[약업신문]J&J corona vaccine candidate FDA’emergency use approval’

The FDA has made a decision to approve emergency use (EUS) on the 27th of the third’Corona 19′ vaccine.

Johnson & Johnson’s’Jansen COVID-19 Vaccine’ has been decided to’emergency use’ so that the’Corona 19′ vaccine, which is used in a single vaccination method to adults 18 years of age or older, can be supplied in the United States.

The FDA concluded an unusually rapid conclusion the next day after the affiliated Vaccine and Biological Products Advisory Committee (VRBPAC) presented the results of a review recommending’emergency use approval’.

FDA’s acting chief executive Janet Woodcock said, “As a decision was made to expand this new vaccine by adding it to the list of available vaccines, the best way to medically prevent’Corona 19,’ It will help us to unfold the battle against the current pandemic situation that has taken our lives.”

“The FDA has gone through an open and transparent scientific review process and has now approved three’Corona 19′ vaccines to be used quickly in pandemic situations,” said Woodcock’s acting chief executive officer. We applied the stringent standards of efficacy, safety and manufacturing quality required to support’approval for use’.”

The FDA made this decision based on the judgment that the Janssen COVID-19 vaccine had met the legal criteria necessary to make a decision to approve emergency use.

Judging from the overall data submitted, it was judged that the Janssen COVID-19 vaccine was clearly proven to be effective in preventing’Corona 19′ infection.

The FDA also supports the request by Johnson & Johnson for use in persons 18 years of age and older, as the known potential effectiveness of the Janssen COVID-19 vaccine outweighs the known potential risk of this vaccine, based on these data. I evaluated that there is.

In making this decision, the FDA added that it can assure the general public and the medical community that it has undergone a thorough evaluation of information on efficacy, safety and manufacturing quality.

The Janssen COVID-19 vaccine is made using a specific type of virus called adenovirus type 26 (Ad26).

The vaccine used this Ad26 to deliver a portion of the DNA or genetic material used to produce the unique dendritic protein of the SARS-CoV-2 virus.

Adenovirus belongs to a relatively rare virus group, but Ad26, which can cause cold symptoms and conjunctivitis, has undergone genetic modification to be applied to the Janssen COVID-19 vaccine. Does not cause

Accordingly, after inoculation of this vaccine, dendritic proteins are temporarily produced in the body, but without leading to an outbreak, the immune system acquires a protective response and an immune response corresponding to SARS-CoV-2 appears.

“After careful analysis of the data by scientists and doctors affiliated with FDA, the vaccine meets the efficacy and safety standards appropriate to the FDA’s’emergency approval’ requirements,” said Peter Max, director of the FDA Center for Biologics Evaluation and Research (CBER). “Today’s decision allows us to add an Eh single vaccine to a medical toolbox for unfolding the fight against the coronavirus,” he said.

In addition, he added that Americans will be able to ensure that the FDA is committed to public health through a comprehensive and rigorous evaluation of the data submitted regarding the vaccines against COVID-19.