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February 27, 2021

FDA authorizes Johnson & Johnson's COVID-19 vaccine

The New Jersey-based company is expected to provide the U.S. with enough shots to inoculate 100 million Americans by June

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Johnson & Johnson COVID-19 vaccine Grid Scheduler/Public Domain via

Johnson & Johnson's COVID-19 had a 66% efficacy rating during clinical trials, but none of the participants who received the vaccine were hospitalized or died due to the coronavirus.

The United States vaccination effort received a boost Saturday as the Food and Drug Administration authorized Johnson & Johnson's COVID-19 vaccine. 

The vaccine is the third to receive an emergency use authorization, but the first to require just a single dose. That characteristic — along with increased vaccine supply — will help speed up inoculations. 

Johnson & Johnson is expected to begin shipping the first doses immediately. The New Jersey-based company plans to deliver 20 million doses by the end of March and 100 million by June.

The FDA's decision came one day after its Vaccines and Related Biological Products Advisory Committee — a group of independent scientists — endorsed the vaccine. Earlier in the week, the FDA's own scientists released an analysis that deemed the vaccine safe and effective.

The vaccine has been authorized for people ages 18 and older. 

"The authorization of this vaccine expands the availability of vaccines, the best medical prevention method for COVID-19, to help us in the fight against this pandemic, which has claimed over half a million lives in the United States," acting FDA Commissioner Dr. Janet Woodcock said. "The FDA, through our open and transparent scientific review process, has now authorized three COVID-19 vaccines with the urgency called for during this pandemic, using the agency’s rigorous standards for safety, effectiveness and manufacturing quality needed to support emergency use authorization." 

On Friday, the FDA informed Johnson & Johnson that it would work "rapidly" toward authorizing the vaccine. It also notified federal partners involved in vaccine allocation and distribution so they could begin executing plans for a timely distribution.

The Johnson & Johnson vaccine was 66% effective at preventing moderate to severe COVID-19 in clinical trials — an efficacy rating significantly lower than those produced by the Pfizer-BioNTech and Moderna vaccines. But it was 85% effective at preventing severe illnesses. And health experts stress the vaccine has proven highly effective at preventing hospitalizations and deaths. 

Of the 20,000 study participants who received in the 40,000-person study, not one was hospitalized with COVID-19 in the months that followed. None of them died of the coronavirus. 

"I'll never stop being amazed at zero hospitalizations among vaccinated in study after study," Dr. Aaron Richterman, an infectious disease physician at Penn Medicine, tweeted Wednesday. "Zero! Of course it will happen rarely in the real world but it's astonishing for an illness with so much morbidity." 

The FDA analysis found "no specific safety concerns" with the vaccine. The most common adverse reactions were injection site pain, headache, fatigue and muscle pain. 

"With today's authorization, we are adding another vaccine in our medical toolbox to fight this virus," said Dr. Peter Marks, director of the FDA's Center for Biologics Evaluation and Research. "At the same time, the American people can be assured of the FDA's unwavering commitment to public health through our comprehensive and rigorous evaluation of the data submitted for vaccines to prevent COVID-19."

The vaccine can be stored in refrigerators for up to three months — a characteristic that removes some of the distribution obstacles previously encountered. The Pfizer and Moderna vaccines each must be stored in freezers, though the latter remain stable in refrigerators for 30 days.   

The Johnson & Johnson vaccine uses a genetically modified adenovirus to trigger an immune response. Non-modified adenoviruses cause the common cold. That differs from the Pfizer and Moderna vaccines, which use mRNA technology, a novel approach that uses genetic material to provide immunity.

Though the Pfizer and Moderna vaccines recorded efficacy ratings of about 95% during clinical trials, health experts say all three vaccines offer substantial protection against the coronavirus.

"A vaccine that protects against COVID-19, especially against the most dire outcomes of hospitalization and death, will help ease the burden on people and the strain on health systems worldwide," said Dr. Paul Stoffels, Johnson & Johnson's chief scientific officer.

This story was updated Saturday, Feb. 27, after the FDA formally authorized the Johnson & Johnson vaccine. 

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