November 16, 2020

J&J starts two-dose trial of its COVID-19 vaccine candidate

Rival drugmakers Pfizer and BioNtech said last week that their potential

COVID-19 shot showed more than 90%efficacy

The U.S. drugmaker plans to enrol up to 30,000 participants for the study. Reuters photo.

Johnson & Johnson launched a new large-scale late-stage trial on Monday to test a two-dose

regimen of its experimental COVID-19 vaccine and evaluate potential incremental benefits for

the duration of protection with a second dose.

The U.S. drugmaker plans to enrol up to 30,000 participants for the study and run it in parallel

with a one-dose trial with as many as 60,000 volunteers that began in September.

The UK arm of the study is aiming to recruit 6,000 participants and the rest will join from other

countries with a high incidence of COVID-19 cases such as the United States, Belgium,

Colombia, France, Germany, the Philippines, South Africa and Spain, it said.

They will be given the first dose of either a placebo or the experimental shot, currently called

Ad26COV2, followed by a second dose or placebo 57 days later, said Saul Faust, a professor

of paediatric immunology and infectious diseases who is co-leading the trial at University

Hospital Southampton.

The trial follows positive interim results from the company's ongoing early to mid-stage

clinical study that showed a single dose of its vaccine candidate induced a robust immune

response and was generally well-tolerated.

"The study will assess efficacy of the investigational vaccine after both the first and second

dose to evaluate protection against the virus and potential incremental benefits for duration of

protection with a second dose," J&J said in a statement.

Rival drugmakers Pfizer and BioNtech said last week that their potential COVID-19 shot

showed more than 90% efficacy in interim data from a late-stage trial, boosting hopes that

vaccines against the pandemic disease may be ready for use soon.

While the Pfizer-BioNtech vaccine uses a new technology known as messenger RNA, J&J's

uses a cold virus to deliver genetic material from the coronavirus into the body to prompt an

immune response.

The platform, called AdVac, is also used in an Ebola vaccine that was approved earlier this

year.

"It's really important that we pursue trials of many different vaccines from many different

manufacturers and be able then to ensure the supply both to the UK and global population,"

Faust told reporters at a briefing.

Recruitment into the study will complete inMarch 2021 and the trial will last for 12 months.


https://www.tribuneindia.com/news/health/jj-starts-two-dose-trial-of-its-covid-19-vaccinecandidate-

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