Tipsheet

Johnson & Johnson Vaccine Gets Thumbs Up from FDA Staff

Staff for the U.S. Food and Drug Administration found that the Johnson & Johnson coronavirus vaccine is safe and effective, meaning it may soon be the third vaccine to get the agency's approval. What makes this news stand out is that unlike the vaccines from Pfizer-BioNTech and Moderna, the Johnson & Johnson vaccine requires only a single dose.

While the Johnson & Johnson jab showed 66% effectiveness overall as opposed to the other vaccines, which have efficacy rates in the 90s, the company notes that their vaccine was shown to prevent 100% of hospitalizations after performing a clinical study of around 44,000 patients in the U.S., South Africa and other countries.

J&J submitted its Covid vaccine data to the FDA on Feb. 4. The vaccine’s level of protection varied by region, J&J said, with the shot demonstrating 66% effectiveness overall, 72% in the United States, 66% in Latin America and 57% in South Africa, where the B.1.351 variant is rapidly spreading. However, the FDA staff documents show the vaccine was 64% effective in South Africa after about a month. The company said the vaccine prevented 100% of hospitalizations and deaths. (CNBC)

The FDA’s Vaccines and Related Biological Products Advisory Committee will meet on Friday to discuss Johnson & Johnson's emergency authorization request, meaning we could get word of an approval as early as this weekend.