Pharmaceutical giant Pfizer, located in New York City, and its German partner BioNTech announced Monday that their COVID-19 vaccine has proven to be 90% effective in large-scale early testing.
The testing involved more than 43,000 people in the U.S. and other countries. No safety concerns have been observed, according to a press release from Pfizer. Some study participants received a placebo instead of the vaccine, and the results indicate those who contracted the virus during the testing period were given the placebo.
The company expects to submit its Emergency Use Authorization application to the federal Food and Drug Administration during the third week in November.
“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,” said Dr. Albert Bourla, Pfizer Chairman and CEO 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. 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.”
Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, called the results “really quite good. I mean extraordinary,” according to The Washington Post.
The FDA requires at least 50% effectiveness for an EUA, while Fauci said he wanted to see 70% to 80% effectiveness in a COVID-19 vaccine.
Pfizer, which says it will provide the vaccine for free, expects to have some 50 million doses of the vaccine available this year for worldwide distribution, and another 1.3 billion doses in 2021, reports The Hill magazine.
Public health officials will be providing vaccines to highest-risk groups first, including health care workers, first responders and the elderly, who are most susceptible to dying from the virus. The consensus is that general distribution may not occur until well into 2021.
The Trump administration is taking credit for breakthrough, although a top scientist with Pfizer said the company did not take part in the administration’s “Operation Warp Speed” program, which provided funds to several companies for vaccine development.
“We were never part of the Warp Speed. We have never taken any money from the U.S. government, or from anyone,” Kathrin Jansen, the company’s vice president for vaccine research, told The New York Times.
Although Pfizer did not take any government funds for developing the vaccine, it did reach a manufacturing and distribution deal with the administration for $1.95 billion “for large-scale production and nationwide delivery of 100 million doses of a COVID-19 vaccine in the United States following the vaccine’s successful manufacture and approval.”
COVID-19 is spiking across the nation and around the globe. The seven-day average for new COVID-19 cases in the U.S. reached 111,775 cases per day Monday, and nearly 240,000 Americans have died from the virus. Worldwide cumulative reported cases are over 50 million with more than 1.2 million deaths.