'No one is saying the vaccine is unsafe'

'Nobody is attacking the company or the vaccine.'
'The concerns are about the process and the lack of transparency.'

"What is troubling is, why are we making the entire process opaque? It would help to have much more transparency," Dr Anant Bhan, former president, International Association of Bioethics, tells Shobha Warrier/Rediff.com in the concluding segment of the interview.

• Part 1: 'We really need to know what they mean by clinical trial mode'

Some surveys have found that there is a vaccine hesitancy in India.
By giving authorisation to vaccines like this, won't people get even more confused, and even more hesitant?

I think it is already happening -- increasing confusion and anxiety about vaccines.

There is confusion among health workers also as to which vaccine to choose if there is a choice.

They wonder whether they know enough about whether these vaccines have gone through adequate checks and balances.

There are also many such questions raised at various levels.

The best way to approach this is to come out in the public domain and satisfy everyone by answering all the doubts.

They can put out a detailed note on what made them take such a decision, and clear all the doubts.

That will help clarify all the concerns.

In the absence of that, some health workers who are the first priority group to get the vaccine, may feel hesitant.

The way the approvals were given might not impart confidence to them.

Many scientists felt the SEC document did not explain properly.
You also tweeted that no one could decipher what it intended to say...

Yes, the document was very confusing.

The cryptic language they used added to the confusion.

Earlier we had vaccine nationalism of one kind.
Is not what happened now in the name of Aatma Nirbhar Bharat another kind of vaccine nationalism?
Don't you think public safety is being compromised in name of nationalism?

I hope not.

I am not interested in the politics behind all this.

What I am interested in is science.

There is a pandemic and you need to make decisions based on sound data and evidence.

That is what is important here also.

All the questions that have been raised by scientists are about lack of data and rationale for the regulatory decision in the public domain.

Where is the data, and on what basis are you making these decisions?

Regulators have given permission to Pfizer and Moderna based on the data provided by them and this is in the public domain.

That makes it easy for scientists to independently assess the data.

These decision-making processes of regulators such as the US FDA (Food and Drug Administration) are also conducted in the public domain through live-casting key decision meetings.

What is troubling is, why are we making the entire process opaque?

It would help to have much more transparency.

I don't think we need to hide anything.

But why are they following these kinds of practices?

Hiding something is not in public interest also.

The question that is being asked is, why the hurry in giving nod to Covaxin?
Why didn't they wait till the Phase 3 trial was over?

Yes, the rationale behind the decision is unclear.

When the efficacy data is not available, on what basis did they make the exception?

You need a much more detailed explanation and a strong argument but that is not provided.

Dr Krishna Ella of Bharat Biotech has argued that it is being targeted because it is an Indian company and the criticism was unwarranted.
Do you feel that way?

Scientists are trained to be sceptical.

They are trained to question.

That's part of being a good scientist.

All of us are strong supporters of Indian science, Indian innovations and Indian vaccines.

Having said that, it is in the interest of the company as well to clear the confusion.

Nobody is attacking the company or the vaccine.

The concerns are about the process and the lack of transparency.

No one is saying that the vaccine is unsafe.

That's not the debate.

The debate is on when decisions of this kind are taken, why is there not much information available in the public domain?

It is also important to take decisions like these based on sound data on efficacy and safety, and ensure there is full confidence in the regulatory processes.

• THE WAR AGAINST CORONAVIRUS

Feature Presentation: Ashish Narsale/Rediff.com