[ad_1]
Johnson & Johnson’s single-dose COVID-19 vaccine is less effective than currently authorized vaccines, new data shows, though it appears to be extremely effective against severe disease.
The J&J vaccine has been described as a “game-changer” in the campaign against the virus because it is a single dose regimen compared to all the others, which call for double doses. It also does not need to be kept frozen, allowing it to be distributed through normal vaccine supply chains without the need for new, expensive equipment.
But that comes at a price.
Results from a study of nearly 44,000 people suggest that its single dose will only be 66% effective – compared to more than 94% effective for Pfizer-BioNTech and Moderna’s double-dose vaccine.
The level of protection against moderate to severe COVID-19 infection was 72% in the United States, 66% in Latin America and 57% in South Africa, a month after vaccination, according to results from the company’s late-stage trial, released early Friday.
It was 85% effective against severe disease across all regions studied, the company said, and its effectiveness against severe disease increased over time with none of the vaccinated volunteers reporting severe disease more than 49 days after vaccination.
The candidate vaccine demonstrated complete protection against COVID-related hospitalization and death, a month after vaccination.
Protection was generally consistent across race and age groups – including adults over 60, who were overrepresented in the trial. About 60% of trial participants were white.
In South Africa, nearly all cases were due to infection with a variant from the B.1.351 lineage. Although the company said the vaccine was generally protective there, too, the lower rates of protection might reflect this different variant.
Side effects appear to be lower with this vaccine than the already approved ones.
The company reported that 9% of participants spiked a fever after injection, but less than 1% had a high fever. Overall, more people who received a placebo reported serious adverse events vaccination than those who received the active vaccine. No one suffered a severe allergic reaction, according to the company.
Both Pfizer-BioNTech and Moderna’s vaccines were authorized for use late last year and at least one shot of each has now been given to more than 24 million Americans.
A vaccine that can be given in just one dose and stored in a standard refrigerator would make a significant contribution to the fight against COVID-19, said Moncef Slaoui, who helped run Operation Warp Speed during the Trump Administration and is now an advisor to the Biden Administration.
“From a public health standpoint, if you get one shot and within a week or two from that shot you’re now vaccinated, and the vaccine can be stable at fridge temperatures, it’s so much easier (than current vaccines),” he said. “Look how difficult it is to vaccinate people. If you cut that by 50%, it’s transformational.”
J&J decided to pursue its single-dose approach at a time when the effectiveness of the other vaccines was not known and the U.S. Food and Drug Administration said it would approve any vaccine that was safe, appropriately manufactured and more than 50% effective.
Explore how COVID-19 vaccine works: An augmented reality journey into the body
Now, the public is unlikely to be happy a vaccine with less than 70% effectiveness, Slaoui said, but “anything in the 70s or 80s is very, very good.”
The company could provide booster shots later, if necessary to improve effectiveness, he said.
J&J tested its vaccine in 44,000 adults in the United States as well as Mexico, South Africa and several countries in South America. The trial overrepresented people over 60 and members of minority communities who are more likely to suffer serious or fatal cases of COVID-19.
Half the participants received the active vaccine and half a placebo.
The company also is conducting a parallel trial in the U.K. testing two doses of its vaccine to see if that boosts its effectiveness. That trial will include up to 30,000 volunteers from Belgium, Colombia, France, Germany, the Philippines, South Africa, Spain, the United Kingdom and the United States. Results from that trial won’t be available for another few months.
Because of the newness of the virus that causes COVID-19, which only came to the world’s attention a little more than a year ago, all three vaccines have only been studied for their short-term effectiveness.
Generally, a second dose of a vaccine is expected to boost its effectiveness and the longevity of its protection.
J&J’s vaccine is based on a different technology than the other two authorized vaccines.
J&J uses a cold virus called adenovirus 26, which has been genetically modified so that it can no longer replicate in humans and cause disease. The modified virus infects human cells and delivers a protein found on the outside of the SARS-CoV-2 virus that causes COVID-19.
Although a second dose is believed to boost effectiveness, repeat dosing beyond that might not be effective, as the immune system can learn to recognize the adenovirus and will clear it out of the body before it can deliver its payload.
The company’s AdVac® technology platform was also used to develop and manufacture its approved Ebola vaccine and its Zika, RSV, and HIV candidate vaccine, which are still being developed. So far, the technology has been tested in more than 200,000 people as part of clinical trials, including the ones for COVID-19.
The COVID-19 vaccine is estimated to remain stable for two years at -4°F and at least three months at 35-36°F, so it could be distributed relatively easily through standard vaccine distribution channels.
The Trump administration bought 200 million doses of each of the Pfizer-BioNTech and Moderna vaccines – with 100 million of each due by the end of March and the balance by summer – and spent nearly $1.5 billion helping J&J develop its vaccine and produce 100 million doses.
Those doses are expected to begin to become available as soon as use of the vaccine is authorized, with the full amount expected this summer.
J&J has said it will quickly submit is candidate vaccine to the FDA for authorization, which is expected to come next month.
Contact Karen Weintraub at kweintraub@usatoday.com.
Health and patient safety coverage at USA TODAY is made possible in part by a grant from the Masimo Foundation for Ethics, Innovation and Competition in Healthcare. The Masimo Foundation does not provide editorial input.
[ad_2]
