Johnson & Johnson filed Thursday for emergency use authorization of its single-dose coronavirus vaccine, readying for a pivotal third option in the battle to immunize hundreds of millions of Americans.
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.
The single dose is appealing to public health officials who say it will be critical to vaccinating vulnerable, hard-to-reach and even skeptical people. It also can be stored in regular refrigerators unlike other options that require ultra-cold freezers.
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.
"Upon authorization of our investigational COVID-19 vaccine for emergency use, we are ready to begin shipping," said Paul Stoffels, J&J's chief scientific officer, in a statement. "We are working with great urgency to make our investigational vaccine available to the public as quickly as possible."
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 likely will convene its expert panel, the Vaccines and Related Biological Products Advisory Committee, to publicly discuss the data. 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."
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February 05, 2021 at 06:10AM
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Johnson & Johnson files for emergency use of Covid-19 shot - POLITICO
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