Indian Council of Medical Research (ICMR), has designated 12 institutes across India for carrying out “Pre-clinical and clinical trials of Covaxin”, developed by Bharat Biotech International Limited (BBIL). ICMR has partnered with BBIL for the pre-clinical and clinical trials of the indigenously developed vaccine candidate.
It has advised the designated institutes to fast track all approvals related to the initiation of clinical trials and to ensure that subject enrollment is initiated no later than July 7. Considering it as the “top priority project”, ICMR has expressed its interest to launch the vaccine for public use by August 15. Which attracted the concerns expressed by medical experts relating to the non possibility of such an early launch of the vaccine. Later ICMR has issued a clarification saying the letter was meant to ‘cut unnecessary red tape’ and speed up recruitment of participants for trials without bypassing necessary process.
King George Hospital (KGH)- Andhra Medical College (AMC) being one among the 12 institutes designated by ICMR, has ‘not yet started the trials’ as they are awaiting for the State Government permission. The volunteer enrollment process did not start yet. All the required information which was received from ICMR and BBIL has been sent to the government and no guidelines were received from them till now.
Inputs from Praveena Mandapati