FDA authorizes emergency use of Janssen COVID-19 Vaccine
The US Food and Drug Administration (FDA) has granted an emergency use authorization (EUA) for the Janssen COVID-19 Vaccine – Ad26.COV2.S manufactured by Johnson & Johnson subsidiary Janssen Biotech.
It is the third vaccine to have been given FDA emergency use authorization for the prevention of COVID-19 caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) virus.
The emergency use authorization enables the Janssen COVID-19 Vaccine to be distributed in the US for use in people aged 18 years or more.
Janet Woodcock – Acting FDA Commissioner said: “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.
“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.”
FDA authorizes emergency use of Janssen COVID-19 Vaccine. Photo courtesy of The U.S. Food and Drug Administration/Wikipedia.org.
The FDA said that the Janssen COVID-19 Vaccine, based on the totality of the available data, offers clear proof that it could be effective in the prevention of COVID-19.
The data also demonstrated that the known and potential benefits of the Janssen COVID-19 Vaccine overshadow its known and potential risks.
The coronavirus vaccine from the Johnson and Johnson subsidiary is manufactured using the adenovirus type 26 (Ad26) virus.
The Janssen COVID-19 Vaccine uses Ad26 for delivering a piece of the DNA, or genetic material, that is used for making the “spike” protein of the SARS-CoV-2 virus.
According to the FDA, Ad26 which can give cold symptoms and pink eye has been altered for the vaccine so that it does not replicate in the human body to result in illness.
The drug regulator assured that after an individual is administered the Janssen COVID-19 Vaccine, the body can temporarily produce the spike protein, which does not result in the disease, but activates the immune system to learn to react defensively, producing an immune response against the SARS-CoV-2 virus.
Peter Marks – director of the FDA Center for Biologics Evaluation and Research said: “After a thorough analysis of the data, the FDA’s scientists and physicians have determined that the vaccine meets the FDA’s expectations for safety and effectiveness appropriate for the authorization of a vaccine for emergency use.
“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.”
In August 2020, Janssen Pharmaceutical agreed to manufacture and supply 100 million doses of the Ad26.COV2.S vaccine to the US government, in a deal worth more than $1 billion.