In a major development, American pharma giant Johnson & Johnson has launched the final trial of its COVID-19 vaccine.
The shot will be tested on tens of thousands of volunteers around the world, joining the ranks of coronavirus vaccines made by AstraZeneca, Moderna, and Pfizer – the three Trump administration-backed players that are already moving through late-stage trials.
Trial with 60,000 volunteers around the world
Under the trial, the Johnson & Johnson vaccine will be given to 60,000 volunteers at 215 sites in Argentina, Brazil, Chile, Colombia, Mexico, Peru, South Africa, and the United States.
The trial will be randomized and double-blind, where the participants would be given either the vaccine candidate or a placebo (for comparison), without them or the administrator knowing what they are taking or giving.
Single and double dose regimen will be tested
In the aforementioned countries, J&J will be testing a single dose regimen of the vaccine candidate dubbed Ad26.COV2.S.
If proven successful, it could be pretty effective in distribution as health workers would not have to call a person for a second dose.
A two-dose regimen will also be studied as part of a separate trial in the UK and Northern Ireland.
Study to look at large-scale safety and efficacy of vaccine
Following the inoculation at the chosen sites (most with a high incidence of COVID-19), the participants will be constantly monitored and tested for COVID-19.
The data from the Ad26.COV2.S-injected participants will be compared with that collected from placebo volunteers, with the ultimate goal of determining whether the vaccine generates a safe immune response and manages to reduce cases of moderate-to-severe COVID-19 or not.
Results likely by the end of this year
If the enrollment goes as planned, the results of the trial could come by the end of this year, following which the company could apply for emergency-use authorization with the FDA.
Meanwhile, the results from the three other front-runners in the global vaccine race – AstraZeneca, Moderna, and Pfizer – are expected as soon as next month.
Manufacturing also being scaled at the same time
In addition to the trials, J&J is also scaling up manufacturing to supply one billion doses of its vaccine each year.
The company has said it remains committed to bringing an affordable vaccine to the public on a not-for-profit basis and is in discussions with various stakeholders, including national governments and global organizations, to make it accessible globally.