FDA panel recommends authorization of single-shot vaccine.
FDA says it’s moving quickly to make J&J’s single-shot available
WASHINGTON — U.S. health advisers endorsed a one-dose COVID-19 vaccine from Johnson & Johnson on Friday, putting the nation on the cusp of adding an easier-to-use option to fight the pandemic.
The acting head of the Food and Drug Administration said in a statement that the agency will move quickly to follow the recommendation, which would make J&J’s shot the third vaccine authorized for emergency use in the U.S.
After daylong discussions, the FDA panelists voted unanimously that the benefits of the vaccine outweighed the risks for adults. Once FDA issues a final decision, shipments of a few million doses could begin as early as Monday.
“There’s an urgency to get this done,” said Dr. Jay Portnoy of Children’s Mercy Hospital in Kansas City, Mo. “We’re in a race between the virus mutating — and new variants coming out that can cause further disease — and stopping it.”
While early J&J supplies will be small, the company has said it can deliver 20 million doses by the end of March and a total of 100 million by the end of June.
J&J’s vaccine protects against the worst effects of COVID-19 after one shot, and it can be stored up to three months at refrigerator temperatures, making it easier to handle than the previous vaccines, which must be frozen.
One challenge in rolling out the new vaccine will be explaining how protective the J&J shot is after the astounding success of the first U.S. vaccines.
“It’s important that people do not think that one vaccine is better than another,” said panelist Dr. Cody Meissner of Tufts University.
The two-dose Pfizer and Moderna shots were found to be about 95 percent effective against symptomatic COVID-19. The numbers from J&J’s study are not that high, but it’s not an apples-to-apples comparison. One dose of the J&J vaccine was 85 percent protective against the most severe COVID-19. After adding in moderate cases, the total effectiveness dropped to about 66 percent.
Some experts fear that lower number could feed public perceptions that J&J’s shot is a “secondtier vaccine.” But the difference in protection reflects when and where J&J conducted its studies.
J&J’s vaccine was tested in the U.S., Latin America and South Africa at a time when more contagious mutated versions of the virus were spreading. That wasn’t the case last fall, when Pfizer and Moderna were wrapping up testing.
Importantly, the FDA reported this week that the J&J shot offers strong protection against the worst outcomes, hospitalization and death.
On Sunday, a CDC panel is expected to meet to recommend how to best prioritize use of the J&J vaccine.