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Eroom's Law might be broken partially, and that will be a great breakthrough


A few musings on how COVID-19 vaccine development has changed the pharma industry.


It’s been a year since the COVID-19 Pandemic broke out and the world has forever changed. One of the sectors that it has forever changed is obviously the healthcare sector. The pharmaceutical and medical industries have stepped up to the grave challenge posed by the pandemic and we have been able to mitigate death to a great extent.


More significantly, we have been able to develop around 10 or so vaccines with a certain amount of efficacy against COVID. The sucess of this development cannot be understanded: We had a tool to fight against the virus within a year of its global spread.


The success of the efforts of many scientists, doctors, pharmaceutical companies, and nations and everyone who participated in the trials of the vaccine ought to be appreciated and remembered. While we endure the exploding cases of the second wave, it should not be forgotten that there is a path to endurance and prosperity, and we will get back on track.

Just like the great success in finding vaccines to the Wuhan Virus1, these developments are likely to produce significant gains in developing vaccines for the other viruses and will boost the pharmaceutical industry and healthcare sector as a whole. The development of mRNA vaccines to combat COVID-19 is an exciting development - Pfizer, Covidshield and a few other vaccines use this exciting new technology. It can change the way we deal with other diseases such as Ebola, Zika and the normal flu or ‘common cold’ as it offers, we can develop mRNA vaccines to combat these viral diseases.


(This xkcd comic explains how mRNA vaccines using a Star Wars analogy, in case you want to understand the basics of the technology.)


 

While a more globalized world has created a situation where no country can be free of a pandemic, but it has also resulted in greater collaboration between countries in their effort to combat the virus.2 The nature of the pandemic also forced many pharmaceutical regulators worldwide to reduce their strict regulations surrounding vaccines. To speed the study and research of vaccines of COVID-19, many regulators relaxed their strict criteria. This is why we had effective vaccines against the virus within a year.


These relaxations offer a break from Eroom’s Law that has characterized pharmaceutical development in the past.


What is Eroom’s Law? Well, it is the inversion of the more famous Moore’s Law.


Moore’s Law, for those unaware, says that the number of transistors that can be packed in an integrated circuit will double every two years. In a similar vein, the inverse is true in the pharmaceutical industry. This is why “Moore’s Law” was inversed to “Eroom’s Law”. In essence, developing new drugs become more expensive and slower over time. This is illustrated by the graph showing approvals by the United States Regulator, the Food and Drug Administration (FDA) for new drugs:


Eroom’s law was first stated in a 2012 paper in the famous science journal Nature. It stated that there are four main causes for the problem, which are:

  1. The' ‘better than the Beatles’ problem;

  2. The ‘cautious regulator’ problem;

  3. The ‘throw money at it’ tendency;

  4. the 'basic research–brute force' bias.

Essentially:

  • Drugs need transformative leaps in its improvement and not incremental improvements,

  • Regulators are overcautious in allowing new drugs due to the nature of the industry,

  • Pharmaceutical research is increasingly attempted to be accelerated by money, and

  • Lastly that the industry is overestimating the gains that can be made by basic research.


This means that the overall gains made in the sector come at an excruciatingly slow space. Considering that the effects of a drug if not properly tested (see The Thalidomide Tragedy). There is indeed a requirement for an abundance of caution in researching pharmaceuticals.

However, this has arguably led to an overabundance of caution, following primarily from the fact the agencies rose the bar for a drug to gain acceptance progressively. The amount of documentation required by the FDA for the approval of a new drug would be taller than the Empire State Building. The inefficiencies of the system are quite apparent.


It was the COVID-19 Pandemic that has rapidly changed the scenario for the entire health sector as the mitigation of risk and vaccine research against COVID-19 became essential, the FDA and almost all drug regulators across the world relaxed the norms to grant expedited reviews for COVID-19 drugs and vaccines as well as to provide for Emergency Use Authorization (EUA) for the same at an expedited pace. This meant that the classic constraints that restricted the development of vaccines were no longer present.


Expedited approval process that both Covidshield and Covaxin was granted in India, as well as the EUA granted for both. In the case of Covaxin, it was controversially granted without the completion of Phase-III trials. However, it was later shown that the vaccine did have an efficacy of around 81% and effective against many varieties including the so-called B.1.617 “double mutant” Indian Variant.


A better illustration of the breaking of expectations in the case of vaccine research is the New York Times op-ed that estimated the earliest date for a vaccine at Late 2033.




While the interactive timeline could be used to shorten the timeline, the expected pace of research and approval of vaccines surpassed these. It is a remarkable achievement of humanity that we have more than half-a-dozen vaccines effective against the virus in such a short span of time. What is ever more remarkable is that more than a few vaccine makers started stockpiling vaccines before they got approval in the hopes that they will eventually receive approval and that rollout of mass vaccinations can be done instantaneously.

The Serum Institute of India (SII) led by Adar Poonawalla, invested hundreds of millions of dollars in producing the Oxford-AstraZeneca vaccine (Branded as “Covidshield” in India) before any clinical trial was completed. This risk, had it failed, could have possibly bankrupted the company. Thankfully for Adar and more importantly for India, the risk paid off.


SII is of course the manufacturer and licensor in India for the vaccine, but it also required to give Astra Zeneca a commission. The costs associated with a vaccine are of course not limited to the manufacturing cost, but supply chain management, and most importantly related to R&D cost as well as required for expanded manufacturing capacity. The latter is not a regular concern the State or the citizens have to account for, but in the case of a pandemic that has sown death and destruction, it becomes a cardinal factor for the recovery of the country that vaccines be manufactured as fast and as safely as possible.


Vaccine manufacturers also obviously account for the pre-ordering that European Union and United Kingdom did in determining the rates for vaccines. This amount goes to the ‘capital cost’ and obviously presents discounted rates for these nations.


For Covaxin, both the cost of clinical trials (which in SII’s case was Astra Zeneca’s cost) as well as the requirements for the manufacturing is more stringent, thus increasing the cost to manufacture the vaccine, as well as to scale up the production of the vaccine.


Moreover, the pharmaceutical industry itself has witnessed quite a silent revolution with three of the four major vaccine manufacturers failing to produce a vaccine - GlaxoSmithKane, Sanofi and Merck. Of the top four, only Pfizer was successful in its endeavor to produce a vaccine. This of course shows that success in the pharma industry is far from guaranteed. The lack of an innovative approaches such as the use of mRNA vaccines from the major producers can be partially attributed as the reason for their failure.


The liberalized stand of regulators and states considering the pandemic has served as a helpful and encouraging platform for innovation that can save millions of lives.

As stated earlier, the success of mRNA COVID-19 vaccines provides a great platform for future development of vaccines. Further, the approach of the regulators in combating diseases should be continued in a limited fashion to combat other perennial ills of humankind.


Already, there is hope for the success of a Malaria vaccine that is being studied in Malawi. The world is more conscious of the need to ensure the health and wellbeing of citizens, which will ultimately translate (hopefully) into more investment into the sector as well from both the government and private sector.


The pandemic has left all of us more aware of our mortality than ever before. The breaking of Eroom’s Law due to increasing tolerance for innovation as well as the new approach of regulators mentioned above will serve us well in dealing with ills of today, and possibly of the future as well.


The perseverance, strength of human kind in its efforts to survive and prosper are breathtaking. Even in the darkest of days, there is hope for the future. If we take a step back and look at what has been achieved, it is quite awe-inspiring.


There are more vaccines on the way as well. In India, we have a variety of vaccines that are pending regulatory approval, such as the Zydus Cadila Vaccine, another two vaccines from Serum, A vaccine manufactured by Biological E., as well as the intranasal vaccine from Bharat BioTech. Johnson & Johnson is also set to introduce its vaccine in India, with a bridging trial about to be conducted. Serum also plans to supply the vaccine jointly manufactured with Novavax in September. This is all not to mention the Sputnik V developed by Russia, though initially set to be imported, will be manufactured domestically in India by July.


Of course, the war is not over. We face the challenge of manufacturing a great number of vaccines and supplying them in a smooth and efficient manner. With the grace of Devi, that too will be achieved.


Most Importantly - Register for the vaccine if you’re 18+, and get it as soon as you can. Stay safe, and #MaskUp until we beat this.


To hope, and to a better tomorrow.


(Copyrighted images are reproduced under fair use exceptions)


 

[1] Since we can refer to each variant by their place of origin (UK Variant, Indian Variant, South African Variant etc.,) I think it is more than fair to call COVID-19 the ‘Chinese Virus’ or the ‘Wuhan Virus’.


[2] We are also now seeing the short end of the stick with western nations following vaccine nationalism and the United Staes not even permitting the export of raw materials for India’s Serum Institute to manufacture Covidshield.


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