Johnson & Johnson files for emergency use of Covid-19 shot
Background: The drugmaker originally promised to provide the U.S. government with 12 million doses this month and 100 million over the spring. But it warned officials in mid-January that it could take until the end of April to hit its early supply projections, according to a person briefed on the matter.
J&J was one of the first manufacturers funded by the U.S. government to quickly develop a vaccine. The Trump administration put $456 million towards early trials and later inked a $1 billion deal with J&J to provide 100 million shots, with the option to buy more.
That initial batch will join supplies from Pfizer/BioNTech and Moderna, who have each promised at least 200 million doses and are planning with the Biden administration to each supply an additional 100 million.
What’s next: The Food and Drug Administration will review J&J’s submission and will convene its expert panel, the Vaccines and Related Biological Products Advisory Committee, to publicly discuss the data on Feb. 26. The agency’s authorization could come within weeks.
Johnson & Johnson said that it planned to submit a conditional marketing authorization from the European Medicines Agency in the coming weeks, and has already “initiated rolling submissions with several health agencies outside the U.S.”