The major question on the issue of the authorization is centered around the point that the phase III trials of the vaccine have not yet been completed.
A statement from Bharat Biotech says the phase III human clinical trials of their vaccine COVAXIN began in mid-November to be done on 26,000 volunteers across the country. (Photo source: IE)
It is a vaccine that is supposed to be the symbol of an indigenous endeavour to combat a deadly pathogen. After all, the Bharat Biotech vaccine, COVAXIN is not just an example of a public and private partnership but is also about some leading Indian institutions coming together to solve a pressing health challenge.
On the one hand, there is Bharat Biotech that is a 25-year-old vaccine company with some well-known vaccines and on the other hand, there is India’s foremost public-health medical research body – the Indian Council for Medical Research (ICMR) along with the National Institute of Virology (NIV).
However, in question today is the recommendation for emergency use authorization of this vaccine by the subject expert committee of the CDSCO (the Central Drugs Standard Control Organisation) to the Drug Controller General of India (DCGI) that the company be given the licence to make vaccine for emergency use. This, after two days of deliberations.
While politicians have also got involved and it is getting the colour of political debate too with arguments that the vaccine’s emergency use approval has been arguably granted in haste. But then leaving that aside, here are the points that a cross-section of experts and medical professionals that Financial Express Online reached out to have been asking.
First, is the level of protection against the virus. We all have heard of statements like a particular vaccine is 95 per cent effective against COVID-19? This is meant to convey the level of protection that a vaccine provides to a person against getting the virus if he or she is exposed to it after getting vaccinated. Statements of such protection have been heard about Pfizer, Moderna, and the Oxford-AstraZeneca vaccines but not yet from Bharat Biotech apparently because the studies themselves have not yet been concluded.
The major question on the issue of the authorization is centered around the point that the phase III trials of the vaccine have not yet been completed. A statement from Bharat Biotech says the phase III human clinical trials of their vaccine COVAXIN began in mid-November to be done on 26,000 volunteers across the country. The statement does not say, how many of these were actually done so far.
This raises the question: How can two doses with a gap of 28 days between them be administered to over 20,000 people in a little over a month? Even at full speed, it could at best take two months and another month for collating and study of the data, which means not before the end of January 2021.
The statement from Bharat Biotech also adds that the vaccine has been evaluated in approximately 1,000 subjects in phase I and phase II clinical trials, with promising safety (read: reaction of the body to the vaccine) and immunogenicity results (amount of antibodies that get produced in the body), with acceptance in international peer-reviewed scientific journals. There is, however, no mention of protection and whether there are studies being made on this.
This raises a further question: On what basis has the subject expert committee recommended the emergency use authorization? Was it then issued based on the phase I and phase II studies?
Based on the above questions, the spotlight then shifts to the Indian drug regulator. If this is really the case then what picture does this project of the Indian drug regulator internationally? Because, if the Indian drug regulator is right in doing what it has done then what is stopping it from sharing the data in the public domain? It might at least help address the concerns and if all is well, put to rest all the controversy.
After all, Bharat Biotech’s chairman and managing director Dr Krishna Ella calls the emergency use authorisation, “a giant leap for innovation and novel product development in India.” All the more reason for all parties concerned to talk more openly about the vaccine and its approval process.