The first single COVID-19 vaccine provides good protection against the disease, Johnson & Johnson said in a key study released Friday, giving the world a potentially important new tool as it struggles 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 Pfizer’s or Moderna’s two-dose formula and was significantly weaker than a worryingly mutant version of the South African virus.
But against the background of a rocky start to global vaccinations, which can be an acceptable compromise to make more people inoculate faster with an easier-to-handle shot that, unlike rival vaccines that need to be kept frozen, can take months in the refrigerator.
“Honestly, it’s simple,” said Dr. Matt Hepburn, the US government’s leader in response to the COVID-19 vaccine.
J&J intends to apply for emergency use permits in the US within a week. It expects to deliver 100 million US doses by June – and a billion doses globally 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.
Defeating the scourge that has killed more than 2 million people worldwide will require the vaccination of billions. Images released in different countries so far require two doses a few weeks apart for complete protection. Nearly 23 million Americans have received a first dose of Pfizer or Moderna vaccines since vaccinations began last month, but less than 5 million have received a second dose.
Also on Friday, regulators removed the third option, the AstraZeneca vaccine, for use throughout the European Union. The decision came amid criticism that the bloc of 27 nations is not moving fast enough, as well as concern that there is not enough data to say how well the vaccine works in the elderly.
J&J studied its single-dose option in 44,000 people in the United States, Latin America and South Africa. The interim results found that the shot was 66% effective in preventing moderate to severe COVID-19 and much more protective – 85% – against the worst symptoms. There were no serious side effects.
“Single-dose gambling is definitely worth it,” Dr. Mathai Mammen, global head of research for Janssen J & J’s pharmaceutical unit, told 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.
Reduced protection against this mutation is “really a wake-up call,” said Dr. Anthony Fauci, the world’s leading infectious disease expert.
The more the virus is allowed to spread, the more opportunities it has to move. Vaccine manufacturers are looking at how to edit their photos if necessary.
For now, the findings are an incentive “to vaccinate as many people as possible,” Fauci said.
Data is mixed on how well other vaccines used around the world work, but Pfizer and Moderna photos have been 95% protection in large US studies.
It’s not fair to compare studies done before the record rose in recent months and the discovery of new mutants – it may not be the same today, warned Dr. Jesse Goodman of Georgetown University, former head of FDA vaccines.
J&J protection is “good enough to help attack a pandemic,” Goodman said. The advantage of having more vaccine in one go would be significant.
The researchers looked at diseases that started 28 days after vaccination – about when, if participants received a variety of two doses in return, they would have needed another shot.
After Day 28, no one who was vaccinated needed hospitalization or died, whether they were exposed to the original virus or “these particularly ugly variants,” Mammen said. When the vaccines 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 covers it. But they are done in very different ways.
J & J’s shot uses a virus as cold as a Trojan horse to carry the spike gene into the body, where cells make harmless copies of the protein to create the immune system where the real virus appears. It is the same technology used by the company to make a successful Ebola vaccine.
It is similar to how the two-dose AstraZeneca vaccine is made, although it is not clear how well that vaccine works. Tests in the UK, South Africa and Brazil have suggested that two doses are about 70% effective. An ongoing US study may provide more information.
Yet another vaccine is in the final test: Novavax reported this week that his vaccine appears to be 89% effective in a British study and appears to work – though not as well – against new mutant versions of the virus circulating in the UK and South Africa. A larger study in the US and Mexico still enrolls volunteers.
Wall Street appeared unhappy with J & J’s results, with shares falling 4.2% in early trading, a rare drop for the world’s largest medical product maker. Its shares fell $ 4.07, or 2.4%, to $ 165.09 when trading in the middle of the morning.
Instead, the small Novavax saw shares rise, jumping 71% to $ 229.72 in mid-morning trading.
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The Associated Press Department of Health and Science receives support from the Howard Hughes Medical Institute’s Department of Science Education. AP is solely responsible for all content.