Belagavi(Karnataka): The COVID-19 pandemic has affected all sections of people and has effectively taken away productive months from the year 2020, adding misery to the wounds of the highly vulnerable.
As the search for vaccine intensifies across the globe, India's indigenous vaccine candidate-Covaxin is currently in clinical trial phase across several medical centre's in India.
According to reports, Jeevan Rekha hospital in Belagavi has started the clinical trials on doctors and staff members. The process is being monitored by the Indian Council of Medical Research (ICMR) and Bharat Biotech International Ltd, the leading vaccine maker behind the drug covaxin.
The hospital will send out invitations to 150 to 200 volunteers willing to take up injectable doses of the vaccine. They will be closely observed. The drug’s effects on them will be recorded and shared with ICMR. That will be considered before recommending general usage.
Read: Trial for indigenous COVID-19 vaccine faces roadblock
The phase-I clinical trial would go on for 28 days, after which the ICMR and the Drug Controller General of India (DGCI) would accord permission for Phase-II trial with more subjects.Phase-1 would have around 375 subjects across the country and Phase-II 875.
Jeevan Rekha is one of the 12 hospitals and health centers in the country chosen by the Union government for clinical trials of the vaccine, whose technical name is the BBV152 COVID vaccine.
Read: Bharat Biotech begins registration for clinical trial of COVAXIN
In a letter to the heads of the selected institutions last week, ICMR Director General Balram Bhargava asked them to fast-track all approvals related to the initiation of the clinical trials and ensure that the subject enrollment is initiated no later than July 7.
While experts raised doubts on the August 15 target, the ICMR defended it, saying its process is in accordance with the globally accepted norms to fast-track vaccine development for diseases of pandemic potential.
Read: NIMS begins subject registration for corona vaccine's clinical trial
The research body said the Director's letter was intended to cut red tape, without bypassing any necessary process, and speed up recruitment of participants for human trials so that these phases can be completed at the earliest.
The Drug Controller General of India - Central Drugs Standard Control Organization (CDSCO), Ministry of Health & Family Welfare granted permission to initiate Phase I and II human clinical trials after the company submitted results generated from preclinical studies, demonstrating safety and immune response.
