FDA Endorses Johnson & Johnson Single-Shot Covid-19 Vaccine

FDA Endorses Johnson & Johnson Single-Shot Covid-19 Vaccine

The FDA has officially cleared the way for a third Coronavirus vaccine in the U.S.

A third vaccine to protect against Covid-19 could be entering the marketplace after the Food and Drug Administration endorsed Johnson & Johnson’s single-shot vaccine for emergency use on February 24.

The FDA staff said the data from the Johnson & Johnson clinical trials was “consistent with the recommendation set forth in FDA’s guidance Emergency Use Authorization for Vaccines to Prevent COVID-19.”

Johnson & Johnson submitted its Covid-19 vaccine data to the FDA on Feb. 4. The vaccine’s level of protection varied by region, with the shot demonstrating 66 percent effectiveness overall, 72 percent in the United States, 66 percent in Latin American and 57 percent in South Africa (where the B.1.351 variant is rapidly spreading).

The company said the vaccine prevented 100 percent of hospitalizations and deaths. As of Feb. 5, there were seven Covid-19 deaths in the study in the placebo group and no Covid-19 related deaths in the vaccine group, according to the FDA.

The FDA staff report, where the Johnson & Johnson vaccination was endorsed, is meant to brief the FDA’s Vaccines and Related Biological Product Advisory Committee, which will meet Friday to review J&J’s request for emergency use authorization.

During similar requests by Pfizer and Moderna, the agency authorized those companies’ vaccinations one day after the committee outside medical advisors backed emergency use authorization. The committee is expected to recommend Johnson & Johnson’s vaccine.

Download Center

  • EHS Buyer's Guide

    Download this buyer's guide to make more informed decisions as you're looking for an EHS management software system for your organization.

  • Online Safety Training Buyer's Guide

    Use this handy buyer's guide to learn the basics of selecting online safety training and how to use it at your workplace.

  • COVID Return-to-Work Checklist, Fall 2021

    Use this checklist as an aid to help your organization return to work during the COVID-19 pandemic in a safe and healthy manner.

  • SDS Buyer's Guide

    Learn to make informed decisions while searching for SDS Management Software.

  • Risk Matrix Guide

    Risk matrices come in many different shapes and sizes. Understanding the components of a risk matrix will allow you and your organization to manage risk effectively.

  • Industry Safe

Featured Whitepapers

OH&S Digital Edition

  • OHS Magazine Digital Edition - September 2021

    September 2021


      Managing Combustible Dust and Risk Mitigation
      The Rising Popularity of Safety Helmets on the Jobsite
      Five Tips for a Successful Wear Trial
      Medical Surveillance Versus Medical Screening
    View This Issue