To Vaccine or Not to Vaccine, That is the Question!

By Edward Canavan

The topic du jour with my friends and colleagues are around the safety of the COVID vaccines that have secured emergency use approval from the US Federal Drug Administration.   We debate its safety, efficacy and the speed at which it was developed and approved.   I believe it is the later that supplies us with some trepidation and uneasiness.  

Innovation - The History of Vaccines

Vaccines have been around for centuries.   In 1796, Edward Jenner developed the world’s first vaccine for smallpox.   His hypothesis proved right, infecting an individual with horsepox could protect them from smallpox.   As the potency of this method diminished, a physician, Edward Ballard identified a new strain of cowpox reintroducing the matter back into cows to boost the vaccines potency.    In 1853, The United Kingdom made smallpox vaccinations mandatory for infants.  The penalty for not complying was a fine or imprisonment.   In 1916, French researchers Charles Nicollem, MD and Ernest Conseill, MD discovered that individuals recovering from measles created protective antibodies that when injected in others helped protect them against the disease.  As the process developed, egg-based manufacturing became the most common way vaccines were made.    In 2012, cell-based vaccines were approved to be used in producing a virus antigen.  Finally, in 2013, flu vaccines started being produced using recombinant technology.  These vaccines are created synthetically by replicating a protein contained in influenza viruses that triggers our immune system to create antibodies that target the virus.  

What is mRNA?

Our bodies naturally produce Messenger Ribonucleic Acid.  It is mRNA that tells our trillions of cells which proteins to make.  In the 1990’s, Katalin Kariko theorized the ability to produce synthetic mRNA to create any protein desired.  The potential, she dreamed, was vast and envisioned utilizing mRNA to vaccinate against infection, reverse rare disease and mend damaged heart tissue.   Every strand of mRNA is made up of four molecular building blocks called nucleosides.  Kariko worked to tweak the synthetic version so it no longer signaled an immune response.   Kariko spawned a biotech revolution that eventually resulted in billions of dollars being raised hinged on creating a fleet of mRNA medicines that can be safely administered.  

How Do mRNA Vaccinations Work?

The synthetic mRNA contained in the newly approved vaccinations provide instructions for our cells to produce a “spike protein.”   This protein is found on the surface of the virus that causes COVID-19.   After the spike protein is made, the cell learns how to get rid of it.   Next, the cell displays the protein on its surface.  This causes our immune system to recognize the protein as foreign and begins to respond by making antibodies.   This process concludes by our bodies learning how to protect against future infections.

How are Vaccines Customarily Developed and Approved?

According to the FDA there is no predetermine timeline for vaccine development and approval.  However, it is a well-defined and often lengthy process.  It starts with the Research and Discovery Stage in which a team must rationalize the need and conduct research to test their idea for a vaccine candidate.   Next, is the Pre-Clinical Phase that customarily includes testing the vaccine on animals to obtain information on how the vaccine works.  The Clinical Development Stage includes submitting an Investigational New Drug application to the FDA.  If approved, the FDA will oversee three distinct phases expanding the testing on humans.    Next, the FDA will determine if they need to make a “Special Consideration” concerning expediting the process based on a public health emergency.   Expediting the process could include Adaptive Trial Designs aimed to shrink the process without compromising the integrity of the clinical trials or results derived.   The FDA will assess the ability to manufacture the vaccine while it is being tested on people.   Finally, the company seeking permission will submit a biologics license application to the FDA for approval.    The FDA does not bow out at this point but will continue to monitor the vaccine as it is administered.  

Should I Take the COVID-19 Vaccine?

It is difficult to tell how we are going to get on the other side of this pandemic without wide distribution of a vaccine.  Whether or not to take the vaccine is a very personal choice.  I am a Type 1 Juvenile Diabetic and have several other underlying health conditions.   In addition, I recently suffered an anaphylactic reaction and prescribed an epi-pen.   When faced with the decision of whether or not take this vaccine, I have several concerns.   However, I have decided to consult with my physician, review the pros and cons and together make a decision on the best option based on my medical history.   

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Edward Canavan - Eddy has over 25 years of experience in the workers’ compensation industry and is currently working as the Chief Claims Advisor for Hudson Claims Consulting. In his present role Eddy serves as a subject matter expert for Hudson's clients helping them with compliance, practices and refining their products and services. Before working for Hudson, Eddy spent 18 years with Sedgwick. Most recently Eddy served as Sedgwick’s Senior Vice President of Casualty Practices helping shape best practices, update auditing methods, support business development, provide expertise to clients, colleagues and the industry. Eddy holds several professional designations including an Associates in Claims and Risk Management and secured his bachelor’s degree in business administration from CA State University of San Bernardino.

To contact Eddy - eddy@hudsonclaimsconsulting.com