July 28 (UPI) — U.S. pharmaceutical Pfizer and German biotech company BioNTech said they have started a late-stage human study of their coronavirus vaccine candidate.
In a statement on Monday, the companies said the trial will consist of up to 30,000 volunteers between the ages of 18 and 85 across 120 locations worldwide where there is significant transmission of COVID-19.
Those in the trial will receive a 30-microgram dose level of the vaccine in a two-dose regimen, it said.
“The initiation of the Phase 2/3 trial is a major step forward in our progress toward providing a potential vaccine to help fight the ongoing COVID-19 pandemic, and we look forward to generating additional data as the program progresses,” said Ugur Sahin, CEO and co-founder of BioNtech. “Many steps have been taken toward this important milestone and we would like to thank all those involved for their extraordinary commitment.”
The late-stage trial follows the success of a preliminary clinical phase that saw 120 patients demonstrate favorable overall tolerability to their candidate drug named BNT162b2, the companies said, adding that none of the patients exhibited serious adverse effects to the drug with some experiencing mild to transient issues, such as fever, fatigue and chills, for one to two days.
The next trial was designed as a 1 to 1 ratio of vaccine candidate to placebo with patients selected from countries such as Argentina, Brazil and Germany as well as from 39 U.S. states.
“If the Phase 2/3 trial is successful, Pfizer and BioNTech expect to be ready to seek Emergency Use Authorization or some form of regulatory approval as early as October 2020,” the companies said in the release. “If authorization or approval is obtained, the companies currently aim to supply globally up to 100 million doses by the end of 2020 and approximately 1.3 billion doses by the end of 2021.”
The announcement follows the U.S. government entering a $1.95 billion agreement with the two companies last week to produce and deliver 100 million doses of its COVID-19 vaccine by the end of the year. Earlier this month, they were also granted Fast Track designation by the U.S. Food and Drug Administration.
U.S. drugmaker Moderna on Monday also announced that it has begun a 30,000-patient, third-stage clinical trial of its COVID-19 vaccine candidate.