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Johnson & Johnson requests emergency authorization from FDA

Johnson & Johnson requests emergency authorization from FDA

February 5, 2021: Johnson & Johnson applied for an emergency use authorization from the Food and Drug Administration for its vaccine against the coronavirus disease after releasing data last week, which shows it was about 66% effective in giving protection.

If J&J’s application gets approved, it would be the third coronavirus vaccine authorized for emergency use in the U.S., apart from the Pfizer-BioNTech and Moderna.

Submission for Emergency Use Authorization of our COVID-19 vaccine is a pivotal step toward reducing the disease for people globally and ending the pandemic. We are ready to begin shipping, J&J’s chief scientific officer, Dr. Paul Stoffels, said.

The FDA scheduled a meeting of its Vaccines and Related Biological Products Advisory Committee to discuss the emergency use on February 26.

U.S. officials and Wall Street analysts eagerly anticipate J&J’s vaccine’s authorization, which could happen by this month.

 Pfizer’s and Moderna’s vaccines require two doses given about three to four weeks apart, whereas J&J’s medication only requires one amount, easing logistics for health-care providers.

According to J&J, the vaccine was 66% effective in protecting against Covid-19 overall. The vaccine appeared to be less effective against other variants.

Infectious disease experts say that J&J’s numbers can’t be used directly compared to Pfizer’s and Moderna’s vaccines, found to be 95% and 94% effective, respectively.

The most crucial finding of the J&J data was the vaccine appeared to be 85% effective in preventing severe disease, said Dr. Anthony Fauci.

The FDA indicated that it would authorize a vaccine that’s safe and at least 50% effective.

By comparison, the flu vaccine reduces people’s risk of getting influenza by 40% to 60% compared with people who aren’t vaccinated, the Centers for Disease Control and Prevention said.

J&J has said it plans to ship the vaccine at 36 to 46 degrees Fahrenheit. In contrast, Pfizer’s vaccine needs to be in ultra-cold freezers amid negative 112 and negative 76 degrees Fahrenheit. At the same time, Moderna’s vaccine should be shipped at between negative 13- and 5-degrees Fahrenheit.