The Food and Drug Administration (FDA) on Saturday authorized the emergency use in the United States of the COVID-19 vaccine developed by Johnson & Johnson.
This is the third vaccine against COVID-19 to have received emergency use authorization from the FDA, after the first developed by the American pharmaceutical company Pfizer in partnership with its German colleague BioNTech, and the second developed by the American company Moderna.
It is also the first vaccine against COVID-19 requiring only a single injection available in the United States.
This clearance allows Johnson & Johnson’s vaccine to be distributed in the United States for use in people 18 years of age and older, according to the FDA.
All of the available data clearly demonstrates that the vaccine can be effective in preventing COVID-19, the FDA said in a statement.
They also show that the vaccine’s benefits outweigh its known and potential risks, which supports society’s demand for its use in people aged 18 and older, she added.
“The authorization of this vaccine expands the availability of vaccines, (which are) the best method of medical prevention against COVID-19, to help us in the fight against this pandemic which has claimed more than half a million lives in the United States, “said Janet Woodcock, acting commissioner of the FDA.
This approval came the day after a key FDA advisory committee recommended that the vaccine be approved for emergency use.
Unlike the vaccines from Pfizer-BioNTech and Moderna, the one from Johnson & Johnson only requires a single injection. In addition, it does not need to be stored at ultra-cold temperatures.
The United States remains the country worst affected by the pandemic, with more than 28 million cases and more than half a million deaths, according to the Center for Systems Science and Engineering at Johns Hopkins University.
US President Joe Biden’s national vaccination campaign aims to deliver 100 million two-phase doses against the novel coronavirus in the first 100 days of his tenure.
More than 96 million doses have been distributed across the United States as of Saturday, and more than 72 million have been administered, according to data from the U.S. Centers for Disease Control and Prevention.