Drug giant Pfizer and its partner BioNTech said Monday they have approval to start an advanced trial of their experimental coronavirus vaccine in US volunteers.
The companies said the US Food and Drug Administration approved their plan for a phase 2/3 trial of the vaccine in the United States.
“Today, we are starting our late-stage global study, which will include up to 30,000 participants,” BioNTech founder Dr. Ugur Sahin said in a statement.
“Participants will be screened and dosed in the next few days,” a spokesperson for the company told CNN.
Earlier Monday, Moderna started a Phase 3 trial in the United States of its experimental vaccine. Pfizer’s vaccine is slightly different, but also uses an experimental approach that employs genetic material to stimulate an immune response against a key part of the coronavirus.
A Phase 2/3 study looks for a combination of safety, efficacy and optimal dosing of a vaccine or drug.
Last week the US Department of Health and Human Services and the Department of Defense announced an agreement with Pfizer for “large-scale production and nationwide delivery of 100 million doses of a Covid-19 vaccine in the United States following the vaccine’s successful manufacture and approval.” The $1.95 million deal also allowed the US government to acquire an additional 500 million doses.
Preliminary data released in a pre-print paper earlier this month from Pfizer and BioNTech said the vaccine appeared safe and elicited antibody and T-cell immune responses in a Phase 1/2 trial. The company had said it could start a Phase 3 trial of the vaccine in late July if it received regulatory approval.
“We selected BNT162b2 as our lead candidate for this Phase 2/3 trial upon diligent evaluation of the totality of the data generated so far. This decision reflects our primary goal to bring a well-tolerated, highly effective vaccine to the market as quickly as possible, while we will continue to evaluate our other vaccine candidates as part of a differentiated COVID-19 vaccine portfolio,” Sahin said. The companies have three other experimental vaccines in the works.
“By the end of the trial, the Phase 2/3 study is expected to be active at approximately 120 clinical investigational sites around the world, including 39 states across the United States and countries including Argentina, Brazil, and Germany. Investigator sites are selected based on factors including scientific expertise and capabilities, the epidemiology of the disease, and prior experience conducting clinical trials,” Pfizer said in the statement.