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COVID-19 UPDATE

move on to more extensive trials, involving sponse. Injecting mRNA into your body will entails unbiased observations and systematic
thousands to tens of thousands of people. not interact nor do anything to the DNA of experimentation." In general, science involves
One Phase III goal is to assess vaccine safety your cells. Human cells break down and get a pursuit of knowledge, and there are always
in a large group of people. Specific rare side rid of the mRNA soon after they have fin- limitations present when studies are per-
effects might not surface in the smaller ished using the instructions. formed. And, as new data become available,
groups of subjects tested in earlier phases. The manufacturing ability of our cells ex- the conclusion of the observations may
Recall that the J&J vaccination was sus- tends beyond human proteins. When we are change slightly, significantly or not at all.
pended for a short period when some people infected with a virus, including relatively Physicians have numerous observations as to
developed blood clots. At the time of the dis- harmless viruses like those that cause the what appears to be effective and what appears
covery, J&J had administered over 7 million common cold, these invaders inject their ge- to be less effective. True science allows con-
vaccinations, and six of those people vacci- netic material into our cells, resulting in clusions that are based upon observations to
nated presented with a blood clot. As in all pieces of mRNA encoding viral proteins be examined. We are still learning about
clinical trials, there are often reported side ef- being sent to our protein-making machinery. COVID-19; however, we have millions of
fects. The question, which takes time to an- Doing so enables the virus to assemble new data points that we previously did not have.
swer, is whether or not the side effects were viral particles out of these proteins and The science should evolve to better under-
the cause of the vaccination or simply a coin- spread. Although mRNA vaccines are a rela- stand COVID-19 and the vulnerable popu-
cidence after taking the vaccination. Further- tively new technology, they are based on the lations that are susceptible to it. Those over
more, even if the vaccine "caused" a potential same ancient premise: delivering mRNA into age 70 with comorbidities are far more vul-
side effect in a small population our cells, which they will use to manufacture nerable than those under 60 with minor
(.00008571% of the J&J population indi- a viral protein. mRNA vaccines don’t carry health problems when acquiring COVID-
cated a blood clot after the vaccine), the enzymes like an HIV virus, so there is no risk 19. We should treat each person as an indi-
number of lives saved by providing the the genetic material that the SARS COVID- vidual and determine which individuals need
COVID-19 vaccine may be seen to outweigh 19 virus contains could alter our DNA. special protection. Individuals in a popula-
the preventable side effect seen in the J&J The delivery systems of both the Moderna tion are generally at very low risk of dying
vaccine. The FDA will continue to monitor and Pfizer vaccines are brilliant. Here is how from such a disease and act accordingly.
the efficacy and production of the vaccine. it works. First, the scientist takes a lipid Doctors should be given a broad latitude
Results from these trials have shown that nanoparticle to introduce the mRNA into a to practice medicine based on the evidence
COVID-19 vaccines are effective. They have protective casing. To maintain the integrity of each patient. As I always say, "be careful
also demonstrated no serious safety concerns of the lipid nanoparticle, the manufacturing what conclusions you come to based upon
after many weeks following vaccination. This process must keep it very cold (between -76 a study or the underlying data." There are al-
is an important milestone, as it is unusual for and -112 degrees Fahrenheit); otherwise, the ways limitations to all studies, and the gen-
adverse effects caused by vaccines to appear efficacy is lost in a few days of the vial of the eralization of any research also has
after this amount of time. vaccine. This creates a transport vehicle to in- limitations when one tries to generalize be-
troduce to the human hosts. The COVID- yond the scope of the study.
Myths of the vaccine exposed 19 S-Protein is contained in the lipid
Anytime there is a new drug or vaccine, nanoparticle. Once it gets into the host cell, Alan Preston, MHA, ScD works
people are skeptical as to the long-term ef- the good news is that it does not enter into in the area of Population Health
fects. There is no shortage of conspiracy the- the cell's nucleus, where the cell's DNA is lo- Management and has a doctorate in
ories about the new vaccines. One of the cated. It is a brilliant transport mechanism Science in Epidemiology and Biostatistics from
more prevalent myths is that the Pfizer and and, in my opinion, safe. Tulane University and has spent his entire ca-
Moderna vaccines introduce the RNA of the reer in the health care space.
virus, which will alter the DNA of the host. Definitions of science
According to the CDC, mRNA vaccines According to one definition, "Science is
work by instructing cells in the body how to any system of knowledge concerned with the
make a protein that triggers an immune re- physical world and its phenomena, and that

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