FDA issues third emergency use authorization for new crown vaccine

Today, the US FDA issued the third emergency use authorization (EUA) for the new coronavirus vaccine to prevent the new coronavirus pneumonia (COVID-19) caused by severe acute respiratory syndrome coronavirus type 2 (SARS-CoV-2) 18 Individuals aged and over.

FDA's evaluation of the vaccine's existing safety data

Johnson & Johnson's new crown vaccine (Ad26.

As part of the EUA, the FDA stated that Johnson & Johnson and vaccination providers must report the following events to the Vaccine Adverse Event Reporting System (VAERS): serious adverse events, cases of multi-system inflammatory syndrome, and COVID-19 cases that lead to hospitalization or death.

FDA's evaluation of the vaccine's existing effectiveness data

The data supporting the effectiveness of EUA includes randomized, placebo-controlled studies that are being conducted in South Africa, certain countries in South America, Mexico, and the United States that have no previous evidence of SARS-CoV-2 infection.

▲Cumulative curve of the number of COVID-19 patients in the vaccine group and the control group

Johnson & Johnson's new coronavirus vaccine uses a vector called adenovirus type 26 (Ad26) to express the unique "spike" protein of the new coronavirus.

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It is worth mentioning that Johnson & Johnson previously stated that if it obtains an EUA granted by the FDA, it is expected to produce 20 million doses of vaccine by the end of March and 100 million doses by the end of the second quarter.

Reference materials:

[1] FDA Issues Emergency Use Authorization for Third COVID-19 Vaccine.