U.S advisers endorse single-shot vaccine from Johnson & Jhonson
WASHINGTON — U.S. health advisers endorsed a onedose 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 recommenda- tion, which would make J&J’s shot the third vaccine autho- rized 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 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, Missouri. “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% of the population, have received at least one shot of the twodose vaccines from Pfizer and Moderna, which the 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 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 protec- tive 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% 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% protective against the most severe COVID-19. After adding in moderate cases, the total effectiveness dropped to about 66%.
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 wrap- ping 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 single-dose version, the company is also studying whe t he r a second do se boosts protection.
J&J representatives said they chose to begin with the single shot because the World Health Organization and other experts agreed it would be a faster, more effective tool in an emer- gency.
On Sunday, a CDC panel is expected to meet to recommend how to best prior- itize use of the J&J vaccine.