In humanity’s fight against viruses, nothing has been more influential than the invention of modern vaccination. Invented by Edward Jenner in 1796 when he successfully used cowpox residues to create immunity to smallpox. His methods underwent technological changes for two centuries and ultimately resulted in complete eradication of smallpox.
- Initial Setbacks
- The Immunisation Renaissance
- Vaccine Adverse Events Reporting System (VAERS)
- National Vaccine Program Office
- Vaccine Information Statements The NCVIA required that all healthcare providers give a CDC approved statement to the legal guardian of the recipient of said vaccine informing them about the side-effects, risks and benefits of each dosage of each vaccine
- Big Pharma but Tiny Vaccine?
- The Deterrents –
- The Future of This Industry
The contribution of vaccines in our lives is undeniable, let’s take for instance measles.
The sharp decline in the reported cases can be without a doubt be linked to the introduction of measles vaccine in 1963 by Dr. Maurice Hileman. Measles has been driven to the point of extinction evidenced by the mere 12 cases reported in the US last year.
Don’t we all remember polio immunisation from our childhood? The polio virus was one which had a fatality rate upwards of 15%. That is a far cry from the CDC’s estimate of COVID-19’s fatality rate of 0.26%! Polio was defeated when scientist Jonas Salk introduced the Polio vaccine in 1955 and the results speak for themselves. There has been less than 100 reported cases worldwide. All thanks to mass immunisation programs.
Now that we have established the imminence of vaccines, why is the vaccine industry so secretive and despite its categorical achievements, why do we see surge in ‘anti-vaccine’ movements rising? How does this industry even work, let’s find out.
The vaccine industry has been plagued with problems which made it not so profitable a business. In the early days of mass vaccinations like with any nascent development, there were serious but rate side effects associated with vaccines. These included allergies, seizures, and other immune reactions which could even cause death.
Our story beings in 1955 when about 200 people were paralysed and ten of them died after they caught polio from vaccine manufactured by Cutter Laboratories. This resulted in a class action with most of the cases being settled with out of court compensations.
However, one Gottsdanker v. Cutter laboratories would get tried by the California Supreme Court and become a landmark case in the development of no-fault liability. The court held that there was no negligence on the defendant’s part, but it was financially responsible for the harm caused.
Diphtheria-Pertussis – Tetanus (DPT) immunisation was another revolutionary gift from the immunology realm. However, since its introduction in the 1970 and through 1980’s there was a dramatic surge in the frequency of personal injury lawsuits being brought against vaccine manufacturers.
This was an obviously hostile environment for the vaccine industry to thrive in, thus most pharma giants sold their vaccine departments and the industry was so hard hit that by the end of 1984, only one company was manufacturing the DPT vaccine. The fate was mirrored by other vaccines as well. To focus on more profitable ventures in the field of generic medicines.
To put the pressure of lawsuits into perspective, in 1984 alone the US supreme court awarded a net total of $ 3 Billion when the combined sales for the year was a mere $ 178 Million.
The Immunisation Renaissance
The US government led by President Ronald Regan realised the massive downside to the failing vaccine industry and enacted the National Childhood Vaccine Injury Act (NCVIA). This resulted in the possibility to avail a federal no-fault system for compensating vaccine-related injuries and even death.
The act had the following provisions –
Vaccine Adverse Events Reporting System (VAERS)
All healthcare providers must report certain adverse events following vaccination to the VAERS.
National Vaccine Program Office
An interdepartmental establishment to coordinate immunisation related activities involving CDC, FDA, National Inst. of Heath, and other related bodies.
The NCVIA required that all healthcare providers give a CDC approved statement to the legal guardian of the recipient of said vaccine informing them about the side-effects, risks and benefits of each dosage of each vaccine
Without a shadow of doubt this was a massive game-changer and revived interest of big pharma to start working on much valuable R&D for development of new vaccines all over again.
Big Pharma but Tiny Vaccine?
The aforementioned act did give the vaccine producers the incentive to offer their products without fear of lawsuits. This did attract a lot of big pharma names such as GSK and Merck to re-enter the market.
However, the vaccine industry despite it being such a revolutionary one is a mere speck in the vast pharma-immunology market accounting for just less than 4% of the trillion dollar pharma industry. Further evidenced by the low figure of $ 42.7 Billion as the total combined revenue generated by the vaccine industry worldwide in 2019. That is less than 1/30th of the entire pharma market.
This begs the question, vaccines have saved tens of millions of lives far and across as well as having clear financial benefits by saving billions of dollars for hospitals and insurance companies by saving trips to the hospital bed. Then why is vaccine industry so small?
The Deterrents –
The vaccine industry is unique because of it’s proposition. The reason why the vaccine industry is still so minuscule can be attributed to the following factors.
Non-Recurring Source of Income
Vaccine industry as I mentioned earlier, is most unique in it’s way of operation. Unlike the more illustrious prescription drug industry which saw a compound annual growth of more than 15% for 2019 through 2024 which amounts to $ 109 Billion increase. That itself is more than twice of total vaccine for the same time period. Prescription drug sales is expected to reach $ 1.18 Trillion by 2024. In stark contrast, the vaccine industry is expected to grow by a mere 7% in the same time frame and reaching a market size of $ 58.4 Billion.
This is facilitated by a simple fact. Vaccine manufacturers have one shot at making their money whereas prescription drugs are taken on a daily basis for long periods.
This makes vaccines a not so lucrative option for the big pharma who can easily earn more by focusing on just generic drug trade.
High Barrier of Entry
The pharma industry is famously and obviously one of the most heavily regulated industry and for good reason, it is expected of a welfare state to ensure that the substance being administered to cure a disease does not cause more harm than it seeks to eradicate. However, the vaccine industry has an exponentially greater regulation being enforced because of it’s target base.
Drugs are administered to the ill to cure then, vaccines are given to the cured to prevent them from falling ill.
This drastically raises the bar. Where it takes about 5-10 years for a drug to be launched by one of the pharma giants after shelling out an average of about $ 350 Million, vaccine development can easily cost upwards of $ 1 Billion and an average of about 30 years before it is introduced to the market.
There is the usual government bureaucracy to be blamed here but more important is the fact that vaccines are administered to healthy individuals. That is the sole reason why vaccine manufacturers are held to a much higher than FDA’s already high safety standard. This is a major let-down for scientists and doctors who want to work on currently incurable diseases such as HIV because of the industry’s many barriers.
This is however good news for the big pharma which can afford to be the only players in this industry and form a cartel to establish their visible monopoly over the industry. This is further evidenced by the massive revenues raked in by the top pharma companies over vaccine sales.
That however is not all.
Vaccines have some of the most complex patent structures in the industry. The procedure to manufacture said vaccine is protected under stringent IP Laws and as a result vaccines never become generic.
For example, Merck is the only company legally allowed to sell the chickenpox and measles vaccine in the US.
This has enabled a government sanctioned monopoly which is a massive deterrent to scientific development by new players in the market.
The Future of This Industry
Disturbingly enough there has been a rise in measles cases in infants in the last couple of years. This coincides with the rise of ‘anti-vaxxer’ movement across the world. With pseudoscience gaining more grounds, an alarming number of people in the recent times have come to associate vaccinations with autism.
Much to the dismay of doctors, this has caused serious harm to children. Not only is there no proof to ascertain the relationship between vaccines and autism, the corollary appears to be true.
However, despite these changes there have been improvements. Vaccinations are however set to being replaced by even more advanced gene-splicing technology which eliminates some of the hurdles faced by the vaccine industry. In the wake of COVID we have realised how important it is to take an inclusive approach while dealing with currently incurable ailments and the necessity to collaborate and work together on scientific endeavours. Hopefully we draw lessons from this pandemic and correct our course to have a better future for humanity.