In a Wednesday news release, the company confirmed its launch of the Phase 3 trial for its COVID-19 vaccine, known as JNJ-78436735, which is being developed by the Janssen Pharmaceutical Companies, a subsidiary of Johnson & Johnson. The final trial comes after the company’s Phase 1/2a clinical trial indicated the vaccine was safe and effective enough to warrant further development. This final trial will involve 60,000 volunteers across three continents and will test a single vaccine dose versus a placebo in preventing COVID-19.
According to its news release, the company is also scaling up its manufacturing capacity, hoping to be able to produce 1 billion doses of the vaccine annually. The release also notes that the company is committed to providing an affordable vaccine to the public on a not-for-profit basis and hopes that the first batches of the drug will be available for emergency use authorization in early 2021, if the Phase 3 clinical trial shows it to be safe and effective.
“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 Johnson & Johnson Chairman and CEO Alex Gorsky.
“As the world’s largest healthcare company, we are bringing to bear our best scientific minds, and rigorous standards of safety, in collaboration with regulators, to accelerate the fight against this pandemic. This pivotal milestone demonstrates our focused efforts toward a COVID-19 vaccine that are built on collaboration and deep commitment to a robust scientific process. We are committed to clinical trial transparency and to sharing information related to our study, including details of our study protocol,” Gorsky added.
In a statement this week, director of the US National Institute of Allergy and Infectious Diseases Dr. Anthony Fauci confirmed that there are currently four COVID-19 vaccine candidates undergoing Phase 3 clinical testing in the US, which are being developed by Johnson & Johnson, Moderna, Pfizer and AstraZeneca.
“It is likely that multiple COVID-19 vaccine regimens will be required to meet the global need. The Janssen candidate has showed promise in early-stage testing and may be especially useful in controlling the pandemic if shown to be protective after a single dose,” Fauci said.
This latest development comes after US President Donald Trump said last week that the US could have a safe and effective vaccine as soon as October and enough doses to vaccinate every American by April.