'Bn Doses Per Yr Capacity by Nov-Dec; No Comments on WHO Nod To Covaxin': Bharat Biotech's Dr Ella
'Bn Doses Per Yr Capacity by Nov-Dec; No Comments on WHO Nod To Covaxin': Bharat Biotech's Dr Ella
On India reaching the milestone of 100 crore Covid vaccine shots, the Bharat Biotech CMD said the country is now better prepared for the battle.

As India on Thursday crossed the historic mark of delivering 100 crore Covid vaccine doses, Bharat Biotech’s chairman and managing director Dr Krishna Ella in an interview with CNN-News18 gave credit to the citizens, scientists and media for making it possible. He also lauded the government’s CoWIN platform, emphasised that people should be careful around Diwali, clarified that no nasal vaccine for children was in the pipeline, and appeared positive on the matter of his company’s Covaxin still awaiting a WHO nod.

A big milestone today. 100 crore doses in 10 months. Bharat Biotech has made India’s first indigenous vaccine. What does this moment feel like to you and your company?

I think I’ll give credit to the people, the citizens of this country and I think they’ve behaved like the best citizens of this country. What is required in the pandemic, how to behave and how to respect the science and how to respect the vaccination is important. I think they deserve the credit. And certainly the political will because of which you can have a vaccine. If there’s no political will, then nothing can be done and I think that’s the second thing that has happened. The third is the media. The media has played a very important role. Vaccination has become a very important debate and discussion. People have become more aware of it…the importance of vaccination. I think the media has played an important role also in awareness creation. I think many media platforms have created good, positive stories. Some created negative stories. Doesn’t matter but it created a good science vibe around the people to believe in it. I think that’s important. I think the CoWIN software…we have to give due credit to that also, because in a country of this size if there is no CoWIN software, it’s a mess to keep documents of anything. Today, we have digitised the entire healthcare system. I’m looking at how CoWIN can be used for many clinical trials in the future. So there’s a lot of other applications that CoWIN can be utilised for. I want to suggest to the government that it can be used for a lot of chemical trials, efficacy trials. So this is amazing, and I salute the scientists of this country. During the pandemic, all scientists worked in manufacturing facilities. If they didn’t work, they would have not got the vaccine. So I think all the scientists of this country deserve the credit, including all the manufacturers.

When you fight a war of this magnitude, every effort counts. It shows the true character of a nation. So what is the next milestone that we are looking at? Are we on track to vaccinate the entire adult population by the year-end, as planned?

We don’t have to worry about it but we know how to handle the disease better now. So whether the vaccination is happening, the capacity is limiting or capacity is increasing, whatever it is but there are many new technologies coming like the nasal strategies coming in. So we are preparing for a better battle. We are better prepared than the general preparation for this year. So we will be well-prepared by December, well-prepared for a lot of other strategies, other technologies. In addition to that, you look at hospitals that are geared up now, so you are not going to have a major impact. What I only suggest to our citizens is let’s be careful about Diwali. Even Diwali we will pass through without much problem. I think we as a country will pass through. And I think that is a litmus test. Diwali time is going to be critical for us…what the disease burden is going to look like for us after Diwali. I think if we maintain certain social distancing and take precautions during Diwali time, we should be alright as the country progresses. But I think we are well-prepared, all the mini manufacturers bringing in different technology platforms…so we are well geared up by December, and I think the hospitals are also geared up also to handle the disease.

We are dealing with a very large population. Bharat Biotech had to rapidly ramp up production to meet the big challenge. Can you tell us how many vaccines Bharat Biotech has delivered and what is your goal, going forward?

See, we supplied around 18.8 crore doses to the government. This month alone we are supplying around 5.5 crore doses. For us, I can produce the nasal vaccine, 20 crores per month. Not a problem. But this takes time, this is a very complicated vaccine. So I always say, the vaccine requires three fundamentals. One, safety, safety, safety. You can have the best effective vaccine but if safety is compromised then it’s not a vaccine anymore. So it’s toxic. I think we have given importance to safety and it takes time but we will definitely, by November-December, reach 1 billion doses annualised capacity. As I promised long back…we reached that by November-December, we will reach an annualised capacity of 1 billion doses by November-December.

Now a question on behalf of all parents. Covaxin has become one of the first vaccines to have been granted emergency use nod for children. When do you think it will be ready for deployment? Is there a timeline? And do you think we would have vaccinated our children by 2022 so that schools and colleges can fully reopen?

I think the same adult vaccine is only going to children also. Absolutely the same. We have not changed the dose, nothing we changed. Because if I change the dose, then I have to do an efficacy trial again on children and it’s complicated. So that’s why we did the same dose, same thing in the children. Whether you get the same immediate response as adults, we checked it, everything is alright. Safety is extremely good, no problem. So that we have taken care of, the same vaccine can be given to children also. Whether I recommend…I am no authority to recommend, it’s the government, DCGI, the NTAGI committee. They have to recommend what is required. But you know, we are all going to movie theatres now and I want our children to go to school and enjoy school and interact with kids and fight with kids. I think that is required in the country. I think it’s definitely required, children are required. Many controversies also started: do children need a vaccine? I mean 2% maybe get affected, but there are a lot of asymptomatic ones. People have an infection but are not showing it. But people have not asked the question of whether they have 5% lung infection. When they are asymptomatic, there must be some effect on the children’s health also. Whether that effect will have a long-term impact, nobody asked this question. So people criticise that we don’t need vaccination for children. I’m not recommending them or advising. I’m only a scientist and, as a scientist, I look at it that children also require vaccines. The reason is if this 5% of infection of children can also have a long-term impact, whether they get bronchitis, asthmatic or other problems, we don’t know what will happen in the future. They can also carry the virus to their home. So that’s all. The government has to make a decision and we’re also looking at alternative strategies to bring our nasal to adults, not children so that one Covaxin dose could be reduced and that one dose can go to children.

But a nasal vaccine for children is not something you’re looking at. A lot of people are saying that instead of injection, a nasal is easier for children. When do you think it will be deployed? When do you think the first kid will be inoculated?

I don’t know about the NTAGI committee recommendation, Government of India’s advice and DCGI’s licence. We still have not got the licence. We are waiting for the licence. Once that comes, the government has to make the decision.

But nasal vaccine for children is not what you’re looking at right now?

We have not done any clinical trial on the nasal on children. We have done it for those above 18 years. But if the nasal works on adults, Covaxin could be released for paediatrics.

We are still waiting for a WHO nod for Covaxin. Why is it taking so long?

I don’t want to say anything on the regulatory issues. But we have six vaccines that have qualified in the test. So, it is not that we are not familiar. We have done a clinical trial in the UK also. We have got US FDI approval. We have done a phase 1 trial in the US on children. We have expertise in trials in other countries. We have an understanding of the regulatory system. So, just a process going on. Just wait and see what happens.

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