The Food and Drug Administration (FDA) Saturday authorized Johnson & Johnson’s *NYSE:JNJ) COVID-19 vaccine for emergency use.
J&J’s vaccine is the 3rd to be approved for use in the United States, and the 1st that requires just 1-shot.
The FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted unanimously to recommend authorizing the vaccine by Janssen, a division of Johnson & Johnson, Friday. The committee provides expert advice to the FDA but does not have final say on approval.
“The authorization of this vaccine expands the availability of vaccines, the best medical prevention method for COVID-19, to help us in the fight against this pandemic, which has claimed over half a million lives in the United States,” said Acting FDA Commissioner Dr. Janet Woodcock Saturday.
“There’s no question that this vaccine is going to be a game-changer,” Dr. Mathai Mammen, global head of pharmaceutical research and development for Johnson & Johnson said. “The real-world effectiveness of this vaccine is apt to be very high.”
The Centers for Disease Control and Prevention (CDC) updated state and local partners on distribution plans for the vaccine on Friday, ahead of the FDA’s authorization and VRBPAC’s approval. According to a pre-decision draft and CDC talking points, the vaccine is expected to be made available for ordering this Sunday.
Johnson & Johnson announced earlier this wk it expected under 4-M doses would be ready to ship after the emergency use authorization.
Have a healthy weekend, Keep the Faith!