Corona Virus Covid 19

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'A proper vaccine will take at least 2-3 years'
By SHOBHA WARRIER
October 06, 2020 09:54 IST
'No matter how much you fast track, you cannot say here is a highly efficient vaccine even by the middle of next year or the end of next year.'



IMAGE: A healthcare worker collects a swab sample from a policeman during a check-up for the coronavirus in Mumbai. Photograph: Niharika Kulkarni/ANI Photo

https://www.rediff.com/news/interview/must-read-how-to-protect-yourself-from-covid-19/20200907.htm
In the first part of his interview with Shobha Warrier/Rediff.com, Dr Rakesh Mishra, director, Centre for Cellular and Molecular Biology, said it was inevitable that the coronavirus will come back in more waves.
Asked by Shobha, "Does that mean 2021 also will be like 2020?", Dr Mishra replies in the concluding part of the interview, "Maybe there will be less panic in society as we know how to live with the virus! When we understand the virus, we will be able to avoid the spread of the virus, unlike in 2020."

While Europe and the UK are talking about a second wave, India, the US and Brazil are still experiencing the first wave and the cases are only going up. When will there be in dip in the numbers?
Yes, we have to reach the peak of the first wave for the cases to start coming down.
To reach the peak, we have to test as many people as possible. But we have to go a long way.
One way of knowing whether you are testing enough is, when the positivity is 2%-3%, that is, when you test 100 people, you will get 2-3 positive people. Then you can say, you are testing enough.
But our numbers are 15%-20%. It clearly shows we are not testing enough.
This is where we have to bring in new ways and new logistics.



Another thing is, whether you are tested or not, if people observe self-discipline, we can bring down the numbers.
So, the two important things are, large number of testing and self-discipline.
Yes, it is easier said than done.

When can we expect a second and third wave in India?
It is very uncertain as we are still in the first wave, and we do not know when it will come down.
A second wave might be two months or three months away depending upon how we manage.
And the second wave also depends on the behaviour of the people. Like in Europe, it matched with the opening up of pubs and restaurants and beaches.
Here also, if people start freely going to cinema halls, beaches, restaurants and malls, and city buses start operating, it may probably lead to a second wave.
A crude guess is, it may take another 3-4 months or more for the second wave to happen. Hopefully, the second wave will be a smaller one and will taper off faster.
Remember, what I am saying is not based on scientific data.

The last time when we spoke, you had said that generally it would take 5-6 years of intense study for a vaccine to be used among people.
But this time, all the countries are fast tracking and trying to come out with a vaccine in 3-4 months's time. In Russia, they did not even do a Phase 3 trial.
What kind of repercussions will this have on people who get vaccinated?

It is like declaring that you have a vaccine, feel good about it and make money out of it. But the fact is, a vaccine will not be there unless it is tested.
When I told you last time that it would take five-six years's time for a vaccine to be used, I meant only then we would know how good or bad or how effective a vaccine would be.
We get to know only that after a few years of using the vaccine on many people.
No matter how much you fast track, you cannot say, here is a highly efficient vaccine against COVID-19 even by the middle of next year or the end of next year.
That's because you have to vaccinate a large number of people first, and it will take several months to know how it works like whether it really prevented the person from getting infected.
That's why we do the trials, to see whether the vaccine protects the person from getting infected or not.
Somebody may announce that he has come out with a vaccine that works. But he will not be able to guarantee that this is the vaccine that will ensure you will not get infected after six months or one year. Or, that it will work for all the people. It will take time to get all this information.
To have a proper good vaccine, it will take at least two-three years. Yes, we may have some candidates which people may assume as a vaccine.
It may give you 50% protection, but 50% protection is meaningless for a large country like India when it has 50 crore (500 million) people not protected.
Yes, it is better than nothing.

Suppose there is a vaccine by early next year, would you say that for those who are getting vaccinated then is like participating in a phase 3 trial?



Yes! When you give a vaccine next year, it is like the continuation of a phase 3 trial, or a phase 4 trial.
Anybody taking the vaccine even after a phase 3 trial is a volunteer, according to me. Their data will be recorded and there will be follow ups too. It is good.
If 50,000 got vaccinated and if it is considered safe, you can give to more people. Only then we will know the efficacy.

Would you say that there is some danger involved when you take the vaccine the moment it comes out?
Yes, there is. See they had to stop the Oxford vaccine in between because a volunteer fell sick. It is a good sign that the system is alert.
Imagine if the vaccine is dangerous for certain people with certain sickness. These things will become apparent only when the number is very large. If you are testing only 10,000 to 20,000 people, you may not get all the variants.
That's why the real trial will continue for a long time, and only after that, we will get the full data.

The advice that you hear now is that you have to learn to live with the virus. How do we live with the virus?
Have discipline, wear a mask, travel less and maintain social distancing.
In short, we have to reduce the chance of getting infected, and also not infecting others unknowingly if you are infected.
This is living with the virus !

How long will this new normal continue?
At least for a year or so, we have to follow this new normal.
While people without any health issues are safe, those with co-morbidities and elderly people will have to be careful.
We will have marriage parties with very few people.
We will travel less.
That is the new normal. Yes, a lot of adjustments have to be made.
We have to chase the virus so that it will not come to you.

Does that mean 2021 also will be like 2020?



Maybe there will be less panic in society as we know how to live with the virus!
When we understand the virus, we will be able to avoid the spread of the virus, unlike in 2020.

'A proper vaccine will take at least 2-3 years'
 

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Only 0.33 per cent Indians have had COVID-19
By VAIHAYASI PANDE DANIEL
September 22, 2020 08:02 IST

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'It might get worse. We don't really know what is it that is resulting in the high value of R now.'



IMAGE: People queue to enter a metro station in New Delhi, September 14, 2020. Photograph: Anushree Fadnavis/Reuters


You may not be able to treat epidemics with mathematics.
But you can certainly fight epidemics with math.
COVID-19 too.


Ever since the epidemic began, in a science lab in Chennai, Professor Sitabhra Sinha has donned a white coat to combat COVID-19 by manipulating numbers and statistics to second-guess the course the devious virus will take in India and its speed.
A professor of Computational Biology and Theoretical Physics at the Institute of Mathematical Sciences, Chennai, Professor Sinha, who has a special interest in applications of statistical physics to the analysis of socio-economic phenomena, earned his doctorate from the Indian Statistical Institute, Kolkata.
He has worked at the Indian Institute of Science, Bangalore and the Weill Medical College of Cornell University, New York.
As a member of the Indian Scientists Response to COVID-19 team, Professor Sinha has been observing the spread of the COVID-19 pandemic ever since it touched our shores early this year.
Being scientists and mathematicians, for Professor Sinha and his colleagues estimations of the growth/shrinking rates of the epidemic across India comes from studying the disease's crucial R value, that all-informative, all-important effective reproduction number that is a method of determining COVID-19's capacity to spread (external link), judging by how many people, on an average, a single infected person can transmit the virus to.
By looking at the incidence data for India as a whole, the states and for the major cities, they then try to quantify the rate at which the active number of cases is evolving by examining the reproduction number and discover how the number of active cases is going to grow or shrink, through short-term forecasts or nowcasting.
At the same time this statistical analysis, which is based on assumptions, gives an indication of how the pandemic is evolving across the country in what Professor Sinha terms as a "heterogenous fashion."



IMAGE: A health worker distributes tea to COVID patients at the CWG covid care centre in New Delhi, September 20, 2020. Photograph: Supreet Sapkal/ANI Photo

Till August India was doing good
"Until about August, there was a steady decline in R, possibly because of the strict implementation of the social distancing measures and other measures, which had been put in place."
Around mid-August Professor Sinha says R measured to be around 1.05, on an average across India, much lower than the 1.83 it began at in March.
When R becomes 1 it essentially indicates plateauing because it means the number of new cases that are arising is exactly balanced by the number of recoveries - one for one.
And if R falls below one, that's even better news.
It shows that people are recovering at a rate faster than new infections are occurring.
"If you can maintain R less than one for a sustained period of time, effectively you can contain the epidemic," Professor Sinha tells

Vaihayasi Pande Daniel/Rediff.com.

But the reverse would be disastrous and R shoots up to a value much greater than one.
The epidemic will keep growing and mushrooming, if even more people are getting infected per day than are recovering.
Using similar calculations, if no measures are taken to contain the epidemic, the fraction of the total population that will be affected, works out close to 60 per cent of India's population, he says.



"It's only when the total number of infected people comes to do some kind of a significant fraction of that, that we could see the natural tapering off of the epidemic."
Looking at the present case statistics it is evident that the epidemic has so far just "barely scratched the surface" given that approximately only 0.33 per cent Indians have been infected till date (a percentage of total cases of 4.6 million against our 1.3 billion population).
You can contrast that with World No 1 America where 2 per cent Americans are already infected.
"Given that we are nowhere close to that (60 per cent) and R went down from 1.83 to 1.05, around mid-August, it means that all the containment measures which were put in place were responsible for this decline."
Although at the moment he says R is around 1.09.


GRAPH: Short-term projection of active cases for India based on the current rate of growth.
If R remains unchanged we would most probably see India breach a million active cases by the middle of this month - just after Sept 15 or so. Kind courtesy Professor Sitabhra Sinha

Patterns across India
Professor Sinha says that the report card for different parts of India is constantly changing.
Delhi is a case in point. Till end it had managed to keep its R less than one.
"It looked for a while that by mid-September or so, they would have their active case count in the hundreds."
But the landscape quickly changed when by August 2, Delhi's R went above one and ever since then they have not been able to take it back down.
"At present it's actually quite high. I believe it's about 1.2 or thereabouts." While India is at the moment about 1.09."
Some states, who were in the top dozen, are still doing better.
Tamil Nadu and West Bengal have succeeded in getting their R value below one.
But they need to take heed of what happened in Delhi and it is critical that they sustain it.
Maharashtra and Uttar Pradesh have shown a marginal increase in their R values recently.
Maharashtra has unfortunately been consistently in the top two states in the state ranking of active cases.
"Whenever we saw the India R value tipping (lower), you could see that it was primarily contributed by any drop in the figure for Maharashtra."
That said Maharashtra has worked hard to lower its R value some.
So, while there is definite progress, its figures are not ideal.
The red herrings have been Chhattisgarh and Odisha, which out of nowhere joined the top dozen states club.
Chhattisgarh is ninth in the list of states with the highest active case count.
Professor Sinha says Chhattisgarh went completely below the radar.
"They started with a very small active case count. Sometime around early July, the effective reproduction numbers suddenly spiked to something like 1.36 or thereabout -- very high compared to the India-wide average."
"The number of active cases was actually, magnitude-wise, very low -- we weren't paying too much attention to it. But they had a very high value of R which was maintained for a fairly long time. Essentially, it maintained at 1.35 or thereabouts through the whole of August, which is the reason why they have a large number of cases at the moment there."
Assam also had a sudden spurt in between.
But it has "kind of steadied itself but has a pretty high active case count because of this sudden spurt in R."


IMAGE: A healthcare worker takes a swab for a rapid antigen test at a brick kiln in Rajoda village in Gujarat, September 18, 2020. Photograph: Amit Dave/Reuters

Cities vs rural areas
Until about August it was primarily the cities which were driving the large active case counts, says Professor Sinha.
If you looked at it, state-wise, it was districts with large cities that were driving up a state's count.
In Tamil Nadu it was mostly Chennai and its neighboring districts, Kanchipuram and Madurai, which were contributing to the state's high R value.
In Maharashtra it was Mumbai, Pune and surrounding districts of Mumbai.
In West Bengal it was Kolkata and nearby North 24 Parganas and in Telangana it was largely because of Hyderabad.
"When states like for example, Chhattisgarh and Odisha start coming up in a big way on the list of states, it means that the pandemic focus has kind of shifted from the big metros to maybe middle-tier towns and possibly rural areas."
He wouldn't go so far as to say that the rural areas were/are at any point driving the pandemic, he says.
"We always see, for example, in states like Bihar, Jharkhand, whenever they come up, it's for very short periods of time. They have extremely high values of R, but then within a few days that kind of dies out.
Bihar and Jharkhand fall in a different basket of states because "the typical trend in these kinds of states, without major metropolitan cities, is the rises come in brief bursts. They have one week of extremely high R value. Following that R will quickly fall and the active case count will actually reflect this. The large value fall means that the active case count will shoot up for a while, but then when R falls back, it will again start slowing. You see this series of growth spurts and collapses."
In rural areas, or states with less dense urban population, when case numbers falls after a spike, "not having actual information about the kind of containment measures (put in place), it's very hard to say whether it's because of containment effects taken by the district administration or there's a natural kind of fizzling out."
Natural fizzling out, Professor Sinha says is possible because in order for the disease to flourish, it needs to find susceptible individuals ie warm bodies.
"That's actually one of the reasons why COVID-19 grows much faster in urban areas where there's a high density of population than in rural areas where the local population density is much lower."
"If you have a scenario where the disease is propagating in a relatively sparse population, where transportation is not readily available, so that people, who are already infected, cannot travel across large distances and inadvertently infect people in other areas, you would naturally have some increases, where the disease is going to quickly spread among the local population. But because it can't travel beyond the capabilities of the transportation system at that point, it will essentially exhaust itself and then just die out."



IMAGE: A crowded street in Delhi, September 13, 2020. Photograph: Anushree Fadnavis/Reuters


How sudden spurts can happen
Areas, cities or states are often successful in getting their R below one.
But another cluster of the disease is all you need to have and R will go up again.
Professor Sinha cites the example of the Coimbatore cluster in Tamil Nadu, which caused a huge spurt sometime in May or June.
"All that happened was essentially, in this wholesale market, a group of people were infected by the disease. They had come from different parts of the state and when they went back, they essentially helped spread the disease to quite a large number of districts.
"Some kind of event like that, and it's very hard to control it, if you allow people to move relatively freely. The moment such events happen, you would have fresh epicenters of the epidemic arising in different parts. You'd have to go all out to contain each of these.
The appearance of cluster is, he says "quite inevitable" if the authorities start relaxing their stricter checks on movement of people.
It is also a question of luck too. "All you need is something like the Coimbatore cluster emerging to kind of wipe out the gains of several weeks of containment."

Accuracy of data



IMAGE: Professor Sitabhra Sinha

Since, while making assessments of the spread of COVID-19, there's a real possibility that they are not getting the all the cases, Professor Sinha says, "That's why we estimate not the total case count, but rather the growth rate. Because the growth rate is essentially a proportion, right. It's basically asking -- given that you have this many known cases -- how many other people are going to get infected.
He adds, "Presumably your testing rate would not change overnight so that you would also have a very similar proportion of undetected cases at a future point of time. Assuming that you have drastically changed your testing criteria within a short period of time, the growth rate is going to be unaffected, because essentially the proportion of people you're missing would be consistent at different time points. So that's why we use this much more robust measure."



IMAGE: A health worker checks a COVID patient at the CWG covid care centre in New Delhi, September 20, 2020. Photograph: Supreet Sapkal/ANI Photo

End of the pandemic: When 60 per cent of India gets the disease or the vaccine - whichever comes first?
When and if an effective vaccine, comes out it will halt the march of the pandemic.
How many people need to be vaccinated for that to happen?
"Once the vaccine is given to enough number of people -- which also one can estimate from the R value ie what proportion of population do you need to give the vaccine to -- of course, you are you will be preventing a recurrence of the epidemic."
But in the absence of a vaccine, he says the only way to ensure that the epidemic is going away is just to "let it play out."
That philosophy did not work in Sweden where they thought they would allow the epidemic to "run its natural course".
But the furor caused by an extremely high death rate among the elderly forced that country's authorities to quickly change their policies.
In absence of the vaccine, Professor Sinha says, "The continuing measures while they have not killed the epidemic, have managed to keep the epidemic burden to manageable levels, where at least it's not causing our health infrastructure to collapse. We've certainly have not seen, the kind of chaos that we saw in Italy and Spain in March and April. Yes and New York, exactly."
This in effect has prevented drastic "upswing of the epidemic" and bought India a few benefits.
"But I think everybody agrees that the kind of containment measures that succeeded in getting R down to 1.05 are simply not sustainable. If you want people to go back to life as it was it's simply not possible to keep doing this indefinitely."
Professor Sinha says India has to make a call on "whether we should keep waiting for the vaccine and in the meantime, at least, allow certain containment measures to be still kept in place. Or do we just let people go back to their ways and allow the epidemic take its natural course?"




IMAGE: Women at an open-air gym in a municipal park in Kolkata, September 21, 2020. Photograph: Rupak De Chowdhuri/Reuters

Why the situation is not that bad
When active case counts were not growing that high because the R value was close to 1.05, COVID-19 didn't look like what it was predicted to be in spite of the "alarming projections of how many deaths we will see."
That, Professor Sinha says could have cause people to become complacent and feel that the disease assessments were all "hyped up" and lose their guard quickly.
But it didn't.
"We also have to take into account the fact that, to some extent, we didn't see those extremely high number of deaths because of the fact that people took precautions and there were containment methods which were put in place.
He explains further: "Let me also put it this way: After the announcement of the Unlock Phase 1 and Phase 2, I was expecting to see R climb to a very large value from what it was at that time. It was that time around 1.15 or thereabouts. I was expecting that within two weeks of phase two, it will go back to 1.4 or 1.5 or thereabouts. When it didn't -- in fact, it decreased after that -- I was actually very surprised this happened."
There was only one possibility why this happened, he reasoned: "People were -- even though they were not forced to do it -- adapting good practices like wearing face masks, maintaining some degree of physical distance with each other."
The increase in R has come quite some time later. "For me, the big surprise was why we didn't show a much higher value of R even earlier. If we hadn't taken those measures, definitely the number of deaths would have been much higher."
A higher R value has come now, after a delay and that is part of the cycle of the disease given there has been a loosening of containment measure.
Is it probably going to get worse? "It might get worse. We don't really know what is it that is resulting in the high value of R now."
The Chart
The actual effective reproduction numbers obtained with data upto September 7 for India, as well as for the top dozen or so states in terms of current active cases. Kind courtesy Professor Sitabhra Sinha.

India
Estimated over Aug 24-Sept 7R: 1.09 +/- 0.005 (r>0.998,p=0)
1Maharashtra
Estimated over Aug 25-Sept 1R: 1.12 +/- 0.01 (r=0.998,p=0)
Estimated over Sept 2-7R: 1.18 +/- 0.03 (r>0.99,p=0.0001)
2Andhra Pradesh
Estimated over Aug 22-Sept 2R: 1.07 +/- 0.01 (r<-0.99,p=0)
Estimated over Sept 3-7R: 0.94 +/- 0.01 (r=-0.995,p=0.0004)
3Karnataka
Estimated over Aug 30-Sept 5R: 1.13 +/- 0.02 (r>0.99,p=0)
4Uttar Pradesh
Estimated over Aug 26-31R: 1.08 +/- 0.01 (r=0.998,p=0)
Estimated over Sept 1-7R: 1.10 +/- 0.01 (r=0.998,p=0)
5Tamil Nadu
Estimated over Aug 30-Sept 7R: 0.98 +/- 0.01 (r<-0.99,p=0)
6Telangana
Estimated over Aug 23-29R: 1.27 +/- 0.04 (r>0.99,p=0)
Estimated over Aug 30-Sept 4R: 1.06 +/- 0.02 (r>0.99,p=0.0001)
7Assam
Estimated over Aug 27-Sept 5R: 1.24 +/- 0.03 (r>0.99,p=0)
At present decreased to less than 1.1 but no robust estimate
8Odisha
Estimated over Aug 25-29R: 1.13 +/- 0.03 (r>0.99,p=0.0005)
Estimated over Sept 4-7R: 1.13 +/- 0.03 (r>0.998,p=0.0014)
9Chhattisgarh
Estimated over Aug 4-Sept 7R: 1.35 +/- 0.01 (r>0.998,p=0)
10West Bengal
Estimated over Aug 22-Sept 7R: 0.93 +/- 0.01 (r<-0.995,p=0)
11Kerala
Estimated over Aug 30-Sept 3R: 0.88 +/- 0.03 (r<-0.99,p=0.001)
At present marginally above 1 but no robust estimate
12Delhi
Estimated over Aug 23-Sept 7R: 1.22 +/- 0.02 (r>0.99,p=0)



*For a few states these estimates are over multiple periods to show that in some cases R is increasing, while in others it is decreasing.
For example, Delhi and UP got marginally worse in early September, while Andhra Pradesh and Telangan have improved with R falling.
Most worrying is the rapid increase in active cases in Chhattisgarh,currently ranked 9th which has an extremely high R consistently for more than a month now.
Feature Presentation: Ashish Narsale/Rediff.com


Only 0.33 per cent Indians have had COVID-19
 

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Serum Institute to provide Covid vaccine at Rs 250 a dose
By Sohini Das
August 08, 2020 10:07 IST

Serum Institute of India plans to make 300 million doses of AZD1222 by December, and will begin phase-2 trials soon. It has also tied up with Novavax for development and commercialisation of its candidate.




IMAGE: Andressa Parreiras, Biomedic, and Larissa Vuitika, biologist, work in a laboratory during the extraction of the virus genetic material in Belo Horizonte, Brazil. The ministry of health convened The Technological Vaccine Center of the Federal University of Minas Gerais laboratory to conduct research on the coronavirus in order to diagnose, test and develop a vaccine. Photograph: Pedro Vilela/Getty Images.


Serum Institute of India (SII) has inked a pact with the Bill and Melinda Gates Foundation, as well as Gavi, The Vaccine Alliance, to make 100 million doses of a potential vaccine. This is for low- and medium-income countries, and with a price cap of Rs 250 a dose.
The Bill & Melinda Gates Foundation, via its Strategic Investment Fund, will provide at-risk funding of $150 million to Gavi for supporting SII in the manufacture, the company noted.

Priced at $3 a dose, the vaccines will be made available in 92 countries, including India. These are those included in Gavi’s Covax Advance Market Commitment (AMC).
Covax is an initiative by the World Health Organization (WHO) -- which is managed by Gavi and the Coalition for Epidemic Preparedness Innovations (CEPI) -- to ensure equitable distribution of the vaccine.
SII also has a tie-up with Oxford-AstraZeneca for its candidate AZD1222, which is under advanced stages of clinical trial. SII will supply 1 billion doses to AstraZeneca, which has already committed to 2 billion doses of AZD1222.
SII plans to make 300 million doses of AZD1222 by December, and will begin phase-2 trials soon. It has also tied up with Novavax for development and commercialisation of its candidate. It will have exclusive rights for that in India (during the term of the deal) and non-exclusive rights during the ‘pandemic period’ in all countries, besides upper-middle or high income countries.
SII said Gavi and the Foundation would provide upfront capital to help increase manufacturing capacity. The funding will aid at-risk manufacturing by SII for AstraZeneca’s and Novavax’s candidates, which will be available for procurement if they are successful in attaining full licensure and WHO's pre-qualification. The arrangement also provides the option to secure additional doses if the vaccines arm of the ACT Accelerator sees the need.
Serum's tie-ups with AstraZeneca and Novavax will continue. Besides the 100 million doses it will supply to Gavi-led Covax (at Rs 250 each), it will be free to price the vaccines in India.



“To make our fight against Covid-19 stronger and all-embracing, SII has partnered with Gavi and Bill & Melinda Gates Foundation to advance the manufacturing and delivery of up to 100 million doses of future Covid vaccines for India, along with low- and middle-income countries in 2021,” said Adar Poonawalla, CEO of Serum Institute of India.


Serum Institute to provide Covid vaccine at Rs 250 a dose
 

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Meet Adar Poonawala, India's COVID-19 vaccine man
By Sohini Das
Last updated on: August 06, 2020 09:22 IST

Serum Institute is investing $200 million to create capacities for the COVID-19 vaccine.
Sohini Das profiles its 39-year-old CEO.




IMAGE: Adar Poonawalla, right, and his father Dr Cyrus S Poonawalla, third from right, at the launch of India's first fully-automated Sample-to-PCR-ready system for molecular diagnostics. Photograph: Kind courtesy MylabSolutions/Twitter

When the pandemic hit, Adar Poonawalla, CEO of Serum Institute, believed that long-term lockdowns wouldn't help much. Instead, the world needed a vaccine -- fast.

In fact, he tweeted on March 26 (when the government announced its first 'relief package' of sorts), 'Given the scale of disruption a relief package of at least $200 billion should supercharge spending and restore confidence in our economy. We can recover it back through taxes as our growth rate moves beyond 6 per cent. I hope our FM announces this in phases soon.'
But a vaccine was a sure-fire way to unlock safely and Poonawalla, who was already working with the University of Oxford on a malaria vaccine candidate, was quick to spot the promise of its COVID-19 vaccine (code named AZD1222).



Serum Institute now has a tie-up with the AstraZeneca-backed Oxford vaccine candidate for one billion doses which it will make for India and the GAVI vaccine alliance of 58 countries.



Poonawalla is perhaps the only Indian vaccine maker who has decided to start making a vaccine (which is still under clinical trials) on'personal risk'. He has said in his recent interviews that the Serum Institute is putting in $200 million to create capacities for the AstraZeneca-Oxford vaccine.
A leading vaccine maker said: "This kind of risk-taking is rare. But it is possible for Adar because his is a closely held firm. They don't need to answer investors."
Indeed, Poonawalla has repeatedly stressed in his interviews that he has no plans to list his firm -- it would result in him losing his "independence," he says, and decision-making can never be the same when a company has to declare quarterly results.
People who have worked with him and know this 39 year old well point to his strong business acumen.
A case in point being his decision soon after his joined the company's board in around 2005-2006 to expand Serum Institute's global reach.
At the time, Serum Institute was supplying vaccines to around 35 countries. With the going turning tough in the domestic market, Adar turned the organisation's focus to global markets.
He got the Serum Institute vaccines validated globally and began supplying to aid agencies including the World Health Organisation.
Today, Serum Institute exports to around 150 countries across the world, sells over 1.5 billion doses of vaccines and is the world's largest vaccine maker in terms of volumes.
Insiders say that under Adar's stewardship, the company's revenues have clocked a compounded annual growth rate of 20 to 25 per cent in the last nine years (he took over CEO in 2011) and Serum Institute has a debt-free balance sheet.
Its forte has been affordable vaccine and high volumes. The firm is known for its tetanus, diptheria and measles vaccines.
In fact, Serum Institute's journey started from the tetanus vaccine when one of India's first-generation vaccine men, Adar's father Cyrus Poonawalla set up a small laboratory at a corner of his stud farm to make tetanus vaccines from horse serum.
Cyrus inducted his son early into the business at 21 years. Adar had studied at St Edmund's School, Canterbury, and graduated from the University of Westminster, London.
As a young inductee to the company, he was not given an official designation. His job was to follow his father and learn the ropes of the business.
Adar has said in subsequent interviews that learning on the job was a more enriching experience than doing a classroom MBA from an Ivy League school.



IMAGE: Adar Poonawalla at the launch of Swasth Immunised India with Kareena Kapoor Khan. Photograph: Kind courtesy adarpoonawalla/ Twitter

In Pune, the Poonawalla family is known for its vaccine business, flamboyant lifestyle, and social ventures. True to his British upbringing, his house in Pune (called Adar Abad) flaunts European architecture.
"He doesn't enjoy being under the media glare. In fact, while the perception of Adar is that he is a Page 3 regular, he is quite the opposite and, has a strong sense of social responsibility," said someone who closely works with him.
Poonawalla's Clean City Movement in Pune, which made him the poster boy of the Swachh Bharat Mission, is a case in point.



But his risk-taking extends beyond Covishield (Serum's brand for Oxford-AstraZeneca vaccine). He has invested in Pune's molecular diagnostics company MyLab, which made India's first locally made RT-PCR kit to test COVID-19.
How these risks will pan out will certainly shape the coming decade for the Poonawalla Group and its young CEO.

Meet Adar Poonawala, India's COVID-19 vaccine man
 

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Tripura shuts down Durga Puja pandal after visuals of massive crowds go viral

Speaking to indianexpress.com this morning, District Magistrate Yadav said that the order had to be passed in order to save human lives and prevent a fresh outbreak of coronavirus.

Written by Debraj Deb | Agartala |October 27, 2020 12:51:22 pm

[https://images]The puja guidelines were visibly flouted by devotees who failed to follow social distancing norms. (Source: Facebook)

After visuals of crowds thronging one of the lartgest Durga Puja pandal in Agartala went viral on social media, West Tripura district administration Monday ordered the organisers, Bharat Ratna Sangha, to shut it down and immerse the idol the same evening.

In an order issued on Monday, West Tripura District Magistrate Shailesh Kumar Yadav said the state government had issued specific guidlines under The Disaster Management Act, 2005 for strict compliance by the club or community puja organizers to avoid community transmission of COVID-19.

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“Pradyut Dhar Chowdhury, general secretary of the Bharat Ratna Sangha, Ushabazaar has submitted a notarial affidavit along with the application for Puja permission, declaring that they will allow 10-15 visitors at a time in the club premises and such gathering will be in conformity to the social distancing norms….on 24th October, 2020, during the evening and night hours, there was assembly of about thousand people/.visitors in the Durga Puja pandal premises of Bharat Ratna Sangha, Ushabazaar, violating all COVId-19 safety norms which is a sheer violation…..”, the order reads.

Speaking to indianexpress.com this morning, District Magistrate Yadav said that the order had to be passed in order to save human lives and prevent a fresh outbreak of coronavirus.

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“There is a provision to pass orders restricting common public to enter the pandal under section 144. So, we have issued that order to prevent imminent danger to public life and health. However, no curfew has been imposed under this section,” he said.

The Bharat Ratna Sangha members did not comment on the matter.

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As per government records, over 640 community clubs organized Durga Puja festivities in West Tripura district this year with over 480 puja pandals in the Agartala city. The figures have come down in the capital city as compared to the 554 from last year. And Idols from over 120 puja organizing clubs were immersed across 17 immersion ghaats in and around Agartala on Monday. The state government has ordered phase-wise immersion of idols.

However, the puja guidelines were visibly flouted by devotees who failed to follow social distancing norms. The streets were crowded yesterday even as the government imposed a seven-hour no entry order on vehicle movement in the city area since Thursday.

Tripura revised its Durga Puja guidelines twice in the last one month as the High Court asked the government to continue vigilance and hold massive awareness campaign to avoid spread of coronavirus during the festival period.

On October 13, the High Court said in an order, “The experience in the state of Kerala during Onam was alarming because despite their management the state saw sudden spike in case which gives us certain amount of anxiety” and asked the government to maintain COVID guidelines properly. Soon after, Law minister Ratan Lal Nath informed his government was working on a formula to contain the spread of coronavirus.

The first Durga Puja guidelines were issued in Tripura on September 4, where the government instructed puja organizers to collect subscriptions through online mode, reduce number of puja pandals through mutual consultation, avoid narrow entrance and exit systems in pandals, allow a maximum of 5-10 people inside the pandal, among others.

The revised guidelines, issued 37 days later, mandated COVID-19 tests for puja organizers, volunteers and priests. The revised rules have also asked the pandals to be open from all sides, sealed roofs of all pandals, cap on stalls outside pandals etc.

[https://media-central]

 

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Bharat Biotech starts Covaxin's at-risk manufacture
By Sohini Das
November 02, 2020 09:47 IST

The first vaccine candidate will be an intra-muscular one, followed by intra-dermal and nasal ones, depending on test results, reports Sohini Das.


Photograph: Kind courtesy Bharat Biotech

https://www.rediff.com/money/report/covaxin-how-bharat-biotech-plans-to-boost-immunity/20201006.htm
As India's first indigenous COVID-19 vaccine candidate gets the nod for phase 3 trials, Hyderabad-based vaccine maker Bharat Biotech has not only started the at-risk manufacturing of its candidate Covaxin, but is also looking to ramp up capacities.
The first vaccine candidate will be an intra-muscular one, followed by intra-dermal and nasal ones, depending on test results.
Besides setting up a second plant at its Genome Valley facility in Hyderabad to make Covaxin, the firm is looking for another site in the country to make the vaccine.
"We are investing to set up a second plant at our Hyderabad site to make Covaxin. We have one plant. Together, these two plants can make 150 million doses a year," says Sai Prasad, executive director, Bharat Biotech International.
"We are also looking for another site in India where we can make the vaccine, so that capacities can be ramped up to over 500 million a year," Prasad adds.



BBIL is spending Rs 100 crore to Rs 150 crore (Rs 1 billion to Rs 1.5 billion) to set up the manufacturing plant. BBIL, Prasad adds, is open to contract manufacturing and is working on accessing one of its own sites which could be converted into a Covaxin-manufacturing one.
This would be crucial as BBIL expects to forge global partnerships with international agencies like Gavi and also some countries for Covaxin by December.
"Our priority will be to supply the vaccine in our own country. We are also in talks with several nations and international agencies like Gavi which are interested in our vaccine," says Prasad.
He said these partnerships could be of three types: Some wanted to buy the vaccine, some wanted to do their own clinical trials, and some others wanted BBIL to do a tech transfer so that a local company could make the vaccine.
It has some doses ready and can release them to the market once government approval comes.
As for the cost of the trials, the company says it will be around Rs 150 crore and it is a risk for the firm.
The Indian Council of Medical Research, however, has said it will share the cost. While BBIL did not wish to put a figure to it, Prasad says it is a significant portion because ICMR would be working with it on testing and some other key parameters.
BBIL has not planned to raise any debt to fund the trials or its expansion, and it is doing it from internal accruals.



The company is gearing up for a large-scale phase 3 trial in India on over 28,000 subjects and expects to generate early efficacy data by April next year.
This would also be the first independent efficacy trial by BBIL. In earlier studies for Rotavax (rotavirus vaccine) and typhoid conjugate vaccine, it had partners.
Typically, vaccine-efficacy studies measure the effectiveness of a vaccine by comparing the disease rate in vaccinated and un-vaccinated groups.
Thus, it is important to have a certain number of disease cases in the cohort to un-blind or analyse the study data.
These are blinded studies, which means who gets a placebo and who gets a vaccine shot is not initially known.
"The reason we are taking a large cohort is to first ensure the safety by testing it on different demographics, and, secondly, it will help us to have an early read-out in efficacy," says Prasad
He explains that the firm would have to wait until a certain number of cases (people with Covid infection) happened in the cohort to un-blind the data.
"By the January-February timeline, we will have some initial data from phase 3, but the efficacy data will be blinded. It will depend on case accumulation. We will have to wait for a certain number of cases, and until we have that we cannot un-blind the data," says Prasad.
"When we do a trial design, we take into account the attack rates, the disease type, the ability of us to detect the disease and then the recruitment timelines," he adds.
Government sources indicate that India plans to start vaccinating its essential services workers (around 30 million) around January. Will we have enough data by then?
BBIL says by December-January it should have at least four to six months of observation data from volunteers (who got a jab in phase 1).
The phase 3 efficacy data will come around the second quarter of 2021, or April-May. "Even after the efficacy readout, we plan to follow the phase 3 subjects for around a year,;" says Prasad.
While the firm has set no internal deadline for recruitment, a back-of-the-envelope calculation shows if the sites (around 20) manage to recruit 30 to 50 candidates daily or every few days, then trial recruitment would not take long, says Prasad. Each site is likely to handle 1,000 to 2,000 subjects.
Will Covaxin need a booster dose?
Prasad says the evaluation of the phase 1 data for neutralising antibodies had shown good immunogenicity.



Analysis of the phase 2 data is on. "We have tested four different strains (clades) in India and done work on functional immunological assays," he says, "which will show us if this generates T-cell response, memory response, etc."
Feature Presentation: Rajesh Alva/Rediff.com


Bharat Biotech starts Covaxin's at-risk manufacture
 

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How To Travel and NOT Get Coronavirus - 7 Tips for Flying and Traveling during COVID 19 Pandemic ✈
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How To Travel and NOT Get Coronavirus - 7 Tips for Flying and Traveling during COVID 19 Pandemic ✈ Catching Coronavirus / COVID-19 in an airplane is possible by inhaling the virus. And the regular face covering that you wear, such as a regular medical mask, won’t prevent you from inhaling the virus if it’s in the air close to you.
 

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Dr. Dana Hawkinson Shows You How Travel Safely Since COVID-19
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First time traveling since COVID-19 hit? Infectious disease physician Dr. Dana Hawkinson at The University of Kansas Health System shows us how he's staying safe while on the move.
 

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ICU beds for COVID-19 patients nearly full in Delhi
STAFF REPORTER
NEW DELHI, NOVEMBER 14, 2020 01:16 IST
UPDATED: NOVEMBER 14, 2020 08:17 IST

1605387191277.png



A recovering coronavirus patient stretches on his bed in the intensive care unit (ICU) of Max Smart Super Speciality Hospital in New Delhi. Photo for representation. | Photo Credit: AFP

Over 87% beds with ventilators and 84% beds without ventilators occupied
ICU beds for COVID-19 patients in the Capital are nearly full with new cases showing an upward trend and often hitting daily highs.
Overall, 87.42% of the total 1,328 ICU beds with ventilators and 84.7% ICU beds without ventilators were occupied. As of 8 p.m. on Friday, there was 52.5% occupancy for COVID-19 beds in city hospitals, but the situation is starker in some cases: in 59 hospitals, all ICU beds with ventilators for COVID-19 treatment were occupied; and in 61 hospitals, all ICU beds without ventilators were full.
When contacted, the Delhi government spokesperson did not comment on the situation.

1605387209535.png



Hospitals without any ICU beds with ventilators include AIIMS Trauma Centre and the city government-run GTB Hospital, Deen Dayal Upadhyay Hospital and Dr. Baba Saheb Ambedkar Hospital, among others.
Also, COVID-19 beds were not available in many private hospitals including Max Hospitals in Patparganj and Shalimar Bagh, Maharaja Agrasen Hospital in Punjabi Bagh and Akash Healthcare in Dwarka.
On Thursday, the Delhi High Court had allowed the city government to reserve 80% ICU beds for COVID-19 patients in 33 private hospitals in view of the situation in the Capital where “cases are spiralling daily”.
Delhi recorded 7,802 fresh COVID-19 cases in a day, taking the infection tally in the national capital to over 4.74 lakh on Friday, while 91 more fatalities during the same period pushed the death toll to 7,423.

Positivity rate of 13.8%
These fresh coronavirus cases were detected from 56,553 tests conducted the previous day. Delhi recorded a positivity rate of 13.8% amid the festive season and rising pollution in the city.
Addressing a press conference on Friday, Chief Minister Arvind Kejriwal said that the cases will come down in 7-10 days. “Corona is rising. I am worried... The Delhi government will take several preventive measures in the coming days to control the situation. I hope in 7-10 days, the number of cases decline and the situation comes under control,” he said.


ICU beds for COVID-19 patients nearly full in Delhi
 
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