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FDA grants Ad26 vaccine COVID-19 as Emergency
Use Authorization for COVID-19 prevention.
Recently, the third vaccine (produced via a particular type of virus- adenovirus type 26 (Ad26)) for COVID-19 prevention was FDA approved on February 27, 2021.
After the EUA has allowed the distribution of this vaccine in the U.S., its availability has been expanded to combat against this COVID pandemic.
Till now, the FDA has authorized 3 COVID-19 vaccines given the exigency of the pandemic situation, abiding the standards for efficacy and safety, and manufacturing quality supporting its emergency use authorization. As per the existing data, the known and probable advantages of the vaccine was found to surpass its known and probable risks, supporting its use in people aged 18 years and above.
The vaccine works by transferring a component of the DNA or genetic material, responsible to make particular “spike” protein of the coronavirus. On receiving this vaccine, the body can briefly make the spike protein which stimulates the immune system to act defensively, thereby generating an immune response against covid virus.
The FDA's safety data evaluation considered an ongoing randomized, placebo-controlled study comprising of 43,783 participants. Out of which, 21,895 received the vaccine and 21,888 received saline placebo, with a follow-up of 8 weeks following the vaccination. Injection site pain, fatigue, muscle aches, headache and nausea were commonly described side effects of mild to moderate severity lasting for about 1 to 2 days.
As per the FDA, it is imperative for the parent company of the vaccine and vaccination providers to report the cases of serious adverse events, Multisystem Inflammatory Syndrome and COVID-19 cases leading to hospitalization or death to the Vaccine Adverse Event Reporting System (VAERS). Also, a review of all identified vaccine administration errors needs to be mentioned in the safety reports submitted monthly to the FDA.
The FDA's effectiveness data evaluation considered analysis of 39,321 patients in an ongoing randomized study. Out of the total, 19,630 received vaccine and 19,691 received placebo. The vaccine was found to be effective in almost 67% patients in preventing moderate to severe/critical COVID-19 occurring at least 14 days and 66% patients in preventing moderate to severe/critical COVID-19 at least 28 days following the vaccination.
FDA
FDA Issues Emergency Use Authorization for Third COVID-19 Vaccine
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