Johnson & Johnson Could Begin Distribution of Covid Vaccine by Monday

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

The Food and Drug Administration's 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 — one that could help speed vaccinations by requiring just one dose instead of two — is safe to use.

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.

"I think what you want from this vaccine is you want it to keep you out of the hospital, out of the intensive care unit and to keep you from dying. And certainly, all the vaccines, the Pfizer vaccine, the Moderna vaccine and the Johnson and Johnson vaccine appear to do exactly that. That's what you want. And certainly, all vaccines provide that.", he said.

That's just one step in the FDA's evaluation of a third vaccine option for the U.S. On Friday, the agency's independent advisers will debate if the evidence is strong enough to recommend the long-anticipated shot. Armed with that advice, FDA is expected to make a final decision within days.

"Well, again, we need to review all the data, but on the surface, there are certain advantages to the Johnson and Johnson vaccine. It is refrigerator stable, it can be shipped and stored at refrigerator temperatures. Once it gets to the final place where it's going to be administered, it's stable and refrigerated for three months. It's given as a single shot," said Offit.

The vaccination drive has been slower than hoped, hampered by logistical issues and weather delays even as the country mourns more than 500,000 virus-related deaths. 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.

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 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.

Still, South Africa recently began giving the J&J vaccine to front-line health workers on a test basis after deciding that a vaccine from rival AstraZeneca hadn't shown strong enough study results.

Offit says part the trial also took part in various parts of the world and the data reflects that.

"Remember that in South Africa, more than 90 percent of this strain was the South African strain, which we don't really have much of in this country. I'm sure it's here, but not in any sort of major force. In Brazil, the major strain that was circulating in sort of more than half the time was this Brazilian strain which we also don't really have much in this country. So the question is, to what extent does that part of those trials is relevant to us? I think will certainly be part of these discussions."

Across all countries, Wednesday's analysis showed protection began to emerge about 14 days after vaccination. But by 28 days after vaccination, there were no hospitalizations or deaths in the vaccinated group compared with 16 hospitalizations and 7 deaths in study recipients who received a dummy shot.

The FDA said effectiveness and safety were consistent across racial groups, including Black and Latino participants.

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