FDA Confirms Johnson & Johnson Single-Dose Vaccine Is 66% Effective And Safe
Pharmaceutical company Johnson & Johnson’s single-dose COVID-19 vaccine has proven to be safe and considerably effective in preventing severe symptoms of the virus.
The Food and Drug Administration (FDA) released a briefing analyzing results from a Johnson & Johnson clinical trial in preparation for an independent advisory panel scheduled for Thursday. The panel will discuss if Johnson & Johnson’s vaccine should be authorized for children under 18 years old.
The FDA’s findings confirmed that the Johnson & Johnson vaccine was 66% effective in all trials against COVID-19. During the 28-day clinical trial, none of the subjects were hospitalized for COVID-19 related symptoms. Johnson & Johnson’s vaccine, however, proved 42.3% effective in people over 60 with preexisting health risks like obesity, high blood pressure, or other heart problems which is below the FDA’s requirement of 50% minimum effectiveness for authorization. The administration is expected to perform more tests; the clinical trial hosted notably fewer people with preexisting conditions.
Similar to two-dose vaccines, members of the Johnson & Johnson clinical trial reported very mild fatigue, pain at site of injection and headaches in the days after the vaccine was administered. One subject required surgery for blood clots, which appeared days after the vaccine’s injection. Johnson & Johnson has since commented that the clotting is not related to the vaccine, instead saying the rate clots occurred in the trial matches the rate of the general population. In their brief, the FDA wrote it “will recommend surveillance for further evaluation of thrombolytic events with deployment of the vaccine into larger populations.”
Thursday’s panel will also likely decide the timeline for roll out of Johnson & Johnson’s vaccine.