Aug. 21 (UPI) — U.S. drugmaker Pfizer and partner BioNTech say their COVID-19 vaccine candidate is on track for regulatory review as soon as October, if it continues to provide positive results.
The companies provided more data Thursday on what they called “positive” results from the Phase 1 study for the vaccine candidate, BNT162b2.
A pivotal Phase 2/3 global study for the potential vaccine with as many as 30,000 participants is now underway.
“BNT162b2 remains under clinical study and is not currently approved for distribution anywhere in the world. Assuming clinical success, Pfizer and BioNTech are on track to seek regulatory review for BNT162b2 as early as October 2020,” they said in a statement. “If regulatory authorization or approval is obtained, [we] currently plan to supply up to 100 million doses worldwide by the end of 2020 and approximately 1.3 billion doses by the end of 2021.”
The companies said Phase 1 results showed the vaccine produced neutralizing antibodies against the virus that causes COVID-19 at rates 3.8 times higher than convalescent blood serum in younger patients after two doses.
Older patients, meanwhile, produced antibodies 1.6 times greater than sera and both groups saw fewer adverse side effects with BNT162b2 than they did with the companies’ initial vaccine candidate, BNT162b1, which was not advanced for further study.
The early trial included 195 U.S. participants who were administered varying amounts of both vaccine candidates on a two-dose schedule, 21 days apart.
Pfizer and BioNTech earlier reported that the BNT162b2 candidate produced favorable T cell responses against the novel coronavirus.
“The totality of the clinical and pre-clinical data informed Pfizer and BioNTech’s decision to select BNT162b2 as the lead candidate to advance into pivotal trials,” Pfizer Vice President Dr. Kathrin Jansen said in a statement.
“As of today, we have already dosed more than 11,000 participants with BNT162b2 in [the Phase 2/3] study,” added Dr. Ugur Sahin, CEO and co-founder of BioNTech.
In addition to the Pfizer-BioNTech effort, a vaccine candidate from Moderna has reached mid-to-late stage clinical trials and Johnson & Johnson is readying late-stage trials for its candidate next month.
A number of potential coronavirus vaccines are now in various stages of development. Click here for our COVID-19 vaccine tracker.
