U.S. ready to distribute COVID-19 vaccine if approved by FDA

Feb. 25, 2021

Leaders of the White House COVID-19 response team said they are ready to distribute Johnson & Johnson's COVID-19 vaccine when and if the U.S.Food and Drug Administration (FDA) issues an emergency use authorization (EUA), which could come as early as this weekend, according to a news report from the Center for Infectious Disease Research and Policy (CIDRAP) at the University of Minnesota.

During a press conference on response efforts, Jeff Zients, the Biden administration's COVID-19 czar, said governors have received information about how to possibly distribute the Johnson & Johnson vaccine, which, unlike the current approved and in-use vaccines, requires only one shot and standard refrigeration.

If approved, the 3 million to 4 million doses of the vaccine could be available in the United States by the end of next week, and 20 million total by the end of March. Johnson & Johnson is contractually obligated to provide 100 million doses of vaccine to the United States by the end of June.

FDA's Vaccines and Related Biological Products Advisory Committee meets on Friday to consider whether to recommend approval of Johnson & Johnson EUA request.

The FDA does not need to follow the committee's recommendations, but often does, and did follow suit when Pfizer and Moderna submitted their vaccines for EUAs in December. The FDA committee data show the Johnson & Johnson vaccine is 100 percent effective in preventing death and hospitalizations, and 64 percent effective in preventing illness from the South African variant, B1351.

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