Johnson & Johnson Single-Shot COVID-19 Vaccine Approved for Use
Johnson & Johnson’s single-shot COVID-19 vaccine was cleared for use by the US Food and Drug Administration (FDA) on Saturday, Feb. 27, 2021.
J&J is the third vaccine approved for the prevention of the coronavirus, joining Pfizer and Moderna.
“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,” said Acting FDA Commissioner Janet Woodcock, M.D. “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.”
The FDA approved the J&J vaccine as it met the statutory criteria for issuance of an emergency use authorization (EUA). The totality of the available data provided clear evidence that the vaccine may be effective in preventing COVID-19.
“The data also show that the vaccine’s known and potential benefits outweigh its known and potential risks, supporting the company’s request for the vaccine’s use in people 18 years of age and older,” FDA stated in a release Saturday.
At this time, data are not available to determine how long the vaccine will provide protection,
The FDA assured the public and medical community that it has conducted a thorough evaluation of the available safety, effectiveness and manufacturing quality information.
“With today’s authorization, we are adding another vaccine in our medical toolbox to fight this virus. 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,” said Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research.