Johnson & Johnson approaches FDA for the approval of ; Covid-19 vaccine

▴ Johnson & Johnson approaches FDA for the approval of ; Covid-19 vaccine
J&J applies for the approval of one shot vaccine developed by the company

Johnson & Johnson on Thursday (Feb. 4) officially asked the US Food and Drug Administration for an emergency-use authorization of its COVID-19 vaccine. This would be the third vaccine in the country, joining the vaccines made by Pfizer and Moderna.

“Today’s submission for Emergency Use Authorization of our investigational single-shot Covid-19 vaccine is a pivotal step toward reducing the burden of disease for people globally and putting an end to the pandemic,” Dr. Paul Stoffels, chief scientific officer at Johnson & Johnson, said in a statement.

CNN reports that as the FDA looks at testing results from Johnson & Johnson’s vaccine, it will schedule a meeting of its Vaccines and Related Biological Products Advisory Committee.

If the FDA authorizes the vaccine, the CDC’s Advisory Committee on Immunization Practices will meet to discuss whether the vaccine should be given and if so, who should get it first.

CNN reports the Johnson & Johnson vaccine is delivered in a single shot and in a global trial, was shown to be 66 percent effective in preventing moderate to severe disease.

“The vaccine is 85% effective overall at preventing hospitalization and death in all regions where it was tested,” CNN reports.

The national news outlet says the US government has already ordered 100 million doses of the vaccine, a commitment, Johnson & Johnson said it can meet by June.

Story Source

https://www.kwch.com/2021/02/04/johnson-johnson-asks-fda-to-authorize-its-covid-19-vaccine/ 

Tags : #JohnsonJohnson #FDA #CDC #CovidVaccine #OneShotCovidVaccine #PaulStoffels #USCovidNews #CNN

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