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Johnson & Johnson COVID Vaccine Safe, Effective: FDA Report

Coronavirus vaccine vials displaying the Johnson & Johnson logo, February 9, 2021 (Dado Ruvic/Reuters)

The Food and Drug Administration’s staff on Wednesday endorsed Johnson & Johnson’s COVID-19 vaccine for emergency use, paving the way for the single-shot vaccine’s approval.

A panel of outside advisers to the FDA will meet Friday to evaluate the vaccine and issue a recommendation on its approval for emergency-use authorization.

The FDA staff said it determined that the clinical-trial results and safety data were “consistent with the recommendations set forth in FDA’s guidance Emergency Use Authorization for Vaccines to Prevent COVID-19.”

According to data submitted to the agency by Johnson & Johnson on February 4, the vaccine was 66 percent effective overall, with variations occurring by region: 72 percent efficacy in the U.S, 66 percent in Latin America, and 57 percent in South Africa, where the B.1.351 variant is rapidly spreading.

However, the company said the vaccine prevented 100 percent of hospitalizations and deaths.

The data show seven COVID-related deaths in the study among those in the placebo group as of February 5 and none in the vaccine group, the FDA said.

If approved, the Johnson & Johnson vaccine would be the third to become available in the U.S., after shots made by Pfizer-BioNTech and Moderna. The agency granted emergency-use authorization for the Pfizer and Moderna shots one day after the committee endorsed the approval of each respective vaccine.

While the Johnson & Johnson vaccine is less effective at preventing infection than the Pfizer and Moderna shots, it is easier, logistically, to distribute given that it requires just one dose, while the Pfizer and Moderna vaccines require two.

The Johnson & Johnson vaccine can also be stored at just 36 to 46 degrees Fahrenheit, while Pfizer’s vaccine requires storage in freezers kept between minus 112 and minus 76 degrees Fahrenheit. Moderna’s vaccine needs to be shipped at 13 below to 5 degrees above zero Fahrenheit.

Johnson & Johnson has a deal with the federal government to supply 100 million doses of its vaccine by the end of June, though President Biden’s COVID Czar, Jeff Zients, warned last week that the company will likely not have a “big inventory” of doses prepared before the U.S. launch.

Health experts hope the authorization of a third vaccine will quicken the pace of vaccination in the U.S. So far, 44.1 million of 331 million Americans have received at least their first dose of the Pfizer or Moderna vaccine.

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