1-shot J&J vaccine OK’d
WASHINGTON (AP) — 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-touse way to fight the pandemic.
The Food and Drug Administration is expected to quickly follow the recommendation and make J&J’s shot the third vaccine authorized for emergency use in the U.S. Vaccinations are picking up speed, but new supplies are urgently needed to stay ahead of a mutating virus that has killed more than 500,000 Americans.
After daylong discussions, the FDA panelists voted unanimously that the benefits of the vaccine outweighed the risks. If the FDA agrees, 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.”
More than 47 million people in the U.S., or 14 percent of the population, have received at least one shot of the two-dose vaccines from Pfizer and Moderna, which FDA authorized in December. But the pace of vaccinations has been strained by limited supplies and delays due to winter storms.
While early J&J supplies will be small, the company has said it can deliver 20 million doses by the end of March and 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 will be explaining how protective the J&J shot is after the astounding success of the first 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 COVID19. 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 “second-tier” 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, and it’s not clear if their numbers would hold against the most worrisome of those variants.
Importantly, the FDA reported this week that, just like its predecessors, the J&J shot offers strong protection against the worst outcomes, hospitalization and death.
While J&J is seeking FDA authorization for its singledose version, the company is also studying whether a second dose boosts protection.
Panel member Dr. Paul Offit warned that launching a twodose version down the road might cause problems.
“You can see where that would be confusing to people thinking, ‘Maybe I didn’t get what I needed,’ ” said Offit, a vaccine expert at Children’s Hospital of Philadelphia.