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FDA Analysis Finds Johnson & Johnson’s COVID Vaccine Safe and Effective

Food and Drug Administration staff released a backgrounder on Wednesday approving Johnson & Johnson’s one-shot coronavirus vaccine as safe and effective.

The last: Assuming the FDA issues an emergency use authorization “without delay,” which means as early as this weekend, White House coronavirus coordinator Jeff Zients said J&J would have 3-4 million dollars ready for distribution next week.

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And after: An FDA advisory committee will meet on Friday to review the backgrounder and vote on whether to recommend an emergency use authorization (EUA). The FDA will then decide whether or not to accept the recommendation and issue the EUA, paving the way for distribution in the United States.

Details: The vaccine was found to be 66.9% effective against moderate to severe / critical COVID-19 cases 14 days after vaccination and 66.1% after 28 days. Against severe / critical cases, the vaccine was 76.6% effective after 14 days and 85.4% effective after 28 days.

  • A large clinical trial showed no hospitalizations or deaths from COVID-19 28 days after patients received the vaccine.

  • “The analysis supported a favorable safety profile with no specific safety concerns identified that would prevent the issuance of an EUA,” wrote FDA staff.

FDA analysis also offered a breakdown of the vaccine’s effectiveness in Brazil and South Africa, where more contagious variants of the coronavirus have been dominant.

  • United States:

  • Moderate to severe / critical: 72%

  • Serious / Critical: 85.9%

  • South Africa:

  • Moderate to severe / critical: 64%

  • Serious / Critical: 81.7%

  • Brazil:

  • Moderate to severe / critical: 68.1%

  • Serious / Critical: 87.6%

Between the lines: Unlike the Moderna and Pfizer vaccines, which are the only two candidates to have received EUA, the J&J vaccine is administered in a single dose and does not need to be stored at ultra-low temperatures – which means the logistics of mass distributions would be much simpler.

The big picture: The US government has reached an agreement with J&J to deliver 100 million doses by the end of June.

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