The world has been fighting against COVID-19 since the start of 2020.With a loss of over 40,000 Americans to this virus, a global death toll of over a million, and new cases and fatalities being recorded each day, there is an urgent cry for some type of vaccine to slow the spread.
But, as is the way with most things related to accelerating research into a new vaccine, financial funding is key. The administration has provided seemingly endless funding to research companies across the globe to provide a safe vaccination for coronavirus and, as of July 2020, 2 leading pharmaceutical companies are closer than others to offering relief.
However, as with everything linked to human application in the field of biotechnology and pharmacology, there are many steps to producing a workable, safe, and trusted vaccine. While many people across the globe have criticized pharmaceutical companies for the delay, there are many stages to testing each type of medication or vaccine before it is safe for usage in human trials.
While there is an indication that these applications are drawing nearer, the development and deployment of a COVID-19 vaccine have been tough and, while it may appear that it has been a long time coming, prior to this vaccine reaching the final stage of clinical trials, the fastest vaccine turn around on record was the mumps vaccination, which took 4 years to develop.
So, who are the 2 pharmaceutical companies responsible for this extremely accelerated turnaround?
The first is AstraZeneca, which is a conglomerate pharmaceutical company, with headquarters in Cambridge UK, and Sweden. However, its research and development department has many facilities on American soil.
The second researcher is another multinational pharmaceutical company, with its roots firmly in the United States, and is called Moderna. But the key question on many people’s lips is why are these 2 companies in the lead when there are so many pharmaceutical giants also looking into the COVID 19 vaccine? To answer that question, we must know a bit more about the processes involved in vaccination trials, with a bit of biology and immunology thrown in for good measure.
Phases of clinical trials
Stage 1- Exploratory
This stage involves strictly laboratory-based work, exploring the virus, understanding its structure, and how it is spread. Typically, this can take up to and over 4 years.
As COVID-19 is a mutation in the SARS-CoV virus, there was a fair amount already known about the structure of the initial virus, allowing researchers an advantage during this stage and speeding up the process.
Stage 2- Pre-clinical stage
Here is where both Moderna and AstraZeneca gained their advantage over other companies through their research design.
Moderna completed a phase 1 trial in human subjects which involved 40 participants, being scaled up to 600 in phase 2. AstraZeneca collapsed both phase 1 and phase 2 into one study, which had a participant group of 1,090.
It is the similarity to the initial SARS-CoV virus that allowed both companies to be so bold in their approach and, as no harm was found in any of the participants who took part in both studies, both companies are now moving on to Stage 3.
Stage 3- Clinical development
This stage involves the tweaking of the virus and turning it into a vaccine.
How much of the virus can be introduced to the human body to prompt an immune response strong enough to protect against it in the future?
While both Moderna and AstraZeneca have determined a set amount for their own vaccines, they have approached the issue very differently, which may be the deciding factor in who develops the approved vaccine first.
This is the biology/immunology bit!
Moderna researchers measured the response to the preset virus strength in two antibodies, the binding and neutralizing of the virus and the T-cell response.
Measuring the response of the antibodies determines their effectiveness at destroying the virus, and the T-cell response measures the body’s complete response to the virus being present.
In the Moderna vaccine, both the T-cell and the chosen antibodies response were stimulated to acceptable levels, thus killing the virus at an accelerated rate when it was injected a second time.
With a similar principle of activating T-cells and antibodies, AstraZeneca’s vaccine is not too different from Moderna’s but they may have the upper hand with their research design.
With their larger sample groups, they were able to determine the virus strength at an earlier stage in the research, and so, their stage 3 development has been shorter than Moderna’s in length while eliciting the same results.
But one thing is for sure; with these pharmaceutical giants working on the vaccine, America, and indeed the rest of the world will soon have a vaccine against the COVID-19 epidemic.
Alan Rosca is an investment fraud lawyer with Goldman Scarlato & Penny, P.C. and an adjunct professor of securities regulation at Cleveland-Marshall College of Law in Cleveland, Ohio.