Adar Poonawalla, Health News, ET HealthWorld

In March, we wanted extra capacity to come about for India and global capacity has been pushed back because of the fire by two and a half months which is why in June –you will get that additional 40 to 50 million doses per month coming up, says Adar Poonawalla, CEO, Serum Institute of India. Edited excerpts:

Tamanna Inamdar: There is a request from Maharashtra to increase vaccination for age 25 plus, Delhi wants to vaccinate all adults. The question is do we have that many vaccines? Can you give us a sense of what capacities we have right now?
Adar Poonawalla: If we just go back to the role of what Serum Institute has to play is that of a global vaccine supplier. I have got heads of States of every country requesting the Indian govt and Serum Institute of how we can supply vaccines to them which we have been doing, but now with the surge of cases and the legitimate requirements of the people of India– the Modi government and Serum Institute have agreed along with other vaccine manufacturers to prioritise temporarily the needs of India before anything else.

Now coming to your point of questions of the request made by individual states, as the health secretary of our country also mentioned that we have to cover the vulnerable first whilst also trying to find ways of cutting transmission etc. etc. Now, do we have enough vaccines to cover everybody —absolutely not, nobody in the world has it, no country has it, we do not have it because you are talking about 1.3 billion people multiplied by two.

We have a capacity of 60 to 70 million doses which we hope to ramp up in the next 2-3 months partly with the government proposal and through borrowing money from banks to build an additional plant and facility that will take at least three months to churn out product. In the interim we are relying on our existing capacity and other vaccine manufacturers in India who will also supply some doses so this is where we are at the moment. Opening up more than this age group of 45 is a very tough decision to make– there is no right or wrong answer. Right now, we have to go with what we have in hand which is the vaccine supply and vulnerable people that you have to protect before the younger population.

Tamanna Inamdar: In previous interviews – you talked about 60 mn capacities that you were hoping to increase to 100 mn by February. What are the causes of delays that we are seeing and do you have a timeline in mind for when these new capacities can be added?
Adar Poonawalla: At that time when we had the fire incident, we said the existing vaccine capacities would not be affected. In March, we wanted this extra capacity to come about for India and you know global capacity has been pushed back because of the fire by two and a half months which is why in June –you will get that additional 40 to 50 million doses per month coming up.

Now, we are trying to claw that time back as much as possible but it is the 85 days cycle from the time to start manufacturing. If we start today, it will take us three months from today to deliver those doses in a filled, packed, tested form which can actually go out to different states. We never imagined that we will need so many doses in India because we did not imagine this kind of surge happening from where new challenge is coming. We hope to launch our Novavax product -which is called Covovax by September so this is where we are at the moment.

Tamanna Inamdar: I just want some clarity on supplies of raw materials from the US as there were reports earlier this month that SII has written to the government about raw materials not coming in as expected. Is this still the case?
Adar Poonawalla: Yes, this is one of the reasons as to why the delays are happening and more so for Covovax than Covishield. If we do not get those critical raw materials by this month onwards, we are actually losing capacity, we would be only able to produce half of what we can and this also ties into the fact that when I had said in May-June– we can make 100-110 million doses that was also including certain volumes of Covovax.

I have done whatever I can -including the Indian government which is helping us trying to explain this situation to the US government. We are going to see that is impacting our production from April onwards and you know the obvious question is whether there are other people who can make these raw materials –the short answer is yes, but that takes six months to implement in your process, validate it and show that your final product remains unchanged.

While we are addressing that issue in the medium to long term, the crunch is that we need more doses in the next three months because after that anyway you are going to see more vaccine supply coming from us and from other companies, the real emergency is for this situation right now– for the next three months.

Tamanna Inamdar: If we do not get these raw materials and this does not get resolved in a month–will this start impacting the production of Covishield as well?
Adar Poonawalla: It is very marginal on Covishield so I would say no, the main scaling up of Covishield is depending on us being able to use an additional facility which was never planned for Covishield which we can scale up by June. Covovax is what is going to be impacted and it does matter because what we would have in the months of April, May, June is now going to be affected because ultimately all this volume would have come to India and other countries and that gets affected.

Tamanna Inamdar: You have said this before that you are not looking at as manufacturer of this vaccine, you are doing this to save lives but the fact is that this is a business that requires investments. Is there enough incentive right now for you to ramp up capacity with the vaccine prices being capped at Rs 150?
Adar Poonawalla: So initially, when this was agreed between vaccine manufacturers and the Government of India –we have done it with the view that we need to support India during this crisis and profits can be made after few months when it opens up to the private market. Right now, we need to support the Modi government in this Herculean task of vaccinating everybody and protecting the poor, the vulnerable and everyone else. So the vaccine industry has sacrificed billions of dollars of profits because we want to support the Modi government in this endeavour in providing this vaccine at this price.

This is a temporary measure for a few months, this is not sustainable for the long term. We have done this in the interest of the nation to be short and precise. You know the average price for this commodity is $20-$30 but we do not care about that, we are doing this to support our nation in a time of crisis and then we will see after two or three months when we can review all of this to a more sustainable level where the industry can innovate, can use its profits to build more factories in the future, to employ more people all that we are hoping to do after few months. This is just a temporary phase where we need to do what the nation needs us to do.

Tamanna Inamdar: It is not quite clear whether mutations are responsible for this huge second surge, Part A-how many mutations are out there–Does Covishield work on these mutations. Part B) For how long, will you require a booster or another round of vaccinations in a year or so?
Adar Poonawalla: Well not fully yet, because we need time to know. I will answer both your questions starting with how effective are the vaccines -for how long -what is the duration right now. We know Covishield is effective for eight months because we have data from the UK and other places at least seven to eight months whether that needs another booster we do not know yet. Other vaccine manufacturers are looking at giving third dose, so we will have to wait and see on that part.

With regards to how well and does it work against the other mutant variants, we have already seen a lot of UK variant cases happening in India now and we have seen also that a few people who have taken the vaccine despite being infected with the UK variant not have to go to hospitals. They have experienced mild to moderate symptoms -they will have fever, little headache, we are hoping that trend continues because that will also prove efficacy against these mutant variants like Covishield has already against the main Wuhan variant.

More than 95% of the people who have taken the vaccine and who have come in contact with the COVID-19 disease virus have not had to go to hospital and be hospitalised on a ventilator etc. So, we know the vaccine works, it is very effective but how well it works against the other variants is yet to be seen but the scientists do not believe there is any reason to believe it is going to be any less effective against hospitalisations in these different variants.

Tamanna Inamdar: Just coming to the point you have made about infections after taking the vaccine and this has caused a bit of concern, panic, people do not necessarily understand why they are getting Covid-19 if they have taken both doses can you give some clarity on this?
Adar Poonawalla: If you look at even non-Covid vaccines for other diseases pneumonia, rotavirus so many others you still get the disease but your severity of the disease goes down to a level which is very manageable and does not require hospitalisation. Perhaps, you know the vaccine industry could have made this clearer whilst we were developing these vaccines, but nobody has ever made a claim or a statement or the government has ever claimed that just by taking the vaccine –it is not a bullet proof vest, what it will do is save your lives but you will still experience some symptoms.

We are in that situation right now where the objective is to save lives, bring down hospitalisation, deburden the healthcare industry I mean in terms of the infrastructure of hospitals and other things so that is where the vaccines are showing excellent efficacy but to expect that you are not going to even get a little scratchy throat or little fever is just not going to happen, so we must explain that to people and say that look the good news is that it will save your life no doubt about it.

Tamanna Inamdar: All the clotting with AstraZeneca those reports that are coming and then some nations putting on hold the use of AstraZeneca in specific groups. Have we in India seen any instances that require more investigations?
Adar Poonawalla: If you go back six months ago you know there was this issue about how effective are these vaccines 70%, 80%, 90%. Then there were those neurological disorders that were supposedly associated with the vaccine in all these cases. We must respect and allow the healthcare authorities to conduct their full investigations and then finally give their reports. WHO said the Oxford AstraZeneca vaccine is safe and effective, EMA said it, UK MHRA said it and the Indian Ministry of Health after investigations held the same thing is going to be the case for these blood clots.

I am not a medical professional, I am not an epidemiologist so I do not want to make a statement that there is no link or there is a link ..let the scientific community investigate fully and decide it. Now coming to your final point on this question you have seen multiple countries from Germany to other European countries suspending this vaccine and other vaccines-conducting investigations and then reapproving it to be used in the immunisation programme.

I imagine this is going to be the same, however, we must wait for it all to be concluded and I am sure it will go on like that because let me tell you if you ask me this question in January how safe are we, does it have a link to this, does it have a cause to that I would have said look I really do not know but now after more than a 160 million doses globally, I think you have mentioned on your show more than 7 crore doses 70 million just in India alone right we have not seen anything serious. I think I am at least relieved because you know a product that we make and we are responsible for we want to ensure that it has the highest levels of safety and we are seeing that right now.

Tamanna Inamdar: Are we going to have trials of Covishield on young adults and children?
Adar Poonawalla: Oxford AstraZeneca has already done that, we were focussing in India on our new candidates going through their regulatory phases because we do not want to dilute our bandwidth too much on what we can do. Based on the data we get from Oxford AstraZeneca on a study in the lower age group probably, we will then apply to the regulator in India to allow the vaccine in the lower age group, may be do another small study to demonstrate that in India or we do not.

We do not know yet we will go by what the Indian regulator suggest but if you were to ask me then by when will this be possible, I would say that on the outer limit is six months where we would have a vaccine which might have a slightly lower dose so that it can be used in children below the age of 18. I would say ask me this question in six and hopefully we will have a solution for that age group then.

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