As government prepares to launch the vaccination drive against coronavirus on Saturday, Bharat Biotech chairman Dr Krishna Ella said India can expect interim efficacy data on its vaccine once the trials are completed.
In an interview to CNN-News18, Dr Ella and Bharat Biotech co-founder and joint MD Suchitra Ella talked about the efficacy data, Covaxin's availability in markets and its effectiveness against the new coronavirus variant. They also hit out at critics who have raised questions about Covaxin and have said those taking Covaxin are guinea pigs
Did you expect to deliver the vaccine in such a short span of time?
We didn’t expect. The pandemic made us do it.
When I interviewed you last year you said you will not give a date. This feat has been achieved in less than a year.
It is historical -- a learning curve for all of us, that this can be done. There will be more pandemics. This has shown how the manufacturing capabilities have built. Global health has transformed because of the pandemic.
Questions have been raised on efficacy. What is the data you have right now?
I don’t have this data now. What I have no one will talk about. What I don’t have they will keep talking. In public health, it is important to know what I don’t have. But there is a process to this. This data is on its way. Phase III trials are going on. This sort of trial – 26,000 volunteers involved is a huge number. This has never happened. But there is not one word of appreciation for that. It is not easy to capture the efficacy now. It is easy to capture efficacy when there is a high disease burden. Neutralisation of antibodies are important. In early days, there was no efficacy. There was neutralisation antibodies, to see the virus gets choked and doesn’t multiply. That’s the concept. My feeling is that WHO in the next few months may ask for correlative protective response. If that happens our phase III trials will end faster.
We have good animal challenging data. Monkeys are closest to human beings. We have that data. We give the vaccine, after 30 days, spray the virus in the mouth and check if the animal is protected or not. That’s an efficacy. We have done it. I have phase I and phase II immunogenicity data, neutralising antibody data. That they should look at.
When do we see wrapping up of phase III trials?
First week of February we will see the end of giving the second dose of the vaccine. After 15 days, we will start monitoring the disease birder. Once we have 46 people infected -- whether placebo or vaccine, we will have interim data. It depends on the disease burden.
Dr Suchitra Ella: These are live scenarios. It has to go through a timeline. We are not fast tracking anything. These are highly compressed timelines. We have never done this kind of fast tracking except once which was for H1N1 flu which was also a pandemic in 2009. Under normal circumstances this doesn’t happen.
Market authorisation is something you will seek for bringing this vaccine to the market after wrapping up of the trials?
If WHO gives out what is the correlative protective responses. If they come out by end of February or March, I can get licensure. When my phase III data opens up, I will have efficacy data. This might allow me approval.
What about the timeline? Should that happen by March?
Suchitra Ella: We can’t put timelines to this.
The government said it is giving an approval to Covaxin because it acts against the B.1.1.7 variant which has more transmissibility? What is the data?
Dr Krishna Ella: We don’t have this. NIV Pune has it. So ICMR will put that out. We have sent our material to the NIV. DG-ICMR a will disclose this in a day or two days.
Do you have any reason to believe that this is a vaccine which is acting against the whole of the virus?
Yes I do. An inactivated vaccine is exactly like a virus. It’s not live. It can’t multiply. You inject it in the body, the body thinks the virus has come and it produces antibodies in different regions. It can produce antibodies to all the four proteins. So we expect multiple antibodies will be good and will protect against the other variants.
Prices of the vaccine will come down eventually? What will be the factors for this?
Purely supply and demand will determine. Also market competition and technological changes. In the vaccine field, when you scale up capacities the prices will drop. We will depreciate in two or three years -- the price will drop again.
Some political leaders said take Covaxin and you are a guinea pig. What do you think about these statements?
Dr Ella: Are my staff, my scientists also Guinea pigs? They are working with live virus in our BSL 3 facility. This is a risk. Are we not taking a risk? Leaders should recognise what we are doing is not for money. In the US, they started animal and human trials started together. Are they guinea pigs?
What about states who said do not send me Covaxin?
Suchitra Ella: It is for reasons best known to them. Maybe they need to recognise the scientists and clinical research. They brought back a live virus from Pune to Hyderabad crossing three states. It took them three days to take back to the facility. The strain came from NIV Pune. And that’s how we started to develop the vaccine.
This shows they are not appreciating the need to make people safe. People have been locked up at homes and we hear stories of how people are suffering. There have been social concerns. The whole world knows this. I leave it to these states to decide. We will go by what the Government of India says. We supply half a dozen vaccines to the GOI for the national immunisation programme and these are vaccines that all these states take.
Dr Krishna Ella: We are transparent. Our data is open. If you still don’t trust then what do you trust? Don’t drag us into politics and political ideology. We are scientists.
You tested the vaccine on children in phase II trials. Tell us what is the data you have?
In Phase II trials, we included (children) of the age of 12 and above. Now we will submit protocol for two to 14 years. The existent vaccines in the market place now can’t be given to less than 16 years. We feel strongly that our vaccine can be given to children as old as two. Because this is the same platform that is used for new babies, like injectable polio vaccine and Japanese Encephalitis. We don’t have data yet but we will be submitting soon a permission to start phase II and II for trials in children
Children as young as two?
Yes. We will submit. Let the SEC review. Let them decide if two is too small.
Last time I spoke with you, you said you want a vaccine like polio drops -- that was your vision. Are you closer to that vision? What is happening with the nasal vaccine?
We are the first in world to bring the rotavirus vaccine as a five-drop concept. This is a simple delivery system. That is what enthused me. We should think of a simple delivery system. Secondly, there is science backing this. All injectable vaccines will not prevent the transmission of the virus. Only nasal vaccine will give you protection in the upper lungs. This will bring herd immunity faster. You will get sterilising immunity and you won’t have lungs infected by the virus. And there is publication to this effect.
You were hoping for indemnity on the vaccine front. Are you disappointed that you haven’t got it?
Suchitra Ella: It is not playing a major role in our minds as of yet. It is for the national agencies and government to take a call. We will continue to do our work.