FDA issues emergency authorization for single-dose Johnson & Johnson COVID-19 vaccine

Silver Spring, MD – On Saturday, the U.S. Food and Drug Administration issued emergency use authorization for the Johnson & Johnson COVID-19 for individuals 18 years of age and older.

The Johnson & Johnson vaccine is the third COVID-19 vaccine to get emergency use authorization by the FDA. But unlike the vaccines made by Moderna and Pfizer, the Johnson & Johnson vaccine only needs one dose.

“We believe the Johnson & Johnson single-shot COVID-19 vaccine is a critical tool for fighting this global pandemic, particularly as it shows protection across countries with different variants. A vaccine that protects against COVID-19, especially against the most dire outcomes of hospitalization and death, will help ease the burden on people and the strain on health systems worldwide,” said Paul Stoffels, M.D., Vice Chairman of the Executive Committee and Chief Scientific Officer, Johnson & Johnson. “We look forward to our continued efforts around the world as we collectively aim to change the trajectory of this global pandemic.”

According to the FDA, in tests, the vaccine was approximately 77% effective in preventing severe/critical COVID-19 occurring at least 14 days after vaccination and 85% effective in preventing severe/critical COVID-19 occurring at least 28 days after vaccination.

The most commonly reported side effects were pain at the injection site, headache, fatigue, muscle aches and nausea. Most of these side effects were mild to moderate in severity and lasted 1-2 days.

The vaccine doses are compatible with standard vaccine storage and distribution channels with ease of delivery to remote areas. The vaccine is estimated to remain stable for two years at -4°F, and a maximum of three months at routine refrigeration at temperatures of 36-46°F.

“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,” said Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research. “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.”