Johnson & Johnson’s coronavirus vaccine is less powerful than existing vaccines but can stave off severe COVID-19 cases with a single shot, according to trial data, presenting a new tool in the effort while creating messaging hurdles for the Biden administration and states.
The J&J vaccine kept death and the worst coronavirus symptoms at bay and proved 66% effective against moderate to severe illness in a multination trial, versus the 95% efficacy recorded by two-dose, messenger-RNA vaccines already in use.
J&J tested its version in trying circumstances, with powerful strains coursing through some of the trial settings. The upshot is a vaccine that, if approved, will help to combat the pandemic but presents thorny choices.
A single-dose vaccine will speed the U.S. rollout and simplify parts of it — people won’t need to return for a second shot, and governments won’t have to balance the booster supply with allotments for first-time shots.
“Frankly, simple is beautiful,” said Matt Hepburn, the vaccine development lead for the Operation Warp Speed, the federal initiative set up by former President Donald Trump.
The J&J vaccine is also easier to store, lasting in a refrigerator for up to three months, so far-flung areas might like it.
However, “it didn’t work as well as the Pfizer, Moderna data showed, so there’s going to be some issues about who gets it, who you offer it to,” said Arthur Caplan, director of the Division of Medical Ethics at the New York University Grossman School of Medicine.
For instance, what if rural areas are given the single-dose shot only for them to “complain about the better one?” Mr. Caplan said.
J&J plans to request emergency-use approval from the Food and Drug Administration next week. If approved, experts said the federal Advisory Committee on Immunization Practices will have to go through the trial data and figure out if some vaccines are better than others for certain populations.
Dr. Anthony Fauci, who leads infectious disease research at the National Institutes of Health, said he knows the government will face a “messaging problem” because of the gulf in efficacy rates. He wants the public to focus on J&J version’s ability to stave off serious disease, which the trial defined as things like admission to an intensive care unit, respiratory failure, shock, organ failure or death — the types of outcomes people fear the most.
The J&J vaccine, developed by subsidiary Janssen Pharmaceuticals, was less effective than others in preventing moderate-to-severe disease, which was defined as evidence of pneumonia, shortness of breath or abnormal blood oxygen saturation and breathing rates.
Protection varied across the globe, at 72% in the U.S. but 66% overall and 57% in South Africa, which is contending with an aggressive strain of the virus. Those rates exceeded the 50% threshold the federal government set for vaccines last year.
If it hadn’t been for the first pair of vaccines at 95% efficacy, Dr. Fauci said, “one would have said this was an absolutely spectacular result [from J&J].”
Notably, the J&J shot was 85% effective in preventing severe symptoms across all regions, including South Africa, where no one in the vaccination part of the trial died or landed in the hospital 28 days after administration of the shot. There were five COVID-19 deaths in the trial, but they all occurred in the placebo group.
U.S. regulators approved the vaccines from Pfizer and Moderna in December, so J&J’s version would add a third to the nation’s arsenal. The company has pledged to provide 100 million doses to the U.S. by the end of June.
For people clamoring for a vaccine, release of the J&J version “would mean they get to move to the front of the line faster,” said Paul Offit, a pediatrics professor at the University of Pennsylvania and member of the Food and Drug Administration’s vaccine advisory panel.
U.S. case counts have plummeted by a third in recent weeks, although transmission remains elevated. Scientists are worried that fast-moving variants will upend progress.
“The fact is that the surge that is likely to occur with this new variant from England is going to happen in the next six to 14 weeks. And if we see that happen, which my 45 years in the trenches tell us we will, we are going to see something that we have not seen yet in this country,” said Michael Osterholm, a key scientist on President Biden’s advisory team, told NBC’s “Meet the Press.”
Vaccines appear to be effective against the U.K. strain.
The U.S. is under pressure to deliver more doses of two-shot vaccines from Pfizer-BioNTech and Moderna. Some doses are used as second-round shots to offer the full protection demonstrated in clinical trials. Experts say it might be worth delaying the second shot to expand the range of initial protection.
Officials haven’t announced any changes, but Dr. Osterholm said they might have to “call an audible.”
“We still want to get two doses in everyone,” he said. “But I think right now in advance of this surge, we need it to get as many one doses in as many people over 65 as we can to reduce serious illness and deaths that are going to occur over the weeks ahead.”
• Tom Howell Jr. can be reached at thowell@washingtontimes.com.
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