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'I would go for Bharat Biotech's Covaxin and not Covishield, and that is my personal judgement since at least 11,500 have got at least one dose by now and it has proven to be safe.'
Emergency authorisation at a time when the pandemic is still raging has to prioritise safety of the vaccine, says Dr Jacob John, former head of the Centre for Advanced Research in Virology at the Indian Council of Medical Research.
While a controversy has broken out that the Bharat Biotech vaccine, Covaxin, has been given restricted use approval without efficacy data being available, Dr John tells Ruchika Chitravanshi that given the circumstances, there were strong ethical considerations on both sides of the decision.
What do you think of the approval given to Bharat Biotech's vaccine?
The authorised regulator did not decide on its own whether to give the approval or deny it.
It asked a committee that had subject experts who sat long hours and discussed at length the data provided to them.
As far as the decision to give emergency use authorisation goes, the regulator goes through the pros and cons.
The pros have been discussed to everyone's satisfaction before the approval is given.
The people sitting on these committees are not ignorant.
They are taking a tough decision for the whole country.
There is no efficacy data available for this vaccine. Isn't that a concern?
I am not worried about the efficacy.
All vaccines are using some spike protein antigen.
Bharat Biotech has shown immunogenicity in phase one and two.
The Serum Institute is also looking for immunogenicity and not efficacy at this stage.
Bharat Biotech has given data for a huge number of volunteers.
Starting November 16, over 22,500 volunteers have received their first dose of the vaccine or the placebo.
Some have received the second dose as well.
There must be reasonable safety data available with the company.
What is the significance of no efficacy data?
Rule of emergency use is safety first.
Efficacy is a promise for the future.
If efficacy was proven, then what stopped them from full registration of the vaccine?
Why go for emergency approval then? The government will decide who can get it in an emergency situation.
Private citizens may not be eligible.
Once a national agency has made a tough decision, I will not criticise it.
For people who are at severe risk of coronavirus, protection delayed could be protection denied.
A person may die waiting for the perfect data.
There are ethics in both approval and disapproval.
Don't think disapproval has no ethical issue. Perfect should not become the enemy of the good.
Globally, has any vaccine been approved without the efficacy data?
In India, this is the first such emergency use.
But we are in the company of China and Russia. Russia had given emergency authorisation without efficacy data.
Bharat biotech has received approval for restricted use in public interest in a clinical trial mode. What does that mean?
The language seems to suggest that a person who gets this vaccine will become part of the trial.
Such a person will not be given a placebo but the actual vaccine.
And this group of persons may or may not be balanced by a group which will get the placebo.
This could mean that the government will not buy their vaccine and the company may be allowed to use it in a restricted way for health workers etc.
Bharat Biotech needs to clarify this.
Serum Institute of India has said that the Oxford-AstraZeneca vaccine is 70 per cent effective. How do you see their candidate?
SII is looking at 1,600 subjects.
Their study has three arms -- one, getting the placebo and the other two getting Covishield and AstraZeneca's vaccine.
The latter two are like step brothers with the same father.
You cannot talk of efficacy on such a small subject group.
The expert group has looked at one vaccine's performance in the UK and the data available in India and has decided that they will bend over backwards and accept their data as they are brothers (developed using the same formula).
Given a choice, which of the two vaccines would you take?
I would go for Bharat Biotech's Covaxin and not Covishield, and that is my personal judgement since at least 11,500 have got at least one dose by now and it has proven to be safe.
If the drug controller believes it is safe, then I would too.
The Serum Institute's vaccine is probably safe.
There have been one or two episodes of neurological problems and one such case in India also.
If it is not related to the vaccine, you will not expect neurological problems in all three.
I am simply asking a question: Can you confidently exclude the link between the vaccine and the neurological symptoms? It could have been a gastro-intestinal or any other problem, but all issues relate to the central nervous system.
It alerts my mind's antennae.
I will think twice before taking their vaccine.
But if no other option was available, then vaccine is far safer than getting Covid.
Feature Presentation: Aslam Hunani/Rediff.com
