On November 9, 2020 Pfizer in collaboration with BioNTech announce a 90% effective vaccine in preventing coronavirus Covid-19.
Final FDA report due in 3rd week of November, 2020.
50 million vaccine doses to be produced in 2020, up to 1,3 billion doses in 2021.
- Vaccine candidate was found to be more than 90% effective in preventing COVID-19 in participants without evidence of prior SARS-CoV-2 infection in the first interim efficacy analysis
- Analysis evaluated 94 confirmed cases of COVID-19 in trial participants
- Study enrolled 43,538 participants, with 42% having diverse backgrounds, and no serious safety concerns have been observed; Safety and additional efficacy data continue to be collected
- Submission for Emergency Use Authorization (EUA) to the U.S. Food and Drug Administration (FDA) planned for soon after the required safety milestone is achieved, which is currently expected to occur in the third week of November
- Clinical trial to continue through to final analysis at 164 confirmed cases in order to collect further data and characterize the vaccine candidate’s performance against other study endpoints.
“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
They reached this critical milestone in vaccine development at a time when the world needs it most with infection rates setting new records, hospitals nearing over-capacity and economies struggling to reopen.
It’s a breakthrough to help bring an end to this global health crisis.
Of course, Trump accuses FDA, Pfizer of deliberately delaying vaccine news until after vote. He suggests that drug maker conspired with Democrats because they didn’t want to have him get a vaccine win.
Mr Trump took to Twitter to attack his opponents and accuse them of manipulating the virus response to harm his re-election chances.
“The @US_FDA and the Democrats didn’t want to have me get a Vaccine WIN, prior to the election, so instead it came out five days later – As I’ve said all along!”Mr Trump wrote on Twitter.
The news came just days after Mr Trump was beaten at the polls by president-elect Joe Biden.
Pfizer have denied any allegations that politics played a part in the timing of their announcement.
Operation Warp Speed, the federal effort to rush a vaccine to market, has promised Pfizer $1.95 billion to deliver 100 million doses to the federal government, which will be given to Americans free of charge. But Dr. Jansen sought to distance the company from Operation Warp Speed and presidential politics, noting that the company — unlike the other vaccine front-runners — did not take any federal money to help pay for research and development.
“We were never part of the Warp Speed,” she said on Sunday. “We have never taken any money from the U.S. government, or from anyone.” On Monday, a spokeswoman for Pfizer clarified that the company is part of Operation Warp Speed as a supplier of a potential coronavirus vaccine.
Dr. Jansen said she learned of the results from the outside panel of experts shortly after 1 p.m. on Sunday, and that the timing was not influenced by the election.
“We have always said that science is driving how we conduct ourselves — no politics.”Dr. Jansen
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