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Johnson & Johnson's coronavirus vaccine is fourth to begin Phase 3 trials in the United States

September 23, 2020. Summarized by summa-bot.

FILE - In this July 30, 2013, file photo, people walk along a corridor at the headquarters of Johnson & Johnson in New Brunswick, N.J. A Philadelphia jury has ruled that Johnson & Johnson and Janssen Pharmaceuticals must pay $8 billion in punitive damages over an antipsychotic drug linked to the abnormal growth of female breast tissue in boys. A law firm for the plaintiff released a statement Tuesday, Oct. 8, 2019, saying the companies used an organized scheme to make billions of dollars while illegally marketing and promoting the drug called Risperdal. (AP Photo/Mel Evans, File)

Johnson & Johnson's Covid-19 vaccine candidate begins Phase 3 trials in the United States today. Trials for the single-dose vaccine will include up to 60,000 adult participants at nearly 215 sites in the US and internationally.

(CNN)Johnson & Johnson's Covid-19 vaccine candidate begins Phase 3 trials in the United States today.

Trials for the single-dose vaccine will include up to 60,000 adult participants at nearly 215 sites in the US and internationally.

Phase 3 trials will begin immediately, with the first participants receiving doses on Wednesday, Johnson & Johnson Chief Scientific Officer Dr. Paul Stoffels said on a call with reporters.

The vaccine candidate was developed by Janssen Pharmaceutical Companies, a subsidiary of Johnson & Johnson.

Johnson & Johnson is now the fourth company to begin large-scale clinical trials for a Covid-19 vaccine in the United States, behind Moderna, Pfizer/BioNTech and AstraZeneca.

While the other vaccine candidates require two doses, Johnson & Johnson's candidate will be studied as a single-dose vaccine, which should expedite results, said Stoffels.

Initial findings from the vaccine's Phase 1/2 trials in the United States and Belgium suggest that a single dose of the vaccine provokes an immune response and is safe enough to move into large-scale trials.

The Phase 3 trial is being conducted in collaboration with Operation Warp Speed, the federal government's coronavirus vaccine effort.

Stoffels said the company plans to make diversity information about participants public and is committed to testing the vaccine in children after it has shown to be safe in the adult population.

The company said the technology has now been used to vaccinate more than 100,000 people for these diseases.

This endpoint is similar to that of the trials for the other three coronavirus vaccine candidates, Operation Warp Speed Vaccine lead Dr. Matthew Hepburn said on a call with reporters.

"Even as Operation Warp Speed was coming together, Our National Institutes of Health colleagues really said, as we do multiple vaccines and multiple clinical trials, we need to harmonize this process as much as possible," Hepburn said.

He said this will ensure all the vaccine candidates are meeting or exceeding the same regulatory bar.

"It's also going to allow us to compare, and that's great for the Janssen vaccine but it's also great for just truly understanding what will protect people from Covid-19, and I think that that insight now is going to pay off for years to come as we address this pandemic," Hepburn said.

On a call with reporters Tuesday, Dr. Anthony Fauci, National Institute of Allergy and Infectious Diseases director, said the timeline for a definitive reading on this vaccine, like the others, will depend on the events that happen during the trial.

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