FDA Approves J&J Vaccine for Emergency Use
On Wednesday, Johnson & Johnson's single-dose COVID-19 vaccine was given emergency use authorization by the FDA, according to Politico.
The US Food and Drug Administration stated that the vaccine appears safe and effective. The vaccine is 66 percent effective against COVID-19 but less effective against the strain found in South Africa.
Data from the briefing showed the shot was very effective in preventing severe disease and death. For the vaccine group testing period, none of the candidates were hospitalized 28 days after inoculation.
The shot is not as effective with older individuals. Individuals over the age of 60 with health risks only received 42.3 percent prevention against COVID-19. This value falls below the FDA's 50 percent floor for authorization. However, Johnson & Johnson claims the data for this group was limited so there was uncertainty about the effectiveness.
There were minimal side effects reported by individuals that participated in the trial. They reported injection site pain, headaches, and fatigue. There were several cases of blood clotting as well, but not very often. The FDA said it “will recommend surveillance for further evaluation of thromboembolic events with deployment of the vaccine into larger populations.”