New Johnson & Johnson single-shot vaccine deemed ‘safe and effective’ by FDA, doses expected to be distributed beginning next week

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The U.S. Food and Drug Administration released a statement on February 24 describing Johnson & Johnson’s single-shot COVID-19 vaccine as “safe and effective.” Following pending emergency use authorization (EUA) from the FDA on Friday, the United States is anticipated to make between three to four million doses of the new COVID-19 vaccine available sometime next week.

How effective is the new vaccine? According to the FDA’s briefing document, during Johnson & Johnson’s phase 3 clinical trial involving 44,000 people the shot was found to be 66.9 percent effective against moderate to severe/critical COVID-19 cases 14 days following the injection, and 66.1 percent effective after 28 days. Against severe/critical cases, the vaccine was 76.7 percent effective after 14 days and 85.4 percent effective after 28 days.

How is this vaccine different from the Moderna and Pfizer vaccines?

  • Unlike the Moderna and Pfizer vaccines, which are the only vaccines to receive EUAs in the U.S., the Johnson & Johnson vaccine is administered in one dose and doesn’t need to be stored frozen—meaning it’s far simpler to store and distribute.
  • The Johnson & Johnson vaccine works differently than the Pfizer and Moderna options, which both use single-stranded RNA. In this new vaccine, researchers added a piece of genetic material from the coronavirus’ spike protein (the part that attaches to human cells) into an adenovirus, which is modified so it has the ability to enter cells but not reproduce inside of them and cause illness. Adenoviruses are very common and produce cold-like symptoms in humans. Once the adenovirus enters a cell's nucleus, the spike protein gene is read by the cell, and it’s then copied into messenger RNA and helps the body mount an immune response to the spike protein.

It’s not yet known how many doses of the new vaccine will be sent to Utah. In speaking about the 20 million doses of the new vaccine that will hopefully be made available in the U.S. by the end of March, Utah Governor Spencer Cox remarked on Twitter, “Remember, this is a one shot vaccine, so the equivalent of 40 million Pfizer/Moderna doses. Also, Pfizer and Moderna have delivered around 80 million doses so far and will deliver a total of 200 million by end of March!”

More information about the new vaccine will soon be made available on Intermountain’s COVID-19 vaccine web page intermountain.com/covidvaccine.