FDA Issues EUA for Johnson & Johnson COVID-19 Vaccine

After declaring that Johnson & Johnson’s COVID-19 vaccine was safe and effective, the U.S. Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) for the third vaccine to aid in the fight against the ongoing pandemic. The new authorized vaccine will allow states to increase distribution to individuals 18 years of age and older.

The vaccine was found to be approximately 67% effective in preventing moderate to severe COVID-19 cases occurring at least 14 days after vaccination; and 85% effective in preventing moderate to severe COVID-19 cases occurring at least 28 days after vaccination. The FDA has not identified any specific safety concerns, stating the vaccine meets its rigorous standards for safety.

“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

The Johnson & Johnson vaccine, also known as the Janssen vaccine, was developed by Janssen Biotech Inc., a subsidiary of Johnson & Johnson. The Janssen vaccine is the only single-shot regimen currently on the market, while the Pfizer-BioNTech and Moderna vaccines require two-injection regimens and have been authorized in the U.S. and other countries.

Johnson & Johnson’s vaccine is based on the virus’ genetic instructions for building the spike protein. Unlike the Pfizer-BioNTech and Moderna vaccines, which store the instructions in single-stranded RNA, the Johnson & Johnson vaccine uses double-stranded DNA.

Shipments of some 4 million doses of this vaccine began on March 1, 2021. Johnson & Johnson plans on providing up to 20 million shots in the next month and 100 million shots over the summer.

As COVID-19 vaccines continue to be authorized and distributed, it is essential for the public to be aware of vaccine updates and seek information surrounding their effectiveness and safety. In the meantime, and as outlined on their website, the CDC encourages everyone to continue taking precautionary steps to help prevent the spread of COVID-19 (i.e. hand washing, mask wearing, social distancing, etc.).

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