NEW YORK -- The Food and Drug Administration (FDA) said Wednesday that Johnson & Johnson's single-dose Covid-19 vaccine has met the efficacy and safety requirements to receive an emergency authorization for use in the United States, where the virus has claimed more than 500,000 lives.
On Friday, the independent experts on the FDA's Vaccines and Related Biological Products Advisory Committee will review the analysis and render a judgment.
If the panel signs off and the FDA approves the drug, the US Centers for Disease Control and Prevention Advisory Committee on Immunization Practices will address the details of delivering and administering the vaccine during an emergency meeting set for Feb. 28-March 1.
The Johnson & Johnson drug would be the third vaccine authorized for use in the US, joining the Pfizer/BioNTech and Moderna medications.
Besides leading the world in coronavirus deaths, the US also has the largest number of confirmed cases: 28.3 million.
The US has more than 28 million confirmed cases of Covid-19 Johnson & Johnson said late last month that its prospective Covid-19 vaccine has proven 66 percent effective in protecting against moderate to severe coronavirus and 85 percent effective in preventing cases requiring hospitalization.
Those findings emerged from a Phase 3 ENSEMBLE clinical trial including 43,783 participants in the US, South Africa and several Latin American countries.
The level of protection against moderate to severe Covid-19 infection varied by region: 72 percent in the US; 66 percent in Latin America; and 57 percent in South Africa, where a more dangerous variant of the virus has taken hold "Vaccine efficacy against central laboratory-confirmed moderate to severe/critical COVID-19 across all geographic areas in which the trial was conducted was 66.9 percent," the FDA said in the analysis released Wednesday.
Though the Johnson & Johnson medication more than meets the minimum standards for effectiveness set by the FDA, it falls short of the 90 percent efficacy achieved by the Pfizer/BioNTech and Moderna vaccines.
But the vaccine candidate developed by J&J's Janssen Pharmaceutical Companies has significant advantages over the Pfizer and Moderna drugs.
While the Pfizer and Moderna medications are two-dose vaccines and the former must be maintained at a super-low temperature, posing a logistical challenge, J&J said that the single-dose Janssen vaccine is "compatible with standard vaccine distribution channels."