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Common Side Effects
Common Side Effects
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)
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.