Johnson & Johnson reported in a key study released Friday that it offered the world a potentially important new tool as it runs to stay ahead of the rapidly mutating virus.
Preliminary findings from the pharmaceutical giant suggest that the single-dose option may not be as strong as the two-dose formula from Pfizer or Moderna and that it was markedly weaker compared to a worryingly mutated version of the virus in South Africa.
But amid a rocky start to vaccines around the world, this can be an acceptable compromise to get more people inoculated faster with an easier-to-handle shot that, unlike rival vaccines that need to be kept frozen, can last months in the fridge.
“Frankly, the simple is beautiful,” said Dr. Matt Hepburn, leader of the U.S. government’s response to the U.S. government’s COVID-19 vaccine.
J&J plans to apply for emergency use authorization in the United States within a week. It expects to supply 100 million doses in the United States in June (and one billion doses worldwide by the end of the year), but declined to say how much it could be ready if the Food and Drug Administration gave the green light. .
To beat the scourge that has killed more than 2 million people worldwide, billions will have to be vaccinated. Traits that are being developed in different countries so far require two separate doses a few weeks for complete protection. About 23 million Americans have received a first dose of Pfizer or Moderna shots since vaccines began last month, but fewer than 5 million have received their second dose.
Also on Friday, regulators authorized a third option, the AstraZeneca vaccine, to be used throughout the European Union. The decision came amid criticism that the 27-country bloc is not moving fast enough, as well as concern that there is not enough data to explain how the vaccine works in the elderly.
J&J studied its dose option in 44,000 people in the US, Latin America and South Africa. Provisional results found that the shot was 66% effective overall to prevent moderate to severe COVID-19 and much more protective (85%) against the most severe symptoms. There were no serious side effects.
“The game with a dose was worth it,” Dr. Mathai Mammen, head of global research at J&J’s Janssen Pharmaceutical Unit, told The Associated Press.
The vaccine worked best in the United States (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 this mutation is “really a wake-up call,” said Dr. Anthony Fauci, the top American expert on infectious diseases.
The more the virus is allowed to spread, the more chances it has to mutate. Vaccine manufacturers are studying how to alter their traits if necessary.
For now, the findings are an incentive “to vaccinate as many people as we can,” Fauci stressed.
Data are mixed on the performance of other vaccines used around the world, but Pfizer and Moderna shots were 95% protection in large U.S. studies.
It is not fair to compare studies conducted before the record rises of recent months and the discovery of new mutants; they may not be the same today, warned Dr. Jesse Goodman of Georgetown University, a former FDA vaccine chief.
J&J protection is “good enough to help attack a pandemic,” Goodman said. “The advantage of having more vaccine, in one shot, would be significant.”
The researchers tracked diseases that began 28 days after vaccination, at about the time when, if participants received a variety of two doses, they would have needed another vaccine.
After day 28, no one who was vaccinated needed hospitalization or died, regardless of whether he was exposed to the original virus or “these particularly nasty variants,” Mammen said. When the vaccinators became infected, they had a milder disease.
All COVID-19 vaccines train the body to recognize the new coronavirus, usually by detecting the spiked protein that coats it. But they are made in very different ways.
The J&J shot uses a cold virus like a Trojan horse to carry the ear gene to the body, where cells make harmless copies of the protein to prepare the immune system in case the real virus appears. . It is the same technology used by the company to make an Ebola vaccine.
This is similar to the way the two-dose AstraZeneca vaccine is made, although it is not clear how accurately it works. Tests conducted in Britain, South Africa and Brazil suggested that two doses are about 70% effective. An ongoing study in the US may provide more information.
There is yet another vaccine in final testing: Novavax reported this week that its vaccine appears to be 89% effective in a British study and that it also appears to work, though not as well, against new mutated versions of the virus circulating in Britain and South Africa. A larger study in the U.S. and Mexico is still enrolling volunteers.
Wall Street seemed dissatisfied with J&J’s results, with a 4.2% drop in early operations, a rare big drop for the world’s largest manufacturer of health care products. Its shares fell $ 4.07, or 2.4%, to $ 165.09 in mid-morning trading.
In contrast, small Novavax saw shares soar, jumping 71% to $ 229.72 in mid-morning trading.
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The Associated Press Health and Science Department is supported by the Howard Hughes Medical Institute’s Department of Science Education. The AP is solely responsible for all content.