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CHICAGO: Johnson & Johnson kicked off a 60,000-person final trial of a single-shot COVID-19 vaccine on Wednesday (Sept. 23) that would potentially simplify the distribution of millions of doses compared to leading rivals using two doses.
The company expects the results of the phase three trial by the end of the year or early next, said Dr. Paul Stoffels, J & J’s chief scientific officer, in a joint news conference with officials from the National Institutes of Health and the Trump administration.
Rival vaccines from Moderna, Pfizer and AstraZeneca require two injections several weeks apart, making them much more difficult to administer.
“The benefits of a single injection vaccine are potentially profound in terms of mass immunization campaigns and control of the global pandemic,” Dr. Dan Barouch, a Harvard vaccine researcher who helped design the COVID vaccine, said in a telephone interview. -19 from J&J.
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Stoffels said J&J would post a detailed study protocol for its phase 3 trial Wednesday on the company’s website, joining the other three vaccine manufacturers that have made these study plans available in recent weeks after the requests for greater transparency in testing.
Stoffels said that J&J began phase 3 testing after seeing positive results in its phase 1 and 2 testing in the United States and Belgium. The company plans to publish those results imminently.
Stoffels said the safety and level of protection in the study were on par with what was seen in the company’s animal studies, and said the results showed that a single dose could offer sufficient protection “for a long time.” . J & J’s last stage trial will use up to 215 sites in the United States, South Africa, Argentina, Brazil, Chile, Colombia, Mexico and Peru. The company plans to make up to 1 billion doses in 2021, and more after that, Stoffels said.
The aim of the trial is to test whether the vaccine can prevent moderate to severe COVID-19 after a single dose, but it will also look at whether the vaccine can prevent a serious illness that requires medical intervention and whether it can prevent milder cases of the disease. . virus.
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Stoffels predicts that it will take six weeks to two months to enroll in the trial, and said the company hopes to get an answer on whether the vaccine works “by the end of the year or the beginning of the next.”
It’s unclear how quickly the company could get regulatory approval, but J&J plans to manufacture doses before approval, so it could begin distribution quickly.
The trial will be overseen by an independent Data and Safety Monitoring Board (DSMB) that will review the safety and effectiveness of the vaccines. At the press conference, Dr. Francis Collins, director of the National Institutes of Health, said that the three vaccines organized and supported by the federal government’s Operation Warp Speed - J&J, Moderna and AstraZeneca – share a common DSMB. Pfizer is running its own test and has a separate DSMB, Collins said.
The J&J trial is designed to test a vaccine that is 60 percent effective. In the study protocol, that could be determined after 154 people were infected with the virus. Stoffels said the company will begin counting cases of COVID-19 infections within the study population 15 days after people are vaccinated.
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The DSMB will test the effectiveness of the vaccine for the first time after 20 people have been infected.
Collins said the DSMB does not include any federal employees and is made up of “very experienced” scientists and statisticians.
“Until they are convinced that there is something in there that looks promising, nothing is cleared up and it is sent to the FDA. So everyone should feel pretty calm,” Collins said. His comments follow concerns that government scientists may be pressured to speed up the vaccine testing process to push for the re-election of US President Donald Trump.
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