Updated: Sep 15, 2020
A Novel Vaccine Candidate is defined as the first of its kind based on the mechanism of protection or as the first vaccine for a disease.
-Journal of Post Graduate Medicine
Hello family! I hope that this lovely day finds you wrapped in the best of health and spirits. I remember just near the end of 2019, reading an article that stated, “The year 2020 would be known as the New Roaring 20’s.” In retrospect, it’s fair to say that was a serious understatement. 2020 has not only roared, it has belted out one of those Earth-shaking T-Rex screams for all the world to hear and feel. Human and civil rights issues are again at the forefront of global news. Alongside these developments we find ourselves in the awesome grip of a global pandemic which rivals the curses of biblical times. The COVID-19 virus is already devastating many areas of life as we’ve come to know and expect it. Every area from politics and society to the global economy and the mental and physical health of nations has been altered by the grim brush of the virus. Fear and uncertainty combined with isolation have left most of us with an overwhelming sense of hopelessness. Now with sharp increases in numbers of newly infected and deaths related to COVID-19, the quest to develop affective vaccines becomes paramount! Today we will focus on coronavirus vaccines . . . history, developments and expectations. If you have not done so, I would suggest reading the “COVID-19 CORONAVIRUS” blog post before continuing. With that being said, let’s take a gander into coronavirus vaccines.
As we look in to coronavirus vaccines, we must keep in mind that these diseases are either animal or human in origin. This is important because vaccines that test successfully as a cure in lab animals are not always successful in human subjects. Some coronaviruses that infect animals can occasionally be spread to humans. While this is rare, it’s exactly what happened with the virus that caused the COVID-19 outbreak. On the reverse of this, the CDC has tracked a small number of pets including dogs, cats, and a zoo tiger, all of which have tested positive after close contact with infected humans. Research results show that ferrets, cats, and golden Syrian hamsters can be infected with and transfer the virus to other animals of the same species. Pigs, chickens, and ducks did not become infected or spread the infection in these studies.
A BIT OF HISTORY
While origin stories of vaccination efforts have been attributed to India or Africa, it is the 15th century Chinese who are credited with the first attempts at vaccination. This can all be debated, since methods of recording and preserving the effectiveness of early efforts were themselves ineffective. That being said, it was the 15th century Ming Dynasty who recognized that patients who had contracted smallpox once were immune to reinfection. This knowledge led them to the idea of preserving the scabs of people who had mild cases, turning these into powder and blowing the powder up the nostrils of newly infected. Since the initial effectiveness of these vaccinations was not accurately documented, it is 18th century British physician Edward Jenner who is credited with development of the first safe and reliable version.
"In science credit goes to the man who convinces the world, not the man to whom the idea first occurs."
In 2003 the world was introduced to a severe and rapidly spreading infection known as Severe Acute Respiratory Syndrome coronavirus (SARS). Shortly after the SARS epidemic, the HCoV-HKU1 and HCoV-NL63 human coronaviruses were identified as common causes of human respiratory tract infections. Again in 2012, Middle East Respiratory Syndrome coronaviruses (MERS) were discovered to cause devastating infections in three continents. The SARS and MERS viruses turned out to be very similar in that both have a high mortality rate and human-to-human transmission. Both of these coronaviruses are also related to bat coronaviruses.
Dr. Jenner noticed that local milkmaids, who had contracted cases of cowpox, would generally be uninfected during later outbreaks of smallpox. In a 1796 experiment, the doctor harvested cowpox pustule from Sarah Nelmes and scratched it into the arm of an 8-year-old boy named James Phipps. In 1798, Jenner’s results were published in the book “An Inquiry into the Causes and Effects of the Variolae Vaccinae: A Disease Covered in Some of the Western Counties of England, particularly Gloucestershire, and Known by the Cowpox." I’m not making this up! That’s the actual title. By the end of 1801 an estimated 100,000 patients had been vaccinated using the same method.
Dr. Jenner’s methods were limited in that some human diseases have no animal equivalent that can provide immunity without causing the virus itself. Also some diseases that effectively make the jump from animals to humans prove to be deadly in both. Such is the case with COVID-19. As a result scientists were forced to focus on two methods of neutralizing the underlying virus and bacteria: 1) First they could kill the virus or bacteria, but keep its physical structure intact. This would allow the body’s immune system to recognize and kill the disease if it were ever encountered again. 2) Secondly, they could attenuate or weaken the virus, rendering it harmless and simultaneously teaching the immune system to destroy it when coming into contact with it later. Two potential problems exist in these two methods. Mutations are always possible with attenuated viruses and in some cases the vaccine itself can cause the disease it seeks to prevent. This led 19th and 20th century researchers to develop vaccines that killed pathogens entirely by use of heat or formalin, a diluted version of formaldehyde. By the late 1940’s scientists began using far smaller amounts of viruses or bacteria to trigger the desired immune response. Proteins extracted from pathogens could work in like-manner. The latest weapon scientists utilize in the never-ending virus war is the coding of genomes. These vaccines rely on the extraction of RNA or DNA from pathogens and introducing these into the body. This genetic material causes cells to produce proteins that cannot cause disease but can evoke the same desired immune response. This is the approach researchers are using to combat COVID-19. These vaccines use the genetic material known as mRNA, extracted from SARS-Cov2, the virus that causes COVID-19.
Many have begun comparing the race to develop a COVID-19 coronavirus vaccine to the Space Race of the 1950’s, 60’s and 70’s. Needless to say that a multitude of pharmaceutical companies around the globe are clamoring to get their vaccines successfully through human testing and ready for the public. During my research, I even came across the story of a Houston-based company whose scientists declare that they were unable to obtain funding necessary to complete development of a vaccine back in 2016. (You can read more about that here) Much like the Space Race, the financial benefits for the first truly successful developers could be astronomically lucrative. On the flip-side of this are the costs to a vulnerable and fearful public. The pharmaceutical industry, with its pill peddling tactics, is a trillion dollar-a-year business. So do the means now justify the ends or does the opposite still hold true? While the health of the world remains priceless, a COVID-19 vaccine will definitely come with an actual price! Our business-centered drug pricing will surely make the medicine unaffordable for many of us in need. Free national drug programs like those of The March of Dimes in the 1950’s are a thing of past lore. These have been replaced by a need for health insurance for outpatient care. New drugs are now protected by patents and the drive to develop new medicines is fueled by the desire to become ever-more wealthy. Although endless court battles have been fought to dispute ownership of drug patents, manufacturers are allowed to set their own prices...no matter how excessive. This immoral practice is the bane of those in need of assistance. As always seems to be the case, the ill and impoverished face great challenges where they should be receiving help instead. Governments have seemed powerless to provide adequate solutions to this pricing plague. That is until now!
Federal and state governments have taken measures to deter price gouging. While there are no federal laws that explicitly prohibit price gouging, 50 U.S.C. 4512 grants the Department of Health and Human Services to prohibit hoarding. While there are several state statutes and rules that give attorney generals the authority to address price gouging, these measures are insufficient at addressing COVID-19 specific issues. This may be about to change. On April 8th, House Democrats introduced the COVID-19 Price Gouging Prevention Act. This bill makes it unlawful for any person to sell or offer for sale a consumer good or service during a public health emergency resulting from COVID-19 (i.e., a coronavirus disease 2019) at a price that 1) is unconscionably excessive, and 2) indicates that the seller is using the circumstances related to the public health emergency to increase prices unreasonably. Now we all know that such measures are only as effective as the level of accompanying enforcement. However, maybe this time the light at the end of the tunnel will not be a train. The bill precludes price gouging and would give the Federal Trade Commission and state AG’s sufficient powers to enforce it. This is a major step taken by the American Government to protect the public in a time of express need.
The original COVID-19 Price Gouging Prevention Act failed to pass through the Senate; however, the House did introduce its equivalent of the original bill – H.R.6472. It has since been referred to the Committee on Energy and Commerce. The House version of the bill seeks to remove the limits of the original to COVID-19. This would establish a federal price gouging law for future national and public health care emergencies. So while the Senate and House remain in negotiations on other issues, they seem to be in agreement on the need for price gouging legislation. It is well worth keeping an eye on these bills and familiarizing yourself with the actual provisions included in each.
Originally my intent was to examine the corporations that are leading the way in the development of a vaccine. This proved to be a futile attempt as the companies kept changing positions as they scramble for pole position in this crucial race. So instead I decided to include the New York Times Coronavirus Vaccine Tracker to keep you abreast of new developments. As always you will find additional information in the provided links. Please be aware that this affects us all. The more information we can garner, the better decisions we are able to make. I know that you are always told to love yourself, but don’t forget to love someone else! POWER UP FAM!
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