Johnson & Johnson Announces Single Shot Phase III Trials On 60,000 Volunteers 

The benefits of a single-shot vaccine are potentially profound in terms of mass immunization campaigns and global pandemic control

Johnson & Johnson began a 60,000 person trial of an experimental single-shot Covid-19 vaccine on Wednesday that could potentially simplify the distribution of millions of doses compared to the leading rivals using two doses. It plans to manufacture about 1 billion doses in 2021 and more after that.

“As COVID-19 continues to impact the daily lives of people around the world, our goal remains the same – leveraging the global reach and scientific innovation of our company to help bring an end to this pandemic,” said Alex Gorsky, Chairman, and Chief Executive Officer, Johnson & Johnson.

Dr. Paul Stoffels, J&J’s chief scientific officer said, in a joint news conference with officials from the National Institutes of Health and the Trump administration, that the company expects results of the Phase III trial by the end of this year or by the beginning of next year. Meanwhile, the rival vaccines from Moderna Inc, Pfizer Inc and AstraZeneca require two shots separated by several weeks, which will take time and make them more difficult to administer.

Dr. Dan Barouch, a Harvard vaccine researcher who helped design J&J’s Covid-19 vaccine, said, “The benefits of a single-shot vaccine are potentially profound in terms of mass immunization campaigns and global pandemic control.”

There is no need of storing the J&J vaccine at extremely cold temperatures which is an advantage over the other rival vaccine candidates, said Barouch.

A detailed study protocol is also published by Johnson & Johnson for its phase 3 trial process on the company’s website; joining the three other vaccine makers that have made these study plans available in recent weeks after calls for increased transparency in the trials.

Hence, Stoffels mentioned J&J started the phase 3 trial after seeing positive results in its phase 1/2 trial in the United States and Belgium and the company plans to release those results soon.

Meanwhile, U.S. President Donald Trump posted a tweet saying, “Big news. Numerous great companies are seeing fantastic results. FDA (Food and Drug Administration) must move quickly,”

The goal of the trial is to check whether the vaccine can prevent moderate to severe Covid-19 cases after a single dose. It will also test to see whether it can prevent other serious disease requiring medical intervention and can it prevent the milder cases of the virus.

It is not apparent how fast the company could get regulatory approval, but J&J plans to manufacture doses before approval so that it could start distribution quickly. This trial is specially designed to test for a vaccine that is 60%effective.

The trial will be inspected by an independent Data and Safety Monitoring Board (DSMB) that will review vaccine safety and effectiveness.

Dr. Francis Collins, director of the National Institutes of Health, said all three of the vaccines being organized and supported by the federal government’s Operation Warp Speed – J&J’s, Moderna’s, and AstraZeneca’s – share a common DSMB while Pfizer is running its trial and has a separate DSMB.

“Until they are convinced that there’s something that looks promising, nothing is unblinded and sent to the FDA. So everybody should feel pretty reassured,” said Collins.

 

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