FDA Advisers to Vet J&J's One-Shot Vaccine for Emergency Use

Johnson & Johnson’s coronavirus vaccine is set for vetting by a panel of outside advisers to the U.S. Food and Drug Administration Friday, one of the final steps toward potential authorization of the country’s first one-dose immunization against COVID-19.

If the panel votes that the vaccine’s benefits outweigh its risks, as expected, the agency could grant emergency clearance within days, providing a badly needed boost to U.S. vaccine supplies. While the committee’s decision is non-binding, the FDA usually follows its advisers’ recommendations.

Biden administration officials have said the U.S. expects J&J to release 3 million to 4 million shots next week, assuming it’s authorized for use. The company is ready to deliver 20 million doses by the end of March, an executive said earlier this week at a congressional hearing.

“If — if — the FDA approves the use of this new vaccine,” President Joe Biden said Thursday at an event to celebrate 50 million doses administered since he took office, “we have a plan to roll it out as quickly as Johnson & Johnson can make it.”

The all-day FDA meeting will include a presentation on how existing vaccines are holding up so far in practice, according to a pre-released agenda. In the morning, a Centers for Disease Control and Prevention official will highlight data on variants that are being closely watched for their threat to vaccine efficacy.

Johnson & Johnson’s vaccine was 72% effective in the U.S.-based portion of a global study that enrolled more than 43,000 people, FDA staff wrote in a document released earlier this week that summarized the company’s final-stage trial results, and was 100% effective in preventing death in the trial

It was highly effective against severe disease in all regions where tested and worked better against mutant strains than the company had previously reported. J&J’s scientists and FDA staff will review the data behind the vaccine in separate presentations. That will be followed by an in-depth panel discussion and vote.

Separately, the CDC’s Advisory Committee on Immunization Practices has set up an emergency meeting on Sunday to consider the shot. This panel makes recommendations on how to use vaccines.

J&J’s vaccine differs from authorized shots from Moderna Inc. and the partnership of Pfizer Inc. and BioNTech SE, which rely on messenger RNA to turn cells into vaccine factories. It instead uses a non-replicating cold virus called an adenovirus to stimulate an immune response, preparing the body to fight COVID-19.

The J&J shot is highly anticipated because it could make it easier to quickly vaccinate people in far-flung places. While the mRNA vaccines require two doses for their full benefits to take hold, J&J’s single-shot regimen is less complicated to administer. It also can be kept in a refrigerator for three months, an advantage over the mRNA vaccines that must be frozen when stored for longer periods.

J&J’s candidate was among six vaccines tapped for the Trump administration’s Operation Warp Speed program, receiving some $1.5 billion in government backing. The company has a contract to deliver 100 million doses to the U.S. by the end of June.