The Food and Drug Administration's (FDA) staff analysis of the new Johnson and Johnson COVID-19 vaccine has emerged as positive ahead of scheduled meetings this week about whether to approve an Emergency Use Authorization (EUA) in the United States. EUA approval is expected as early as next week, pending meeting outcomes.

Johnson and Johnson applied for an EUA on Feb. 4, and FDA staff has been reviewing the data. The release of the analysis comes ahead of a Vaccines and Related Biological Products Advisory Committee meeting on Friday. Once the committee meets, it will discuss and provide recommendations on whether the vaccine’s benefits outweigh its risk in patients aged 18 or older. If approved, the FDA will release additional information, and the Advisory Committee on Immunization Practices (ACIP) at the Centers for Disease Control and Prevention (CDC) will weigh in on recommendations.

Johnson and Johnsons’ vaccine represents an option with a less demanding supply chain as the nation continues to amplify mass immunization. It is the first one-dose vaccine and can remain stable for two years at -20°C (-4°F) and for three months when stored in most standard refrigerators 2°-8°C (36°F–46°F). It is supplied in a multidose (five doses) vial that does not contain a preservative.

In the primary analysis of nearly 40,000 participants, the vaccine demonstrated a vaccine efficacy of 67 percent for the prevention of moderate to severe/critical COVID-19 occurring 14 days after vaccination and 66 percent for the prevention of cases occurring at least 28 days after vaccination.

Common side effects generally resolved within one to two days and included:
  • Injection site pain (49 percent)
  • Headache (39 percent)
  • Fatigue (38 percent)
  • Myalgia (33 percent)

There were more frequent, generally mild to moderate reactogenicity in participants aged 18-59 than in those over 60. More serious adverse events were not able to be attributed to the vaccine at this time.