Pfizer & BioNTech to file for emergency use US approval of their Covid-19 vaccine with FDA
Pfizer and BioNTech announced on Friday that they are about to request emergency use approval for their coronavirus vaccine from the American Food and Drug Administration (FDA) after saying it is 95 percent effective.
If granted, the emergency use authorization would allow the companies to provide the jab to the “high-risk populations” in the US by the “middle to end of December 2020,” Pfizer said in a statement.
Apart from the US, the companies said they have already “initiated rolling submissions” with the European Medicines Agency (EMA) as well as with the regulatory authorities in the UK, Australia, Canada and Japan. American Pfizer and German BioNTech also plan to submit applications with some other regulators in the near future.
— Pfizer Inc. (@pfizer) November 20, 2020
“Our work to deliver a safe and effective vaccine has never been more urgent, as we continue to see an alarming rise in the number of cases of COVID-19 globally,” Dr. Albert Bourla, the Pfizer CEO, said in a statement, adding that his company now has “a more complete picture of both the efficacy and safety profile of our vaccine.”
Ugur Sahin, the CEO and co-founder of BioNTech, also called the application filing with the FDA a “critical step in making our vaccine candidate available to the global population as quickly as possible” while saying that dealings with Europe’s EMA are “of particular importance” as well.
We are submitting our first request for an #EUA in the U.S. for vaccine candidate #BNT162b2 against #covid19. We look forward to continuously providing data to various regulatory authorities as part of our rolling review process – including the @EMA_News. https://t.co/Lk7MTlwE5R pic.twitter.com/OjZ2IxiU3a
— BioNTech SE (@BioNTech_Group) November 20, 2020
The companies also stated they would be ready to distribute the vaccine “within hours” after authorization. Pfizer and BioNTech expect to be able to produce and supply up to 50 million vaccine doses globally until the end of 2020 and up to 1.3 billion doses by the end of 2021.
Still, transportation and storing of the jabs could pose a challenge to the companies since the vaccine candidate can only be effectively kept in extremely cold conditions of minus 70 degrees Celsius. Pfizer, however, stated that it had specially designed GPS-controlled shippers that can maintain the recommended storage conditions for 15 days.
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A thawed vaccine can still be stored for up to five days but needs to be kept at refrigerated conditions of between two and eight degrees Celsius to be effective through that time.
The news comes two days after Pfizer and BioNTech announced their coronavirus vaccine candidate to be 95 percent effective in preventing infections with no serious side effects observed. The companies cited the results of the final analysis of the vaccine’s Phase-Three trial, involving over 43,000 volunteers.
Earlier, another US firm, Moderna, also said its vaccine has demonstrated almost similar results amounting to over 94 percent effectiveness. It is also expected to apply for emergency authorization in the coming weeks.
The world’s first nationally registered vaccine, Russia’s Sputnik V, has demonstrated 92 percent effectiveness, according to its developers, who cited the preliminary results of its Phase-Three trial.
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