Dr T. Jacob Johan, an eminent virologist and former professor with Vellore Christian Medical College speaking to media said, “the coronavirus epidemic seems to be nearing its end and is likely to transition to the endemic phase in a month or two”.
Answering a question on what the need of the hour is for a country like India when it comes to vaccination, he said, “Had India planned well, beginning in February-March 2020, we could have used a vaccine to curtail the epidemic. Now curtailing the epidemic is not the need of the hour, but preventing death due to coronavirus is. Those who are at risk of death are the immediate priority for vaccination. The second need is to prevent coronavirus in those with comorbidities. Another challenging need is for a plan for the elimination of the virus from the country, through vaccination, as a model for global eradication. That requires vision and courage of conviction.
An obvious need for early vaccination is to reopen educational institutions urgently, with vaccination of all staff and protection of aged parents and grandparents of students.”
Replying to a question on whether there is a possibility of more strains of coronavirus evolving, Dr Johan said, “That possibility is real and the best way to counter it is to get rid of the current strain globally.”
He added, “So far no second “strain” has emerged but there is no guarantee one or more may not emerge. That is all the more reason to plan for elimination/eradication. So far all mutants seem to be covered by the immunity induced by vaccines.”
Giving his opinion on the process of approval given to Bharat Biotech’s Covaxin and controversies surrounding it, Dr Johan said, “I understand that many experts are confused, and that is understandable, given the words used by Drugs Controller General of India (DCGI ) – ‘Restricted’, ‘Emergency’, ‘Trial mode’. The Ministry of Health is planning to roll out Covishield rather liberally. Covaxin will be restricted and only Emergency Use Authorisation is given to it”.
Further, replying to a question on why a vaccine has been given emergency-use authorisation without efficacy, the expert said, “If efficacy data were available and above 50%, the Covaxin vaccine would have been eligible for full registration. If the efficacy data was demanded, the trial code had to be broken to provide it. This is under the purview of the Data and Safety Monitoring Board (DSMB). Emergency use authorisation is dependent on clear evidence of excellent safety and promise of reasonable efficacy as indicated by Phase 2 immunogenicity results. Obviously, DCGI was satisfied on both counts. The vaccine is not very “reactogenic”- an expert said it is as non-reactogenic as water. I understand some 24,000 trial participants had been inoculated with the Covaxin vaccine or placebo. The safety seems excellent- if the Bhopal case of death was unrelated- as it appears to be. I should think the DCGI did not ask for the code to be opened to know if the person got a vaccine or placebo. Once the company applied, DCGI may not have had any reason to deny it”.
ON CONGRESS’ QUESTIONS ON BHARAT BIOTECH VACCINE
On Saturday, Congress leader Manish Tewary asked whether the Bharat Biotech vaccine is safe for human use and whether the government can guarantee both its safety and efficacy.
To this, Dr Johan said, “It was DCGI, an autonomous body, that gave emergency-use authorisation (EUA), not the government. Since efficacy evaluation was not completed, EUA was given but the vaccine was not given registration. DCGI must have been reasonably sure of safety and hopeful of acceptable efficacy (will be known for sure after Phase 3 trial is complete and data analysed). I do not think that the government has the power to guarantee anything but when DCGI gives EUA the government is guided. EUA demands safety data but not quantitated efficacy”.
COVAXIN OR COVISHIELD?
When asked to chose between Covaxin and Covishield, Dr Johan said, “If I have equal access to both vaccines, I will prefer Covaxin over Covishield. If only Covishield was available I will take it. One reason is that with available information, my confidence of the safety of Covaxin is higher than that of Covishield. However, for me, the risk of coronavirus is greater than that of the vaccine’s adverse reaction.”