J&J Submits Single-Shot Vaccine To FDA For Emergency Use Review
An advisory panel is expected to vote on Feb. 26 on whether the Food and Drug Administration should authorize Johnson & Johnson's one-dose covid vaccine.
CNBC:
Johnson & Johnson Requests Emergency Authorization From FDA For Covid Vaccine
Johnson & Johnson applied for an emergency use authorization from the Food and Drug Administration for its coronavirus vaccine after releasing data last week showing it was about 66% effective in protecting against the virus. If J&J’s application is approved, it would be the third Covid-19 vaccine authorized for emergency use in the U.S. behind those developed by Pfizer-BioNTech and Moderna. ... The FDA has scheduled a meeting of its Vaccines and Related Biological Products Advisory Committee on Feb. 26 to discuss the emergency use authorization. (Lovelace Jr., 2/4)
NPR:
Johnson & Johnson Applies For Emergency Use Authorization For COVID-19 Vaccine
In a statement released Thursday, the company said if emergency use is granted, it aims to supply 100 million doses in the first half of 2021. Unlike Pfizer and Moderna, Johnson & Johnson's Janssen vaccine can be stored for at least three months at 36-46 degrees Fahrenheit, compatible with standard vaccine distribution channels, the company said. (Jones, 2/4)
Politico:
Johnson & Johnson Files For Emergency Use Of Covid-19 Shot
The J&J shot is 66 percent effective broadly against moderate to severe infection but provides strong protection against hospitalization and death, according to a global study. ... But the J&J shot also proved less effective against a virulent Covid-19 strain first found in South Africa, falling to just 57 percent efficacy in a trial run in that country. Cases of the strain, dubbed B.1.351, have already popped up in the U.S. while scientists meanwhile warn that other variants, like the one first found in the United Kingdom, could soon adopt the strain’s hardiness against vaccines. (Owermohle, 2/4)
The Wall Street Journal:
Johnson & Johnson Asks U.S. Regulators For Emergency Approval Of Its Covid-19 Vaccine
The addition of J&J’s vaccine could jump-start a U.S. mass-vaccination campaign that has been choppy since it began in December. There has been a limited supply of the first two vaccines, from Moderna Inc. and Pfizer, with its partner BioNTech SE, and distribution roadblocks have caused a slower-than-expected pace of vaccinations. J&J’s shot wouldn’t only boost the overall supply of Covid-19 vaccine doses, but also could simplify vaccinations for many because it is given in one dose. (Loftus, 2/4)
