J&J Vaccine
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The Food and Drug Administration’s staff endorsed Johnson & Johnson’s Covid-19 vaccine for emergency use, a critical step in bringing a third shot to the U.S. marketplace.
The staff report released Wednesday is meant to brief the FDA’s Vaccines and Related Biological Products 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 of outside medical advisors backed emergency use authorization. The committee is expected to recommend J&J’s vaccine. The FDA doesn’t have to follow the committee’s recommendation, but it often does.
The FDA staff said it determined that the clinical trial results and safety data were “consistent with the recommendations set forth in FDA’s guidance Emergency Use Authorization for Vaccines to Prevent COVID-19.”
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The Food and Drug Administration’s staff endorsed Johnson & Johnson’s Covid-19 vaccine for emergency use, a critical step in bringing a third shot to the U.S. marketplace.
The staff report released Wednesday is meant to brief the FDA’s Vaccines and Related Biological Products 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 of outside medical advisors backed emergency use authorization. The committee is expected to recommend J&J’s vaccine. The FDA doesn’t have to follow the committee’s recommendation, but it often does.
The FDA staff said it determined that the clinical trial results and safety data were “consistent with the recommendations set forth in FDA’s guidance Emergency Use Authorization for Vaccines to Prevent COVID-19.”
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I’ve never seen an article relating to the supply chain distribution efforts in anticipation of approval? Have we taken advantage of the UK’s approval a month ago to be truly ready to start vaccinations on Friday??
Or are all eyes on new Cruz memes?
@loki said in J&J Vaccine:
I’ve never seen an article relating to the supply chain distribution efforts in anticipation of approval? Have we taken advantage of the UK’s approval a month ago to be truly ready to start vaccinations on Friday??
Or are all eyes on new Cruz memes?
Cruz memes, silly man....
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“... Biden will announce plans Wednesday to purchase an additional 100 million doses of the single-dose Johnson & Johnson Covid-19 vaccine, giving the U.S. more than enough supply to vaccinate the entire U.S. population.”
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From the piece:
The U.S. had already secured deals for enough vaccine doses for every adult even without the addition of the J&J vaccine as of last month when the U.S. finalized a deal with Pfizer and Moderna for 200 million more coronavirus vaccine doses by the end of July. But having the agreement in place with J&J for an additional 100 million doses could help serve as a backstop should Pfizer or Moderna run into manufacturing issues.
