The latest SARS-CoV-2 epidemic, which began in December
2019, triggered a global crisis. Lockdowns of varying degrees of magnitude were
enforced globally. Although the number of daily deaths due to COVID-19 seems to
have decreased significantly by June 2020, the rising number of ‘cases’
(positive test findings for viral exposure) has raised some questions about
governments’ and decision-making authorities’ ability to limit viral
transmission and its effects.
Common social distancing, isolation, the use of disinfectant
agents, and the wearing of defensive face masks have also been used to keep the
infection from spreading. These policies have negative psychological and
economic implications, and there is significant debate among medical
professionals and government decision-makers about their effectiveness.
Parallel to the imposition of restrictions to deter viral
spread and the testing of (mostly) repurposed antiviral treatments, vaccines
are being developed at a faster pace to prevent/restrict future viral injury.
Whether an aggressive vaccine production can be done safely,
avoiding possible adverse vaccine effects not only in the short-term, but also
in the mid- to long-term, has been questioned.
Checking for vaccine Safety:
In order of increasing credibility, there are three methods
for measuring vaccine safety: computer modelling, Animal experimentation, and
human clinical trials.
Computer
simulations:
Although the advancement of new models is enabled by the growth
of statistical software packages and chemical descriptors, protections that
account for flaws in the underlying models may be missing. This could
jeopardise the legitimacy of any safety or toxicity conclusions. As a result,
while these models can provide useful information, they cannot yet replace
human trials, at least not at this stage in their development.
Animal experimentation:
Whole animal trials have been shown to be unreliable
predictors of human reactions to environmental exposures or medications in many
instances. In rodents, primates, and humans, for example, isotretinoin
(acutane) has been shown to cause birth defects, but not in mice or rats. Corticosteroids,
for example, are teratogenic in laboratory animals but not in humans. There’s
also Thalidomide, which is “a teratogen in humans but not in many
laboratory animal organisms,” as well as other well-known examples.
Human clinical trials:
Human studies have at least two benefits over animal tests
in the lab. For starters, there are no questions about species variations that
can arise by extrapolating data from laboratory animal experiments to possible
human consequences. Second, humans are subjected to a variety of toxic
stressors prior to, after, and during the trial cycle, yielding effects that
are representative of real-life situations. Human experiments would be more
applicable in all situations if the research population’s features match those
of the target/user population.
Covid-19 Vaccine In USA:
In the United States, two coronavirus disease 2019
(COVID-19) vaccines are officially approved for use. On December 11, 2020, the
Food and Drug Administration (FDA) granted an Emergency Use Authorization (EUA)
for the Pfizer-BioNTech COVID-19 vaccine, and on December 18, 2020, the FDA
granted an EUA for the Moderna COVID-19 vaccine; all vaccines are given in a
two-dose sequence.
During the first month of the vaccination campaign, 13.8
million doses of Pfizer-BioNTech and Moderna COVID-19 vaccines were
administered to the US public Both vaccines have reassuring post-authorization
safety profiles. The majority of VAERS cases (90.9 percent) were for
non-serious accidents with local and systemic symptoms; intermittent local and
systemic reactions were also recorded regularly in v-safe. Anaphylaxis has been
reported after the administration of both vaccines. During the analytic era,
there were 4.5 cases of anaphylaxis after receiving COVID-19 vaccinations,
which is below the range recorded after receiving inactivated influenza vaccine
(1.4 per million), pneumococcal polysaccharide vaccine (2.5 per million), and
live attenuated herpes zoster vaccine (9.6 per million); successful therapies
for anaphylaxis are available.
