[약업신문]J&J Corona Vaccine Candidate Recommendation FDA Advisory Committee Approval

Johnson & Johnson has applied for’Emergency Use Approval’ (EUA) of the’Corona 19′ vaccine candidate developed by the Janssen Pharmaceutical Company, a subsidiary of its company, for one dose inoculation to adults over 18 years of age. In connection with this, the FDA Vaccine and Biological Products Advisory Committee (VRBPAC) announced on the 26th that it recommended EUA with unanimous agreement.

The FDA Vaccine and Biological Products Advisory Committee drew the conclusion of the EUA recommendation based on the entire scientific evidence submitted by Janssen Pharmaceutical Company, including efficacy and safety data obtained in the phase 3 clinical’ENSEMBLE test’.

The EUA application for Johnson & Johnson’s’Corona 19′ vaccine candidate was submitted to the FDA in early February.

Johnson & Johnson’s Vice Chairman and Chief Academic Officer of the Board of Directors Paul Stoffels said to the members of the FDA Vaccine and Biological Products Advisory Committee, who have extensively reviewed the data supporting the urgent use of our single-dose vaccine candidates “Our’Corona 19′ vaccine candidate has the potential to help change the trajectory of the current pandemic, and will be used to protect the general public in the near future. Johnson & Johnson believes that they will be able to do so.”

As the Vaccine and Biological Products Advisory Committee published the results of the approval recommendation, only the final procedure for deciding whether the FDA will approve the EUA of this’Corona 19′ vaccine candidate remains.

The decision of the Vaccine and Biological Products Advisory Committee to recommend approval does not necessarily have the binding force that FDA must take over and draw a conclusion.

The EUA is responsible for diagnosing, treating, or treating serious or life-threatening diseases during the period of a public health emergency being declared in relation to a medical product that has not yet been approved by FDA or the unauthorized use of a licensed medical product. It is a system that allows it to be used urgently for prevention.

Once the FDA makes a decision, the CDC’s Vaccination Advisory Committee (ACIP) recommends and supplies the vaccine using Johnson & Johnson’s’Corona 19′ vaccine candidate.

Matthew Mamen, Global CEO of Janssen Research & Development, a subsidiary of Johnson & Johnson, said, “Clinical trial subjects, researchers and research teams belonging to clinical trial institutions, and various alliances, and we have been working hard until we can meet this important moment. I would like to express my gratitude to all those who have contributed to ensuring that the data we have released today, including those who have worked hard, to ensure that the data we have released today are secured in abundance.” “It’s our conviction that it can have a profound effect on doing things.”

Johnson & Johnson is focusing their efforts on ensuring that its’Corona 19′ vaccine candidate can be used urgently as a non-profit in a pandemic situation.

As a result, we are prepared to ensure that vaccines can be supplied as soon as EUA is approved.

Johnson & Johnson forecasted that the company’s single-dose vaccine candidates for’Corona 19′ could be supplied to more than 20 million people in the United States with sufficient supply by the end of March.

In addition, in the first half of this year, the company plans to supply 100 million doses of this single dose of’Corona 19′ vaccine to the United States.

Meanwhile, in February, Johnson & Johnson submitted an application for conditional approval of this’Corona 19′ vaccine candidate to the European Medicines Supervisory Service (EMA), so that it can be listed on the Emergency Use List (EUL) of the World Health Organization (WHO). I have submitted the requested application.

In addition, applications for sequential screening of candidates for the’Corona 19′ vaccine for this single vaccination are in progress in countries around the world.