July 13 (UPI) -- U.S. pharma giant Pfizer and BioNTech announced Monday that they have received "fast track" designation from U.S. health officials for two COVID-19 vaccine candidates.
The companies said the designation from the Food and Drug Administration -- a process used by reguators to speed the development and review of potential drugs and vaccines -- means a large-scale human trial of their BNT162b1 and BNT162b2 candidates could begin as soon as this month.
"The FDA's decision to grant these two COVID-19 vaccine candidates Fast Track designation signifies an important milestone in the efforts to develop a safe and effective vaccine against SARS-CoV-2 [the novel coronavirus that causes COVID-19]," Pzizer Senior Vice President Peter Honig said in a statement.
The FDA granted fast-track status based on preliminary data from ongoing studies in the United States and Germany, as well as earlier animal studies.
Pfizer and BioNTech are evaluating at least four experimental vaccines in its BNT162 program, all based on an mRNA, or "messenger RNA," technique -- which, unlike traditional vaccines, does not use an inactivated virus but rather a portion of the coronavirus' own genetic code to trigger production of antibodies.
The initial results of the Phase 1 and 2 studies, published earlier this month, showed that all 24 participants who received lower dose levels of the BNT162b1 candidate generated antibodies against COVID-19.
Some of the antibodies were found to be "neutralizing," or sufficiently powerful to halt the virus. Pfizer called the results encouraging because the vaccine succeeded in activating antibody responses at least as robust as convalescent sera -- the antibody collected from patients who have recovered from COVID-19.
The companies said last month they're preparing to produce millions of vaccine doses this year and hundreds of millions in 2021.
Other vaccine candidates have also shown early promise in fighting COVID-19, including potential drugs from Inovio Pharmaceuticals, Moderna and China's CanSino Biologics.