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Photo: Pavlo Gonchar/SOPA Images/LightRocket via Getty Images

The Food and Drug Administration's staff released a briefing document on Wednesday endorsing Johnson & Johnson's one-shot coronavirus vaccine as safe and effective.

The latest: Assuming the FDA issues an emergency use authorization "without delay," meaning as soon as this weekend, White House coronavirus coordinator Jeff Zients said J&J will have 3 million to 4 million ready for distribution next week.

What's next: An FDA advisory panel will meet Friday to review the briefing document and vote on whether to recommend an emergency use authorization (EUA). The FDA will then decide on whether to accept the recommendation and issue the EUA, clearing the way for distribution in the U.S. to begin.

Details: The shot was found to be 66.9% effective against moderate to severe/critical COVID-19 cases 14 days after vaccination, and 66.1% effective 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 COVID-19 hospitalizations or deaths 28 days after patients received the vaccine.
  • "The analysis supported a favorable safety profile with no specific safety concerns identified that would preclude issuance of an EUA," FDA staff wrote.

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

  • United States:
    • Moderate to severe/critical: 72%
    • Severe/critical: 85.9%
  • South Africa:
    • Moderate to severe/critical: 64%
    • Severe/critical: 81.7%
  • Brazil:
    • Moderate to severe/critical: 68.1%
    • Severe/critical: 87.6%

Between the lines: Unlike Moderna and Pfizer's vaccines, which are the only two candidates that have received EUAs, the J&J vaccine is administered as a single dose and does not need to be stored at ultra-low temperatures — meaning the logistics for mass distributions would be far simpler.

The big picture: The U.S. government has struck an agreement with J&J to provide 100 million doses by the end of June.

  • More than half of the J&J doses sold thus far are destined for the developing world, with 500 million doses purchased by the global COVAX initiative and 120 million by the African Union.

Go deeper

Feb 24, 2021 - Politics & Policy

In photos: Congress holds moment of silence for coronavirus victims

Congressional leadership outside of the Capitol on Feb. 23. Photo: Sarah Silbiger/Bloomberg via Getty Images

Congress held a candlelight vigil on the steps on the U.S. Capitol Tuesday evening in honor of the Americans who have died from the coronavirus.

Why it matters: The U.S. death toll from the virus passed 500,000 on Monday, just one year after the country's first COVID-19 death was confirmed.

Updated Feb 24, 2021 - Health

First COVID-19 vaccines distributed by COVAX arrive in West Africa

Photo: STR/NurPhoto via Getty Images

The first COVID-19 vaccine doses distributed by the World Health Organization’s global sharing scheme COVAX arrived in Ghana, West Africa, on Wednesday.

Why it matters: The shipments represent the "beginning of what should be the largest vaccine procurement and supply operation in history," per a joint statement from the WHO and UNICEF hailing the arrival as a "momentous occasion."

Updated 58 mins ago - Health

Lawsuit challenging Houston Methodist's COVID vaccine mandate dismissed

Houston Methodist Hospital in Houston, Texas. Photo: Brandon Bell/Getty Images

A federal judge on Saturday dismissed a lawsuit brought by 117 Houston Methodist staff over the hospital's policy requiring all employees to be vaccinated against COVID-19.

Why it matters: This is the first federal court ruling on a coronavirus vaccine mandate. Attorney Jared Woodfill, representing the plaintiffs, told KHOU 11 it's "the first battle in a long fight," as he vowed to file another lawsuit soon.