Hyderabad: The ideal time period required for the development of a vaccine is two and a half years. In the fast-track mode, it will take eight months to a year for completing the process of clinical trials, data testing, accuracy and efficacy of vaccine, experts say.
Human trials of the inactivated BBV152 or Covaxin, a vaccine candidate being developed by Bharat Biotech along with ICMR and the National Institute of Virology, Pune, that begin on July 7 will be required to follow these processes. The globally accepted ‘fast-track mode’ allows for eliminating one or two steps that are repetitive in nature but does not allow for any process or data to be sidelined.
The adverse effects of vaccine, discrepancies in human body reactions and antibody studies will make the basis of going forward in every step.
All of this may not be completed in the 38-day timeline set by ICMR, and may put paid to its plan of secure a vaccine by August 15, Independence Day. Animal studies of Covaxin have been encouraging and that has given confidence for human trials but there cannot be over-confidence, warn scientists who are keen that scientific norms cannot be bypassed.
Dr Rakesh K. Mishra, director of the Centre for Cellular and Molecular Biology in Hyderabad said, “If everything goes absolutely as per textbook plan we have six to eight months for a vaccine. We must also remember that the number of people enrolled must be high as that will give us better data analysis. At the same time, there are different strains and whether the vaccine candidate works for all the strains needs to be evaluated.” The efficacy of the vaccine will be derived on its ability to create antibodies, how it works on different virus strains and if it will work on all humans is what the researchers have to look for.
Dr Ahmed Kamal, formerly a scientist at the Indian Institute of Chemical Technology, said, “We have to evaluate the risk versus benefit situation in development of a vaccine. While the processes must be followed there is now an opinion that fast-track methods will help. If we can protect the maximum population without causing harm, the benefit is a priority in these times.”
Processes which take time and require cross-verification can be expedited and more resources must be put in place, urge scientists from different sectors. The confidence of the people to opt for vaccine will come from safety standards that are followed.
A senior scientist said, “Safety is a priority for all of us. In making a vaccine it must be protection from the virus and not creation of another problem. This aspect must be kept in mind. Hence it is a responsibility on all of us and fast track methods require double protection schedules and alertness.”...