The pharmaceutical company Pfizer says that its developmental vaccine for COVID-19 may be 90% effective at inoculating people against the disease.
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.
Despite striking an agreement with the Trump administration in July to participate in Operation Warp Speed, a federal initiative to hasten the development and mass creation of a vaccine, the company is now attempting to distance itself from the program.
“We were never part of the Warp Speed,” Kathrin Jansen, a senior vice president and the head of vaccine research and development at Pfizer, told The New York Times. “We have never taken any money from the U.S. government, or from anyone.”
The Trump administration launched Operation Warp Speed to expedite vaccine creation around the beginning of the outbreak of the coronavirus in the United States. As early as May, Trump was predicting that the United States may have a viable vaccine by the end of the year.
“We think we’re going to have a vaccine by the end of this year, and we’re pushing very hard. You know, we’re building supply lines now – we don’t even have the final vaccine,” Trump said at a town hall on May 3. “We have many companies are, I think, close because I meet with the heads of them and I find it a very interesting subject because it’s so important, but I think we’ll have a vaccine by the end of the year.”
Should the vaccine be out by the end of the year, it likely won’t be widely available for some time. Early doses will be rationed among the most vulnerable populations while doses for the public at large will continue to be manufactured.
This article has been updated to reflect that Pfizer Senior Vice President Kathrin Jansen says that the company did not participate in Operation Warp Speed, despite announcing an agreement to partner with the U.S. government in July.