Hyderabad: 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.
Telangana State Pharmacy Council member and senior pharmacologist Dr Sanjay Reddy said, "The animal study results were encouraging. For human trials, the time limit has caused worry. Humans are different and every human body has a different reaction. These results are usually recorded over a period of time. Efficacy studies are derived based on reaction on 80 per cent of trial subjects. Our scientific evaluation must be the basis for launch of the vaccine."
There are 11 different strains of the virus in India. The question is which inactive strain will be used and whether that particular strain will work to create antibodies for all the other existing strains.
Human trials usually take one to four years to complete.
The vaccine experience in India has been satisfactory and there is thus some euphoria that a preventive measure against COVID-19 is in the offing.
A senior scientist, speaking on condition of anonymity said, “The work taken up by Bharat Biotech is scientific. The ICMR must support and not pressurise them to deliver within a time frame. This (timeline) will put a lot of stress on scientists who have to check and re-check at different levels."
He said that till last year, human trials were not allowed expeditiously in India and scientists had very minimal subjects. "Now we want subjects to come forward for trials but do we have a conducive environment for it? Let a proper scientific method be followed that will add confidence in the vaccine development programme and help us opt for many other drugs which require research and innovation in India."
Bharat Biotech has refused to comment on the deadline.