By Zack Budryk, THE HILL, 11/09/20
Pfizer announced on Monday that late-stage data show that its vaccine candidate is over 90 percent effective in preventing COVID-19.
The drugmaker said it conducted an analysis of 94 confirmed cases in trial participants after enrolling 43,538 participants in a larger study. The company added that it hopes to have the amount of safety data required for a Food and Drug Administration Emergency Use Authorization by the third week of November.
The results indicate protection from the virus is achieved 28 days after the initial two-dose vaccine is administered, according to Pfizer.
“We are reaching this critical milestone in our vaccine development program at a time when the world needs it most with infection rates setting new records, hospitals nearing over-capacity and economies struggling to reopen,” Pfizer Chairman and CEO Albert Bourla said in a statement.
“With today’s news, we are a significant step closer to providing people around the world with a much-needed breakthrough to help bring an end to this global health crisis. We look forward to sharing additional efficacy and safety data generated from thousands of participants in the coming weeks,” he added.
“The first interim analysis of our global Phase 3 study provides evidence that a vaccine may effectively prevent COVID-19. This is a victory for innovation, science and a global collaborative effort,” Ugur Sahin the co-founder and CEO of BioNTech, a German firm that is partnering with Pfizer, added in a statement.
Anthony Fauci, the nation’s top infectious diseases expert, has previously said a vaccine with between 50 percent and 60 percent effectiveness would be effective for immunization.
Pfizer and German firm BioNTech said they intend to submit full phase 3 trial data for peer review. The companies project they will produce up to 50 million doses by the end of this year and as many as 1.3 billion doses in 2021.