CHICAGO, Jul 30 (Reuters) – Johnson & Johnson launched human security trials in the US for its COVID-19 vaccine on Thursday after publishing details of a study in monkeys that showed its best-performing candidate vaccine offered a strong protection in a single dose.
When exposed to the virus, six out of six animals that received the candidate vaccine were fully protected from lung disease and five out of six were protected from infection, as measured by the presence of virus in nasal swabs, according to the study published in Magazine. Nature.
“This gives us confidence that we can test a single injection vaccine in this epidemic and know if it has a protective effect on humans,” Dr. Paul Stoffels, chief scientific officer at J&J, told Reuters in a telephone interview.
The US government is backing J & J’s vaccine effort with $ 456 million in funding as part of a wave of spending aimed at speeding up production of a vaccine to end the pandemic, which has infected millions and killed more than 660,000 people.
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Seattle coronavirus vaccine test
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A pharmacist gives Jennifer Haller, left, the first injection in the first-stage safety study clinical trial of a potential vaccine for COVID-19, the disease caused by the new coronavirus, on Monday, March 16, 2020, at the Kaiser Permanente Washington Health Research Institute in Seattle. (AP Photo / Ted S. Warren)
Jennifer Haller poses for a photo in her living room on Monday, March 16, 2020, in Seattle. Earlier in the day, Haller was the first person to receive an injection of a potential vaccine for COVID-19, the disease caused by the new coronavirus, at the start of the vaccine clinical trial in the first-stage safety study in the Kaiser Permanente Washington Health Research Institute in Seattle. (AP Photo / Ted S. Warren)
Pharmacist Michael Witte opens a package from a freezer containing the potential vaccine for COVID-19, the disease caused by the new coronavirus, on the first day of a clinical trial of the first-stage safety study vaccine, Monday. March 16. 2020, at the Kaiser Permanente Washington Health Research Institute in Seattle. (AP Photo / Ted S. Warren)
Pharmacist Michael Witte, left, gives Rebecca Sirull, right, a clinical trial injection of the first stage of the safety study of a possible vaccine for COVID-19, the disease caused by the new coronavirus, Monday, March 16, 2020, at the Kaiser Permanente Washington Health Research Institute in Seattle. Sirull is the third patient to receive the injection in the study. (AP Photo / Ted S. Warren)
Jennifer Haller reflects in a mirror while waiting in an examination room before receiving an injection in the first-stage clinical trial of the safety study of a possible coronavirus vaccine, Monday, March 16, 2020, at the Kaiser Permanente Washington Health Research Institute in Seattle. Haller was the first person to receive the injection in the study. (AP Photo / Ted S. Warren)
Pharmacist Michael Witte, left, gives Neal Browning, right, a clinical trial injection of the first stage of the safety study of a possible vaccine for COVID-19, the disease caused by the new coronavirus el Monday, March 16, 2020 at the Kaiser Permanente Washington Health Research Institute in Seattle. Browning is the second patient to receive the injection in the study. (AP Photo / Ted S. Warren)
The first clinical trials to find a coronavirus vaccine began at a Seattle hospital. A total of 45 men and women have volunteered to inject. Unlike most vaccines, these COVID-19 vaccines have not been tested in mice and will be shipped directly to humans due to the urgent need for the drug. Lisa Guerrero spoke to Neal Browning, one of the men participating in the trial. She explained what has to happen as part of this brave new experiment.
The first clinical trials to find a coronavirus vaccine began at a Seattle hospital. A total of 45 men and women have volunteered to inject. Unlike most vaccines, these COVID-19 vaccines have not been tested in mice and will be shipped directly to humans due to the urgent need for the drug. Lisa Guerrero spoke to Neal Browning, one of the men participating in the trial. She explained what has to happen as part of this brave new experiment.
Pharmacist Michael Witte, left, gives Rebecca Sirull, right, an injection in the first-stage clinical trial of the safety study of a possible coronavirus vaccine, Monday, March 16, 2020, in the Kaiser Permanente Washington Health Research Institute in Seattle. Sirull is the third patient to receive the injection in the study. (AP Photo / Ted S. Warren)
Dr. Lisa Jackson, principal investigator at the Kaiser Permanente Health Research Institute in Washington, poses for a photo on Sunday, March 15, 2020 in Seattle. Jackson is leading the first-stage safety study clinical trial of a possible vaccine against COVID-19, the disease caused by the new coronavirus, which was administered to the study’s first volunteer by injection on Monday, March 16 in Seattle. (AP Photo / Ted S. Warren)
Dr. Lisa Jackson, principal investigator at the Kaiser Permanente Health Research Institute in Washington, works in her office with an image of COVID-19 taped to her door on Sunday, March 15, 2020, in Seattle. Jackson is leading the first-stage safety study clinical trial of a possible vaccine against COVID-19, the disease caused by the new coronavirus, which was administered to the first volunteer in the study by injection, Monday, March 16. (AP Photo / Ted S. Warren)
Rebecca Sirull, center, poses for a photo with roommates Anna Thomas, left, and Madeleine Busch, Monday, March 16, 2020, at their shared home in Seattle. Earlier in the day, Sirull was the third person to receive an injection of a potential coronavirus COVID-19 vaccine at the start of the first-stage clinical trial of the vaccine safety study at the Kaiser Permanente Washington Health Research Institute in Seattle. . (AP Photo / Ted S. Warren)
Rebecca Sirull works on her laptop on Monday March 16, 2020 at her home in Seattle. Earlier in the day, Sirull, an editorial coordinator for the Institute of Health Metrics and Assessment, was the third person to receive an injection of a potential coronavirus COVID-19 vaccine at the start of the first-ever safety study clinical trial. Vaccine stage at the Kaiser Permanente Washington Health Research Institute in Seattle. (AP Photo / Ted S. Warren)
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Stoffels said previous tests of this type of vaccine on other diseases found that a second injection significantly increases protection. But in a pandemic, a single shot vaccine has a significant advantage, bypassing many of the logistical problems involved in getting people back for their second dose.
The company plans to address the issue of one or two doses in its phase 1 trial, which started this week in the United States.
Depending on those results, J&J plans to begin large-scale phase 3 testing with a one-shot regimen in the second half of September. At about the same time, the company will begin a phase 3 parallel study to test a two-injection regimen of the vaccine, Stoffels said.
The J&J vaccine uses a common cold virus known as adnovirus type 26 or Ad26 to transport coronavirus proteins to the cells of the body, causing the body to mount an immune defense against the virus.
In the monkey study, scientists at J&J and Harvard’s Beth Israel Deaconess Medical Center studied seven different potential vaccines in 32 animals and compared the results with 20 control animals that received placebo injections.
Six weeks later, all animals were exposed to the SARS-CoV-2 virus. The 20 animals that received the placebo developed high levels of the virus in their lungs and nasal samples.
In the best-performing candidate, which J&J selected for the human test, none of the animals had viruses in the lungs and only one showed low levels of virus in the nasal swabs. Laboratory tests showed that everyone had developed antibodies capable of neutralizing the virus after a single injection.
“This study shows that even a single immunization with the Ad26 vaccine leads to neutralizing antibody responses and robust protection of monkeys against COVID-19,” said Dr. Dan Barouch, vaccine researcher at Beth Isreal Deaconness who led the research. in collaboration with J&J.
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