Johnson & Johnson Vaccine Clears Major Step for US Authorization

Is good news allowed on the web?

Wednesday, the staff at the Food and Drug Administration endorsed Johnson & Johnson’s single-shot COVID-19 vaccine for emergency use, a critical step toward the U.S. authorizing a third vaccine.

The report is meant to brief the FDA’s Vaccines and Related Biological Products Advisory Committee before its Friday meeting to review J&J’s request for emergency use.

While the FDA doesn’t have to follow the committee’s recommendation, it usually does. The FDA authorized both Pfizer and Moderna just one day after the committee's recommendation.

J&J's vaccine has been of significant interest as it requires just one dose, compared to two for Pfizer and Moderna. In addition, J&J has planned to ship the vaccine at 36 to 46 degrees Fahrenheit, differing greatly from Pfizer's vaccine, which is stored in super freezers that kept between -112 and -76 degrees. Moderna has shipped its vaccine in temperatures between -13 and 5 degrees.

J&J's overall level of protection does, however, trail both Moderna and Pfizer. According to the data J&J released on Feb. 4, J&J's single-shot coronavirus vaccine is 66% effective overall but varied by region, recording 72% in the United States and just 57% in South Africa. The company says -- and this is key -- the shot has prevented 100% of hospitalizations and deaths.

Though J&J's numbers are not as promising as Pfizer's 95% and Moderna’s 94%, infectious disease experts say J&J’s numbers can’t be used as a direct comparison to the other two because the company’s trial was conducted when there were more infections and newer, more contagious variants. Plus, of course, it requires one fewer shot.

It has been a long, hard, emotional past 12 months. We are getting through this. Normalcy is within distance.