Tag Archives: Coronavirus

Create Novel Marketing Pathways As Covid Mutants Keep Emerging

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The World’s battle against wave after wave unsettling onslaught of Coronavirus on human lives and livelihood continues, since December 2019. The first wave was triggered by the novel Covid-19 from Wuhan in China, the second by its deadly – Delta variant, and now – the third by Omicron. In India, first case of Covid-19 was reported on January 31, 2020.

Initially, global experts contemplated vaccines to prevent and contain Covid-19 and were the best hope for ending the pandemic. However, the effectiveness of existing Covid vaccines apparently declines against its subsequent mutants. This is evident even in India when the next variant Omicron commenced its onslaught.

The good news is, AstraZeneca has now claimed, a third booster shot of its Covid-19 vaccine willsignificantly boost antibody levels against the Omicron variant. However, Omicron may not be the last Covid-19 variant, as it appears today.

As the world grapples with the highly mutated Omicron, scientists have identified another new strain of the COVID-19 causing virus – in Southern France – known as ‘IHU’. This B.1.640.2 variant was reported by researchers at institute IHU Mediterranee Infection in at least 12 cases. However, it is too early to speculate on how this variant behaves as far as infection and protection from vaccines is concerned. This process is likely to take, at least, some more time.

Thus, in the current situation, when increasing numbers of even fully vaccinated individuals are getting re-infected caused by emerging mutants of Covid-19, and some more than once, the focus expanded towards more effective disease treatment. Some countries, such as the US, have decided for the 3rd booster shot of Covid-19 vaccine. Israel has even gone for the 4th booster shot of Covid vaccine. Be that as it may, in this fast-evolving scenario, even bright pharma marketers have been experiencing new strategic challenges, as we move on. Against the above backdrop, this article will delve into that space, focusing on some of the new trends of the new normal.

Pharma’s focus expands towards more effective Covid specific treatment:

Visualizing the way Covid-19 pandemic could possibly pan out in the foreseeable future, several global pharma and biotech companies have started focusing on specific treatment for this virus, ensuring speedy patient recovery.

For example, on November 21, 2020, the U.S. FDA issued an emergency use authorization (EUA) for a cocktail therapy of casirivimab and imdevimab for the treatment of mild to moderate COVID-19 in adults and pediatric patients.

Just a month later, on December 22, 2021, the U.S. FDA issued another emergency use authorization (EUA) for Pfizer’s (nirmatrelvir tablets and ritonavir tablets, co-packaged for oral use). This was also for the treatment of mild-to-moderate coronavirus disease (COVID-19) in adults and pediatric patients.

A day after Pfizer’s the first oral COVID-19 treatment, approval, on December 23, 2022, the U.S. FDA issued one more emergency use authorization (EUA) for Merck’s molnupiravir. This is the second antiviral pill authorized in the U.S, for the treatment of mild-to-moderate coronavirus disease (COVID-19) in adults. Nearer home, the Drug Controller General of India (DCGI) has also given EUA to Molnupiravir for the treatment of adult patients.

Interestingly, French regulators rejected Merck’s molnupiravir pill for low efficacy. They found other therapies were much more effective than this molecule. Even in India on January 06, 2022, the Indian Council of Medical Research (ICMR) also expressed safety concerns on Molnupiravir. Thus, it has not been included in the national list of Covid treatments in India. That said, such brilliant initiatives by several pharma companies in the battle for saving lives and livelihoods against Covid-19 pandemic, made those companies household names like never before.

Covid made several pharma companies household names, but not brands:

This point was restated in a recent article, published in the Fierce Pharma on December 22, 2021. It emphasized, Covid-19 ‘has brought the words of the pharma industry into people’s lives like never before: Moderna, Pfizer, BioNTech, AstraZeneca and Merck have become household names.’ One may not remember the names of their Covid products, but will mostly know the company.

Many people have now started referring to Covid vaccines and drugs in generic names. As from the very beginning we started hearing people saying, like – I got ‘AstraZeneca Vaccines’, ‘Remdesivir’, or ‘Covid Cocktail therapy’. Company names usually followed the generic names in most cases. Although, ‘that’s been good for pharma’s reputation, but has left marketers in a bind about branding, commented the above article.

Most Covid-19 drugs and vaccine brands are on ‘emergency use approval’

In the Covid dominated year of 2021, drug and biotech companies managed to get USFDA approval for 55 new drugs. However, many of those drugs and vaccines got only Emergency Use Approval (EUA) and only under emergency use basis. This basically means, under EUA these companies did not get full marketing approval and were handicapped to go whole hog with the usual new brand marketing campaigns.  This critical issue is expected to remain even in 2022.

In a situation, such as this, when the full scale branding initiatives can’t be undertaken, intenseCorporate Branding Campaigns, I reckon, would pay a rich dividend. This process will be quite different from creative new brand marketing in the old normal. Some global innovator companies are using even the mass media to promote their respective vaccines, albeit differently.

Such promotions include, Open Letter from the Company CEO, creative use of TV shows, messages of the head honchos through twitter or word of mouth campaigns – creating a snowballing effect. Alongside, healthcare marketing professionals are also intensifying their Covid-vaccine ad campaigns, sans brand names, to increase awareness and persuade more people to get vaccinated, soon.

To move in this direction, at least, during EUA period for Covid drugs and vaccines, hybridization of pharma marketing will be necessary in many cases, which won’t be an easy task for all, though.

Hybridization of pharma marketing – necessary – but not an easy task:

Based on experience of almost the last two years, many drug companies have realized that virtual-only customer engagement models have some serious shortcomings to fetch desired outcomes. This issue was studied and well-articulated in an article, published in the Reuters Events on November 30, 2021.

It found: “Virtual-only engagement can make it harder to create a real connection.” Further, as the paper articulated: “Even if HCPs share their video, we are losing the third dimension, hence losing out on parts of that personal component.’ Besides, although, online meetings are flexible regarding timing, if a doctor doesn’t dial-in, there is only a small chance the meeting will happen later that day, unlike waiting in a clinic for the interview to take place.

To address this issue, pharma players are now in various stages of creation and adoption of their respective hybrid marketing models. However, the process offers its own challenges. Working out customer-specific hybrid engagement models are a different ball game altogether- requiring very different skill sets, continuous training and above all a very different mindset.

Conclusion:

As reported on January 06, 2022, rapidly spreading Omicron variant of the novel Coronavirus threatens to rewrite the business recovery timelines, even in India. Even recently, many CEOs and top executives have opined, businesses would have to live with Covid-19 uncertainty. The article further added: ‘Many companies have suspended their return-to-work plans and are reassessing business continuity measures as a third wave of the pandemic starts to surge.’ Most CEOs also expressed one of their top priorities was to ensure Covid-19 protocols were being followed and all employees were safe.

Similar situation arises for all Covid drugs approved under the EUA by the Drug Controller general of India, and are being marketed by Indian companies against non-exclusive voluntary licensing agreements with the innovators. Thus, an analogous marketing issue exists surrounding all such EUAs, as the company concerned can’t undertake a full brand marketing campaign. This constraint is likely to pose a major marketing challenge for several potential Covid blockbuster drugs in India, at least in 2022, which marketers need to overcome, creatively.

From the above perspective of Covid-19 drugs and vaccines, companies would need to create novel and effective strategic pathways for performance excellence. At least, as long as Covid-19 mutants will continue to emerge, causing operational disruptions in the pharma business.

By: Tapan J. Ray

Disclaimer: The views/opinions expressed in this article are entirely my own, written in my individual and personal capacity. I do not represent any other person or organization for this opinion.

 

To Allay Customers’ New Apprehensions Pharma Needs A New Conversation

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Since the beginning of 2020, witnessing the rapid spread of Covid pandemic with very high global fatality rate – virtually the entire global populations – directly or indirectly, have been looking up to the health care industry for help. This, of course, includes the drug industry – with high expectations of people on deliverables, blended with palpable apprehensions on what’s happening around.

Amid the wave after wave attack of Covid-19, many have realized that there will neither be any quick-fix or immediate solution to tame the virus. As India goes through the Covid 2.0 catastrophe, while waiting for Covid 3.0, a similar situation prevails in the country – with a sense of lurking fear for future uncertainties, slowly but steadily creeping in.

Thus, an unprecedented public expectation for speedy disentanglement of Covid-19 disruptions, confer a huge responsibility to all health care providers and entities, such as, the drug industry, which will be my key focus in this article. Just as any extraordinary situation calls for extraordinary initiatives, this national tragedy also demands from pharma professionals to start a new and proactive conversation, driven by ‘out of-box’ thinking.

I shall explore in this article, in which areas pharma needs to roll out a new conversation to meet with new expectations of its stakeholders, formed during the Covid Pandemic. This engagement needs to go beyond drugs and vaccines, spanning across key contemporary developments that are bothering pharma customers. The aim should be to help customers visualize a brighter horizon based on scientific reasons, in not-too-distant future, such as:

  • How several pharma companies are taking novel initiatives, as a part of their corporate objectives to save lives and livelihoods, faster.
  • How pharma players are thinking ‘out of the box’ to allay Covid related public apprehensions and neutralizing gross misinformation on Covid cure – based on scientific reasons, often selectively deploying their staff members.

In this regard, let me start with a recent advice of a top pharma veteran of global repute, especially on political and public expectations of ‘the endpoint’ for successful prevention and effective treatment of Covid-19 infections.

When focus is on ‘the end point – the price point’, it needs pharma’s attention:

Former CEO of Novartis Joe Jimenez – Ex-Novartis CEO and CEO & Cofounder of Aditum Bio, advised the same in an interview with Reuters Events, published on April 06, 2021. Although this was against the backdrop of the United States, the same is applicable to India, as well.

There, Jimenez said: “And I think the political focus in the United States is too often on the end point, the price point, which definitely needs attention, but not enough on the whole pipeline. And that absolutely needs attention and can bring down the price point at the end of the day.”

“It’s the pharmaceutical industry’s responsibility to show how their drug can lower total costs through the system, whether it’s reducing hospitalization or whether it is reducing other health care costs and comorbidities that lead to ever increasing budgets. If the industry focuses on that, I think I think that’s going to result in better launch success in the next few years,” he added.

However, there is another endpoint – of equal importance, especially in the Covid-19 prevention and the treatment process.

The other end point is equally important, as there may be an extended need for Covid vaccines: 

Wider access to Covid drugs and vaccines is another political and general public’s ‘end point’ of expectations, besides price. As I wrote in my previous article, on October 02, 2021, India and South Africa had proposed at the WTO about an IP waiver for Covid-19 drugs and vaccines to resolve the issues of access and affordability for these products.

Thereafter, on May 05, 2021, the United States also issued a statement supporting the IP waiver for Covid-19 vaccines at the WTO, in its ‘service of ending this pandemic.’ As reported on May 13, 2021, even China now backs the drugs and vaccine IP waiver at the WTO.

Patent waiver for Covid drugs and vaccines make sense for the coming years, especially, in view of the reports that ‘Pfizer, Regeneron CEOs see extended need for COVID-19 vaccines, treatments as pandemic enters the next phase.’ Adding that the data stressed a “need” for re-vaccinations, the Pfizer CEO said, while protection remains high for those six months, it does “go down by time.” Thus, the need for Covid vaccine may continue to remain as important as of date, to prevent the pandemic over, at least, a couple of years, if not beyond.

That apart, some interesting developments followed soon – coincidentally or otherwise.

Meanwhile, some pharma companies responded with laudable initiatives: 

Presumably, for wider availability and affordability of Covid drugs and vaccines, several pharma players alone or in association with governments, took some laudable initiatives. A few examples are, as follows:

  • On May 10, 2021, BioNTech, which has partnered with Pfizer to produce its COVID-19 vaccine, said it plans to set up a new manufacturing site in Singapore, with a capacity to produce several hundred million doses of mRNA-based vaccine.
  • As reported on the same day, as above, Eli Lilly promised to supply India with thousands of tablets of baricitinib for hospitalized COVID-19 patients. It also pledged to sign a royalty-free, non-exclusive voluntary licensing agreements with Cipla, Lupin and Sun Pharma—to expand baricitinib’s availability in the country. Notably, in this month itself, the DCGI has authorized baricitinib plus remdesivir combo for emergency use of ‘hospitalized patients requiring supplemental oxygen, invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO).’ Baricitinib has also faced a shortage of during the Covid 2.0 surge.
  • As per reports of May 12, 2021: ‘The US is looking at joint production of Johnson and Johnson’s Covid vaccine in India and ways to help manufacturers like Serum Institute of India (SII) to boost production,’

Pharma’s new role to allay public apprehensions in many Covid related areas:

In this complex scenario, various public apprehensions on Covid vaccines and drugs, need to be explained with scientific evidence – in a common man’s language. These include frequent changes in the dosage interval between two doses of some vaccines, whereas for other vaccines there isn’t any change in this area. Or why in India even within a group of fully vaccinated individuals, wearing masks or maintaining social distancing norms are necessary, when these requirements have been relaxed for fully vaccinated people in the United States. Or, when reports like: ‘Covid Cases Double In World’s Most-Vaccinated Nation, Raising Concerns,’ add fuel to the fire of public apprehensions in this regard.

Drug companies, especially those who are engaged in the global battle against Covid-19 – in their research lab, product development process, including clinical trials, can play an additional stellar role in this area, too. With ‘out of the box ideas’ for Covid related public engagement, they can scientifically respond to all public apprehensions with scientific reasons, in a simple language, on what is happening around most people, nowadays. Selective deployment of their own staff members can also make the initiative more meaningful.

This conversation may also include, science-based response to some bizarre claims of ‘Covid cure’ – from religious leaders having significant followers, and even by Union Ministers, without hurting their feelings or sentiments. These ‘advices’ were widely circulated by the mainstream global and local media, including the Wall Street Journal.

For example, one such report said: The president of a century-old religious organization declared that “consuming cow urine and cow dung will stop the effect of infectious coronavirus.” The swami added that a “person who chants ‘om namah shivay’ and applies cow dung” on his body “will be saved.” However, it was also reported that ‘Indian doctors warn against cow dung as Covid cure.’ Similar advice in different forms, even by elected politicians, keeps misguiding many unsuspected members of the public.

Conclusion:

A series of Covid related contemporary needs and apprehensions, besides the traditional ones are surfacing. These are to be mitigated, on an ongoing basis. Pharma players – individually and collectively, instead of being always reactive, may wish to volunteer to proactively address these issues to help people move in the right direction.

As Covid appears to be a medium to long-haul battle – unlike most other pandemics, pharma companies need to think ‘out of the box’ to create innovative – new – and proactive conversation models in this space. In turn, the initiatives will help them win long-term trust and loyalty of customers – that will always remain as invaluable assets, fueling sustainable growth in business.

By: Tapan J. Ray     

Disclaimer: The views/opinions expressed in this article are entirely my own, written in my individual and personal capacity. I do not represent any other person or organization for this opinion.

 

Impact of Covid Vaccines’ Possible IP Waiver In India

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Just when Covid 2.0 rages in India with almost 4,000 people died in just 24 hours, scientists warn that Covid 3.0, and further waves are now ‘inevitable, reported Reuters on May 06, 2021. With hospitals running short of beds and oxygen during the onslaught of Covid 2.0, the World Health Organization (WHO) highlighted, ‘India accounted for nearly half the coronavirus cases reported worldwide last week, and a quarter of the deaths.’

The report revealed some more heartrending details: ‘Many people have died in ambulances and car parks waiting for a bed or oxygen, while morgues and crematoriums struggle to deal with a seemingly unstoppable flow of bodies.’

No visible overall improvements with ‘here and now decisions’ or maybe the lack of it, of the National Covid Management Team, is perceptible, just yet. It’s also a matter of further concern that unlike what happened during Covid 1.0, the second wave of the virus, reportedly, ‘started hitting even young adults hard – leaving countless children to fend for themselves.’

Ironically, alongside a rapid surge in infections, India witnesses a sharp decline in Covid vaccination numbers though more people are eligible. The key reasons being supply chain related problems, despite India being one of the largest vaccine producers, globally. In my last article  published in this blog, I broached on finding a possible exit to this covid 2.0 maze in India. However, this article will explore some unprecedented developments of the last week in this area. To give a perspective, let me start by exploring whether the people responsible for Covid Governance in India, grossly misjudged the situation, claiming the ‘endgame’ of Covid-19, too soon.

‘India announced its triumph over Covid-19 early’:

A third Covid-19 wave is inevitable, but the timing could not be predicted, said India’s principal scientific advisor on May 05, 2021. Intriguingly, less than two months back, the national Government announced its triumph over Covid-19. On March 08, 2021, as Covid vaccination process for senior citizens and people above 45 years with comorbidities had just commenced, the Union Health Minister claimed, ‘India is in the endgame of the novel coronavirus pandemic.’ Just about a couple of months later, it sounded akin to a note of hubris for many, which prevailed, by and large, across the nation.

Acknowledging the same, on May 04, 2021, even Uday Kotak, MD&CEO Kotak Mahindra Bank and President CII commented, ‘India announced triumph over Covid-19 early’. He further urged: “We have to do whatever it takes to save lives first, even as we battle for livelihoods. And if our healthcare capacity is currently going through its challenges, we must be ready to curtail non-essential economic activities.” The latest editorial from ‘The Lancet’ also highlighted the same.

India’s Covid 2.0 – “A self-inflicted national catastrophe” – The Lancet 

Yes. The editorial of the latest – May 08, 2021 issue of The Lancet, also reiterated so. It emphasized, ignoring warnings about the risks of super spreader events, the government allowed congregations of millions of people from across India in religious festivals, along with huge political rallies with utter disregard to Covid appropriate behavior. ‘The message that COVID-19 was essentially over also slowed the start of India’s COVID-19 vaccination campaign, which has vaccinated less than 2% of the population.’ India’s national vaccination plan soon fell apart with the government abruptly expanded vaccination to all 18 years, draining supplies, ‘and creating mass confusion and a market for vaccine doses in which states and hospital systems competed.’

The IHME estimates a staggering 1 million deaths from COVID-19 in India by Aug 01, 2021. ‘If that outcome were to happen, Modi’s Government would be responsible for presiding over a self-inflicted national catastrophe. India squandered its early successes in controlling COVID-19. Until April, the government’s COVID-19 task force had not met in months,’ The Lancet editorial revealed.

Besides, India also misjudged the complexities involved in procurement, distribution and for speedy inoculation of affordable Covid vaccines, at least, to its entire adult population. But, before delving into that area, let me highlight an interesting mismatch.

India’s vaccine shortage when Pfizer logs a record vaccine turnover during pandemic:

Two contrasting scenario surfaces – as the world is reeling under unprecedented disruptions caused by successive waves of Covid-19. Witnessing India’s unparalleled healthcare tragedy in Covid 2.0, the W.H.O director general said: “The situation in India is beyond heartbreaking.” Outlining the reason for the same a separate report commented: A ‘complete collapse’ of preventive health: How India’s 2nd COVID wave exploded.

Concomitantly, one reads news items, which bring out, ‘Pfizer eyes $26B in COVID-19 vaccine sales for the year, with $3.5B already in the bag.’ Notably, most vaccine companies received huge public funding much before Covid vaccines were rolled out. For example, ‘The New York Times’ article of July 22, 2020 came with a headline: ‘Pfizer Gets $1.95 Billion to Produce Coronavirus Vaccine by Year’s End.’

The Scientific American also reported on November 18, 2020, ‘For Billion-Dollar COVID Vaccines, Basic Government-Funded Science Laid the Groundwork.’ It added: ‘Much of the pioneering work on mRNA vaccines was done with government money, though drugmakers could walk away with big profits.’ That’s exactly, I reckon, is the reality today.

Similarly, Moderna’s COVID-19 vaccine generated $1.73 billion in revenue during the first quarter, as compared to $3.5 billion of Pfizer’s Covid vaccine in the same quarter. Moderna now predicts its vaccine will generate $19.2 billion by year’s end. Interestingly, through its COVID-19 vaccine partnership with the U.S. government, Moderna also received nearly $1 billion in research aid. The Company is now joining a list of other vaccine players to take a supply order from the federal government.

By the same token, Serum Institute of India (SII) – the contract manufacturer of Covishield, developed and owned by Oxford University and AstraZeneca has also received initial advance funding from the governments, prior to its manufacturing.

Was India’s ‘Vaccine Maitri’ a pragmatic step?

Today, India is one such country facing the brunt of Covid vaccine shortage alongside arriving at an affordable price per dose of the same – a part of which is due to ‘unrealistic’ planning, as many experts believe.

For example, on January 20, the Indian government launched Vaccine Maitri – an ambitious program to export the two Indian-made shots – Covishield and Covaxin – to the world. On that exact date, India counted 14,112 fresh cases of Covid-19. Going by a report of May 01, 2021: ‘According to the government’s own submission before the Parliament, more shots were sent out of the country than administered to Indians as of mid-March.’ Many, therefore, wonder, whether this was a pragmatic decision that helped save lives of Indians during Covid pandemic.

An unprecedented development on vaccine IP waiver:

This is regarding IP waivers for Covid vaccines. In my last article, I wrote about it, stating, on October 02, 2021, India and South Africa had proposed at the WTO about an IP waiver for Covid-19 drugs and vaccines to resolve the issues of access and affordability for these products. It was also widely reported: ‘Richer members of the World Trade Organization (WTO) blocked a push by over 80 developing countries to waive patent rights in an effort to boost production of COVID-19 vaccines for poor nations.’

However, on May 05, 2021, a statement of the U.S. Trade Representative said, ‘as the extraordinary circumstances of the pandemic call for extraordinary measures, in its service of ending this pandemic the US also supports the IP waiver for Covid-19 vaccines, although the US administration supports IP protections generally. As expected, Big Pharma lobby groups, including PhRMA, reportedly, have strongly criticized the move.

Let me hasten to add, there is, at least, one exception in this area. Months ago, on October 8, 2020, Moderna said, ‘it won’t enforce its vaccine patents against other companies during the pandemic.’ Without specifying any names, the Company revealed, ‘other Covid-19 vaccines in development might already be using Moderna-patented technology.

The WTO process is expected to begin now, but how long will it take?

As the Reuters report dated May 06, 2021 indicated – with the U.S. backing a proposed waiver of Covid-19 vaccine IP rights, the next stop is for the World Trade Organization to hammer out a deal – a process that could take months. “At a minimum, it’s going to be a month or two,” said a former Trump White House trade official who previously worked at the U.S. trade mission to the WTO in Geneva. The waiver, if happens, could also be significantly narrower in scope and shorter in duration than the one initially proposed by India and South Africa.

The relevance of IP waiver:

Currently, only drug companies which own patents or their authorized manufacturers like SII can produce Covid vaccines. A global decision on patent waiver may encourage the patentees to share the formula and manufacturing technology, instead of reverse engineering, as is done for off-patent small molecules and some biotech drugs.  All companies with requisite resources may legally manufacture Covid vaccines, in that situation, leading to cheaper, and significantly more quantity of generic versions of Covid vaccines. This may help overcoming vaccine shortages, making the vaccines affordable, as well.

Some counter arguments and response:

As I wrote in my last article, the following three critical questions may arise in that scenario:

  • Will IP waiver help solve the immediate issues of vaccine shortages?
  • Can Covid vaccines be reverse engineered by domestic pharma industry without inventors sharing ‘Know-How’?
  • If yes, how long can it take?

The answer to the first question is – it may not help resolve the immediate crisis. But, for a medium to long term solution, there will be an emphatic yes, as Covid-19 fight is expected to be a long-haul one, as experts caution about subsequent waves of rapidly mutating new Coronavirus.

Moreover, Pfizer – BioNTech vaccine took less than a year from ‘mind to market,’ with support from all concerned. This is evident from Pfizer’s Press Release for the launch of Covid vaccine in the United States last year, on December 11, 2020. Thus, an efficient reverse engineering may also take that much time to respond to medium and long-term issues with Covid vaccines, especially in India.

Subsequent Covid-19 waves could be triggered by unpredictable compliance to Covid appropriate behavior of people. W.H.O has also warned: “When personal protective measures are being relaxed, when there are mass gatherings, when there are more contagious variants and the vaccination coverage is still low this can create a perfect storm in any country,”

Conclusion:

‘The pandemic is not a competition between companies and will not end without more-equal distribution of coronavirus vaccines,’ wrote Nature on March 30, 2021. It suggested: ‘It’s time to consider a patent reprieve for COVID vaccines.’

The world needs around 11 billion doses of Coronavirus vaccines to immunize 70% of the global population – assuming two doses per person. Interestingly, around 6 billion doses are meant for high- and upper-middle-income countries, against advance orders. Poorer nations, accounting for 80% of the global population, so far, have access to less than one-third of the available vaccines. ‘Unless manufacturing and supply can be distributed more evenly, researchers forecast that it will be at least another two years before a significant proportion of people in the lowest-income countries are vaccinated’, the paper concluded.

In this situation, I reckon, a temporary IP waiver would help in accelerating the end of the pandemic. It may not help immediately, but certainly in the foreseeable future, as discussed above. It may also call for an efficient and well thought out ‘Hub and Spoke’ distribution model. Simultaneously, of course, similar systems for raw and ancillary materials for vaccine production need to put in place to avoid intermittent shortages. 

As reported on May 08, 2021, India registered a record 4,187 Covid death with 4.01 Lakh new cases, in 24 hours. Capturing the depth of the Indian crisis, ‘India Today’ is coming out with a cover page article in its May 17 issue, with the headline – ‘Covid 2.0 – The Failed State.’ Another article terms India as the ‘Flailing state in Covid storm.’

As I reasoned above, if this unprecedented step of IP waiver for Covid vaccines is finally taken by the WTO, it will significantly help India – along with the world – may not be immediately, but certainly in the foreseeable future. Only adverse impact that the decision could possibly make, is curbing Big Pharma’s unprecedented profit on Covid vaccines, and that too, during a deadly global pandemic.

By: Tapan J. Ray     

Disclaimer: The views/opinions expressed in this article are entirely my own, written in my individual and personal capacity. I do not represent any other person or organization for this opinion.

 

Exploring An Exit To India’s Covid Management Maze

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‘India’s Covid-19 Crisis is Spiraling Out of Control. It Didn’t Have to Be This Way,’ was the headline of the lead article, published in The Time with the cover page ‘India in Crisis.’ All Indians also believe the same, as the current reality is shown virtually live in TV news channels daily, with experts commenting on the same.

Ironically, many in the country’s leadership still remain in a ‘denial mode’, even when the country records globally highest number, ever – over 402,110 daily new Covid-19 cases with 3,688 daily deaths, on April 30, 2021. One can also gauge how grim the situation is from the example of the US alert to its citizens in India. It says, ‘access to medical care is becoming severely limited because of a surge in Covid-19 infections and those wishing to leave the country should take advantage of available commercial transportation options.’

Notably, when most Indians, including the President of India, were taking pride in the country’s ‘Aatma-Nirbhar Bharat Abhiyan,’ especially in the Covid-19 vaccine area, during the pandemic, the stark reality appeared to be quite different. Pandemic demonstrated that each country is, in fact, interdependent. One may not acknowledge it in the days of hubris. However, when a crisis, like Covid 2.0 strikes the nation hard and interestingly – not unannounced, as many experts write, the reality dawns. This is also a reality that India as a nation could not adequately prepare itself for Covid 2.0 onslaught, even over a yearlong Covid 1.0 pandemic.

Nonetheless, India now needs global help, almost for everything – in the prevailing calamity – Oxygen, drugs like, Remdesivir – and vaccines, besides many others. Quite expectedly, witnessing the Covid 2.0 tragedy in India ‘Aid (also) pours in from the world to counter India’s Covid-19 second wave.’ Alongside, along with Indian media, even foreign media reports, ‘Bodies piling up at crematoriums: Record death toll may hide extent of India’s COVID-19 crisis.’

Amid Covid crisis, most countries in the world, including the United Kingdom, the United States,Israel and even India’s neighboring country - Bhutan focused on the mass Covid vaccination drive – at a blistering pace, to create a herd immunity. In this article, I shall explore the drivers and barriers for India to achieve a similar goal, soon.

Current developments with vaccine in India:

The latest development is – after a protracted hesitation, the Government of India opened ‘Covid-19 vaccination for all above 18 years of age,’ effective May 01, 2021. However, not so good news is, this happened at a time when the country is experiencing a Covid-19 vaccine shortage even for all adults above 45 years of age. Believing that government has taken this decision without enough advance preparation, experts warn, India is likely to face extreme Covid vaccine shortage from May 1.

They express concern: ‘India is running out of vaccines just as the new wave of Covid-19 infections batters the country, complicating Prime Minister Narendra Modi’s plan to inoculate the nation’s workforce while threatening to drag out the world’s worst healthcare crisis.’

India rejected ‘emergency use’ of imported Pfizer and other vaccines, unlike other countries:

Some decisions by Indian vaccine expert panel also delayed more vaccine availability in the country for ‘emergency use,’ sooner. For example, Reuters reported on February 05, 2021, ‘Pfizer drops India vaccine application after regulator seeks local trial.’ The Company had applied to the DCGI for a waiver of a local trial for importing its mRNA vaccine in India.

Similarly, as reported on February 25, 2021, ‘Expert panel seeks safety data for Russia’s Sputnik V Covid-19 vaccine before emergency use nod,’ in India. Ironically, it was again rejected on April 01, 2021. However, facing the fierce Covid.2.0 wave Sputnik V vaccine is now being imported from Russia. Similarly, as reported on April 30, 2021, ‘Pfizer begins exporting U.S.-made COVID-19 vaccine to Mexico.’ Pfizer has already exported 10 million doses to Mexico.

In the quagmire of indecision, late decision and other non-life saving priorities are omnipresent:

Many Indian and overseas experts opined that valuable time was lost to have more vaccines in India, by now. This is because, amid a wrenching surge in infections and deaths, on April 14, 2021 – ultimately, India agreed to fast-track vaccine approvals for ‘emergency use,’ without local trial. These are now applicable to all those Covid vaccines that have already been authorized by ‘drug regulators in the US, UK, European Union and Japan or cleared by the WHO, without having to conduct a local bridging trial.

The above developments, I reckon, gave rise to two core issues in vaccinating the Indian population of above 18 years of age – at a ‘blistering pace,’ as happened or is happening in countries, like the UK or the US.

Whereas, for speedy mass vaccination wealthy governments took a quick decision to stock up on COVID-19 shots from Pfizer and Moderna Inc, because of their extremely high efficacy. More so, when safety concerns and production problems temporarily sidelined vaccines from AstraZeneca Plc and Johnson & Johnson.

Two core issues for a speedy vaccination process in India:

No domain experts in the world doubt that mass vaccination is India’s Covid-19 escape route from the prevailing health care massacre. However, arising out of the above developments, successful implementation of Covid vaccination process  on the ground, making it available and affordable to all, poses a giant challenge. Thus, to effectively address the two core issues, with the quality of speed that it deserves, finding answers to the following questions are critical:

  1. How to add speed to the vaccination process?
  2. How to avoid different pricing for the same vaccine for the Central Government, the State Governments and the Private Hospitals? This will give a choice to the population for speedy vaccination, removing many personal apprehensions involving the entire process.  

Let me give an example, each of the most recent quagmire related to each one of the above issues.

All vaccination centers in Mumbai were shut for three days for shortages:

Reuters reported on April 30, 2021 carrying a headline, ‘Indian states run out of COVID-19 vaccines; nationwide inoculation delayed.’ It added, several Indian states have run out of COVID-19 vaccines a day before a planned widening of a nationwide inoculation drive. Interestingly, quoting Indian authorities it elaborated: ‘All vaccination centers in India’s financial capital Mumbai were shut for three days starting Friday due to a shortage of vaccines, as the country posted another record daily rise in coronavirus cases.’ The same saga can be witnessed in the national capital of India. ‘Don’t queue up outside Covid-19 vaccination centers tomorrow, the stock will arrive in 1-2 days,’ urged the Chief Minister of Delhi.

The Government allowed Covishield and Covaxin price increase amid pandemic:

Covishield and Covaxin were being purchased by the central government at a price of Rs. 150 per/dose. While announcing Covid vaccination eligibility to all Indians above 18 years of age – despite vaccine shortages, the government allowed the two Indian vaccine manufacturers to increase the same vaccine prices – for direct supply to the state governments and private hospitals.

The manufacturers lapped up this decision and increased the vaccine prices by several times, amid catastrophic Covid 2.0 pandemic. For example, for state governments the Covishield price was raised to Rs.400/per dose and Rs.600/per dose – for Covaxin. However, facing severe criticism from all quarters the prices were revised to Rs 300 (Covishield) and Rs.400 (Covaxin). Interestingly, still the price increases were double or even more from the initial prices of Rs.150/per dose.  Interestingly, one manufacturer even boasted  this so called ‘price reduction’ from their initial humongous price increases, as a ‘philanthropic gesture’. Interesting indeed!

A hidden solution within Supreme Court questions to the Center:

While hearing a Suo Moto case in connection with the ongoing Covid 2.0 calamity in the country, the Supreme Court of India also took note of the difference in Covid vaccine prices for the Centre and the state governments. It observed Covid vaccine manufacturing is publicly funded, hence are public goods – these are ultimately meant for the people of India. At the same time, the apex court asked some of the following profound questions to the central government on Covid 2.0 management in the country:

  • Why is the center not following the national immunization program policy in its Covid-19 vaccination drive where the Centre will buy all vaccines from the manufacturers?
  • How much investment has the Centre made into the vaccine companies and given advances in the last year?
  • What has been the financial contribution by the Union govt in research etc. in the development of vaccines?
  • How will the Centre ensure registration for vaccines for illiterate people and those without internet access as registration through Co-Win is mandatory in the third phase of vaccination?
  • Will one state get priority access over another in getting the vaccines?
  • How will the Centre ensure equity by private vaccine manufacturers when it is buying only 50 percent of the doses?
  • Has the center considered invoking Section 92 of the patents act and issue compulsory licenses so that drugs can be manufactured while the royalty is sorted?
  • Why are we paying so much for this vaccine for which AstraZeneca has set at a far lower price to the US citizens?

One may possibly find a hidden solution to the question of invoking Section 92 of the Indian Patent Act (IPA 2005) to address some critical Covid vaccine related issues in India.

Is invoking section of IPA 2005 a near-term solution?

As many would know, Section 92 of the Indian Patents Act is a special provision enabling the Central Government to issue Compulsory Licenses for the manufacture of patented drugs in a public health emergency. Section 100 of the IPA enables the Central Government to use patented inventions for government purposes. Curiously, the Supreme Court of India has, reportedly, also observed: “This is an exact case where we should go for compulsory licensing. This is a situation of Public Health Emergency.”

Just to recap, on October 02, 2021, India and South Africa had proposed at the WTO about an IP waiver for Covid-19 drugs and vaccines that could help resolve the urgent issues of access and affordability to these products. It has also been reported: ‘Richer members of the World Trade Organization (WTO) blocked a push by over 80 developing countries on Wednesday to waive patent rights in an effort to boost production of COVID-19 vaccines for poor nations.’

Although, U.S. Trade Representative has recently met with Pfizer and AstraZeneca to discuss this proposed IP waiver for Covid vaccines and drugs, what stops India to invoke Section 92 and 100 of its own Patent Act even during this seemingly uncontrollable Covid 2.0 pandemic?

The April 06, 2021 article of the Observer Research Foundation aptly epitomized the need of the hour. It articulated: ‘As the pandemic continues to rage, countries collectively have to find innovative ways to not just increase the production of vaccines, but also ensure their timely distribution at affordable prices.” Such an initiative may encourage more manufacturers in India to manufacture enough Covid vaccine, facilitating speedy inoculation to Indians and at the same time the government can make its price affordable for all concerned.

Conclusion:

The question, therefore, arises: Is India’s exit to the Covid 2.0 maze now visible? But, before arriving at any possible conclusion in this regard, one may try to address, at least, the following two critical questions:

  • Can Covid vaccines be reverse-engineered by domestic pharma industry without inventors sharing ‘Know-How’?
  • Can the IP waiver by the WTO or invocation of section 92 and 100 of IPA 2005 by India, legally mandate vaccine developers, like AstraZeneca, Pfizer-BioNTech or Johnson & Johnson, to share know-how with others, if they do not want to do so?

The resolution of the above issues won’t happen in a jiffy – at this stage. It may take more time. So, I reckon, will be the search for a permanent exit to India’s Covid 2.0 management maze, to avoid a similar strike by Covid 3.0, if or as and when it will come. Thus, till all adult Indians get vaccinated, each one of us must comply with Covid appropriate behavior responsibly, to save ourselves, our families, neighborhood, and above all our own nation.

By: Tapan J. Ray     

Disclaimer: The views/opinions expressed in this article are entirely my own, written in my individual and personal capacity. I do not represent any other person or organization for this opinion.

Covid 2.0 Rampages India As Top Echelon Policy Makers Ignore Science

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‘India is in the endgame of COVID,’ announced the union health minister of India, just in the last month – March 08, 2021. Although, it was then clearly known to medical fraternity that today’s Covid vaccines won’t be magic bullets against rapidly mutating new Coronavirus. Interestingly, a scientific-data based MIT study, published last year – on July 01, 2020 predicted that India might record the highest ever in the world – 287,000 new Coronavirus cases per day, by February 2021. At that juncture also Covid vaccines were expected to be available in India before that predicted time frame. The MIT study warning received a wide coverage even in India - by almost all news dailies, on that very month of the last year. The national Covid management team did not seem to have taken it seriously, along with others. These include, besides the top echelon of governance – a vast majority of Indians – across the social, political, religious and economic strata.

The fallout of such callousness – both at the individual Covid-appropriate behavior level, as well as Covid governance level, have been more disastrous than what was forecasted even in the above MIT study. The ferocity and scale of the second Covid-19 wave in India did not just overwhelm the nation, but raised grave concern across the world too. On April 22, 2021, India recorded the world’s biggest ever single-day rise with 314,835 new cases of Covid-19, causing death to 2,104 people. The very next day, this number increased to 332,730 new cases with 2263 deaths.

But, the peak of the Covid second wave hasn’t come, just yet. According to a mathematical model developed by a team of scientists from the IIT Kanpur and reported by news media on April 22, 2021, the number of active covid-19 cases in India during the second wave is expected to peak in May. The daily infection count is expected to exceed 350,000 cases. In this article, I shall dwell on three specific areas – acknowledging that the current scenario is the outcome of national misjudgment, if not a humongous misgovernance to prepare India for Covid 2.0:

  • Current struggle of India’s fragile and long-ignored health care infrastructure.
  • Need to neutralize some general misgivings on Covid vaccines and associated dilemmas.
  • Who is equipped to save people, if no external remedial measures remain unavailable for some more time?

India’s fragile and long-ignored health infrastructure can’t take anymore:

Amid this calamity, India has run short of oxygen, hospital beds, important Covid medicines, including Remdesivir. Curiously, reports keep coming incessantly confirm and reconfirm: ‘Ever since the second wave of the pandemic started, the healthcare systems in India have been teetering on the brink, with many hospitals unable to handle the relentless inflow of patients whilst also running short of beds, oxygen cylinders and other essentials.’

Doctors and many health care workers are overwhelmed by the massive scale of the human tragedy and in tears, as they articulate: ‘Many lives could have been saved had there been enough beds, oxygen supplies, ventilators and other resources – if the healthcare system had been better prepared for the second wave.’

The Supreme Court intervened, noting the ‘grim situation’ in the country:

Meanwhile, the Supreme Court of India, reportedly, ‘Suo motu’ (on its own) took note of the grim situation in the country and the havoc caused due to shortage of Oxygen cylinders in hospitals. Consequently, on April 22, 2021, the top court said, ‘it expected the Centre to come out with a “national plan” on the supply of oxygen and essential drugs for treatment of infected patients and method and manner of vaccination against the disease.’  The Delhi High Court also observed, “We all know that this country is being run by God,” coming down heavily on the Centre over the Covid-19 management.

Some Covid vaccine related misgivings and dilemmas:

Many people are raising questions of the efficacy of two currently available Covid vaccines in India – Covishield and Covaxin, especially against our probably ‘desi’ double mutant variety of Covid-19. The trepidation increased manifold when India’s former Prime Minister – Dr. Manmohan Singh got Covid infected after taking two doses of Covaxin. Or, reports, such as: ‘Sri Lanka reports six cases of blood clots in AstraZeneca vaccine recipients, 3 dead.’ Incidentally, these vaccines were made in India. Some may not possibly know that both the issues have been deliberated by the Indian scientists, who haven’t expressed any concern, as yet. This has to be shared with all by all concerned, soon. Let me explore some of these related issues, as follows:

Re-infection after taking Covid vaccines:

Regarding re-infection rate after taking two doses of Covid vaccines, the scientists have now released data establishing that only a very small fraction of those vaccinated with either Covaxin or Covishield, have tested positive. In any case, instances of a few “breakthrough” infections do not undermine the efficacy of the vaccines, they added.

The ICMR has also clarified, “These vaccines definitely protect against disease. However, the immune response begins to develop usually two weeks after every dose and there are variations within individuals, too. Even after the first dose, if exposure to the virus happens, one can test positive.”

Efficacy of Covishield and Covaxin against double mutant strains:

Notably, both – the Indian Council of Medical Research (ICMR) and the Centre for Cellular and Molecular Biology (CCMB) have announced last week that Covishield and Covaxin protect patients even from the ‘double mutant’, B.1.617, variety of Covid-19. Scientists believe that the “double mutant” is responsible for the sudden spike in the number of cases in Maharashtra and other parts of the country. They had earlier feared that this “double mutant” or B.1.617, may escape the immune system and thus vaccines may not offer protection from this strain of the novel coronavirus.

Reported risk of blood clotting with Oxford-AstraZeneca’s Covid-19 vaccine:

No cases of blood clotting have come to light in India. However, a government panel of experts is,reportedly, investigating for any domestic cases of blood clotting, even mild ones, as a side effect of the two COVID-19 vaccines being administered in India. According to India’s leading virologist Gagandeep Kang, “blood clots reportedly caused as a result of Oxford-AstraZeneca’s Covid-19 vaccine amount to a very small risk.”

As reported on April 24, 2021, the United States has also decided to immediately resume the use of Johnson & Johnson’s Covid-19 vaccine, ending a 10-day pause to investigate its link to extremely rare but potentially deadly blood clots. These details, I reckon, need also to be shared with all people, soon, in order to neutralize any doubt on administering Covid vaccines.

Covid vaccine availability and pricing:

Recent media reports highlight, at least six states of India – Andhra Pradesh, Chhattisgarh, Haryana, Maharashtra, Odisha and Telangana – are facing Covid vaccine shortage, as Covid 2.0 overwhelms India. Most of these states have already apprised the Centre of the situation, as the Supreme Court of India also seeks the details from the center about its current status.

As on April 22, 2021, India has administered over 135 million vaccine doses, where each individual will require two doses. Whereas, as published in Bloomberg on April 23, 2021, ‘1 billion Covid-19 vaccines have been administered around the world.’ The good news is, effective May 01, 2021, everyone above the age of 18 years will be eligible to get vaccinated. The Central Government will also lift its singular control on supply and delivery of Covid-19 vaccines in a bid to tackle the massive rise of cases that have crippled the country’s health infrastructure.

That said, the key question that follows – would Covid vaccine manufacturers be able to meet this increasing demand in India, when there already exists more demand than its supply? According to Niti Aayog Covid-19: Vaccine availability will improve by July 2021. The two major vaccine manufacturers in India are also indicating broadly similar time frame.

Meanwhile, amid a deadly second wave of Covid infections, a third Coronavirus vaccine - Russia’s Sputnik V, has been approved for emergency use in India. Incidentally, Sputnik V’s approval came not before India overtook Brazil to become the country with the second-highest number of cases globally. According to its local distributor – Dr. Reddy’s Laboratories, India will start receiving Russia’s Sputnik V vaccine by end May.

Be that as it may, it is still unclear whether enough Covid vaccine doses will be available right from May 1, 2021, to start inoculating all Indians above 18 years of age, across the length and breadth of the country. Besides, SSI’s decision to fix the rate of Covishield vaccine for private hospitals and state governments, has attracted sharp criticism from the Opposition, who argued that there was no logic in charging the state governments a higher price, when the Centre is getting the same vaccine at Rs 150 per dose.

This question surfaces, especially when SII Chief himself acknowledged that they are making profit even with Rs.150/per dose price as the pandemic ravages the nation. A news item of April 24, 2021 also underscores ‘Serum Institute’s Rs.600/dose for Covishield in private hospitals is its highest rate in the world.’ Nonetheless, price sensitivity to Covid vaccines during the pandemic is not specific to India.

Shareholders of Pfizer, J&J, reportedly, are also pushing for detailed COVID-19 pricing strategies of the respective companies, at their annual meetings. Curiously, at the same, yet another report highlights: ‘With the competition struggling, Pfizer’s COVID vaccine sales could hit $24B this year.’ Amazing!

India utterly overwhelmed, angry outbursts of concern beyond its shores:

Witnessing the nature of rampage caused by Covid 2.0 in India, global press blames the Indian top policy makers for utter failure to anticipate and tackle the devastating second wave. For example, The Guardian of the UK flashed a headline on April 21, 2021 – ‘The system has collapsed’: India’s descent into Covid hell.’ It further elaborated: ‘Many falsely believed that the country had defeated Covid. Now hospitals are running out of oxygen and bodies are stacking up in morgues.’ The Times, UK was harsher. It reported, ‘Modi flounders in India’s gigantic second wave.’ It further added: ‘Record levels of infection have put huge strain on the health service and highlighted the perils of complacency in the nationalist government.’

The New York Times reported on April 23, 2021: ‘India’s Health System Cracks Under the Strain as Coronavirus Cases Surge.’ The report also cited examples of ‘recent political rallies held by Mr. Modi that have drawn thousands, as well as the government’s decision to allow an enormous Hindu festival to continue despite signs that it has become a super spreader event.’

Conclusion:

Keeping aside the responsibility, or rather lack of it, of the National Covid governance team, individual Indians – like you and me – can’t in any way shy away from our own responsibility of compliance to Covid appropriate behavior, religiously. We are equally responsible, at least, for our own lives and fate. Even today, many of those who are wearing a face mask, are wearing in the chin – keeping the nose exposed – forget about double masking! Moreover, how many of us were or are eligible for Covid vaccination till date, but did not or could not take?

Curiously, Covid 2.0 is no longer striking mostly the poor urban population, living in slums or hutments, or the migrant laborer. Nor it is attacking mainly the senior citizens or people with co-morbidities. More young people, including children are getting infected in Covid 2.0. In Covid 2.0 – over 90 per cent of Covid new cases concentrate in in high rise and other buildings in major cities, like Mumbai. While urban slums account for just 10 per cent. On April 24, 2021, Bloomberg also reported, ‘India’s Urban Affluent Hit By New Virus Wave After Dodging First.’

Terming Covid 2.0 as concerning and scaring‘, Tata Sons Chairman also said, ‘India needs to get as many different Covid-19 vaccine licenses as possible. And replicate multiple factories on a war footing to ramp up production in order to meet the requirements as the country reels under the devastating second wave of the pandemic.’ It’s incredible, how a small country in the Indian subcontinent – Bhutan with limited resources, got its vaccination plan right and carried out, reportedly, the world’s fastest immunization drive.

Coming back to the last year’s above MIT study forecast for 2021 Covid situation in India. It goes without saying that this one, among several others, was based on credible data. It also brought to the fore the scientific reasons of consequences for not following the norms of Covid appropriate behavior. Looking back and coming back to real life scenario of date, one thing becomes crystal clear. When science is ignored, both at the highest echelon of national governance where the buck stops – or at the individual, social, religious or political level – it is virtually inevitable that a disaster would strike. And in most cases, it will strike hard – very hard. Much beyond what a human can withstand to survive. We have choice for survival – even in today’s frightening scenario. Let’s individually and collectively behave, as the science demands. Life and livelihood are important – for all of us.

By: Tapan J. Ray    

Disclaimer: The views/opinions expressed in this article are entirely my own, written in my individual and personal capacity. I do not represent any other person or organization for this opinion.

 

 

2020: Learnings From A Yearlong Catastrophic Disruption And Crystal-Gazing 2021

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 Wishing All My Readers A Very Happy, Healthy, Peaceful and Prosperous 2021

Just a few days left for the year 2020 to merge with history. It will be remembered by all – as a year of all-round catastrophic global disruption. With unprecedented impact on human lives, livelihoods, economy, and ways of doing things – sparing virtually nothing. The sole cause of which is an unprecedented single event – Covid-19 pandemic. As of December 27, 2020 morning, India recorded a staggering figure of 10,118,392 new Coronavirus cases with 147,659 deaths. The threat of subsequent waves for further infection of Covid-19 infection continues.

In this article, I shall focus on some critical lessons learnt from the 2020 health crisis, while crystal-gazing 2021. I’ll do this purely from the health care perspective, in general, and the pharmaceutical industry, in particular. Keeping this in view, some of the lessons learnt during the pandemic are as follows:

A. Never allow a sense of hubris setting in:

This is easier said than done. Nonetheless, before the Covid pandemic played havocs with all, many top pharma leaders were, apparently, in a hubris. It was often laced with excessive confidence, if not arrogance. The predominant belief was nothing can go so wrong sans unfavorable policy decisions by the governments. This was against a much-known management dictum for all – always anticipate future probabilities that may impact the business and keep prepared for the worst, while hoping for the best. On a hindsight, this was, obviously jettisoned – lock, stock and barrel. No one was prepared for any biological threats, such as, Covid pandemic, till the deadly virus caught the humanity off-guard around December 2019, as we see below:

The pandemic was expected, but struck unexpectedly:

A pandemic wasn’t totally unexpected either. Therefore, they question that surfaces - Experts warned of a pandemic decades ago. Why weren’t we ready? Just in 2015, even Bill Gates, during a Ted talk titled, “The next outbreak? We’re not ready,” also predicted - based on available facts that an epidemic would kill millions in the future.

He further added: “If anything kills over 10 million people in the next few decades, it’s more likely to be a highly infectious virus rather than a war – not missiles, but microbes.” Gates further emphasized: “We have invested a huge amount in nuclear deterrents, but we’ve actually invested very little in a system to stop an epidemic. We’re not ready for the next epidemic.”

B. Research on anti-infective drugs shouldn’t be pushed to the back burner: 

These warnings were, apparently, ignored by the pharma industry. For example, as reported in the first quarter of 2020, many research-based pharma companies shifted ‘resources away from emerging infectious diseases into more lucrative areas like cancer treatment. Their business decisions risk leaving gaping holes in the fight against epidemics, such as the one caused by the novel Coronavirus.’

Let’s now take a pause for pharma players to ponder. Are they ready, at least now, with a robust plan – based on almost a year’s experience of an unprecedented agony along with its customers, specifically to counter any future biological threat? Be that as it may, there have also been some good outcomes out of the Covid crisis, both for the pharma industry and also for the health care customers.

C. The pandemic hastened pharma’s digital transformation process:

As is known, compared to many other industries, pharma industry was a late learner in the digitalization process of organizations. The new realities of disruptions caused by the pandemic had significantly expedited this process to keep the business going. There were no other effective options available, either, but to move beyond business stabilization and redefine how they do business. The IQVIA article, ‘Digital transformation in a post-Covid-19 world,’ published in the Pharmaceutical Technology, on August 31, 2020, also reiterated this point.

Elaborating the point further, the article pointed out: ‘As a result, acceleration of three key capabilities is occurring to create sustainable competitive advantage,’ as follows:

  • Digital capabilities with modern technology are enabling companies doing the right things during the pandemic and accelerating the process.
  • Providing access to granular data to support the extraction of precise insights into the needs of patients and physicians.
  • Ensuring capabilities for sustaining relationships. While face-to-face interaction has been dramatically reduced, relationships with HCPs and patients are taking new shapes and are of more importance than ever before.

D. Telemedicine came under mainstream care, supported by Government:

Finding no other viable alternatives during the Covid lockdown period and the need to stringently follow prescribed health measures, many patients were pushed to search for a robust digital solution for health care needs. Just as many of them were already using online platforms to meet other regular needs. In that sense, Covid propelled health care into a virtual world, bringing telehealth or telemedicine toward mainstream care, supported by the Government with a policy, for the first time, ever.

E. Quality of pharma response to pandemic enhanced industry image:

As I had discussed before in this blog, Consumer centric communications, driven by the  ‘hope and confidence as companies rushed to come up with COVID-19 vaccines and treatments’ of all, helped to significantly enhance the industry’s image during the year. In my view, pharma shouldn’t let go this opportunity to reposition itself, to reap a rich harvest in the years ahead.

Crystal-gazing 2021: 

A. A lurking fear will keep haunting:

Moving away from the outgoing year – 2020, if one crystal gazes the incoming – yet another brand-new year – 2021, a lurking fear still haunts most peoples’ minds. Will the all-round disruptions of 2020 be the new normal in 2021 – with no further escalation of the current situation?

B. Vaccine rollout will reduce rapid spread, but not eliminate Covid-19:

Gradual rolling out of vaccines may reduce the rapid spread of pandemic, provided Covid-19 doesn’t throw more surprises, such as, complicated mutation, blunting this initiative. However, currently available evidence indicates, the new variant could be more transmissible, yet vaccines may work very well against it.

 C. Masking, physical distancing, hand washing, etc., will continue:

Besides, many yet unknown side effects, the duration of immunity following coronavirus vaccination is still largely unknown due to the simple lack of time we’ve had to study such immune responses. Moreover, the trials do not tell us if the vaccines can block the transmission of the disease from those who are asymptomatic and have been vaccinated. Thus, masking, physical distancing, hand washing, testing, treating and contact tracing, reportedly, will continue to be important in the global campaign against COVID-19, even after vaccine rollout.

D. NDDS for Covid drugs and vaccines may come: 

New formulations, new Covid drug delivery systems, newer methods to bring Covid vaccines, like nasal sprays, in a powder form for easy transportation and to reach more people around the world, are expected to commence in 2021.

E. Waiting for going back to pre-Covid game plan is a losing strategy:

Vaccines are unlikely to take us back to pre-Covid time, any time soon. Even McKinsey & Companypredicted the same in its article: ‘‘How COVID-19 is redefining the next-normal operating model,’ published on December 10, 2020. It emphasized: “With everything disrupted, going back to the same old thing is a losing strategy. The strongest companies are reinventing themselves by embracing pandemic- driven change.”

Many pharma majors are also echoing the same, even as Covid-19 vaccines have started rolling out for public in different parts of the world. After weighing-in the pros and cons of waiting, many of them have articulated: ‘We will not return to the old ways of working.’ They believe, it’s too early to put a specific timeline on turning that page now. Hence, the year 2021, working of the pharma companies is unlikely to be significantly different from the year 2020.

F. Need to capture and respond fast to changing customer behaviors:

Covid-19 pandemic is fast changing many human attitudes and behaviors, forcing organizations to respond. ‘However, the need to respond won’t end when the virus’s immediate threat eventually recedes,’ reaffirmed the Accenture article ‘COVID-19: 5 new human truths that experiences need to address.’ The massive behavior changes of key pharma stakeholders, at a never before scale and speed, will continue to prompt many leading drug companies to respond to them with well thought through digital tools, to gain competitive advantages.

G. Virtual meetings with reps, doctors and others will continue:

As witnessed in 2020, often for the first time – virtual meeting of sales reps, key opinion leaders and others will continue in 2021, even after ‘live’ ones return, but with more innovative structure and content. Pharma marketing’s long awaited and comprehensive digital foray will continue gaining a strong foothold, entering into new areas, without glancing back over the shoulder, in 2021.

H. More new drug launches will move entirely digital:

It began in 2020. For example, dozens of new drug launches moved entirely to digital, for the first time in 2020. As a pharma leader remarked, with the traditional launch framework gone during the pandemic, “we had to throw out the playbook and really embed into people’s heads that playbook is no longer meaningful. It no longer works, and we have to think outside the box.” She further added: “There’s truly no bigger place for a marketer right now. This is the new world.” None can deny this fact as we enter into the new year.

I. Success requirements of pharma professionals will be different:

With significant transformation of pharma’s operational strategies, success requirements of pharma professionals will also be significantly different in the new normal. Quick capturing and fast adaptation to the changing customer behavior for multi-channel engagement digital platforms, will be fundamentally important – not just for business excellence, but for its long-term sustainability, as well. This is a totally new and highly cerebral strategic ballgame, where obsolescence of cutting-edge technology is much faster than anything in the tradition driven old normal.

J. More pharma companies will explore inorganic growth opportunities:

More pharma companies will look for acquisitions to bridge the strategic gaps, as AstraZeneca did in 2020.

Conclusion:

In 2021, Covid Mayhem may possibly be over with a gradual rollout of vaccines. But, the impact of utter disruptions that the pandemic has caused in multiple areas of businesses in 2020, especially within the pharma industry, would continue, as we step into 2021. As the drug industry overwhelmed by Covid-19, reset themselves with the digital transformation in the new normal -for growth beyond Coronavirus, one may also view this much awaited metamorphosis, as a blessing in disguise, as it were.

Overall, as the W.H.O observed very rightly on December 27, 2020: “We throw money at an outbreak, and when it’s over, we forget about it and do nothing to prevent the next one. This is dangerously short-sighted, and frankly difficult to understand.” He further added: “History tells us that this will not be the last pandemic, and epidemics are a fact of life.” I hope, all concerned will realize this point in 2021. Alternatively, we may need to keep ourselves prepared to move, in a similar way, from the current new normal to yet unknown next normal.

By: Tapan J. Ray     

Disclaimer: The views/opinions expressed in this article are entirely my own, written in my individual and personal capacity. I do not represent any other person or organization for this opinion.

 


Pharma Not To Let Go This Never Before Opportunity To Reposition Itself

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‘While the COVID-19 pandemic has placed unparalleled demands on modern healthcare systems, the industry’s response has vividly demonstrated its resilience and ability to bring innovations to market quickly.’ This appeared in the McKinsey & Company article – ‘Healthcare innovation: Building on the gains made through the crisis,’ published on November 12, 2020.

Just a couple of days before that, on November 09, 2020, an interesting article appeared in The Wall Street Journal (WSJ) on the resilience of the pharma industry. It also discussed on how ‘an often-disparaged industry is finding a rare opportunity to promote its value,’ to turn around public perception of its image and reputation during the pandemic. The article elaborated this point by quoting: “It was a fight between pharma, tobacco companies and the government for who would be at the bottom in terms of reputation,” – now “Covid is giving them an opportunity to step out of that world and into the world of ‘we can help,’ and it’s giving pharma a comeback.”

As is known to many, pharma industry was long vilified for its many self-serving objectives. But the Coronavirus pandemic helped immensely to highlight its role in developing medications and vaccines to save the humanity. It happened never before – ever, with this intensity and scale. Thus, the shift is inspiring many pharma giants to reposition their marketing and communications, the WSJ report added. This article will deliberate on how pharma marketers can leverage this once in a lifetime opportunity, with actionable insights on Covid pandemic-induced – changing needs of healthcare customers.

Covid-19 to change the way companies do business - A recent survey:

In this McKinsey & Company survey, published on June 17, 2020, more than 200 organizations across industries had participated in this study. Notably, over 90 percent of the participating executives expect the fallout from COVID-19 to fundamentally change the way companies do business over the next five years, with a lasting impact on their customers’ needs. In the pharma industry too, these trends are clearly visible and undergoing a metamorphosis. I quote below a few important points from this study, as illustrations:

  • Nearly 73 percent respondents from the pharma and medical supplies industries agree that the changes brought about by Covid-19 will be a big opportunity for growth.
  • Only 21 percent of the same executives feel that they are prepared with resources, expertise and commitment to address the changes they see coming, for harvesting the new growth opportunities.
  • Curiously, only 25 percent of respondents reported that capturing new growth was a top priority today, compared to roughly 60 percent before the crisis hit.
  • Notably, across the industries only pharma and medical product industries have increased their focus on innovation during Covid crisis. Although, many are still playing safe, which may be a shortsighted decision, the research paper observed. 

Understand the shifts and the opportunities with actionable insights:

That the current Covid crisis has significantly exacerbated and accelerated many disruptive forces, is vindicated by another survey: ‘Global B2B decision-maker response to COVID-19 crisis.’ This was published by the McKinsey & Company on October 20, 2020. It also reiterated, ‘B2B decision-maker preferences and behaviors have shifted dramatically since the onset of COVID. The GTM revolution is here and B2B sales is forever changed.’ I shall quote two of these areas, as follows:

A. Changes to pharma sales models: Companies with significant field forces can no longer rely on in-person coverage to outcompete. This is because:

  • The tide has turned: digital self-service and remote rep interactions are likely to be the dominant elements of the B2B go-to-market model, going forward.
  • Don’t count on returning to a pre-COVID-19 level of in-person sales coverage, as only 20–30% of B2B buyers want to ever interact with reps in person even in their ideal/post-COVID-19 model.
  • Around 90% of B2B decision makers expect the remote and the digital model to stick around for the long run, and 3 in 4 believe the new model is as effective or more so than before COVID-19 (for both existing customers and prospects).
  • 97% of B2B buyers claim they will make a purchase in an end-to-end, digital self-serve model, with the vast majority very comfortable spending more online.
  • Video-conference connections are critical and are preferred over audio/phone by almost 4 out of 5 B2B buyers.

B. Influx of competitors from different industries: Medical-device firms historically had a narrow competitive set and were insulated by a complex and highly technical regulatory approval process. They are now facing competition from previously unexpected new entrants, including Wearable Health Devices (WHDs) makers, such as Google, Apple among several others. As I also wrote about a year ago, on December 02, 2020, this is mostly because, WHDs help improve disease outcomes, creating a unique disease treatment experience.

Which is why, in the new normal, creating a holistic and innovative ‘Customer Experience’ is as important and challenging as creating ‘Innovative Drugs’.

Reposition pharma to create a holistic ‘Customer Experience’ in the new normal:

At the very beginning of this year, on January 13, 2020, I asked: What Pays More: Creating Innovative ‘Customer Experience’ Or ‘Innovative Drugs’? Although both are crucial for pharma, in the current scenario, the former, I reckon, is no less important or less demanding than the latter for pharma marketers. The question, therefore, arises, what new insights it will entail to meet the unmet changing needs of healthcare customers? The answers may point towards several areas, which are worth pondering over.

Leaving this exhaustive search for pharma professionals to gain the necessary insights for action, let me give an example of only one such area to drive home the point. An interesting article deliberating this area was published by Reuters Events on November 17, 2020. Especially in the new normal, finding solutions to unmet customer needs would prompt harnessing the combined and synergistic power of medical and marketing skills, creating a culture to match, as the article highlighted.

Elaborating this need, the author stressed, the traditional model of medical and marketing functions working in silos is often a barrier to a holistic customer approach. This is because it stifles the opportunity for co-creation of well-synchronized solutions on a number of medico marketing issues during patients’ disease treatment journey mapping. These customer-centric medico-marketing issues, I reckon, are coming more often now with the increasing number of more informed patients, especially about their personal health care and treatment needs.

Traditionally, in the pharma industry ‘working in silo culture’ is quite prevalent – medical and marketing functions are no different. Encouragingly, during this pandemic, several companies have formed cross-functional teams of medical and marketing professionals. They also create brand plans, develop content and communication strategies in the new digital platforms, as preferred by the customers. Let me hasten to add, most companies, especially in India will need to catch up with this new way of working, creating a new culture, soon.

Two interesting examples of medico-marketing during Covid Crisis:

There will be several examples in this area. However, to illustrate the point of creating a holistic ‘Customer Experience’ in the new normal, let me cite two examples of medic-marketing in this area, during Covid crisis. Coincidentally, both the examples are from the global pharma major Pfizer – the Company (along with BioNTech) that offered the first Covid-19 vaccine to the western world for public use under ‘Emergency Approval’ by the British drug regulator.

The first example is a website for Pfizer prescription medicine assistance program – called Pfizer RX Pathways. It mentions at the very top, ‘Pfizer recognizes the public concern in relation to COVID-19, which continues to evolve. Click here to learn how we are responding.’ When clicked, it takes the viewers to another website, where Pfizer says, ‘we are committed to helping keep people safe and informed.’

The second one tackles the uncertainty and anxiety that many people feel during the Covid pandemic – reassuring the viewers that “science will win.”  It starts with: “At a time when things are uncertain, we turn to the most certain thing there is—science. Science can overcome diseases, create cures and yes, beat pandemics. It has before; it will again.”

There are many other examples, including a social media series on Covid-19 of the Company, which help enhancing holistic ‘customer experience’ in the contemporary situation, for which the concerned companies’ brands are also rewarded by the customers.

Conclusion:

As of December 13, 2020 morning, India recorded a staggering figure of 9,857,380 of new Coronavirus cases with 143,055 deaths. The threat of subsequent waves for further spread of Covid infection still looms large in many states. The good news is, at least, one Covid-19 vaccine is expected to be available in India within a month’s time. Meanwhile, as many people believe, when a company or an industry does most things right, as experienced by its customers, its reputation goes up, and vice versa. For example, the Gallup Poll, published around a year ago – on September 03, 2019 said: ‘The pharmaceutical industry is now the most poorly regarded industry in Americans’ eyes, ranking last on a list of 25 industries.’ Interestingly, similar Gallup Poll, published a year later – on September 08, 2020 noted, ‘the pharmaceutical industry’s image has improved modestly since last year, and it has yielded the “worst rated” distinction back to the federal government.’

So, something good must have happened during this one-year period, the most influential of which being Covid Pandemic. We have seen above, how some pharma players have repositioned themselves to provide a holistic ‘Customer Experience’, through innovative multichannel communication – being on the same page with customers. Medico-marketing approach played a stellar role in these efforts. As more healthcare customers get enlightened on their health and treatment needs by charting through the cyberspace, they are expected to lap-up such multichannel communication, alongside other equally cerebral pharma initiatives.

Undoubtedly, Covid pandemic is a triggering factor for this change, both among the healthcare customers and the pharma players. This trend is not going to disappear soon, as various top research studies have highlighted. Well-deserved pharma image and reputation boost has started gaining speed, following what some companies are demonstrating to customers during the Covid crisis. Pharma marketers, I believe, will not let go this never before opportunity to reposition their respective companies. It will help them achieve well-cherished brand excellence, supported by a robust Company image and reputation. As the good old saying has proved again to the pharma industry – even during the Covid pandemic, ‘as you sow, so shall you reap.’

By: Tapan J. Ray     

Disclaimer: The views/opinions expressed in this article are entirely my own, written in my individual and personal capacity. I do not represent any other person or organization for this opinion.

India Not To Vaccinate All For Covid Control: Upsides And Unknowns

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With 9.46 million cases and 137,621 deaths, India has currently the world’s second-highest number of coronavirus infections, behind only the United States, reported Reuters on December 01, 2020.

Fathoming seriousness of rapidly unfolding Covid induced all round disruptions across the nation, on October 17, 2020, the Indian Prime Minister issued a clarion call. He called for full preparedness of the country to ensure speedy access to Covid vaccines for every citizen.

However, the above view was subsequently changed. On December 02, 2020, quoting Union Health Ministry of India, it was reported, ‘the Government has never spoken about vaccinating the entire country.’ The Director General of the Indian Council of Medical Research (ICMR) said, “the Indian government is of the opinion that vaccination against the deadly pandemic may be needed only to the extent of ‘breaking the chain.’ If we’re able to vaccinate a critical mass of people and break virus transmission, then we may not have to vaccinate the entire population.”

Why the PM said ‘Covid vaccines for every citizen’ at that time?

In my view, what the PM said made perfect sense at that time. This is also vindicated by a fact-based interesting discussion in The Wire on July 16, 2020, carrying a title – ‘How Effective Does a Vaccine Need to Be to Stop the Pandemic? It quoted an in-depth study concluding, “a vaccine with an efficacy as low as 60% could still stop the pandemic and allow society to return to normal. However, most, if not all of the population would have to be vaccinated.”

This research article, titled ‘Vaccine Efficacy Needed for a COVID-19 Coronavirus Vaccine to Prevent or Stop an Epidemic as the Sole Intervention,’ was published in The American Journal of Preventive Medicine (AJPM) on July 15, 2020. The study found that the vaccine has to have an efficacy of at least 70% to prevent an epidemic and of at least 80% to largely extinguish an epidemic without any other measures (e.g., social distancing).

The PM’s observation will make even better sense, while taking into account the draft ‘Regulatory Guidelines for Development of Vaccines with Special Consideration for Covid-19 vaccine in India. This guidance document for vaccine developers was issued by the Central Drugs Standard Control Organization (CDSCO), and was reported by the media on September 23, 2020. It also says, among other specifics, a COVID-19 vaccine candidate should show at least 50 per cent efficacy during phase III of clinical trials for it to be widely deployed.”

Why health ministry’s current plan of not vaccinating all, also makes sense:

Indian Health Ministry’s latest assessment that vaccination against the deadly pandemic may be needed only to the extent of ‘breaking the chain,’ also makes sense in the rapidly emerging contemporary scenario.

It makes sense, considering, even the World Health Organization (WHO) experts have, reportedlypointed to a 65%-70% vaccine coverage rate as sufficient to reach population immunity, based on scientific reasons. This raises the subsequent question of who in India will get priority for vaccination.

The priority group for Covid vaccination in India:

As reported on November 26, 2020, according to the Principal Scientific Advisor of India, about 300 million people will be part of the first ‘wave’ to receive Covid vaccines in India. This number includes, health care workers, totaling 30 million, police personnel and those above 50 and those younger with underlying illnesses that make them vulnerable. However, everything in this area doesn’t seem to be as clear or straight forward as is widely expected. India’s Covid vaccination plan still seems to be a work in progress.

India’s Covid vaccine plan is still a work in progress:

This is evident from many reports, such as one of December 01, 2020. This report says, experts still believe that the government should spell out whether the vaccination should be confined to only uninfected individuals or encompass everyone. These reports may vindicate the murmur in the corridors of power that many details of Covid vaccination in India are yet to crystallize.

Let me quote the Indian Prime Minister in this regard, as he is not only the head of the current Government, but is also the national voice on all contemporary issues in the external world.

Interestingly, on November 24, the Prime Minister himself acknowledged: ‘Will go by scientific advice on Covid vaccine, don’t have many answers yet.’ He made it clear that he did not yet have answers to:

  • Vaccine dosage
  • Pricing or sourcing

Although, his Government has been in touch with local and global vaccine developers, nations and multilateral institutions to ensure vaccine procurement, the PM added.

Curiously, unlike what the Principal Scientific Advisor of India, reportedly articulated on November 26, 2020, just a couple of days before that, on November 24, 2020, the PM has put it quite differently.He then said, priority groups for vaccine administration would be fixed based on state inputs and added that additional cold storage must be created by states. These confirm, India’s final plan on Covid vaccination is still a work in progress.

The Covid vaccination plan is still evolving in India:

Interestingly, on December 04, 2020, in an all-party meeting chaired by the Prime Minister, it was further announced - the first set to receive the Covid -19 vaccine will be about one Crore frontline health workers and the next will be two Crore armed forces, police, and municipal personnel. Besides, around 27 Crore senior citizens, too, would be receiving the vaccine. Thus, the Government’s vaccination plan seems to be still evolving. Meanwhile, something sensational happened in the global race for having a Covid vaccine for a country’s population.

Curiously, much before the commencement of Covid vaccine prioritization discussion in India, on September 14, 2020, it was reported that China is also not going for its entire population. They are prioritizing frontline workers and high-risk populations in its fight against the new Coronavirus.

The first emergency-use authorization for a Covid-19 vaccine happened:

On December 02, 2020, both the local and global media, such as The Wall Street Journal (WSJ) reported: ‘The U.K. became the first Western nation to grant emergency-use authorization for a Covid-19 vaccine, clearing a shot developed by Pfizer Inc. of the U.S. and BioNTech SE of Germany to be distributed in limited numbers within days.’

In the war against Covid pandemic, it also marks a key milestone in efforts to translate a promising new vaccine technology into a widely available shot, the report highlighted. It was developed, tested and authorized and is now poised to be distributed amid a pandemic that has sickened tens of millions of people and killed more than 1.4 million around the world, the news article added.

Interestingly, the U.K could make it happen, even before the United States, where this vaccine is now being reviewed by the USFDA, where a similar authorization could come later this month and a rollout before the end of the year. It’s noteworthy that the USFDA Commissioner has defended the pace of review of Pfizer’s COVID-19 vaccine on the grounds that a thorough assessment is needed to reassure a skeptical public.

NIAID director of the US also believes so, and has claimed, “We have the gold standard of a regulatory approach with the FDA.” This brings us to the question – will Pfizer’s Covid vaccine be available in India soon?

Will Pfizer’s Covid vaccine be available in India soon?

Just a day after U.K’s emergency approval of Pfizer’s Covid vaccine to be rolled out to the public early next week, Pfizer, reportedly, said, the Company is in discussions with many governments around the world, and “… will supply this vaccine only through government contracts based on agreements with respective government authorities and following regulatory authorization or approval.”

However, as reported on December 06, 2020, Pfizer has now sought approval from the DCGI for emergency use authorization of its Coronavirus vaccine. In its application dated December 4, Pfizer India has sought approval to “import the vaccine for sale and distribution in the country, besides waiver of clinical trials on Indian population in accordance with the special provisions under the New Drugs and Clinical Trials Rules, 2019.”

It’s worth noting, conducting Phase III clinical trials on Indian volunteers has, so far, been a pre-requisite for the DCGI to give authorization to a particular investigational Covid vaccine. For example, AstraZeneca-Oxford vaccine is, reportedly being tested in a phase-3 trial on over 1,600 subjects in India by Serum Institute. So is the Sputnik V, developed by Russia, and touted as the world’s “first registered Covid-19 vaccine” after it received Russian regulatory approval in early August 2020.

Further, the head of the Indian National Task Force on COVID-19, had also said the arrival of the Pfizer vaccine in India might take some months. This is, reportedly for two reasons. One, the vaccine has stringent temperature requirements (-75 degree Celsius), which make it unviable for the current cold-chain logistics in India. And the second, could possibly be, its Indian clinical trial requirements, as has been the practice of even Russia approved Sputnik V vaccine.

Thus, it appears, India is now looking at the vaccines being developed by Oxford-AstraZeneca or Bharat Biotech against the pandemic, as these are expected to complete clinical trials and seek a regulatory approval at an early date.

Upsides and unknowns of the current status of Covid vaccines in India:

Along the obvious upsides, such as – not all in the country needs to be vaccinated and, at least, one Covid vaccine is widely expected to come shortly that is being manufactured in India, there are several critical unknown factors, too. For example, apace with several similar articles, the research paper titled, ‘Will covid-19 vaccines save lives? Current trials aren’t designed to tell us,’ published in The BMJ on October 21, 2020, also raised this issue.

It pointed out: “Ideally, you want an antiviral vaccine to do two things . . . first, reduce the likelihood you will get severely ill and go to the hospital, and two, prevent infection and therefore interrupt disease transmission.” Yet the current phase III trials are not actually set up to prove either, it emphasized. None of the trials currently underway are designed to detect a reduction in any serious outcome, such as hospital admissions, use of intensive care, or deaths. Nor are the vaccines being studied to determine whether they can interrupt transmission of the virus.

Conclusion: 

As of December 06, 2020 morning, India recorded a staggering figure of 9,644,529 of new Coronavirus cases with 140,216 deaths. The threat of subsequent waves for further spread of Covid infection now looms large in many states. The Prime Minister of India is also intimately involved in search of a meaningful solution to end the pandemic.

In this scenario, that a Covid vaccine is coming so soon, is a very good news, undoubtedly. There are several obvious upsides of this development, alongside many critical unknown areas, including how long the immunity will last after administration of a Covid vaccine. Incidentally, ‘Moderna vaccine-induced antibodies last for 3 months’ says NIAID study. Even in India a ‘Minister tested positive after the first dose of vaccine.

I am sure, the right answers will surface as the research will progress. Meanwhile, there doesn’t seem to be any other alternative sans vaccines, to kick start the globalized world – for a holistic and inclusive long-term progress, economic prosperity and, if not survival with dignity, for all.

By: Tapan J. Ray     

Disclaimer: The views/opinions expressed in this article are entirely my own, written in my individual and personal capacity. I do not represent any other person or organization for this opinion.