FDA staff endorses J&J’s single-shot COVID-19 vaccine for emergency

February 25, 2021: The Food and Drug Administration’s staff approved Johnson & Johnson’s Covid-19 vaccine for emergency use, a crucial step that brings the third shot to the U.S. marketplace. On Wednesday, the staff report is meant to brief the FDA’s Vaccines and Related Biological Products Advisory Committee, which will meet on Friday.

The FDA staff said it determines that the clinical trial results and safety data were “consistent with the recommendations outlined in FDA’s guidance Emergency Use Authorization for Vaccines to Prevent COVID-19.”

J&J submitted its COVID-19 vaccine data to the FDA on February 4. The vaccine’s protection level varied by region, J&J said, with the dose demonstrating 66% effectiveness, 72% in the United States, 66% in Latin America, and 57% in South Africa, where the B.1.351 variant is spreading rapidly. The vaccine prevented 100% of hospitalizations and deaths, according to the company.

Vaccine effectiveness was similar across age, race, and people with comorbidities, the FDA staff said. However, the point appeared to be lower in people who were 60 years and above who also had comorbidities, like diabetes or heart disease, the agency said.

The news comes after the Biden administration works to ramp up the dose supply after states complained that demand for the shots was outpacing supply.

 According to data by the Centers for Disease Control and Prevention, 44.1 million out of some 331 million Americans have received at least their first dose of Pfizer’s and Moderna’s two-dose vaccines roughly. Above 19 million have received their second shot

 already.

J&J’s application would be the third Covid-19 vaccine authorized for emergency use in the U.S. if approved, which follows those developed by Pfizer-BioNTech and Moderna. Pfizer’s vaccine was approved on December 11, and Moderna’s was authorized a week later. J&J’s vaccine requires one dose only, which makes logistics easier for health-care providers.

J&J has a deal with the federal government to supply 100 million doses of its vaccine by June end. Jeff Zients, President Joe Biden’s Covid czar, told reporters the company would likely not have a “big inventory” of doses ready before its U.S. launch, with few million doses manufactured.