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FDA Authorizes J&J COVID Vaccine After Unanimous Vote

The US Food and Drug Administration on Saturday evening granted emergency use authorization for Johnson & Johnson’s COVID-19 vaccine. The vaccine is the third authorized in the US and the first to require only a single shot, which can be shipped at refrigerator temperatures.

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“The authorization of this vaccine expands the availability of vaccines, the best medical prevention method for COVID-19, to help us in the fight against this pandemic, which has claimed over half a million lives in the United States,” acting FDA Commissioner Janet Woodcock said in an announcement.The vaccine uses a non-replicating adenovirus (Ad26)—a type of virus that causes common colds—to deliver the genetic blueprints of the SARS-CoV-2 spike protein to cells. The FDA authorized it for use in people ages 18 and older.“After a thorough analysis of the data, the FDA’s scientists and physicians have determined that the vaccine meets the FDA’s expectations for safety and effectiveness appropriate for the authorization of a vaccine for emergency use,” Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said. “With today’s authorization, we are adding another vaccine in our medical toolbox to fight this virus. At the same time, the American people can be assured of the FDA’s unwavering commitment to public health through our comprehensive and rigorous evaluation of the data submitted for vaccines to prevent COVID-19.”


Post time: 08-22-2022