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Law360 (February 4, 2021, 11:21 PM EST ) Johnson & Johnson on Thursday asked the U.S. Food and Drug Administration for emergency authorization of its single-shot COVID-19 vaccine candidate, which the drugmaker said is 85% effective in preventing severe cases of the virus.
The FDA's Vaccines and Related Biological Products Advisory Committee said it planned to discuss the request at a Feb. 26 meeting. New Jersey-based J&J said it's prepared to ship the vaccine immediately following authorization. Should the vaccine garner FDA approval, it will be the third vaccine approved in the U.S. since December and the first to require just one shot.
The vaccine, named JNJ-78436735, was developed by J&J's pharmaceutical arm, Janssen Biotech Inc. J&J said it expects to supply 100 million doses to the U.S. during the first half of 2021.
Last week, J&J said the vaccine had met efficacy and safety requirements, noting that the vaccine was 72% effective in preventing moderate to severe infection in adults in the U.S., 66% effective in Latin America and 57% in South Africa. Efficacy is measured 28 days post-vaccination, according to J&J.
J&J Chief Scientific Officer Dr. Paul Stoffels said in a statement Thursday that the company's submission to the FDA "is a pivotal step toward reducing the burden of disease for people globally and putting an end to the pandemic."
"Upon authorization of our investigational COVID-19 vaccine for emergency use, we are ready to begin shipping," he said.
J&J has also submitted authorization requests to health agencies abroad and plans to submit a conditional marketing authorization application with the European Medicines Agency, according to the company.
In a statement Thursday, acting FDA Commissioner Dr. Janet Woodcock said the advisory board's public discussion on the vaccine "will help ensure that the public has a clear understanding of the scientific data and information that FDA will evaluate in order to make a decision about whether to authorize this vaccine."
The FDA will make background materials available to the public ahead of the meeting, the agency said.
Members of the FDA's vaccine panel are "independent, scientific and public health experts" who advise the agency on the safety and effectiveness data provided by the drugmaker, according to the statement.
The agency said it would "review the request as expeditiously as possible, taking into consideration the discussion by the advisory committee, while still doing so in a thorough and science-based manner."
The FDA's timeline for J&J's vaccine is on par with those for vaccines developed by Pfizer, its German partner BioNTech and Moderna. Pfizer and BioNTech lodged their emergency use authorization request with the FDA in late November.
On Dec. 10, the FDA gave its first stamp of approval to a COVID-19 vaccine when it signed off on that authorization. The first doses of that vaccine were administered to front-line health care workers in the U.S. in mid-December. Pfizer's and BioNTech's two-dose vaccine is about 95% effective, according to the agency.
Moderna also filed its authorization request in late November. The FDA approved its vaccine, which is 94% effective at preventing infection among individuals 18 and older, in mid-December.
J&J's FDA submission Thursday includes data from a phase 3 clinical study involving about 43,800 participants, of which 468 became symptomatic.
"These topline results with a single-shot COVID-19 vaccine candidate represent a promising moment," Stoffels said last week. He added that a one-shot vaccine "is considered by the World Health Organization to be the best option in pandemic settings, enhancing access, distribution and compliance."
J&J's study results include efficacy against newly emerging strains of the virus, including those highly contagious variants in the U.S., Latin America and South America, the company said.
Most participants in the clinical trials tolerated the vaccine well, J&J said. There were no significant safety concerns with the vaccine, though a small number of individuals developed fevers.
--Additional reporting by Dorothy Atkins, Kevin Stawicki and Britain Eakin. Editing by Emily Kokoll.
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