Categories
Change Password!
Reset Password!
In
the fight against the deadly pandemic, a vaccine has been granted FDA approval
to prevent COVID-19.
As per the notification published on 23 August 2021, the United States Food and Drug Administration (US-FDA) has approved the first COVID-19 vaccine for preventing coronavirus disease in people 16 years of age and older. For people 12-15 years of age and for administration of 3rd dose in some immunocompromised people, this vaccine continues to be available under emergency use authorization (EUA).
Since 11 December 2020, this vaccine containing messenger RNA (mRNA, a kind of genetic material) was available under EUA in people 16 years of age and more, and the approval was extended to incorporate people 12-15 years of age on 10 May 2021. The mRNA present in the vaccine is utilized by the body to produce a mimic of one of the viral proteins that cause SARS-CoV-2 infection. The immune system of a person receiving the vaccine reacts defensively to the coronavirus.
The presence of vaccine's mRNA in the body is only for a short period of time. It is neither incorporated nor does it change a person’s genetic material. This COVID-19 vaccine is given as a series of 2 doses, 3 weeks apart and has similar formulation as EUA vaccine. On the basis of efficacy and safety data from an ongoing randomized, controlled, blinded trial of thousands of participants, the first EUA was issued on 11 December for the vaccine for individuals 16 years of age and older.
Notably, FDA reviewed the updated data from the trial that favored EUA and incorporated a longer duration of follow-up in a bigger trial population. In the FDA’s review for approval, the efficacy data was examined from about 20,000 vaccine and 20,000 placebo-treated participants aged 16 years and older who didn't have evidence of SARS-CoV-2 disease within one week of getting the 2nd dose.
The vaccine's safety was examined in about 22,000 participants who were given the vaccine and 22,000 participants who were given a placebo 16 years of age and older. The findings from the clinical trial revealed that the vaccine was 91% effective for prevention of coronavirus infection. Following the 2nd dose, greater than half of the trial subjects were monitored for safety outcomes for at least 4 months. In total, 12000 recipients have been monitored for at least six months. Headache, fever, redness, chills, pain, fatigue, joint or muscle pain, and swelling at the site of injection were frequently reported treatment-emergent adverse effects. The vaccine is efficacious to prevent coronavirus disease and potentially severe outcomes, including hospitalization and mortality.
Furthermore, the FDA carried out a meticulous assessment of the post-authorization safety surveillance data with respect to pericarditis and myocarditis after vaccine administration and has demonstrated that the data shows elevated risks, specifically within 7 days after the 2nd dose. The reported risk is more among men under 40 years of age in comparison with women and older males. The reported risk is greatest in males 12-17 years of age.
The
available data from short-term follow-up imply that the symptoms resolved in
most of the people. But, some people needed intensive care support. There is a
paucity of information about the potential long-term health outcomes. In
future, a pregnancy registry study might be performed for assessing pregnancy
and infant outcomes after receiving the vaccine during pregnancy.
US-FDA
FDA Approves First COVID-19 Vaccine
Comments (0)