One-shot vaccine proves effective

The first one-shot COVID-19 vaccine provides good protection against the illness, Johnson & Johnson reported in a key study released Friday, offering the world a potentially important new tool as it races to stay ahead of the rapidly mutating virus.

The pharmaceutical giant’s preliminary findings suggest the single-dose option may not be as strong as Pfizer’s or Moderna’s two-dose formula, and was markedly weaker against a worrisome mutated version of the virus in South Africa.

But amid a rocky start to vaccinations worldwide, that may be an acceptable trade-off to get more people inoculated faster with an easier-to-handle shot that, unlike rival vaccines that must be kept frozen, can last months in the refrigerator.

“Frankly, simple is beautiful,” said Dr. Matt Hepburn, the U.S. government’s COVID-19 vaccine response leader.

J&J plans to seek emergency use authorization in the U.S. within a week. It expects to supply 100 million doses to the U.S. by June — and a billion doses globally by year’s end — but declined to say how much could be ready if the Food and Drug Administration gives the green light.

J&J studied its one-dose option in 44,000 people in the U.S., Latin America and South Africa. Interim results found the shot 66% effective overall at preventing moderate to severe COVID-19, and much more protective — 85% — against the most serious symptoms. There were no serious side effects.

“Gambling on one dose was certainly worthwhile,” Dr. Mathai Mammen, global research chief for J&J’s Janssen Pharmaceutical unit, told The Associated Press.

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, where a more contagious mutant virus is spreading.

The reduced protection against that mutation is “really a wakeup call,” said Dr. Anthony Fauci, the top U.S. infectious-disease expert.

The more the virus is allowed to spread, the more opportunities it has to mutate. Vaccine makers are looking into how to alter their shots if necessary.

For now, the findings are an incentive “to vaccinate as many people as we possibly can,” Fauci stressed.

Data is mixed on how well other vaccines being used around the world work, but the Pfizer and Moderna shots were 95% protective in large U.S. studies.

It’s not fair to compare studies done before the record surges of recent months and discovery of new mutants — they might not turn out the same today, cautioned Dr. Jesse Goodman of Georgetown University, a former FDA vaccine chief.

The J&J protection is “good enough to help attack a pandemic,” Goodman said. “The advantage of having more vaccine, in a single shot, would be significant.”

Researchers tracked illnesses starting 28 days after vaccination -— about the time when, if participants were getting a twodose variety instead, they would have needed another shot.

After Day 28, no one who got vaccinated needed hospitalization or died, regardless of whether they were exposed to the original virus or “these particularly nasty variants,” Mammen said. When the vaccinated did become infected, they had a milder illness.

JOHNSON & JOHNSON VIA AP This Sept. 2020 photo shows a scientist in Janssen laboratory in Leiden, The Netherlands. Johnson & Johnson’s long-awaited COVID-19 vaccine appears to protect against symptomatic illness with just one shot, not as strong as some two-shot rivals but still potentially helpful for a world in dire need of more doses. Johnson & Johnson said Jan. 29 that in the U.S. and seven other countries, the first single-shot vaccine appears 66% effective overall at preventing moderate to severe COVID-19. It was more protective against severe symptoms, 85%.