Following months of research, development, and clinical trials, two COVID-19 vaccines were authorized for emergency use by the United States Food and Drug Administration (FDA). The first in this sequence was the Pfizer-BioNTech vaccine, authorized on December 11, 2020. This vaccine will be available for distribution to individuals over the age of 16. The second authorized vaccine authorized on 18th December 2020 was the Moderna COVID-19 vaccine, for those over the age of 18. Although immunization is now available for frontline workers such as residents of nursing homes and healthcare providers, it will be months before the average citizen is vaccinated. Nevertheless, fear has settled in the hearts of Americans, months or possibly a year in advance regarding a vaccine that isn’t even readily available for them. For the COVID-19 vaccine to effectively reverse the effects of the coronavirus in the United States, it is imperative for Americans to make an informed decision about receiving the vaccine. This begins with providing accurate facts, figures, and explanations regarding the immunization as quickly as possible.
The COVID-19 Vaccine Debate
A universal concern of the COVID-19 vaccine is whether or not it can be trusted due to its short timeline from research to distribution. Aware of this paradigm in vaccine development, scientists were methodic in not providing hope for immediate success. It is true that on average, vaccines take 10 years to fully develop and distribute. The quickest any vaccine had been developed prior to the 2020 COVID-19 vaccine was for mumps in the 1960s, with a development timeframe of four years (Ball, 2020.)
Today, the effectiveness or safety of medical developments cannot be assessed based on time alone. There are many factors to consider beyond time. As with the COVID-19 vaccine, some of the factors that have shortened the development timeline are the unique structural integrity of the virus itself and the innovative mRNA virus development stratagem.
COVID-19 Structural Analysis
The coronavirus protein contains a spike module (review figure A) which is compatible with mRNA retroviral immunizations. This protein has the potential for the optimization of antigen design. A strong antigen design ensures that the vaccine has pinpoint accuracy in targeting either the full-length protein of the virus or the receptor-binding domain (Lurie et. al, 2020.) Additionally, while COVID’s initial symptoms progress into acute respiratory disorders, the coronavirus is a type SARS/MERS virus. And as plenty of vaccinations for SARS/MERS viruses exist, built using different platforms, meant researchers could easily manipulate the structures of these existing vaccinations to create one that immobilizes the coronavirus. Thus, no time was spent on manufacturing specific vaccination bases (Lurie et. al, 2020.)
Figure A: The COVID-19 Module
*The red clusters indicate the presence of spike modules. These spikes, when replicated in a vaccine, allow for the effective inoculation of antibodies into the target virus cell.
Traditional Vaccine Development
Traditionally, making vaccines required live virus strains suspended in cell culture. The most common class of retroviral cell culture is a shell vial culture. In this type of culture, viral strains are centrifuged onto a single layer of cells and the growth of the virus is determined by changes in antigen patterning. Once these cultures displayed structural changes that hinder its ability to infect, also known as cytopathic effects, researchers were able to confirm that the culture is positive. These concoctions were then purified in bulk to regulate its effects in the human body (Neergaard, 2020.) It is expected that there is some level of safety concern among vaccine consumers due to mass vaccine production practices and possible errors.
mRNA Vaccine Development
The mRNA approach to vaccine fabrication is radically different from the conventional means of development. By eliminating the requirement for a live strain of the virus to be present in the vaccine. An mRNA vaccine replicates a harmless piece of the target virus with the purpose of generating an immune response. The vaccine then chemically synthesizes RNA to target infectious cells. This modern approach to vaccine production is activated by utilizing a snippet of genetic code that delivers instructions for producing polypeptide chains. These chains then target foreign virus proteins, starting the immune response (Neergard, 2020.) With novel viruses, such as COVID-19, the structure of the protein can be utilized with the advantage of presenting a promising immunogen in the vaccine itself. Another way that mRNA technology reduces the time traditionally associated with vaccine development protocols is that it uses a synthetic processing mechanism. This method does not require facilitating culture growth or fermentation on an inordinate scale. Already, this shaves off a significant portion of time in the development process that would otherwise be allocated to ensuring the safety of the vaccine.
What is in the Vaccine?
The second concern in question regards the composition of the vaccine. Currently, there are two widespread misconceptions that undermine the potential of the vaccine. First, it is alleged that the immunizations will contain microchip tracking devices. Second, there is a notion that live strings of the virus will be present in the vaccination. Moderna and Pfizer, the two major distributors of the COVID-19 vaccine in the United States have debunked these assumptions in their respective official statements with the FDA, confirming that these concerns are invalid.
The mRNA-1273 vaccination that has been authorized under the title of “Moderna COVID-19 Vaccine” by the FDA encodes an S-2P antigen in conjunction with a SARS-CoV-2 glycoprotein. This glycoprotein is an inactive protein agent of the virus. S-2P is stabilized with proline replacements at amino acid positions 986 and 987, located in the top of the central helix in the S2 subunit. These proline replacements ensure that the chemical body is stable. The lipid nanoparticles of the vaccine consisting of four essential fats in a 1:1 ratio of lipid to mRNA. Lipids act to replicate the outermost surface of the coronavirus on ordinary cells, promoting immunity. This concentrated solution is diluted in standard saline (FDA, 2020.)
The Pfizer vaccination authorized under the title of “Pfizer-BioNTech COVID-19” vaccine has a similar chemical composition to its Moderna counterpart. The primary differences between the two vaccines lie in the ingredients used to maintain the pH and stability of each respective vaccine. The Moderna vaccine is suspended in a solution of tromethamine, tromethamine hydrochloride, acetic acid, sodium acetate, and sucrose (FDA, 2020.) The Pfizer vaccine is suspended in potassium chloride, monobasic potassium chloride, sodium chloride, dibasic sodium phosphate dehydrate, and sucrose.
Although the ingredients lists are slightly different for each vaccine, ultimately the results are the same, states Jamie Alan, an assistant professor of pharmacology and toxicology for an interview with Prevention. However, the slight formulaic differences could explain the different storage requirements for each. The Pfizer vaccine must be stored at a strict -70 degrees Celsius. On the other hand, the Moderna vaccine must be shipped in -20 degrees Celsius but can be comfortably stored in a refrigerator unit for 30 days afterwards (Miller, 2020.)
*Although the ingredients of the vaccines slightly vary in nature, there are no significant differences between the two vaccines. One is not inherently better than the other. However, it is recommended to talk to your provider before receiving an administration of the vaccine to discuss safety concerns (allergies, possible reactions) pertinent to you.
There are two primary concerns for the American public with regard to the coronavirus vaccines. The first is a debacle of time. While historically vaccines have taken an average of 10-15 years for successful development and testing before public use. The vaccines by Moderna and Pfizer have been developed, tested and distributed in a matter of months. This concern is made invalid when one considers the technological advances made in vaccine development in the years prior to the coronavirus pandemic. Because COVID-19 replicates a SARS/MERS virus, researchers don’t require time to develop a specialized basic suspension for a COVID-19 vaccine. The second is a matter of safety. Both major distribution companies have announced that the vaccine is composed of mRNA, lipids, and a standard saline solution reassuring the public that there will be no viral strain in the vaccine.
Sabriyah Morshed, Youth Medical Journal 2021
@NicholasFlorko, N., Florko, N., Goldhill, O., Branswell, H., About the Authors Reprints Nicholas Florko Washington correspondent Nicholas Florko is a Washington correspondent for STAT, Nicholas Florko Washington correspondent Nicholas Florko is a Washington correspondent for STAT, . . . Says:, R. (2020, December 29). Frustration over vaccine rollout grows as new variant reported in U.S. Retrieved December 31, 2020, from https://www.statnews.com/2020/12/29/public-health-experts-grow-frustrated-with-pace-of-covid-19-vaccine-rollout/
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Miller, K. (2020, December 17). What’s in the COVID-19 Vaccines? We Asked Experts to Explain the Ingredients. Retrieved December 31, 2020, from https://www.prevention.com/health/a35002158/pfizer-vs-moderna-covid-19-vaccine-ingredients/
Neergaard, L. (2020, December 07). Years of research laid groundwork for speedy COVID-19 vaccines. Retrieved December 31, 2020, from https://www.pbs.org/newshour/health/years-of-research-laid-groundwork-for-speedy-covid-19-vaccines
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2 replies on “Evaluating the Coronavirus Vaccine”
As both the vaccines have concerns over time and safety how the FDA approved them for American public use? By using these vaccines the users may fall in acute troubles or even they embrace death. Shouldn’t the FDA think over their uses once again?
Hello, good question! The purpose of this article was to debunk these concerns. In sum, the time taken to develop this vaccine is not an adequate measure of safety because of major advancements in technology. In particular, the time it previously took to develop vaccines was in manually creating cell culture in bulk and ensuring that the live virus string did not pose any threats upon entrance in the bloodstream. In regard to safety, the presence of a live virus in the vaccine was of primary concern. The vaccine uses mRNA to combat the virus, eliminating the need for a virus in the bloodstream.
It is true that certain users may experience acute symptoms or death post-immunization. This is rare and due to allergies caused by the substances used in the vaccine. It is recommended to discuss with a healthcare provider about which vaccine is right for you. On average, 94.5% of vaccine recipients in Moderna and Pfizer clinical trials reported common side effects such as muscle soreness, lightheadedness, and nausea, lasting 2-3 days post-vaccination. There is a much higher probability that the vaccine will be effective than create more troubles.
In the frame of this emergency, the FDA is forced to release this vaccine given the circumstances. As hospitals continue to exceed 100% capacity, it is imperative that these hospitals do not receive any more patients. The death toll due to COVID-19 will only continue to rise because hospitals do not have the capacity to treat more incoming COVID-19 patients. It is in the FDA’s best interests to release a vaccine and stop more hypothetical patients from entering already full hospitals.