The Food and Drug Administration reported Wednesday that Johnson & Johnson’s single-dose vaccine to protect against COVID-19 was safe and 72% efficacious in the United States, setting it up for a quick authorization process in the coming days.
The FDA’s 62-page report showed that the single-shot vaccine developed by Johnson & Johnson-owned Janssen Pharmaceutical had an efficacy rate of 72% in its U.S.-based trial and 66% overall across three regions where the shot was tested. The vaccine is also 85% effective overall at preventing hospitalization and 100% effective at preventing death due to COVID-19.
The report’s authors also concluded that the shot has a “favorable safety profile with no specific safety concerns identified that would preclude issuance of an [Emergency use authorization].” The FDA’s panel of vaccine experts will meet for an all-day meeting on Friday to determine whether the vaccine should be authorized for public use.
The clinical trial also enrolled subjects in two other regions — South Africa and Latin America — where efficacy rates differed slightly. Still, the FDA review found that efficacy against severe cases of COVID-19 “was similarly high across the United States, South Africa, and Brazil.”
Vaccine experts at the FDA attributed the disparate rates to the different coronavirus variants circulating across those regions. In fact, the efficacy rate reported in the South Africa-based study was determined to be higher in Wednesday’s report than it was in the company’s January results, at 64% compared to 57%. This is good news for South Africa, which is currently dealing with a highly contagious variant.
A single shot of the Johnson & Johnson vaccine provides its full level of protection, whereas the Moderna and Pfizer vaccines require two shots spaced 28 and 21 days apart, respectively. It is also easier to ship and store than the Pfizer vaccine, which requires a freezer at temperatures between minus 112 to minus 76 degrees Fahrenheit. Johnson & Johnson’s shot, meanwhile, can be stored for at least three months at 36 to 46 degrees Fahrenheit.
The addition of a single-dose vaccine would be a boon to the Biden administration’s efforts to accelerate immunizations. So far, about 65 million doses of Pfizer or Moderna’s vaccines have been administered in the U.S., with an average immunization rate of about 1.3 million shots per day.
Johnson & Johnson is prepared to ship out 20 million doses of its vaccine “assuming necessary regulatory approvals relating to our manufacturing processes.” The company’s goal is to ship out enough shots to immunize 20 million people by the end of March.
JOHNSON & JOHNSON PREPARED TO SHIP OUT 20M COVID-19 VACCINES AS IT NEARS FDA AUTHORIZATION
The shot could be granted the emergency use authorization as early as this weekend, just as the FDA granted authorization to the Pfizer and Moderna vaccines almost immediately after past vaccine panel deliberations.
