FDA PANEL RECOMMENDS EMERGENCY USE OF J&J VACCINE
The Food and Drug Administration's vaccine committee on Friday recommended Johnson & Johnson's coronavirus vaccine, one of the final steps in approving it for emergency use in the United States, United Press International (UPI) reported.
The FDA's Vaccines and Related Biological Products Advisory Committee voted unanimously to recommend that the FDA grant emergency use authorization (EUA) for the vaccine. The FDA must make a final determination before granting the EUA and distributing it for use.
The Centers for Disease Control and Prevention must also give its approval before shots can start going into arms. The vaccine would be the third approved and distributed nationally.
An FDA analysis on Wednesday confirmed the vaccine's effectiveness, which was shown in clinical trials to be about 66% effective for all human volunteers in the United States, Latin America and South Africa. It was shown to be 85% effective in preventing severe COVID-19.
The available vaccines from Pfizer and Moderna went through this process in mid-December. Johnson & Johnson's vaccine is different from the other two, in that it is adenovirus-based as opposed to messenger RNA (mRNA), like those from Pfizer and Moderna. Also, it is a one-shot vaccine, without a need for a booster and can be stored and transported at much warmer temperatures than the other two formulations.