New Delhi: India's attempt to bring the indigenous COVID-19 vaccine by August 15, is facing a roadblock as only five clinical sites out of 12 have got the approval from the ethics committees as of now.
According to reports, the approval to seven more clinical sites are yet to be given by the concerned ethics committees. Interestingly, ethics committees of AIIMS and Visakhapatnam-based King George Hospital are hesitant in giving approval for the clinical trials, after they found discrepancies in the protocol submitted for trials.
Read: Bharat Biotech begins registration for clinical trial of COVAXIN
The trials cannot start without the approval of the ethics committees. Five ethics committee including Gillurkar Hospital Ethics committee (Nagpur), Institutional Ethics Committee, (AIIMS-Patna), Institutional Ethics Committee, (IMS & SUM Hospital-Odisha), Institutional Ethics Committee, SRM College Hospital and Research Centre (Tamil Nadu) and NIMS Institutional Ethics Committee (Hyderabad) are still reviewing the protocol.
Sources told ETV Bharat that these five ethics committee are evaluating the total design. The absence of the child assessment document in the protocol may delay the trial further. The phase I and II trial will have volunteers between the age group of 12-65.
Read: Aug 15 target for COVID-19 vaccine launch 'unfeasible', claims Indian Academy of Sciences
The Indian Council of Medical Research (ICMR) DG Dr Balram Bhargava recently in a letter said that after phase I and II trial in five different clinical trial sites, India will have its first indigenous COVID-19 vaccine by August 15.
Leading vaccine maker Bharat Biotech recently initiated registrations for the clinical trial of COVID-19 vaccine 'COVAXIN' at the National Institute of Virology (NIV) in Hyderabad.
The preclinical studies demonstrate safety and immune response. Under the preclinical trial, scientists give the vaccine to animals such as mice or monkeys to see if it produces an immune response.
However, in a pandemic situation, a vaccine may receive emergency use authorisation before getting formal approval.
Referring to the ICMR's letter which states that it is envisaged to launch the coronavirus vaccine for public health use latest by 15th August, the Indian Academy of Sciences claimed that the ICMR's target to launch a vaccine by August 15 is "unfeasible" and "unrealistic".
Notably, the ICMR and Bharat Biotech India Limited are jointly developing the vaccine.
