J&J Vaccine Nears FDA Approval After Single Dose Found to Prevent Severe Covid

Johnson & Johnson’s single-dose vaccine offers strong protection against severe COVID-19, according to an analysis released Wednesday by U.S. regulators that sets the stage for a final decision on a new and easier-to-use shot to help tame the pandemic.

The long-anticipated shot could offer the nation a third vaccine option and help speed vaccinations by requiring just one dose instead of two. Food and Drug Administration scientists confirmed that overall the vaccine is about 66% effective at preventing moderate to severe COVID-19, and about 85% effective against the most serious illness. The agency also said J&J’s shot is safe.

The analysis is just one step in the FDA’s evaluation. On Friday, the agency’s independent advisers will debate if the evidence is strong enough to recommend the shot. With that advice, the FDA is expected to make a final decision within days.

The COVID-19 death toll in the U.S. topped 500,000 this week, and the vaccination drive has been slower than hoped, hampered by logistical and weather delays. So far, about 44.5 million Americans have received at least one dose of vaccine made by Pfizer or Moderna, and nearly 20 million of them have received the second dose required for full protection.

Tests showed the Pfizer and Moderna vaccines were 95% effective at protection against symptomatic COVID-19.

Dr. Paul Offit, a vaccine expert at Children’s Hospital of Philadelphia, is part of the FDA advisory panel that will scrutinize the J&J data on Friday and cautions that none of the vaccines have been directly compared. Still, he was encouraged that one dose of the J&J vaccine appears as good at preventing serious illness as its two-dose competitors.

“This is a vaccine to prevent you from going to the hospital and dying at a level that’s certainly comparable” to the Pfizer and Moderna vaccines, he said.

J&J tested its single-dose option in 44,000 adults in the U.S., Latin America and South Africa. Different mutated versions of the virus are circulating in different countries, and the FDA analysis cautioned that it’s not clear how well the vaccine works against each variant. But J&J previously announced that the vaccine worked better in the U.S. — 72% effective against moderate to severe COVID-19, compared with 66% in Latin America and 57% in South Africa.

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