Johnson & Johnson launches large trial for two-dose version of vaccine
Johnson & Johnson launches large trial for a two-dose version of its coronavirus vaccine and aims to enroll 30,000 participants from around the world
- Johnson & Johnson is launching a large-scale trial to test two doses of its experimental COVID-19 vaccine
- It plans to enroll 30,000 participants worldwide and run it simultaneously with its 60,000-person trial testing one dose
- Recruitment into the study will complete in March 2021 and the trial will last for 12 months
- J&J’s vaccine uses genetic material from the coronavirus with the genes of the virus that causes the common cold to induce an immune response
- The news comes as Pfizer Inc and Moderna Inc both recently announced its coronavirus vaccines are 90% and 95% effective, respectively
Johnson & Johnson launched a new large-scale trial on Monday to test a two-dose regimen of its experimental COVID-19 vaccine.
The late-stage study will evaluate if a second dose provides longer protection than a standard one-dose vaccine.
The New Jersey-based drugmaker plans to enroll up to 30,000 participant 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 US, Belgium, Colombia, France, Germany, the Philippines, South Africa and Spain.
It comes on the heels of news that Pfizer Inc and Moderna Inc both announced their coronavirus vaccines – each of which are two doses – were highly effective.
Johnson & Johnson is launching a large-scale trial to test two doses of its experimental COVID-19 vaccine and enroll up to 30,000 participants. Pictured: The experimental vaccine being produced by Johnson & Johnson
The vaccine uses genetic material from the coronavirus with the genes of the virus that causes the common cold to induce an immune response. Pictured: The Johnson & Johnson logo is seen above an entrance to a building at their campus in Irvine, California, August 2019
Participants will be given a first dose of either a placebo or the experimental shot, currently called Ad26COV2, said Dr Saul Faust, a professor of pediatric immunology and infectious diseases, who is co-leading the trial at University Hospital Southampton.
This will be followed by a second dose or placebo 57 days later.
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.
Recruitment into the study will complete in March 2021 and the trial will last for 12 months.
‘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.
It comes as rival drugmakers Pfizer Inc and Moderna Inc announced that their potential COVID-19 vaccines are highly effective.
Last week, Pfizer announced its shot was more than 90 percent effective and, on Monday, Moderna announced its jab was 94.5 percent effective.
The news has raised hopes that vaccines against the disease that has killed more than 246,000 Americans may be ready for use soon.
Both Pfizer and Moderna’s vaccine use part of the pathogen’s genetic code called messenger RNA, or mRNA, to get the body to recognize the coronavirus and attack it if a person becomes infected.
They works by tricking the body into producing some of the viral proteins, which the immune system then recognizes and builds a defensive response against.
However, J&J’s vaccine combines genetic material from the new virus with the genes of the adenovirus – which causes the common cold – to induce an immune response.
It is the same technology the company used to make an experimental Ebola vaccine for people in the Democratic Republic of Congo in late 2019.
‘It’s really important that we pursue trials of many different vaccines from many different manufacturers and be able than to ensure the supply both to the UK and global population,’ Faust told reporters at a briefing.
In August, the Trump administration signed a contract with J&J saying it would pay more than $1 billion in exchange for 100 million doses of its potential coronavirus vaccine.
Under the deal, the government can order an additional 200 million doses of the vaccine.
The latest contract is priced at roughly $10 per vaccine dose, including a previous $456 million the government promised to J&J for vaccine development in March.
That compares with the $19.50 per dose the US is paying for the immunization being developed by Pfizer and its German partner BioNTech SE.
Meanwhile, the jab being developed by AstraZeneca and the University of Oxford is estimated to cost between $3 and $4 per dose.
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