FDA approves Johnson & Johnson’s Covid vaccine
The U.S. Food and Drug Administration has given emergency use authorization to Johnson & Johnson’s Covid-19 vaccine, sending into circulation the first such medicine requiring just one shot.
The vaccine is approved for use in the U.S. for adults 18 and older.
Already, the FDA has approved a two-dose vaccine made by Moderna and Pfizer-BioNTech. At least two other large-scale clinical trials are in progress or being planned for additional vaccines.
"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 Janet Woodcock, MD, said in a statement. “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.”
Unlike the other two available Covid-19 vaccines, J&J’s vaccine is given in a single dose. The vaccine was shown to be 72% effective in the U.S. and 66% effective at preventing moderate to severe Covid-19 28 days after vaccination.
“Our goal all along has been to create a simple, effective solution for the largest number of people possible, and to have maximum impact to help end the pandemic,” Alex Gorsky, chairman of the Board of Directors and CEO at Johnson & Johnson, said in a statement at the end of January.
The vaccine was approved under an EUA, which allows the FDA to facilitate the approval of medicines and medical devices during public health emergencies. The agency can allow use of unapproved medical products in an emergency to diagnose, treat or prevent serious or life-threatening diseases or conditions, according to the FDA’s website. The Covid-19 vaccines, while approved under an EUA, were still rigorously tested. J&J’s vaccine was supported by safety data from nearly 44,000 participants enrolled in an ongoing randomized study.
Chief medical advisor at the White House, Anthony Fauci, MD, urged Americans to take any of the three available Covid-19 vaccines whenever they become eligible.
“If you go to a place and you have J&J, and that’s the one that’s available now, I would take it,” Fauci said on NBC’s Meet the Press. “I personally would do the same thing. I think people need to get vaccinated as quickly and as expeditiously as possible.”
Amy joined TriMed Media as a Senior Writer for HealthExec after covering home care for three years. When not writing about all things healthcare, she fulfills her lifelong dream of becoming a pirate by sailing in regattas and enjoying rum. Fun fact: she sailed 333 miles across Lake Michigan in the Chicago Yacht Club "Race to Mackinac."