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Johnson & Johnson COVID Vaccine Safe, Effective: FDA Report

Added 02-24-21 10:04:07am EST - “According to data submitted to the agency by Johnson & Johnson on February 4, the vaccine was 66 percent effective overall.” - Nationalreview.com

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Posted By TheNewsCommenter: From Nationalreview.com: “Johnson & Johnson COVID Vaccine Safe, Effective: FDA Report | National Review”. Below is an excerpt from the article.

The Food and Drug Administration’s staff on Wednesday endorsed Johnson & Johnson’s COVID-19 vaccine for emergency use, paving the way for the single-shot vaccine’s approval.

A panel of outside advisers to the FDA will meet Friday to evaluate the vaccine and issue a recommendation on its approval for emergency-use authorization.

The FDA staff said it determined that the clinical-trial results and safety data were “consistent with the recommendations set forth in FDA’s guidance Emergency Use Authorization for Vaccines to Prevent COVID-19.”

According to data submitted to the agency by Johnson & Johnson on February 4, the vaccine was 66 percent effective overall, with variations occurring by region: 72 percent efficacy in the U.S, 66 percent in Latin America, and 57 percent in South Africa, where the B.1.351 variant is rapidly spreading.

The data show seven COVID-related deaths in the study among those in the placebo group as of February 5 and none in the vaccine group, the FDA said.

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