The Food and Drug Administration approved Johnson & Johnson’s Covid-19 vaccine on Saturday for emergency use, Adding a third vaccine to the U.S. arsenal to fight the pandemic.
“The approval of this vaccine expands the availability of vaccines, the best medical prevention tool for COVID-19, to help us fight this pandemic that has killed over half a million people in the United States,” said the incumbent FDA -Commissioner Dr. Janet Woodcock in a statement.
The decision is made one day after an FDA advisory committee elected unanimously in favor of the vaccine recommendation.
“We’re in a race between the mutating virus, with new variants Finding out what can cause and stop more diseases, “said Dr. Jay Portnoy, professor of pediatrics at the University of Missouri-Kansas City Medical School and a member of the advisory board.
“The fewer people infected with the virus, the less chance it will develop into a more virulent strain.”
President Joe Biden issued a statement following the announcement describing the decision as “exciting news for all Americans and an encouraging development in our efforts to end the crisis.”
Dosing is expected to begin on Monday, starting at around 4 million. Johnson & Johnson, who developed the vaccine in partnership with Janssen Pharmaceuticals, said 20 million doses will be available by the end of March.
This will be enough to fully vaccinate 20 million people since the Johnson & Johnson vaccine is given as a single dose. The other available vaccines from Pfizer-BioNTech and Moderna are given in two doses three to four weeks apart.
Although the Johnson & Johnson vaccine is given as a single dose, the company is investigating the effects of a second dose.
On Friday, members of the FDA’s independent panel of experts wondered what would happen if a two-dose formulation were ultimately approved.
Dr. Paul Offit, a vaccines expert at Philadelphia Children’s Hospital, suggested it might be difficult to communicate the change to those who received only the one dose.
“You can see where that would be confusing for people, where they might think, ‘Maybe I didn’t get what I need?'”
On FDA analysis, which was posted online on Wednesday, found the vaccine to be safe and effective. The single shot has been shown to be 86 percent effective at preventing serious illness. In the US, the shot was found to be 72 percent effective at preventing moderate to severe illness. In South Africa, where a worrying variant is circulating, that number was lower: 64 percent.
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Dr. Richard Besser, President and CEO of the Robert Wood Johnson Foundation and former acting director of the Centers for Disease Control and Prevention, welcomed the FDA’s decision.
“With three Covid-19 vaccines now available, with the number of cases and deaths continuing to fall across the country, and with Congress taking steps to approve additional much-needed economic relief, I’ve never been more encouraged that we should finally turn the corner could this pandemic, “he said in a statement.
Still, Besser said Americans need to remain vigilant, adhere to the wearing of masks, distance themselves and limit travel. “Whether and when the pandemic ends is – as always – largely up to us.”
In December, the FDA approved Covid-19 vaccines from Pfizer-BioNTech and Moderna. Two other vaccines from AstraZeneca and Novavax complete phase 3 clinical trials and are expected to file for FDA approval in the spring.