whether the adverse reaction  was related to the vaccine and the trail has been stopped to find that out, Bhatnagar said.

''If the link between the vaccine and the reaction is established, we need to understand if similar adverse event could happen in the indian population or was it related to specific population,''Bhatnagar said.



The oxford vaccine consist of two doses and the second doses is taken 28 days after the first shot. There is no official decision yet as all details are not known about the adverse incident, Bhatnagar said.

Commenting on astra zeneca's decision halt the trails in the UK, a serum spokesperson said,'' we can't comment much on the UK trail, but we have paused for future review and hope to restart soon. As far as the indian trail are concerned,it is continuing and we have faced no issues at all.



Meanwhile, late on wednesday, central drug regulator DCGI issued a show-case notice to serum for not informing it about astra zeneca pausing the clinical trails of the oxford vaccine candidate in other countries and also for not submitting casualty analysis of the ''reported serious adverse event''.

Serum said in its response: we are going by DCGI's direction and so far were not told to pause the trails. If DCGI has any safety concerns, we will follow their instructions and abide by the standard protocols.''



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