Pfizer will request FDA emergency use authorization for COVID-19 vaccine

Drugmakers Pfizer and BioNTech announced that they will submit their emergency use authorization request to the Food and Drug Administration for their mRNA-based COVID-19 vaccine candidate on Friday.

“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,” Pfizer Chairman and CEO Dr. Albert Bourla said in a statement. “Filing in the U.S. represents 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 the efficacy and safety profile of our vaccine, giving us confidence in its potential.”

The Friday filing means that the vaccine candidate could be approved for use in the United States as soon as mid-December.

The two drug companies’ mRNA-based vaccine showed early promise in July, when the vaccine was shown to be safe in human trials. They found that two rounds of smaller doses led participants to develop more coronavirus antibodies than taking a single higher-dose vaccine. Following those early results, Pfizer and BioNTech were awarded a $1.95 billion contract from the federal government to produce 100 million doses of the vaccine as soon as it is proven to be safe and effective. The contract was part of the Trump administration’s Operation Warp Speed vaccine initiative.

The filing follows the completion of the vaccine candidate’s phase three trial and found that the vaccine was 95% effective against the coronavirus. The trial involved more than 43,000 participants, and the drug manufacturers concluded that there were no “serious safety concerns” reported in the trial. Only 3.8% of participants reported fatigue, and another 2% reported a headache.

“Filing for Emergency Use Authorization in the U.S. is a critical step in making our vaccine candidate available to the global population as quickly as possible,” said BioNTech CEO and co-founder Ugur Sahin. “We intend to continue to work with regulatory agencies worldwide to enable the rapid distribution of our vaccine globally. As a company located in Germany in the heart of Europe, our interactions with the European Medicines Agency (EMA) are of particular importance to us and we have continuously provided data to them as part of our rolling review process.”

In the announcement, the companies added that they “have already initiated rolling submissions with several regulatory agencies around the world, including the EMA and the Medicines & Healthcare Products Regulatory Agency in the United Kingdom,” and will submit applications to other regulatory bodies around the globe. They said that they would be able to begin distributing the vaccine “within hours after authorization.”

Following EUA authorization, Pfizer and BioNTech’s biggest hurdle will be distributing and storing the vaccine, which must be kept at roughly -70 degrees Celsius and can only be stored for up to 15 days. Pfizer says that it “has vast experience and expertise in cold-chain shipping and has an established infrastructure to supply the vaccine worldwide” and that it has designed temperature-controlled shippers for distribution.

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