The fast-tracked clinical trial of BBV152, or Covaxin, a COVID-19 vaccine developed by Hyderabad-based Bharat Biotech, with a timeline of 38 days set by Indian Council of Medical Research (ICMR) for human trials, has raised concerns over whether it can be carried out in such a short time when vaccines typically take several years to come to the stage when they can be dispensed to the general population.
ICMR has stated that human trials must start on July 7 and be completed, and the data evaluated, so that the vaccine can be launched on August 15. Independence Day is being seen as a date for independence from SARS CoV-2, the coronavirus strain that causes COVID-19.
The scientific community and researchers in pharmacology are divided over the time period set for completing human trials.
Covaxin has been developed by Bharat Biotech in collaboration with ICMR and the National Institute of Virology (NIV), Pune, by taking an inactive strain of SARS CoV-2.
The inactive strain methodology is similar to that used for the polio vaccine. The inactive strain, when injected into the human body, allows for development of antibodies that will help fight the virus.
This is an ‘immunity booster’ and protects against the virus. Animal research studies of Covaxin were carried out on monkeys and, according to sources, there was 96 per cent efficacy.
This has paved the way for the next stage, human trials. Twelve institutes across the country have been identified for the trials, and they have been asked to enrol human subjects before July 7 to complete trials on a ‘priority basis’.
Nizam’s Institute of Medical Sciences (NIMS) in Hyderabad is one of the institutes where human trials will be carried out.