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J&J Closes Final Study of Single-Shot Kovid-19 Vaccine in 60,000 Volunteers

CHICAGO: Johnson & Johnson on Wednesday kicked off the final 60,000-person trial of a single-shot Kovid-19 vaccine, which would potentially simplify the delivery of millions of doses compared to leading rivals using two doses.
The company expected the results of the Phase III trial by the end of next year or early next year, Drs. Paul Stoffels, J & J’s chief scientific officer, said at a joint press conference with officials from the National Institutes of Health and the Trump administration.
Rival vaccines of Modern Inc., Pfizer Inc. and AstraZeneca require two shots separating them for several weeks, making them more difficult to administer.
Harvard vaccine researcher Drs. “The benefits of a single-shot vaccine are potentially profound in the context of large-scale vaccination campaigns and global epidemic control,” Dan Barch said in a telephone interview.
Stoffels said Jammu and Kashmir will publish a detailed study protocol for its Phase 3 trial on the company’s website on Wednesday, including three other vaccine manufacturers who have in recent weeks called for these study plans to increase trials The latter is provided.
Stoffels said that J&J began Phase 3 testing after seeing positive results in its Phase 1/2 test in the United States and Belgium. The company plans to release those results imminently.
Stoffels said the level of safety and security in the study was comparable to what was seen in the company’s animal studies, and said the results suggest that a single dose may provide adequate protection “over a longer period of time.”
J & J’s late-stage trial will use 215 sites in the United States, South Africa, Argentina, Brazil, Chile, Colombia, Mexico and Peru. The company plans to make more than 1 billion doses in 2021, followed by Stoffels.
The goal of the test is to test whether the vaccine can prevent moderate to severe Kovid-19 after one dose, but also to see if the vaccine can prevent a serious disease requiring medical intervention and whether it is milk. May or may not prevent cases of the virus.
Stoffels predicted that it would take six weeks to two months to enroll for the trial, and said the company expected the vaccine to work “at the end of the year or early next year”.
It is not clear how soon the company may get regulatory approval, but Jammu and Kashmir plans to make the dose before approval, so it can start distribution early.
The test will be conducted by an independent data and safety monitoring board (DSMB) that will review vaccine safety and effectiveness. At the press conference, the director of the National Institutes of Health, Drs. Francis Collins said all three vaccines are supported by the federal government’s Operation Tana Speed ​​- J&JS, Modern K and AstraZeneca – share a common DSMB. Collins said that Pfizer is running its own trial and has a separate DSMB.
J & J’s trial is designed to test for a 60% effective vaccine. In the study protocol, it can be determined that 154 people were infected with the virus. Stoffels said the company would begin counting cases of Kovid-19 infection within the study population 15 days after vaccinating people.
DSMB will have its first impact on the efficacy of the vaccine after 20 people have been infected.
Collins said DSMB does not include any federal employees and is made up of “very highly experienced” scientists and statistical experts.
“As long as they are confident that there is something that looks promising, nothing is there and sent to the FDA. So everyone should feel very confident,” Collins said. His comments on government scientists’ concerns to accelerate the vaccine testing process to boost US President Donald Trump’s re-election bid may follow.


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