The first one-time COVID-19 vaccine offers good protection against the disease, Johnson & Johnson reported in a major study released Friday, providing the world with a potentially important new tool as it races to stay ahead of the rapidly mutating virus.
The pharmaceutical giant’s preliminary findings suggest that the single-dose option may not be as strong as Pfizer’s or Moderna’s two-dose formula, and was markedly weaker against a worrying mutant version of the virus in South Africa.
But in the midst of a slow start of vaccinations worldwide, that may be an acceptable trade-off to get more people vaccinated faster with an easier-to-handle injection that, unlike competing vaccines that must be kept frozen, can stay in the refrigerator for months.
“Honestly, simple is beautiful,” said Dr. Matt Hepburn, the US government’s leader in COVID-19 vaccination.
J&J plans to seek approval for emergency use in the US within a week. It expects to deliver 100 million doses to the US by June – and a billion doses worldwide by the end of the year – but declined to say how many could be ready if the Food and Drug Administration gives the green light.
To overcome the plague that killed more than 2 million people worldwide, billions must be vaccinated. The shots that have been rolled out in various countries so far all require two doses a few weeks apart for full protection. Nearly 23 million Americans have received a first dose of Pfizer or Moderna injections since the vaccinations began last month, but less than 5 million have received their second dose.
On Friday, regulators approved a third option, the AstraZeneca vaccine, for use across the European Union. The decision came amid criticism that the 27-country bloc is not moving fast enough, as well as concerns that there is not enough data to tell how well the vaccine works in older people.
J&J has investigated the single-dose option in 44,000 people in the US, Latin America and South Africa. Interim results showed that the injection was generally 66% effective in preventing moderate to severe COVID-19, and much more protective – 85% – against the most severe symptoms. There were no serious side effects.
“Single dose gambling was well worth it,” said Dr. Mathai Mammen, head of research worldwide for J & J’s Janssen Pharmaceutical division, at The Associated Press.
The vaccine worked better in the US – 72% effective against moderate to severe COVID-19 – compared to 66% in Latin America and 57% in South Africa, where a more contagious mutant virus is spreading.
The reduced protection against that mutation is “a real wake-up call,” said Dr. Anthony Fauci, America’s top infectious disease expert.
The more the virus is allowed to spread, the more possibilities it has to mutate. Vaccine manufacturers are exploring how to adjust their shots if necessary.
For now, the findings are an incentive to “vaccinate as many people as we can,” Fauci stressed.
There is mixed data on how well other vaccines in use around the world work, but the Pfizer and Moderna injections were 95% protective in large US studies.
It’s not fair to compare studies done before the record highs in recent months and the discovery of new mutants – they may not turn out to be the same today, Dr. Jesse Goodman of Georgetown University, a former FDA vaccine chef.
The J&J protections are “good enough to help fight a pandemic,” Goodman said. “The benefit of more vaccine, at one time, would be significant.”
Researchers tracked illnesses from 28 days after vaccination – about the time when, if participants received a two-dose variant instead, they needed one more injection.
After Day 28, no one who was vaccinated needed to be hospitalized or died, regardless of whether they were exposed to the original virus or “these particularly nasty variants,” Mammen said. When the vaccinees became infected, they had a milder disease.
All COVID-19 vaccines train the body to recognize the new coronavirus, usually by spotting the spikey protein that envelops it. But they are made in very different ways.
J & J’s shot uses a cold virus like a Trojan to deliver the spike gene into the body, where cells make harmless copies of the protein to boost the immune system in case the real virus comes along. It’s the same technology the company used to create a successful Ebola vaccine.
This is similar to how the vaccine with two doses of AstraZeneca is made, although it is not clear how well that vaccine works. Tests in Great Britain, South Africa and Brazil suggested that two doses are about 70% effective. An ongoing US study may provide more information.
Yet another vaccine is in the final testing phase: Novavax reported this week that the vaccine was found to be 89% effective in a UK study and that it also appears to work – albeit not so well – against new mutated versions of the virus circulating in Britain and South Africa. A larger study in the US and Mexico is still enrolling volunteers.
Wall Street seemed unhappy with J & J’s results, with stocks falling 4.2% in early trading, a rare big drop for the world’s largest health product manufacturer. The stock fell $ 4.07, or 2.4%, to $ 165.09 by mid-morning.
Small Novavax, on the other hand, saw its shares skyrocket, rising 71% to $ 229.72 in mid-morning trading.
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The Associated Press Department of Health and Science is supported by the Science Education Department of the Howard Hughes Medical Institute. The AP is solely responsible for all content.