Johnson & Johnson, the world’s largest health care company, announced Wednesday it is the launching large-scale Phase 3 trails of its coronavirus vaccine, becoming the fourth company to do so.
The company anticipates the first batches of the vaccine to be available for emergency use authorization in early 2021, if proven to be safe and effective, according to a statement from the company.
The other three companies that have announced the start of Phase 3 trials of COVID-19 immunizations include Moderna, Inc., a biotechnology company based in Cambridge, Massachusetts, Pfizer and BioNTech as well as AstraZeneca, a biopharmaceutical company based in Cambridge, England.
Earlier this month however, AstraZeneca announced it would be pausing all COVID-19 vaccine trials due to one of its recipients developing an unexplained illness.
Safety concerns and skepticism surrounding the development of a vaccine have been thrust into the spotlight in recent months, with the Trump administration pushing for a vaccine to start being administered across the country later this year or in January.
On Sept. 8, the leaders of nine biopharmaceutical companies, including Johnson & Johnson, signed a safety pledge, assuring the public that high scientific and ethical standards will be followed when developing any COVID-19 immunization.
In its statement Wednesday, Johnson & Johnson repeated that it will develop and test its vaccine candidate in accordance with “high ethical standards” and “sound scientific principles.”
“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,” Johnson & Johnson CEO Alex Gorsky said in the statement. “As the world’s largest health care 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."
The kickoff of the third phase study comes after Johnson & Johnson reported that results from Phase 1 and 2 trials met safety requirements needed for further development, according to the company’s statement. The results are expected to be published online shortly.
Based on the positive results and after discussions with the U.S. Food and Drug Administration, Phase 3, which the company has named the ENSEMBLE phase, will enroll up to 60,000 adult volunteers across three continents, the statement said.
The randomized Phase 3 study aims to include a significant number of volunteers over the age 60 as well as individuals who are of demographics that have been disproportionately impacted by the pandemic, including Black, Hispanic/Latinx, American Indian and Alaskan Native participants.
The New Jersey-based company added that it hopes to enroll participants in Argentina, Brazil, Chile, Colombia, Mexico, Peru, South Africa and the United States.
The ENSEMBLE study is being run in collaboration with the U.S. federal government’s Biomedical Advanced Research and Development Authority (BARDA).
The company has also agreed to collaborate with the United Kingdom on a separate Phase 3 clinical trial in multiple countries to explore a two-dose regimen of a vaccine candidate.
“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," Gorsky said of Wednesday’s announcement. “We are committed to clinical trial transparency and to sharing information related to our study, including details of our study protocol."
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Johnson & Johnson becomes 4th company to begin large-scale Phase 3 trials of COVID-19 vaccine in the United S - MassLive.com
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