With no Covid-19 cure in sight, the government needs to quickly get its vaccination drive back on track.
By Anil Manchanda
As everyone knows by now, India’s Covid-19 vaccination project is in an almighty mess. This is an effort to see how we got here and where we need to go. Basically from the beginning, India showed a strange reluctance to commit to even provisional orders with our domestic manufacturers, almost as if by procrastinating the need might just vanish.
By the end of August 2020 when the US, Canada, UK, and EU had placed orders with all potential vaccine makers to cover their needs many times over, India had ordered ZERO.
By December 2020 when UK and USA had already started vaccinating people India had not yet ordered a single dose. But to take stock we go back to the beginning.
The Opening Act
By February 2020 it had become clear to anyone following world news that the entire globe was headed into a serious pandemic far worse than SARS, the previous respiratory illness also caused by a coronavirus, which threatened to sweep the globe in 2003 but faded away before doing much damage.
For some strange reason the leading western nations, to whom the rest of the world looks for a lead, and the World Health Organisation (WHO) were all tardy in recognising the threat and reacting to it, much less in cautioning the rest of the world well in time. The fact that Serum Institute of India (SII) started testing vaccine candidate on animals in February 2020 should give us an idea of how far ahead of the curve some people were.
It was also in February 2020 that Donald Trump and Narendra Modi, the flamboyant elected leaders of the world’s oldest and largest democracies respectively had committed to a mutual image boosting joint jamboree of enormous scale in the largest open air stadium in the world, located in Ahmadabad, India. Both have claims to raw masculinity, and were either not given good advice or chose to disregard it. Be that as it may, by the time the event came to pass, the pandemic was well on the way to hitting large parts of the world with scary virulence.
After a month of dilly dallying India went into a severe lockdown on March 25th at very short notice of a few hours, creating havoc in the lives of ordinary citizens and uprooting lakhs of migrant workers. Thousands of medium and small businesses went into a dead stop and serious financial stress. Migrant workers who could no longer stay on in urban centres trudged home, mostly on foot, carrying their paltry belongings on their heads. Their suffering can only be imagined from the TV images etched in our minds permanently. No one has any real idea of how many died on the way. We only know for certain that no organised help was forthcoming whether by way of cash support, sustenance or logistics. Many of those still in cities had lost their livelihoods, again with no state support. All this was a re-confirmation of the complete absence of any humanitarian concerns after the earlier demonetisation misadventure and the botched GST roll out.
Initially meant for 21 days, the lockdown would ease only at the end of May 2020, over two months later. Thereafter gradual and select opening and relaxations started.
In India, the untold misery brought upon the people early in the pandemic had a definite role in slowing down the infection rate in the cities and spread through the countryside. Meanwhile our healthcare infrastructure started creaking in a wobbly attempt at dealing with the enormous numbers that were coming up particularly in urban areas. Shortages of medical equipment like ventilators, personal protective materials, hospital beds and trained staff made life miserable for patients and their families especially in urban areas. Rural India was spared these excesses in the initial onslaught, but in a role reversal had to provide for the unemployed returnees who normally sent money home.
On the international stage, a pattern began to quickly emerge. The United States egged on by Trump who kept playing down the seriousness of the pandemic in public and to mock the scientists who advocated caution, fared the worst in the world emerging with the highest case numbers. Brazil came in second and India third. This lasted all the way to mid-September 2020. In a another role reversal while the western world was reeling under the onslaught, many Asian nations managed to handle the crisis fairly well. New Zealand and Australia too, with their locational advantage, were able to isolate from the rest of the world quite effectively. Even so, on the whole, the world hadn’t seen such havoc since the Spanish Flu.
Development of Vaccines
However, away from public limelight some very remarkable developments were taking place. Many organisations, basically in the west but some also in Russia, China and India, commenced work on developing vaccines to deal with the SARS-Cov2, the virus that causes the disease Covid-19.
Donald Trump, the much mocked and derided then president of the US set up Operation Warp Speed, a public-private partnership to facilitate and accelerate the development, manufacturing, and distribution of COVID-19 vaccines, therapeutics, and diagnostics.
By September 2020 he had authorised a total of USD 18 billion of government money to be put into this initiative. To put this in perspective, India’s population is around 1.4 billion. Enough money went into Operation Warp Speed to vaccinate all of adult India some ten times. And all this was done on speculation and trust without any certainty of returns or even results.
Around the world, building on work previously done, experimental vaccines using different technologies were developed and tested in record time. Fortunately some one dozen vaccine candidates from different countries came up with promise of safety and effectiveness. By end June there was even an Indian candidate under testing. Developed by Bharat Biotech in collaboration with the Indian Council for Medical Research (ICMR), it went on to get emergency use approvals by the end of the year.
Meanwhile the virus spread around the world in the pattern it had started with and by mid-September 2020 India was nearing 100,000 new cases a day. The total number crossed Brazil and India seemed well on the path to leadership over the US.
On the vaccine front, by this time, the European Union, the UK, Canada and the USA had already negotiated provisional orders on multiple potential manufacturers with advance payments. Most of these countries had covered their entire requirements many times over as a matter of abundant caution. This was not happening secretly, it was public information available to anyone in the whole wide world who was interested. The Indian government, however, showed no interest and had booked a total of ZERO.
On 12th September I wrote on my social media pages, “Successful development and productionisation of a COVID-19 vaccine will only mark the beginning of a humanitarian, financial and logistical nightmare”.
The Turning Point
Mid-September was the point in time when the Indian government, to use a sports metaphor, took its eyes off the ball. The daily fresh case load in India started dipping. The country started opening up more and more. With life returning to near normal by festival time in mid-November it seemed as if we were past the worst. People came out and celebrated at almost normal levels with little attention to social distancing and crowd avoidance. Masks and other measures also took a back seat with many mocking those who still observed basic precautions.
Migrant workers who had trooped off to distant villages and towns had also started returning to their places of livelihood as the restrictions eased. They had all basically used up whatever individual or family savings they had at the beginning of the pandemic. Industry and other economic activity resumed and started to move towards near normal.
In a near euphoric mood the Indian government and its acolytes started patting themselves and each other on the back and making fun of critics who had found fault with its handling of the crisis. The number of daily fresh cases moved quickly from around 100,000 to 50,000 or so in mid-November on its way towards 10,000 levels in mid-February 2021.
Addressing the annual World Economic Forum at Davos, Switzerland on January 28th 2021, the Indian Prime Minister claimed victory over Covid-19 and said ‘India’s success will help the entire world’.
Vaccines for India
The Serum Institute of India, which is the largest vaccine manufacturer in the world, tied up with Astra Zeneca to contract manufacture their Oxford developed vaccine for export and in the process secured a license to make it for India too. In a bold move the SII started manufacturing the vaccine and stockpiled some 5 crore doses of the AZ-O vaccine in advance of formal approvals, or even tentative orders.
Sometime in mid-December the US approved the Pfizer vaccine for emergency use and by end-December the UK approved the AZ-O vaccine for emergency use after they had completed the necessary phase 1, 2 and 3 trials. Shortly thereafter actual vaccinations started in those countries, all at governmental cost. It was obvious by this time that the Pfizer and Moderna vaccines based on the new mRNA technology were only of academic interest to India, being very expensive and needing to be stored and transported etc at temperatures well below normal refrigeration levels.
In India, meanwhile, bridging trials needed for the AZ-O vaccine had been started but not completed. As expected, a few days after the UK approval the AZ-O vaccine, christened Covishield for India, also got emergency use approval. Covaxin, the indigenous vaccine developed by Bharat Biotech/ICMR was still under clinical trials. This vaccine had been proven safe in accelerated phase 1 and 2 trials but had just started phase 3 trials. The Covishield approval led to much noise about desi vaccine being discriminated against and in violation of all drug approval protocols, Covaxin was also given emergency approval with some weird verbiage to set it apart but not too much. The phase 3 trial results, due in March, are not yet formally out in May 2021.
Approvals notwithstanding, the important thing is that the sum total of orders placed by the government till early January was Zero; leaving the manufacturers guessing about how to plan their production. The makers had also asked for financial support to scale up their facilities but did not get it for a long time. A nominal quantity of 1.1 crore doses was ordered on 11th of January, just five days before vaccination was started for the frontline workers in healthcare and other public services.
An important factor in government’s tardiness in ordering vaccines must have been the fresh infections rate, which seemed to be heading inexorably towards zero.
In mid-January India had a daily fresh infections rate of 15,000 or so, down from around 1 lakh daily in mid-September. By this time many countries were moving through their second wave peaks. It seemed like India had bypassed the second wave.
This perception also tied in neatly with projections from the supermodel developed by a government appointed specialist task force, which said that India had reached herd immunity by mid-September and will have put Covid 19 behind it by mid-February. This taskforce, its members as also its work are not held in high esteem in academic circles, but in January 2021 it seemed churlish to question what seemed like perfection. The task force will not meet for three months from the very date when the government ordered the first batch of vaccines, almost as if they thought their job was over and done with.
What of the opposition parties in all this? During the period February to December 2020, the opposition played a childish role of bitterly criticising everything that was done by the government; while doing not much in the non-BJP states. Towards the end of the year, however, as vaccines became a real possibility, their conduct turned despicable. Many important leaders loudly proclaimed that they will never accept the “BJP” vaccines. The media also harped on the incomplete Covaxin efficacy trials while downplaying the ‘safety’ and ‘effectiveness’ established in phase 1 and 2 trials. This generated a fair amount of ‘vaccine hesitancy’, even among staunch supporters and diehard fans of the BJP.
The Second Turning Point
The combined effect of the government’s victory narrative, the concerns about uncompleted trials and the actually reducing fresh infection numbers created a deadly cocktail of misinformation, wild conjecture and reckless abandon as a combined result of which the importance of vaccines seemed to recede. Almost no one was in a tearing hurry to order vaccines or to get vaccinated.
Of the first priority group consisting of medical and other frontline workers, many refused to get vaccinated. In the first six weeks or so only 1.4 crore people were vaccinated against the target of 3.0 crores.
The predominant feeling was that there was no fire. There were various drivers of this perception. One was, of course, that the initial nationwide strict lockdown had actually been a brilliant move which had taken the sting out of the pandemic. The other was the idea that Indians were somehow biologically immune to serious viral infections. Another said that because of the general unhygienic conditions we live in, we had greater general resistance to disease. Still another harked back to the already discarded hypothesis of the widespread BCG vaccination in India.
The daily fresh infection rate continued down to 10,000 or so by mid-February. For all practical purposes in the official mind and in the public’s view India had all but defeated Covid-19. As a result, even when vaccination was opened up on 1st March 2021 to general population of “60+” and “45+ with co-morbidities” there were neither long queues nor a general rush to vaccination centres. On many days while most centres were reasonably busy quite a few vaccination centres, public and private, wore a near deserted look. Reports of vaccine wastage resulting from opened vials meant for 10 shots not being fully used began to appear in news media.
Simultaneously with all this some 6 crore vaccine doses were gifted or exported to other countries because they were thought to be surplus to our needs as then seen.
The feeling was that India was able to produce at a faster clip than we were likely to need, but nature had something else in store. Mid-February, far from being the end of the pandemic, turned out to be the second turning point and the daily fresh infection rate began to climb; slowly at first and then with increasing rapidity. Having taken the eye off the ball, the governments at the centre and states went around relaxing most restrictions, giving the go ahead to humongous religious gatherings and permitting huge political rallies for state elections.
In the current scheme of things, the largest of religious gatherings were in BJP ruled states at Hindu holy places and the largest of political rallies were headlined by the Home Minister and the Prime Minister. The opposition leaders didn’t lag behind by much. The accelerating new case rate was seen as an aberration with a barely concealed hope that it will somehow just die down and go away. There was even a theory floated, and cited by none other than the Home Minister that the second wave was primarily an NRI wave as its initial impact was basically in Kerala, Maharashtra and Punjab, three states with a high overseas linkage.
As April progressed, however, it became clear that what we had was not an aberration but a genuine, bona fide second wave. In fact, it turned into a veritable tsunami. Too late in the day a signal went out to the key organisers of the Kumbh Mela in Haridwar to quickly wind down and wind up. Too late in the day the elections in various states somehow got over.
The fresh case load increased from 10,000 or so in mid-February to over 4 lakhs per day in early May. It was time to wake up and smell the coffee. The clamour for vaccines started rising from early April with long waits and early stock-outs at most centres. By mid-April there was an unignorable demand for making vaccines available for all age groups. The very same people who had shouted from rooftops that they will never ever accept the “BJP” vaccine were now quietly manoeuvring to get vaccinated and that too preferably with Covaxin, the desi vaccine.
During this time vaccine procurement for domestic use slipped badly. Till mid-May a total of 17 crore doses have been procured. That is enough to cover 8.5 crore people; well below 10% of the adult population of India. Further orders for some 19 crore more doses are pending, with deliveries scheduled between now and July 2021. Whether this could have been accelerated by giving more purchase orders or advancing cash earlier than was done is now a moot question.
The original vaccine procurement was done directly by the central government. As the largest single buyer in the world, it has tremendous negotiation power both in pricing and scheduling. The delivery protocol for the general public involving government hospitals, for free, and after initial hesitation private hospitals, on payment of Rs 250, was a fair and balanced approach. In March it had seemed that our earlier cynicism about the mammoth vaccination exercise creating endless headaches was misplaced.
Come April, however, all too soon the good feeling vanished giving way to dread. People were scared by the accelerating case load and high fatality rates. Terrifying visuals of patients or their families running helter-skelter for hospital beds or for oxygen or waiting in cars or just on the roads outside hospitals for admission didn’t help. People realised that Covid-19, far from receding as felt just two month earlier was out to get them. One consequence of this realisation was the beeline to vaccination centres.
In mid-April the government announced that from 1st May vaccination will be available to all above 18 years of age. So far so good, but suddenly everything started going south.
A new procurement and delivery protocol was revealed. Starting 1st May, the local manufacturers will sell 50% of their output to the central government and the balance to the states and to private hospitals. A differential pricing scheme was also revealed with states paying Rs 400 for Covishield and private players paying Rs 600 per dose. Similarly for Covaxin the states would pay Rs 600 and private hospitals Rs 1200. The centre will continue to get everything at Rs 150.
On top of this the government made it clear that it was determined to not waive the GST charged on all vaccines. To add insult to injury, it emerged that the ICMR, as a joint holder of IP rights, was getting a 5% royalty on all Covaxin sales, including those to the centre.
Basically the government is getting GST and royalty on selling its own product to itself!
To everyone’s surprise, the centre further revealed that only the 45+ age group would be eligible for free vaccination. For people below age 45 negotiations for procurement schedules, delivery arrangements and pricing were all left to the states and to the private players.
With a needless self goal India had moved from being the world’s largest and most powerful buyer to ‘one impaired potency buyer’ plus some ‘200 medium to small buyers’ with no negotiating strength against basically a duopoly of sellers. While the Russian vaccine Sputnik V is also approved for emergency use its rollout plan is not clear. There are some five or six other Indian vaccines under development which could release delivery and pricing pressures, but we don’t know if and when they might be available for use.
Vaccination for all
The 1st of May came and went. As expected there was complete chaos as Cowin, the vaccine registration and booking portal, repeatedly crashed and as of today it is only with great luck and perseverance that registration and booking can happen. Meanwhile supplies have dwindled. The states have no certainty of supplies and many have temporarily suspended vaccinating people in the age group 18-45. Many are also not giving the first jab to 45+ in order to complete the second jab to those in this age group who already got one.
In a further incomprehensible twist, the centre now says the states can import vaccines directly and many states are talking of global tenders and so on as if it is a construction contract or a sand procurement project. There are just some half a dozen major manufacturers worldwide; of those Pfizer and Moderna are out, partly because of prior commitments but largely because of the cost, storage and transportation issues. That leaves Johnson & Johnson from the west on the one hand and the Russian and Chinese makers on the other. J&J is in discussions with the centre, Russia has already a tie up with Dr Reddy’s and it is difficult to say how many Indian companies have an appetite of joining the Chinese in this area.
In any case, importing vaccines is not as simple as importing chocolate, the DCGI will still have to approve their use in India, and some solution will need to be found for the liability waiver that J&J has sought and others will.
So where do we go from here? The path is fairly clear. We have to reverse some of the actions of the last few weeks and get back on a solid track.
- Set up a small task force consisting of two or three of India’s best business brains, drawn from public or private sector, two or three epidemiologists and not more than two or three medical specialists. This taskforce will take back control of demand forecasting, pricing negotiations and setting procurement schedules of vaccines for the whole country. It will also plan and execute imports, if necessary.
- Give emergency use approval to all international vaccines which have completed clinincal trials; specially in the US or UK where, apart from anything else, a large number of people of Indian origin have already been vaccinated without any observed adverse effects. Also waive off any liability except for defective product supplies.
- Immediately license the IP and arrange to transfer technology for Covaxin to other vaccine manufacturers in the public or private sector and waive royalty payments for sale in India.
- Set up a small task-force of up to three epidemiologists, three medical specialists and three administrators to devise and execute a plan for allocation to states and to private chains.
- Revert back to the public-private delivery protocol that worked reasonably well, but expand it. Update the SOPs and allow all army, railways and hospitals of public and private enterprises and even private doctors and clinics to vaccinate. It is a very simple process and there is no reason for any delivery bottlenecks to exist.
- Make vaccination free at all public vaccination centres for all comers and at controlled prices at all private centres.
Updated 24 May 2021: By last week the cut off date for the Bombay Municipal Corporation’s global tender was passed and had received NIL response. News has also come in that Pfizer and Moderna have refused to deal with states or other private buyers, preferring to deal with the centre.
The author is a business strategy consultant. He welcomes suggestions, criticisms and corrections amspock@gmail.com
