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FDA: Johnson & Johnson shot safe and effective, awaits approval

FILE - This Dec. 2, 2020 photo provided by Johnson & Johnson shows vials of the Janssen COVID-19 vaccine in the United States. (Johnson & Johnson via AP)

    (CNN) — In an analysis released Wednesday, the US Food and Drug Administration said the Johnson & Johnson Covid-19 vaccine has met the requirements for emergency use authorization.

The efficacy of the Johnson & Johnson vaccine against moderate to severe/critical Covid-19 across all geographic areas was 66.9% at least 14 days after the single-dose vaccination and 66.1% at least 28 days after vaccination, a new analysis meant to brief the FDA’s Vaccines and Related Biological Products Advisory Committee said.

“There were no specific safety concerns identified in subgroup analyses by age, race, ethnicity, medical comorbidities, or prior SARS-CoV-2 infection,” the analysis said.

In a briefing document, the FDA said that it has reviewed the data for the vaccine and has determined that it is “consistent with the recommendations set forth in FDA’s guidance Emergency Use Authorization for Vaccines to Prevent COVID-19.”

An independent group of FDA advisers, the Vaccines and related Biological Products Advisory Committee, will consider the documents and make a recommendation about whether the Covid-19 vaccination should be authorized. The committee meets on Friday.

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How To Prevent the Spread of COVID-19 Coronavirus

COVID-19 coronaviruses transmitted from person to person. It is a virus that is similar to the common cold and the flu. So, to prevent it from spreading:

  • Wash hands frequently and thoroughly, with soap and water, for at least 20 seconds.
  • Wear a mask.
  • Don’t touch your face.
  • Keep children and those with compromised immune systems away from someone who is coughing or sneezing (in this instance, at least six feet)
  • If there is an outbreak near you, practice social distancing (stay at home, instead of going to the movies, sports events, or other activities.)
  • Get a flu shot.

Local resources

KSL Coronavirus Q&A

Utah’s Coronavirus Information

Utah State Board of Education

Utah Hospital Association

The Church of Jesus Christ of Latter-day Saints

Utah Coronavirus Information Line – 1-800-456-7707

National Resources

Centers for Disease Control and Prevention

Commonly asked questions, World Health Organization

Cases in the United States

 

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