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COVID-19 COVID-19
VACCINES VACCINES

Development of COVID-19 The mRNA will begin making

Vaccinations proteins using the cell's ribo-
somes. The ribosomes help de-
code the message. The process of
making proteins from the
mRNA is called translation. The
new proteins get expressed on
By Alan Preston, MHA, ScD the cell membrane on two types
of proteins. One of the existing
Operation Warp Speed has resulted in the creation of two, soon to a. The proper dosage of the vaccine is tested at this phase to find cells' proteins is called MHC-2
be three or more, COVID-19 vaccinations. This is excellent news for the correct dosage protein, which is only found on
all who are anxious to get back to normal without the restrictions im- 3. Phase-2: Moderate sample size of 100 to over 1,000 antigen-presenting cells. The
posed on small businesses and individuals. Operation Warp Speed's a. Trying to match the demographics of the target population who MHC-2 protein is only found
goal is to have private industry develop a vaccine and quickly allow will receive the vaccine on B-cells and Dendritic Cells,
the supply chain to deliver 300 million doses of safe and effective vac- 3. Phase-3: Testing vaccine on humans which act as messengers between
cines. Many people are, however, skeptical as to the safety of the vac- a. Large sample size (30,000 to 60,000) the innate and the adaptive im-
cinations. Even with a vaccine for H1N1, only 50% of the population b. The sample matches the demographics of the population mune systems.
decides to take a vaccine to prevent the disease. c. Monitor how effective the vaccine is The body's response to attract
The FDA has created the gold standard for the approval of prescrip- d. The population will have both the active and placebo vaccine is to attack the S-protein. But
tion drugs. The objective of all clinical trials is two-fold; one to assure how does that work? The T-
safety to the patients, and the second to ensure the intervention works If all goes well, the trial goes to approval for the Emergency Use helper cell and the T-cell be-
as intended. The last goal is what we call efficacy. Authorization (EUA) from the FDA. Once the EUA is achieved, come activated, which begins to release a lot of cytokines. Interleukin about 21 days later (Pfizer) or 28 days later (Moderna) for the second
then the distribution of the vaccination is cleared. There is a lot of 2 and 4, and 5 are created. It tells the B-cells to proliferate and to differ- injection. The first injection is only about 57% efficacious and requires
Efficacy can be thought of in two ways for a vaccine: confusion at this step. Our country is based on a republic that sepa- entiate and have the plasma cells to make antibodies. The antibodies to have the second vaccination to become 95% effective. Managing
1. Efficacy can attempt to prevent the disease and the transmission rates the federal government's roles from that of the States and local go after any virus that has an S-protein. It also stimulates the T-cells this population to assure compliance with these parameters will be a
of such. municipalities. The federal government can set "guidelines" as to what to produce memory antibodies. challenge for the doctor's offices and other institutions that administer
2. In the rare case someone gets COVID-19, does the vaccine the priorities should be as to who gets the vaccination first; however, the vaccine.
protect against severe symptoms? it is up to each state and local officials to work with the private com- How long will the antibodies stick around?
munity to coordinate the vaccination of patients, frontline caregivers We don't know yet. It may be six months or nine months or longer, What will it take to get to “herd immunity”?
To test the hypothesis as to whether the trial is both safe and the vulnerable. but time will tell. What we do know based on the clinical trials is that There is not a definitive answer to that question; however, the con-
and effective, four study phases are required for approval The early distribution of the vaccinations has been smooth in some it is effective, over 95% for Moderna and 94.5% for Pfizer. Again, there sensus is about 75% of the population vaccinated can substantially
from the FDA: communities and a disaster in others. Blaming the federal government are two ways to look at efficacy. One is against getting the disease, and mitigate the transmission of COVID-19. And of course, if the vaccine
for the local municipalities' inadequacies will not make the process the other is stopping the severity of the disease. is administered to the vulnerable population in more significant per-
1. The pre-clinical phase is the animal studies to determine safety and
easier or more effective. As an example, Moderna tested nearly 30,000 patients. They were centages, the COVID-19 death rate should plummet. The other
efficacy
The two vaccinations that have EUA from the FDA are Pfizer and divided into two groups; one group had the vaccine injected, the other tremendous benefit of a vaccine is that it should mitigate the impact
2. Phase-1: Small human trials to assure safety and no adverse side ef-
Moderna. Both companies use a similar approach to the development had saline (the placebo) injected. For those who had symptoms and on hospitals and, in particular, the ICU beds. I suspect there is a sig-
fects (usually less than 100 subjects)
of the vaccination. Both locate the Messenger RNA from one of the tested positive, this is what they found. For the placebo group, about nificant population that needs attention to many other diseases that
many found on the COVID-19 virus proteins and use that protein, 185 tested positive. For the vaccine group, only 11 tested positive; are not being addressed during this pandemic. If we continue to scare
which contains the messenger RNA, to introduce it to the human but in the vaccine group none had severe symptoms of COVID-19. people from getting the necessary care they need, far more of those
host. The objective of vaccination is to have the host create antigens In the placebo group, about 30 were severe cases. Therefore, Moderna’s individuals will die from not being vaccinated than from those who
to attack the COVID-19 protein. Then the human host will develop efficacy against getting the disease is 185-11=174/185= 94%. Mod- actually get the COVID-19 disease.
antigens to fight off the foreign RNA, and by producing antigens to erna vaccine’s efficacy for preventing severe symptoms of COVID-19 Let's hope that these and other vaccines put an end to the COVID-
fight off the m-RNA, your body is one step ahead if you encounter the was 100%! 19 pandemic. We need to be patient and understanding as the local
real COVID-19. How does this work? The challenge of keeping the vaccination cold is a real challenge to infrastructure evolves to manage the vaccines' dispensing. It is time to
Here is how it works. The scientist takes a lipid nanoparticle to in- many communities throughout the USA. To store the vaccines and be get the country opened up again and allow people to get back to work.
troduce the m-RNA into a protective casing. To maintain the integrity viable, it needs to be -4 Fahrenheit for the Moderna, and it needs to The nature of people is to socialize; isolation is never good for a
of the lipid nanoparticle, the manufacture must keep it very cold; oth- be – 94 degrees Fahrenheit for Pfizer. And therein lies part of the prob- healthy society.
erwise, the efficacy is lost in a few days of the vial of the lem with the distribution system. Which providers have the necessary
vaccine. This creates a transport vehicle to introduce to freezers to keep the vaccine vials at such a low temperature? Alan Preston, MHA, Sc.D. works in the area of Population
the human hosts. The COVID-19 S-Protein is con- Additionally, each vial can administer about ten patients. One of Health Management and has a doctorate in Science in Epi-
tained in the lipid nanoparticle. Once it gets into the the issues is making sure that all ten doses are give to patients who demiology and Biostatistics from Tulane University and has
host cell, the good news is that it does not enter into show up at the same time to receive the vaccination. Another challenge spent his entire career in the healthcare space.
the cell's nucleus, where the cell's DNA is located. is making sure that once patients receive the first injection, they return

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