Johnson & Johnson is planning to start a late-stage clinical trial of its experimental coronavirus vaccine in up to 60,000 people worldwide in late September.
If the company hits the enrollment aim, which was reported on a US government database, it would be the largest-ever study looking at a possible immunization for the virus.
Rival companies, such as Moderna Inc and Pfizer Inc, are only recruiting half as many volunteers, about 30,000 each for their respective late-stage studies.
A J&J spokesman told The Wall Street Journal the company wants ‘to enroll a robust number of participants who are representative of those populations affected by COVID-19.’
According to The Journal, the trial will be conducted at 180 locations in the US and eight other countries including Brazil, Chile, the Philippines and South Africa.
In the US, locations will be in 28 states such as California, Florida, Texas, the states with the most cases and among the highest transmission rates.
The spokesman said the New Jersey-based company hopes the trial will also determine safety, efficacy and the proper amount of dosing.
Subjects will be followed for at least two years but preliminary results will be published much sooner.
Dr William Schaffner, who is not part of the trial, a professor of preventive medicine at Vanderbilt University School of Medicine, said determining if the jab is effective could be easier with more subjects.
‘It will certainly speed up the evaluation process,’ he told The Journal.
The timeline is quite surprising given that J&J only recently began phase I clinical trials, testing safety and efficacy for a one-dose and two-dose jab, in the US and Belgium.
This places the company behind others such as AstraZeneca, Moderna and Pfizer, which have started phase III clinical trials looking at large-scale volunteer use and examines if the vaccine is better than what’s already available.
J&J’s vaccines 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.
Shares of the company rose marginally on Thursday, paring their earlier losses, after The Journal first reported the news.
The developments comes on the heels of news that US government will pay J&J more than $1 billion in exchange for 100 million doses of its potential coronavirus vaccine.
It’s the latest move by the Trump administration as it stocks up on inoculations and drugs in an attempt to tame the pandemic that has killed 173,000 Americans.
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 German biotech BioNTech SE.
Meanwhile, the jab being developed by AstraZeneca and the University of Oxford is estimated to cost between $3 and $4 per dose.
According to the World Health Organization, more than 100 COVID-19 vaccines are under development around the world and at least 23 are in human trials.