FDA analysis finds Johnson & Johnson COVID vaccine is safe and effective
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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.
