‘Corona will remain a part of our lives for a long time. But at the same time, we cannot allow this to happen that our lives will be confined only around the corona. We would wear masks, follow two yards distance and pursue our goals. Therefore, the fourth phase of lockdown, lockdown 4, will be completely redesigned, with new rules,’ said the Prime Minster of India, during his televised address to the nation on May 12, 2020.
Many countries around the world, have already decided to move ahead, phasing out Covid-19 lockdowns cautiously, in a manner that each country will deem appropriate. Alongside, in line with many other industries, several pharmaceutical companies seem to have also started accepting this new reality. For example, Novartis, which reportedly, started digitizing its sales and marketing even before the COVID-19 pandemic, has hit the fast forward button.
This is evident from what Novartis said: “We were already on a journey in terms of our commercial model where digital and other channels and virtual detailing were becoming a bigger part of our mix.” The Company is planning an omnichannel digital launch for its latest new product – Tabrecta for metastatic lung cancer. This was prompted by the very sensitive situation that the world is going through ‘and the extra burden that’s put-on physicians and patients” as the pandemic continues - the company clarified.
This leads to the key question, are most companies on the same wavelength as Novartis, in this area? Or, a large majority of drug players, is still nurturing the hope that prescription demand generation activity from doctors and hospitals will soon return to the traditional mode of what was prevailing during pre-Covid-19 pandemic days? This flows from an age-old experience – a large number of sales or medical representatives have always spearheaded the demand generation mechanism for any patented or brand-generic medicine.
Still, for many it is difficult to even think of any quantum shift in this space, as the traditional core mechanism continues, despite so much hype of digitalizing pharma operations. Whereas, several others do feel, at least, a Covid-19 vaccine or a drug for its effective treatment, which, apparently, are almost knocking at the door, will bring the current situation back to the previous normal. Will vaccine or an effective drug be a panacea to win the war of Covid-19 pandemic, decisively? In this article, I shall dwell on this subject. To set the ball rolling, let us fathom whether or not coming out with a safe and effective Covid-19 vaccine, in a jiffy, is rather a certainty.
Is Covid-19 vaccine a certainty?
No doubt, a large majority of people believe, a vaccine to prevent COVID-19 is perhaps the best hope for ending the pandemic, as Mayo Clinic has also said so. However, it also records the following major apprehensions or challenges in developing a COVID-19 vaccine, based on the research data:
- Ensuring vaccine safety
- Providing long-term protection
- Protecting older people
On May 12, 2020, at the US Senate hearing about the path forward from pandemic lockdowns in the United States, NIAID director Anthony Fauci also said, there’s “no guarantee” any of the vaccines in testing will be effective, though based on his knowledge of other viruses, he is “cautiously optimistic.” Thus, projections about how COVID-19 will play out, are still mostly speculative.
Why ‘projections about how COVID-19 will play out are still speculative’?
A recent article – ‘How the COVID-19 Pandemic Could End,’ published in the ‘Scientific American,’ also commented so. It said, the end game will most likely involve a mix of everything that checked past pandemics:
- Continued social-control measures to buy time,
- New antiviral medications to ease symptoms,
- And a vaccine.
Citing the famous example of the H1N1 influenza outbreak of 1918–1919, it said, doctors and public health officials had far fewer weapons than they do today. Thus, the effectiveness of control measures, such as school closures depended on how early and decisively, they were implemented. Over two years and three waves, the pandemic infected 500 million and killed between 50 million and 100 million. It ended only as natural infections conferred immunity on those who recovered.
Which is why, as on date the pursuit to achieve all three goals as mentioned above, would likely to continue. That said, a safe an effective Covid-19 vaccine will be the most preferred way to stop rapid transmission of the Coronavirus outbreak. However, this comes with a critical caveat.
Would the entire population need to be vaccinated?
Experts believe, unless a vaccine is administered to all of the world’s eight billion inhabitants who are not currently sick or recovered, COVID-19 is likely to become endemic. It will circulate and make people sick seasonally—sometimes very sick. But if the virus stays in the human population long enough, it will start to infect children, showing mild symptoms.
In that process, children appear less likely to develop severe disease if they get re-infected as adults. Thus, the combination of vaccination and natural immunity will protect many of us. ‘The Coronavirus, like most viruses, will live on—but not as a planetary plague,’ the ‘Scientific American,’ article concluded.
Covid-19 end game to involve a mix of those that checked past pandemics:
Let us now look at the possible mix of the Covid-19 end game, which were involved in checking the past pandemics, one by one:
Continued social-control measures to buy time:
The social control measures would include compliance with the prescribed social distancing norms, in tandem with aggressive testing for the infected individuals, isolating them, and quarantining their contacts. These measures were well tested in the past epidemics and useful if followed well, by all.
Therefore, from the pharma industry perspective, getting back to the traditional ‘pre Covid-19 mode’ of prescription demand generation mechanism, will indeed be challenging for most drug players.
Availability of well-tested antiviral medications to ease Covid-19 symptoms:
So far, there is no scientifically and well-tested medications for the treatment of Covid-19. However, many different medications are under clinical trials in various parts of the world. So far, most hyped among them appears to be remdesivir, an experimental antiviral developed by Gilead for the treatment of Ebola.
However, the clinical study result of ‘Remdesivir in adults with severe COVID-19,’ published in The Lancet on April 29, 2020 found that the dose regimen of intravenous remdesivir used in the study, was adequately tolerated, but did not provide significant clinical or antiviral effects in seriously ill patients with COVID-19.
The World Health Organization (WHO) also, reportedly, announced a large global trial, called ‘Solidarity’, to find out whether any of those drugs can treat infections with the Covid-19. In India, several drug companies are also testing the water, with their shortlisted drugs, such as, Zydus Cadila want to test a form of interferon, usually used against hepatitis B and C, as a potential treatment for COVID-19. More trials on remdesivir are ongoing, let us keep our fingers crossed.
Interestingly, Gilead has, reportedly, signed nonexclusive licensing agreements with five Indian generic drug makers – Cipla, Mylan, Ferozsons Laboratories, Hetero Labs and Jubilant Lifesciences, to produce COVID-19 therapy remdesivir for low- and lower-middle income countries. Under the agreements, Gilead will share its manufacturing know-how with them to help gear up remdesivir local production. Moreover, each of these companies will be allowed to set the price for its own generic version of the drug.
In any case, scientifically proven safety and efficacy of any drug or vaccine for the prevention or treatment of Covid-19, is yet to be known. Hence, for all individuals, strict compliance with social distancing measures is the only way to avoid this highly contagious infection. The same is also applicable to doctors and sales representatives while working in the field, at least, till an effective Covid-19 vaccine or drug comes.
Affordability and access to Covid-19 drug and vaccine:
Assuming that a safe, effective and clinically proven vaccine or a drug for Covid-19 will be available sooner than what experts anticipate now, yet another critical issue needs to be resolved, soon. This is related to their affordability and access, to contain the mortality and morbidity of the disease, for a vast majority of the population, especially in the developing nations, like India.
Even Gavi noted: ‘In the race to produce a safe and effective vaccine against the COVID-19 virus, one of the many challenges will be the cost of developing the vaccine and eventually getting it to the vast number of people worldwide who will need it.’ However, it is generally anticipated that ‘COVID-19 vaccine or a drug may end up costing people a small fortune.’ Another article also echoed the same sentiment by saying, ‘Covid-19 treatments won’t work if people can’t afford them.
However, India’s Serum Institute based at Pune, has announced that it is ready for 20-40 million vaccine shots at Rs 1,000/dose, by September-October 2020. The company is ‘’putting its weight behind an Oxford University-led consortium, which announced the start of human clinical trials on April 23 and is one of the first such projects to get underway globally.’
At the same time, another report emphasized: “Even after India approves the Coronavirus vaccine, it might not be possible to produce more than 10-20 million doses in the first year,” again raising the availability and access issue for a Covid-19 vaccine, as and when available in India.
As on May 17, 2020 morning, the recorded Coronavirus cases continue to climb sharply to 90,927 with 2,872 deaths.. Moreover, on May 13, 2020, the world Health organization has also warned that “this virus may become just another endemic virus in our communities, and this virus may never go away.” Thus, the world has to live with it. By the way, the accuracy of many Covid-19 test kits has also been widely questioned. This reportedly includes speedy Abbott test, as well.
In this scenario, people may have to necessary live with social distancing norms and the practice of wearing a mask outside the home, always. Besides, the template for relief from Covid-19 becomes more complex, particularly considering availability, affordability and access to a safe and effective drug or vaccine in India, as and when these will come. Taking these together, the end game for Covid-19 in the foreseeable future, becomes anybody’s guess.
Coming back to the pharma industry, curiously, some people are still hoping for ‘business as usual’ in the traditional pre-Covid-19 mode, although the writing on the wall is increasingly getting clearer. The only alternative that people can possibly follow under the circumstances, is strict compliance to social distancing norms, which pharma companies, doctors, healthcare consumers and others would also require to adhere to, with as much earnest. Thus, envisaging a return to pre-Covid-19 prescription generation mode, may not be prudent choice, anymore.
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.