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FDA Authorized Johnson & Johnson’s Single-Dose COVID-19 Vaccine

February 27, the U.S government authorized Johnson & Johnson’s single-dose COVID-19 vaccine for emergency use.

In J&J’s 44,000-person global trial, the vaccine was found to be 66% effective at preventing moderate-to-severe COVID-19 four weeks after inoculation, and 100% effective in preventing hospitalization and death due to the virus.

“This is an emergency use authorization to really mitigate hopefully the devastating effects of the current pandemic,” said Marion Gruber, FDA’s Director of the Office of Vaccines Research & Review.

The FDA’s emergency use authorization kickstarts the federal government’s plan to distribute nearly 4 million doses of J&J’s vaccine to states, pharmacies, and community health centers across the nation next week.

J&J’s one-dose regimen eliminates the need for patients to return for a second dose and it can be stored at refrigerator temperatures for months.

“It potentially could play a very substantial role if we have enough doses because it’s only a single-dose vaccine and that will make it attractive to people who are difficult to reach,” said Dr. William Schaffner, an infectious disease expert at Vanderbilt University Medical Center in Nashville. “It’s one and done.”

J&J’s vaccine “makes it operationally easier in lots of contexts,” Dr. Nancy Messonnier said, Director of the CDC’s National Center for Immunization and Respiratory Diseases.

“I expect lots of considerations state health departments are having around these vaccines is more about the ease of use of the J&J vaccine and how it might be better suited for some populations,” she added.

J&J is testing a two-dose version of its vaccine, with results expected this summer.

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