9 November 2020 – The pharmaceutical company Pfizer and their partner, BioNTech, said on Monday their Phase 3 trials vaccine data show effective evidence of preventing COVID-19 with a 90% success rate.
The company announced the news in a statement issued Monday morning. The rate of effectiveness was calculated by analyzing early data from 94 trial participants in a study involving 43,538 subjects from all over the world. The small early sample means that the protection rate could change by the time the study ends and all the participants are accounted for, according to The Associated Press.
“Today is a great day for science and humanity. The first set of results from our Phase 3 COVID-19 vaccine trial provides the initial evidence of our vaccine’s ability to prevent COVID-19,” Pfizer Chairman and CEO Dr. Albert Bourla said in a statement.
“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,” Bourla continued. “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.”
The company said that it plans to apply for Emergency Use Authorization from the U.S. Food and Drug Administration (FDA) later this month after passing certain safety thresholds. The FDA has required that companies study the effects of their vaccines in at least 30,000 subjects, including people considered elderly and others in high-risk categories. Those subjects must then be monitored for adverse side-effects for at least two months. Pfizer is poised to meet that criteria for its vaccine by the end of November, according to the AP.
According to Statsnews, the vaccine is the first to be tested in the United States to generate late-stage data. The companies said an early analysis of the results showed that individuals who received two injections of the vaccine three weeks apart experienced more than 90% fewer cases of symptomatic Covid-19 than those who received a placebo. For months, researchers have cautioned that a vaccine that might only be 60% or 70% effective.
The Phase 3 study is ongoing and additional data could affect results.