Although non-medical public health efforts have been successful in other nations, the majority of the

world's population will rely on vaccines to control the pandemic. Since SARS-CoV-2 was identified as
the causative agent of COVID-19 in January 2020 (Wu, 2020) (Zhou, 2020), extremely efficient
vaccinations have been created and used at an incredible rate. Both the Pfizer / BioNTech and
Moderna mRNA (Polack, 2020) (Baden, 2020) vaccines have shown 94–95 percent vaccination
against SARS-CoV-2 in independent clinical trials. Based on this information, regulatory bodies in
North America approved both Pfizer / BioNTech and Moderna plans to employ emergency services
in December 2020.

Objective

On evaluating the BNT162b2 vaccine's safety, effectiveness, and immunity in adolescents and adults.
The current summary of the study's findings in sections 2–3 focuses on safety assessments among
participants 16 years of age or older, as well as a 6-month randomized controlled trial of persons 12
years of age or older. vaccination. Because 12- to 15-year-old participants began enrolling on
October 15, 2020, 6-month immunization data for this age group is not currently available.
Participants aged 12 to 15 have their short-term safety, immunological function, and performance
data reported separately, Data from this collection, on the other hand, are included in the study of
the vaccine's effectiveness in the entire population (all 12 participants aged) described here. (R.W.
Jr. Frenck et al., 2021)

Methodology

People aged 16 and older were randomly assigned at a ratio of 1: 1 to receive two doses, 21-day,
placebo or BNT162b2 vaccine in a continuous international investigation with placebo-controlled,
blinded observers. (30 g in each dose). BNT162b2 is a nucleoside-modified RNA synthesized from
lipid nanoparticles that bind to a previously powerful spike protein, with membrane-anchored SARS-
CoV-2 for the full-length spike. The efficiency and safety of the Covid-19 laboratory-certified
vaccination were the key findings. (Polack, 2020)
Figure 1, Vaccine Efficacy of 95 percent (95 percent credible interval, 90.3-97.6 percent), (Polack, 2020)

In a continuous, placebo-controlled, blind, blind, international, randomized study, we randomly

assigned 44,165 participants aged 16 or over and 2264 12- to 15-year-olds to receive two doses of
30- μg, 21 days apart., of BNT162b2 or placebo. (Thomas, 2021) The endpoint of the trial was the
effectiveness of the vaccine against laboratory-safe and Covid-19, which was analyzed every 6
months after vaccination.

Participants were randomly randomized to receive two 30-g intramuscular injections of BNT162b2
(volume 0.3 ml per dose) or placebo saline, 21 days apart, in a 1: 1 dosage. (Thomas, 2021) Web-
based interactive software is used for randomization. Participants 16 years of age and older who
were eligible for Covid-19 vaccination based on national or local guidelines were given the option to
learn their experimental work as of December 2020, when BNT162b2 was received under
emergency or conditional use authorization. BNT162b2 was given to those who were randomly
assigned to receive a placebo. Participants were monitored during an open-label experiment once
the group assignments were not bound. (Thomas, 2021)
Figure 2, The SARS-CoV-2 virus's structure. Membrane protein (M). Nucleocapsid (N) Nucleocapsid (N) Nucleocapsid (capsid
protein & RNA). Spike protein (S). Lipid bilayer (L), (P. Anand et al., 2021)

Figure 3, Mechanism of COVID-19 mRNA immunization. The mRNA vaccination is administered intramuscularly, most
commonly into the deltoid muscle. The vaccination can enter the cell's cytosol thanks to the lipid coat vehicle surrounding
the mRNA. The mRNA is translated into spike proteins by the ribosomes. The injected mRNA degrades over time. The cell
releases spike proteins, which trigger an adaptive immune response. Immune cells mount cell-mediated and antibody-
mediated immunity against the SARS spike protein via multiple activation pathways. -Virus CoV-2, (P. Anand et al., 2021)

Ethical Procedures
Requested localized, specific, systemic events, and use of antipyretic drugs or pain within the first 7
days after receiving each vaccine or placebo dose, as documented in an electronic diary; unsolicited
adverse events after receiving the first dose 1 month after the second dose; and severe adverse
events after receiving the first dose 1 and 6 months after the second dose, as documented in an
electronic diary. Blind tracking and label opening timings are used to convey security data. (Thomas,
2021)

Common Side Effects

Since the publishing of this research, phase 3 clinical studies of both the Moderna and Pfizer/
BioNTech mRNA vaccines have found no notable negative effects (Polack, 2020) (Baden LR et al.,
2021). Vaccines cause higher local adverse effects, such as fever, discomfort, redness, and
inflammation, than placebo (common salt) (Polack, 2020) (Baden LR et al., 2021). Other systemic
adverse effects, such as fatigue, fever, headache, myalgias, and arthralgias, are more common with
the vaccine than with placebo, with the majority occurring 1 to 2 days after immunization (Polack,
2020) (Baden LR et al., 2021). In both trials, Hypersensitivity side effects were recorded equally in
the placebo and immunization groups (Castells MC et al., 2021). As previously reported, two doses of
mRNA vaccine provided 94-95 percent protection in COVID-19 for people aged 16 and up after two
months. When compared to other viral vaccines, the vaccine is safe. (Polack, 2020) (Baden LR et al.,
2021)

Local Reaction
Preliminary experiments using mRNA vaccines against COVID-19 found that vaccine recipients had a
better local response than the placebo control group (Polack, 2020) (Baden LR et al., 2021). Within
one week of immunization, the most common local reaction was soreness at the injection site. The
majority of local reactions were mild to moderate in intensity and persisted between 24 and 48
hours (Polack, 2020) (Baden LR et al., 2021). Less than 1% of participants in all age groups reported
severe pain, and pain of any sort was increasingly recorded with participants over the age of 55.
(Polack, 2020) (Baden LR et al., 2021)

Systematic Reaction
Younger insurance recipients (ages 16 to 55) reported system occurrences more frequently than
their older counterparts (above 55 years of age) in the same research (Polack, 2020) (Baden LR et al.,
2021). This increased rate of systemic occurrences could indicate that young people have a higher
immune response than adults. When compared to the first dose, the second dose of the vaccine
resulted in more adverse effects (Polack, 2020) (Baden LR et al., 2021). Fatigue and headaches were
the most common side effects after the second dose. However, the same side effects were also
recorded in a substantial number of placebo-controlled patients. (Polack, 2020) (Baden LR et al.,
2021)

Systemic adverse effects were reported at a rate of less than 1% after the first dosage and fewer
than 2% after the second dose, with fatigue (3.8%) and headache (2.0%) being the most common
(Polack, 2020) (Baden LR et al., 2021). Only 0.2 percent of vaccination users and 0.1 percent of
placebo receivers developed a fever of up to 40 degrees Celsius after the first dose. 0.8 percent of
vaccination recipients and 0.1 percent of placebo receivers relapsed to 40 ° C after the second dose.
In both the vaccination and placebo groups, two people experienced temperatures above 40 ° C.
Systemic events such as colds and flu disappeared within 24 to 48 hours of vaccination. (Polack,
2020) (Baden LR et al., 2021)
Timelines

Vaccination is only effective if the vaccine is developed into a product that is approved for use and
distributed to the intended population. The development of vaccines is a step-by-step, pyramidal,
and selective process. 5 Human immunisation testing start phase I, which assesses the safety, dose,
and immunity in a limited number of healthy individuals, if preliminary laboratory studies (cell lines
and experimental animals) agree. Only a small percentage of vaccine candidates make it to phase II
testing, which is used to determine the right composition, dose quantities, and intervals. Hundreds
to thousands of people are needed for these examinations. Phase III vaccination trials assess the
efficacy and safety of clinical immunisation. The scale of their study is determined by the predicted
number of patients, which is frequently in the thousands.

Generally, progress in all stages of the trial lasts at least ten years. The severity of the COVID-19
epidemic, on the other hand, has resulted in financing for the creation of "rapid epidemic vaccines"
by running other processes in parallel (see Figure 1). 4 Many research used phase I and phase II
trials, while a few used a combination of phase II and III trials to hide time frames. This did not
jeopardise science's credibility because safety, fitness, and performance findings were rigorously
validated, and safety monitoring will continue even after enrolment.

Table 1, Demographic Characteristics of the Participants, (Thomas, 2021)

Figure 4, Screening, Randomization, and Follow-up, (Thomas, 2021)