Nov. 9, 2020 -- Pharmaceutical giant Pfizer says data from clinical trials shows its experimental coronavirus vaccine is 90% effective, and company leaders say they hope to seek emergency use authorization from the FDA this month.
The news about Pfizer’s vaccine sent the U.S. stock market soaring on Monday. Pfizer is one of several companies racing to develop a vaccine for the virus, which has killed more than 1.2 million people worldwide and upended life around the globe.
In a news release, the company said more than 43,000 people are enrolled in phase III of the clinical trials, with half of the people receiving the vaccine and half receiving a placebo. Ninety-four confirmed cases among participants were studied.
The company didn’t specify how many people who received the vaccine became infected, but said “the case split between vaccinated individuals and those who received the placebo indicates a vaccine efficacy rate above 90%, at 7 days after the second dose. This means that protection is achieved 28 days after the initiation of the vaccination, which consists of a 2-dose schedule.”
That 90% efficacy rate is far above the 50% benchmark the FDA says it wants to see in the vaccine.
“Today is a great day for science and humanity," Albert Bourla, PhD, Pfizer's chairman and chief executive, said in the release. "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’s partner in the vaccine is German company BioNTech. Ugur Sahin, MD, BioNTech co-founder and CEO, said in the release that researchers will keep collecting data until 164 confirmed cases have been studied.
“When we embarked on this journey 10 months ago this is what we aspired to achieve,” he said. “Especially today, while we are all in the midst of a second wave and many of us in lockdown, we appreciate even more how important this milestone is on our path towards ending this pandemic and for all of us to regain a sense of normality.”
In July, Pfizer signed a $1.95 billion contract with the U.S. government to deliver hundreds of millions of doses of a vaccine. The company and the U.S. Department of Health and Human Services said the vaccine would be free to Americans.
In its Monday news release, Pfizer said it expected to produce up to 50 million vaccine doses in 2020 and up to 1.3 billion doses in 2021.
The vaccine uses messenger RNA in different combinations to targeted antigens, with the goal of producing antibodies.
The news release said Pfizer hopes to finish collecting safety data in the third week of November so it can submit information for the emergency use authorization. The FDA insists that people who are in a clinical trial must be studied for 2 months after receiving their second dose of the vaccine.
The news release said the primary “endpoint” of the clinical trials is to evaluate confirmed cases 7 days after the second dose of the vaccine. Pfizer will also include a secondary endpoint of evaluating confirmed cases 14 days after the second dose.
“The companies believe that the addition of these secondary endpoints will help align data across all COVID-19 vaccine studies and allow for cross-trial learnings and comparisons between these novel vaccine platforms,” the release said.