Pfizer announced that it will submit an application to the Food and Drug Administration on Friday for an emergency use approval for its experimental Covid-19 vaccine.
Early results from Pfizer’s Phase 3 clinical trials have yielded promising news: Two shots at three-week intervals appeared to be 95 percent effective in preventing symptomatic Covid-19.
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Pfizer and its German partner BioNTech are ready to have 50 million doses available this year and 1
“Our work to deliver a safe and effective vaccine has never been more urgent as we continue to see an alarming increase in the number of cases of COVID-19 globally,” said Dr. Albert Bourla, Pfizer’s chairman and CEO, in a news release.
“Filing in the United States is a critical milestone in our journey to deliver a COVID-19 vaccine to the world, and we now have a more complete picture of both our vaccine’s efficacy and safety profile, giving us confidence in its potential.”
The companies said they have also “initiated rolling submissions” with medical regulators in Europe and the UK and that they intend to “submit applications to other regulators around the world in the coming days.”
A potential stumbling block for the Pfizer vaccine is its ultra-cold storage requirements. The shoots should be stored at minus 94 degrees Fahrenheit – far colder than standard cooling systems at health facilities across large parts of the country.
To meet the additional cooling needs, Pfizer has developed a super-cold storage unit filled with dry ice.
On Thursday, Health and Human Services Secretary Alex Azar said Pfizer’s forthcoming application will be reviewed by an independent research board before permission is granted.
“Hope and help are on the way,” he said.
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Still, it is clear that more than one Covid-19 vaccine will be needed to fight the pandemic. The drug manufacturer Moderna is also expected to submit approval for emergency use of its vaccine candidate in the coming weeks.
In total, more than 100 Covid-19 vaccines are either under development or in clinical trials.
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